MESSAGE

JAIME C. MONTOYA, MD, MSc, PhD, CESO II

Executive Director, Philippine Council for Health Research and Development
Department of Science and Technology (DOST-PCHRD)

Launch of 2020 PHREB SOP Workbook

23 June 2020

It is a great pleasure to congratulate the Philippine Health Research Ethics Board (PHREB) on the
launch of Workbook for Developing Standard Operating Procedures (SOP).

The rights, safety, and welfare of research participants should always be the most important
consideration in the conduct of health and health-related research. And as part of the health
research community, we are mandated to make sure that these principles are carried out in all
our efforts.

The establishment of PHREB has been instrumental in providing effective and integrated support
for all aspects of ethics review for research involving human participants. The SOP workbook is a
testament of PHREB’s commitment to the universal principles for the protection of human
participants in research.

The SOP workbook will guide Research Ethics Committees (RECs) to ensure consistency,
transparency, and quality in ethical review. It contains step-by-step description of the different
procedures and easy to follow instructions designed specifically for RECs.

I commend the dedicated efforts of PHREB and its committee members whose shared vision of
human research participants’ protection led to the development of this SOP workbook. I hope
RECs in the country will use this in planning, developing, and improving their own SOPs.

I am certain that PHREB will continue to be relentless in addressing emerging ethical issues and in
safeguarding the rights, safety, dignity and well-being of research participants. We, in DOST-
PCHRD, are pleased to be part of this another milestone of PHREB.

Thank you and Mabuhay!

Jaime C. Montoya, MD, MSc, PhD, CESO II

Executive Director
Philippine Council for Health Research and Development
Department of Science and Technology
 FOREWORD

The system of accrediting research ethics committees (RECs) is a very important component of
our national effort to ensure the protection of human research participants in the country. We
have invested a lot of resources so that the process of accreditation can be done professionally
and expediently. Dr. Marita V. T. Reyes, former PHREB Chair, invested much of her own time and
energy in preparing the first PHREB SOP Workbook that came out in 2015.

The 2020 PHREB SOP Workbook, is a fruit of Dr. Reyes’ continuing investment in the
professionalization of research ethics committees. It provides guidance for institutions
establishing research ethics committees and applying for PHREB accreditation.
Using the workbook, RECs can expect to gain from Dr. Reyes’ insights drawn from her accumulated
experience in ensuring that there is consistency, transparency, and quality assurance in the ethics
review of health and health-related research proposals. The second edition of the workbook is
meant to assist RECs not only in preparing but also in revising their current standard operating
procedures. It provides samples of forms and templates that may be adopted by the research
ethics committees.

The entire research ethics review community will be indebted to Dr. Reyes for her voluntary
contribution in producing the 2020 SOP Workbook and to all the kind-hearted people who gave
their relevant and helpful comments in improving the workbook.

Leonardo D. De Castro, PhD

Chair, PHREB
 Table of Contents

Introduction 1
SOP 01 – Selection and Appointment of REC Members 4
SOP 02 – Designation of REC Officers 8
SOP 03 – Appointment of Independent Consultants 11
SOP 04 – Expedited Review 14
SOP 05 – Full Review 18
SOP 06 – Management of Initial Submissions 23
SOP 07 – Management of Resubmissions 27
SOP 08 – Review of Progress Report 30
SOP 09 – Review of Amendments 33
SOP 10 – Management of Protocol Deviation and Violations Report 37
SOP 11A– Review of RNE Reports 41
SOP 11B – Review of SAE and SUSAR Reports 45
SOP 12 – Management of an Application for Continuing Review 49
SOP 13 – Review of the Final Report 53
SOP 14 – Review of Early Termination Reports 57
SOP 15 – Management of Appeals 61
SOP 16 – Conduct of Site Visits 64
SOP 17 – Preparing for a Meeting 68
SOP 18 – Preparing the Meeting Agenda 72
SOP 19 – Conduct Meetings 76
SOP 20 – Preparation of the Minutes of Meetings 81
SOP 21 – Communicating REC Decisions 85
SOP 22 – Management of Incoming/Outgoing Communications 88
SOP 23 – Management of Active Files (Administrative and Study Files) 91
SOP 24 – Archiving 95
SOP 25 – Management of Access to Confidential Files 98
SOP 26 – Management of Queries/Complaints 102
SOP 27 – Writing and Revising SOPs 106
Glossary 110
Sample Forms 119
Group A 120
Nomination Form 121
Curriculum Vitae Form 122
Group B 123
Appointment of Member Template 124
Appointment of REC Officer Template 125
Appointmnet of Independent Consultant Template 127
Group C 128
Decision Letter Template 129
Ethical Clearance Template 130
Certificate of Exemption from Review Template 131
Group D 132
Confidentiality Agreement 133
Disclosure of Conflict of Interest Agreement 134
Group E 135
Protocol Reviewer Worksheet 136
Informed Consent Checklist 139
Protocol Reviewer Worksheet (For STEM Cell Research) 141
Informed Consent Checklist (For STEM Cell Research) 145
Group F 147
Application for Ethics Review of a New Protocol 148
Resubmission Form 150
Application for Ethics Review of Amendments 151
Application for Ethics Review of Progress Reports 152
Protocol Violation/Deviation Report 153
Reportable Negative Event Report 154
Application for Continuing Review 155
Site Visit Report 156
Early Termination Report 157
Final Report Form 158
Group G 159
Notice of Meeting 160
Provisional Agenda 161
Minutes of the Meeting 162
Group H 165
Logbook of Outgoing Communications 166
Logbook of Protocol Submission 167
Protocol Folder Index 168
 PHILIPPINE HEALTH RESEARCH ETHICS BOARD
A Workbook for Developing Standard Operating Procedures
“The SOP Workbook”

INTRODUCTION

Standard Operating Procedures (SOPs) are the step-by-step description of the different procedures
done to accomplish the objective of an activity. SOPs guide Research Ethics Committees (RECs) in
ensuring consistency, transparency, and quality in ethical review. They consist of simple and easy
to follow instructions. SOPs are supposed to answer the question, “How does the REC do this
particular activity efficiently and consistently?”

This Workbook is intended for RECs who are planning to develop their SOPs and for those who
would like to revise and improve theirs. This edition follows the first edition that came out in
2015. It differs from the first edition in how the SOPs are organized and numbered, the strict
observance of the principle that SOPs are from the perspective of the REC, the inclusion of new
SOPs like Management of Resubmissions, Management of an Application for Continuing Review,
and Management of Appeals. As before, the workbook was developed from the materials used by
the Philippine Health Research Ethics Board (PHREB) in its conduct of SOP seminar-workshops since
2016 and is a work in progress.

THE SOP MANUAL

The Workbook begins with an outline of the SOP manual.

The SOP Manual contains an OVERVIEW that presents the environment where the REC operates.
Here, the rationale for establishing an REC should be well stated. This rationale should be related
to the Vision-Mission of the Institution. An organogram that shows the governance structure of the
institution, the location of the REC and how it relates with the other units should be included. It
is also suggested that institutional policies related to human protection and research ethics review
be mentioned including the structure, composition, and mandate of the REC. The international
and national ethics research guidelines and regulations that inform the review and decisions of
the REC are cited. It will also be informative if the history of the research ethics committee, how
it was established, when, the former Chairs and their accomplishments are included.

In RECs with limited activities, a straightforward listing of SOPs may suffice and be simpler to use.
The order of listing may vary depending on how RECs sequence their activities. Below is a list of
SOPs recommended for RECs.

SOP 01 – Selection and Appointment of REC Members

SOP 02 – Designation of REC Officers
SOP 03 – Appointment of Independent Consultants
SOP 04 – Expedited Review
SOP 05 – Full Review
SOP 06 – Management of Initial Submissions
1
 SOP 07 – Management of Resubmissions
SOP 08 – Review of Progress Report
SOP 09 – Review of Amendments
SOP 10 – Management of Protocol Deviation and Violations Report
SOP 11A– Review of RNE Reports
SOP 11B – Review of SAE and SUSAR Reports
SOP 12 – Management of an Application for Continuing Review
SOP 13 – Review of the Final Report
SOP 14 – Review of Early Termination Reports
SOP 15 – Management of Appeals
SOP 16 – Conduct of Site Visits
SOP 17 – Preparing for a Meeting
SOP 18 – Preparing the Meeting Agenda
SOP 19 – Conduct Meetings
SOP 20 – Preparation of the Minutes of Meeting
SOP 21 – Communicating REC Decisions
SOP 22 – Management of Incoming/Outgoing Communications
SOP 23 – Management of Active Files (Administrative and Study Files)
SOP 24 – Archiving
SOP 25 – Management of Access to Confidential Files
SOP 26 – Management of Queries/Complaints
SOP 27 – Writing and Revising SOPs

Each SOP is developed using a recommended template consisting of the header and 10 sections.
Many sections are accomplished by answering questions meant to guide the REC. Some questions
have sample answers. These sample answers maybe adopted by the REC in a manner reflective of
the specific context and actual practice of the committee. Italicized entries indicate examples.
These examples may not apply to all institutions and the REC can customize these to fit its specific
context.

The Header consists of the name and logo of the Institution, name of the REC, title of the SOP
(i.e. Activity), the SOP Number, Version Number, Date of Approval, and Effective Date. The header
codifies the SOP through the assignment of the SOP number and version number. The version
number is the latest edition of the SOP. The suggested format is as follows:

Logo and name of Name of the REC (e.g. Research Ethics Committee,Ethics
Institution Review Committee, Institutional Ethics Review Committee,
Institutional Review Board)

SOP No. ___ Version No:

SOP TITLE
Date of Approval:

Effectivity Date:

Section 1. The Policy Statement consists of institutional or committee policies upon which the
activity and procedures are based. This section may also include specific provisions from
international and national guidelines pertinent to the activity.

2
Section 2. The Objective refers to the purpose of the activity (e.g. for SOP Preparing for a
Meeting, the objective may be stated as “Preparing for a meeting aims to ensure that all meeting
documents and necessary logistics are available during the meeting.”).

Section 3. The Scope is based on the Workflow (Section 5) and includes the initial and final steps
involved in the activity.

Section 4. The Workflow section is a diagram or a matrix briefly showing the different steps
involved in the activity and the responsible persons. It may be illustrated as a flowchart using
standard symbols like circles (denoting the start and end steps), rectangles (denoting the specific
steps), and diamonds (for decision points). The person/s doing the action in each step is identified.
Usually, verb-nouns like “receipt of”, “submission of”, “conduct of “, “distribution of”, “filing
of”, “approval of” are used.

Section 5. Detailed Description of Procedures describes the performance of each step in the
Workflow. The person/s responsible and the forms to be used are mentioned and cited. The active
forms of verbs are used. It is important to ensure that the number of steps in the Workflow
(Section 4) is the same number of steps described in Section 5.

Section 6. The Glossary is a list of terms, including acronyms and abbreviations used in the SOP
that need to be defined or explained. (Note: the glossaries of the different SOPs may be put
together in one list and included as an annex or appendix of the whole SOP Manual).

Section 7. The Forms section lists the specific forms (and corresponding codes) used in the activity
(e.g. application form, checklist, review guide, communication templates).

Section 8. The History section is a tabulation of the version dates and number, authors, and the
enumeration of major changes that the SOP has undergone. For example, the history section of
SOP Designation of REC Officers may be represented as follows:

Version Number Date Authors Change/s

1 2012 June 12 ABC Initial version

2 2014 December 10 DEF Added the

determination of
type of review as a
responsibility of the
member secretary
3 2018 December 5 GHI Included a co-chair
as an officer.

Section 9. The References section is a list of guidelines, other institutional SOPs, manuals used
in the development of the SOP.

3
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 01
Date of Approval: Selection and Appointment of REC Members
Date of Effectivity :

1. Policy Statement

The Policy Statement should cite international, national and institutional policies with regards to
selection of committee members. Which policy shall be used by the appointing authority in
constituting the REC? How will the members be selected, e.g. through a nomination process or by
direct appointment? Will there be regular and alternate members?

Compliance with the provisions of the WHO Operational Guidelines/CIOMS Guidelines and the
National Ethical Guidelines on the composition of ethics review committees need to be mentioned.

Example: The selection of REC members shall be through a nomination process that ensures
representation of different disciplines (scientists and non-scientists, medical and non-medical
members), sectors (male and female, older and younger age groups) and member/s who are not
affiliated with the institution. Members shall be classified as regular or alternate members. The
regular members shall serve for a period of 3 years but may be renewed for a number of terms.
The alternate members shall serve on a yearly basis and shall attend meetings whenever called
to ensure that meetings are conducted with sufficient members.

2. Objective of the Activity

The objective of the activity specifies the intended outcomes of the steps involved in the selection
and appointment of REC members. For example, “Selection and Appointment of REC Members
aims to ensure that the composition of the REC complies with the international, national and
institutional guidelines and that appropriate expertise is taken into consideration.”

3. Scope

Some institutions have different kinds of review committees, such as the Institutional Animal Care
and Use Committee (IACUC) and the biosafety committee. Therefore, it is important to clarify
that the SOP is applicable only to the Research Ethics Committee.

For example: “This SOP applies specifically to the selection of members of the REC. This SOP
begins with the call for nominations and ends with the filing of appointment documents and CVs
of REC members in the membership file.”

4. Workflow

What are the different steps involved in the process of selection and appointment of the REC
members? Who is the actor in each of these steps?
For example:

4
 ACTIVITY RESPONSIBILITY

Step 1: Call for nominations Chair

Step 2: Receipt of nominations Staff

Step 3: Shortlisting of nominees Chair

Step 4: Receipt of Appointment of new members Chair

Step 5: Forwarding of Appointment papers to the new

Staff
members

Step 6: Signing of conforme, conflict of interest

New Member/s
disclosure and confidentiality agreement

Step 7: Filing of appointment documents and CVs in the

Staff
membership file (SOP on Managing Active Files (SOP#__))

5. Description of Procedures

Based on the workflow (see above) describe each step.

Step 1 - Call for nominations: The Chair informs the Research Authority regarding the need for
new member/s. The call for nominations should be based on qualifications and requirements
stated in the international, national and institutional policies. It shall require accomplishment
of a nomination form (Form ##) and submission of other documents, e.g. CV (Form ##) and
acceptance of nomination (Form ##). The call of nominations is coursed through the head of the
institution and sent to the heads of units or other entities that the authorities deemed to be
concerned.

Step 2 - Receipt of nominations: “The nominators submit the nomination form (Form ##) and
other required documents including CVs and acceptance of nomination to the REC Office. The
Staff checks the completeness of the nominations, e.g. CVs of the nominees, Ethics training
record, endorsement of the unit/department, etc.”

Step 3 - Shortlisting of nominees: How will the nominees be shortlisted? Who will do this?
Example. “The REC Chair prepares a shortlist of the nominees for both regular and alternate
members based on requirements and qualifications.”

Step 4 - Receipt of Appointment papers of new members: Who is the appointing authority?
What should be included in the appointment document (e.g. terms of reference) (Form ##)? The
staff receives the appointment papers from the University President and informs the Chair
accordingly. The appointment papers specify the conditions of the appointment including the
roles and responsibilities.
5
Step 5 - Forwarding of Appointment papers to the new members: The Chair signs the
appointment papers as noted and dated and then instructs the staff to forward the documents to
the concerned new member.

Step 6- Signing the conforme, and the conflict of interest disclosure and confidentiality
agreement: The new REC member/s sign the confidentiality and conflict of interest disclosure
agreements (Form ##).

Step 7 - Filing of appointment documents and CVs and signed Agreements in the membership
file: See SOP Management of Active Files.

6. Glossary

What terms/abbreviations used in this SOP need to be defined for better for effective
implementation? Examples:
Scientists – are individuals whose formal education is at least a master’s degree in a
scientific discipline, e.g. biology, physics, social science, etc.
Non-Scientists – are individuals whose primary interest is not in any of the natural,
physical and Social sciences and whose highest formal education is a bachelor’s
degree.
Medical Members – are individuals with academic degrees in the medical profession and a
master’s in the nursing profession.
Non-medical members- are individuals without academic degrees in the medical profession
nor a master’s degree in the nursing profession.
Non-affiliated Member/s – are regular members who are not in the roster of personnel or
staff of the Institution. They are not employees of the institution nor do they
receive regular salary or stipend from the institution.
Regular Members – are members constituting the research ethics committee, who receive
official appointments from the institutional authority with specific terms and
responsibilities including review of research proposals and attendance of
meetings.
Alternate Members – individuals who possess the qualifications of specified regular
members. They are called to attend a meeting and substitute for regular members
to comply with the quorum requirement when the latter cannot attend the
meeting.
Conflict of Interest – a situation in which aims or concerns of two (primary and secondary)
different interests are not compatible such that decisions may adversely affect
the official/primary duties.
Confidentiality – is the duty to not freely disclose private/resarch information entrusted
to an individual or organization.

7. Forms

What forms/templates/tools are used in the implementation of this SOP? The forms should be
numbered and labelled. Examples:
Form ##: Nomination Form
Form ##:CV Template
Form ##: Acceptance of Nomination

6
 Form ##: Appointment Letter Template
Form ##: Confidentiality and COI Disclosure Agreements

8. History of SOP

Indicate the date of the first draft and the authors, date of approval of the final draft, and the
approving authority. If this is not the first time, then it should include information on the previous
versions (see SOP on Writing and Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC First draft

Change in the appointing

2 2013 May 01 DEF
authority

Added responsibilities of
3 2018 June 03 GHI members in the Terms of
Reference

9. References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)? Examples:
CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

7
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 02
Date of Approval: Designation of REC Officers
Date of Effectivity :

1. Policy Statement

The policy statement shall indicate who are the officers of the Research Ethics Committee, e.g.
Chairperson, Vice-Chair, Member-Secretary, their qualifications and how they are chosen. For
example, “The ethics review committee shall have a chair, vice-chair, and member-secretary who
shall be selected among the members who have been with the committee for, at least, one year,
by election in a special meeting initially presided by an outgoing officer.” The requirement of
membership for, at least, one year may not be necessary. It is just used here as an example.

Institutional policies regarding selection of committee officers need to be mentioned for

compliance. For example, it may be a requirement that committee officers are full-time
personnel.

In many instances, the Chair is pre-selected by the appointing authority and the task of the REC
is just to select other officers (i.e. Vice. Chair, Member Secretary, or even a Treasurer).

2. Objective of the Activity

The objective of the activity specifies the intended outcomes of the procedures involved in
designation of REC officers What are the intended outcomes of the procedures involved in
designation of REC officers? For example, “This activity aims to ensure that the REC officers are
qualified and are selected in a transparent manner in conformity with institutional policy and
practice.”

3. Scope

Common across all institutions to have a Chair and Secretary, but may not have a Vice Chair. A
statement must indicate the types officers covered by the SOP. For example: “The scope of this
SOP includes the selection of Chair, Vice-Chair and Committee Secretary. It starts with the call
for a special meeting to elect the concerned officers and ends with the filing of appointment
documents of the officers.”

4. Workflow

The procedure involved in the selection of REC officers varies in different institutions. Some by
direct appointment of the authorities. Others elect the officers during a special committee
meeting. In the latter case, the workflow will be as follows:

8
 ACTIVITY RESPONSIBILITY

Step 1: Call for a special meeting (SOP on Preparing for a Meeting

Incumbent REC Chair
(SOP #__)

Step 2: Nomination of specific official REC Members

Step 3: Election of specific official REC Members

Step 4: Endorsement REC Chair

Step 5: Receipt of Appointment of new officers REC Staff

Step 6. Signing of Conforme New Officers

Step 7: Filing of appointment documents (SOP on Managing

REC Staff
Active Files (SOP #__))

5. Description of Procedures (Note that the following steps are described based on the above
workflow)

Step 1 - Call for a special meeting: see SOP on Preparing for a Meeting (SOP #__) The REC Staff
upon instruction of the incumbent Chair sends a Notice of Meeting (Form ##) to all members of
the REC. Copy furnished the Head of the Research Division of the Institution stating the purpose
of the meeting to be the election of (an) officer/s.

Step 2 - Nominations:
The incumbent Chair presides over the nomination process for the next Chair. In case, the
incumbent Chair may be nominated for another term, a REC member may be asked to preside
over the process. In turn, the newly elected Chair leads the nomination process for the Vice-Chair
and Committee Secretary who must also have been members of the REC for at least one year.

Step 3 - Election:
Election of officers shall be by secret ballot and is based on the majority rule. A tie shall be
settled by a “toss-coin” or alternative process.

Step 4 - Endorsement: The list of elected officers is submitted to the appointing institutional
authority,

Step 5 - Receipt of the Appointment of new officers: The REC Office receives the appointment
papers of the elected officers that contain the role and responsibilities of the specific officers
and the corresponding term of office.

Step 6 - Signing of Conforme: The REC staff notifies the officers of their appointments and the
need to sign the conforme. The concerned officers forthwith report to the REC office to sign the
conforme documents.

9
Step 8 - Filing of appointment documents: The REC Staff files the appointment papers
accordingly (see SOP for Management of Active Files (SOP 21).

6. Glossary

What terms/abbreviations used in this SOP need to be defined for an effective implementation of
this SOP? The terms must be defined accordingly. Examples:
Special meeting – an assembly of the Committee outside of the regular schedule of
meetings for a specific purpose, usually to decide on an urgent matter like
selection of officer, approval of a revised or new SOP, report of critical research
problem that requires immediate action
Secret Ballot – is a system of casting votes (opinions or choices) such that the voters are
not identified or are anonymous.
Majority rule- is a policy based on the principle that the decision made by the greater
number should be carried/accepted.
Term of office – the specified length of time that a person serves in a particular
designation /role.
Appointing authority- the institutional official that has the power to designate or appoint
individuals to specific offices or roles.
Conforme- acceptance of or agreement to an assignment or designation.

7. Forms

Form ##: Notice of meeting

8. History of SOP

Indicate the date of the first draft and the authors, date of approval of the final draft, and the
approving authority. If this is not the first time, then it should include information on the previous
versions (see SOP on Writing and Revising SOPs (SOP #__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC First draft

2 2013 May 01 DEF Changed the election process

3 2018 June 03 GHI Added a Vice Chair as an officer

9. References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)? Examples:

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020
10
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 03
Date of Approval: Appointment of Independent Consultants
Date of Effectivity :

1. Policy Statement

The REC shall secure the services of affiliated or non-affiliated consultants when their expertise
is needed to make an effective review of a protocol. Their role is not to review but rather to
clarify technical aspects of the protocol (e.g. an engineer may be needed to explain the mechanics
of a new medical device that is being proposed for a study).

A sample policy could be, “The REC shall invite an independent consultant whose expertise is not
represented in the current membership but is needed in a study under review. He/she need not
be affiliated with the institution.”

2. Objective of the Activity

The objective of the activity specifies the intended outcomes of the procedures involved in
appointment of independent consultants. For example, “This activity aims to ensure that the
appointment of independent consultants conforms with institutional practice and complements
the pool of expertise in the REC.”

3. Scope

The work of research ethics committees is supported by independent consultants. The scope
begins with the identification of studies that require an independent consultant and ends with the
inclusion of the name of the Independent Consultant in the pool of consultants. For example, if a
study requires expertise outside those that are represented in the current membership, an
independent will be invited to review the study. Sample statement: This SOP specifically pertains
to the selection and designation of independent consultants in the review of research protocols
of the REC. This SOP begins with the identification of the study that requires an independent
consultant and ends with the inclusion of the name of the Independent Consultant in the pool of
consultants.

4. Workflow

What are the different steps involved in the process of selection and designation of independent
consultants? For example:

ACTIVITY RESPONSIBILITY

Step 1: Identification of the study that requires an Primary Reviewer, Member-

independent consultant Secretary, or Chair

11
 Step 2: Identification of the independent consultant Primary Reviewer, Member-
Secretary, or Chair

Step 3: Invitation to the independent consultant Chair

Step 4: Receipt of the Appointment of independent REC Staff

consultant

Step 5: Receipt of the Signed conflict of interest REC Staff

disclosure and confidentiality agreement

Step 6: Inclusion in the pool of independent consultants REC Staff

5. Description of Procedures

Each of the identified steps in the workflow should be described in detail.

Step 1 - Identification of the study that requires an independent consultant: Either the Primary
Reviewer, Member-Secretary, or Chair identifies the study that requires an expertise necessary
in the review of a research proposal and that may not be provided by the current members of
the REC.

Step 2 - Identification of the independent consultant: The Chair refers to the roster of
specialists in the institution or in other institutions for the necessary expertise and selects the
appropriate expert. S/he instructs the REC staff to prepare the letter of invitation.

Step 3 - Invitation of the independent consultant: The REC Staff prepares a letter of invitation
(Form ##) containing the Terms of Reference for signature of the Chair and sends this to the
identified expert. The letter of invitation contains a section for acceptance of the invitation.

Step 4 - Appointment of independent consultant: Upon receipt of the acceptance of the

invitation, the REC Staff prepares a letter of appointment (Form ##) for signature of the Chair
and sends the appointment to the independent consultant together with the COI disclosure and
confidentiality Agreement.

Step 5 - Receipt of the signed conflict of disclosure and confidentiality agreement: The staff
receives the signed Confidentiality and Conflict of Interest Disclosure agreement and files this in
the appropriate folder.

Step 6 - Inclusion in the pool of independent consultants: The REC Staff enters the name of the
new independent consultants in the appropriate database containing name, expertise, institution
and date of appointment.

6. Glossary

12
What terms/abbreviations used in this SOP need to be defined for effective implementation?
Examples which must be defined accordingly:

Independent consultants - Resource persons who are not members of the Research Ethics
Committee, whose expertise is needed in the review of a research
protocol/proposal and who may be invited to attend a committee meeting but
are non-voting during the deliberations.
Expertise – a proficiency, skill or know-how possessed by experts in a certain academic or
Professional field.
Database – a structured/organized collection of information so that the data can easily be
accessed, managed and updated.

7. Forms

Form ##: Invitation Letter

Form ##: Letter of Appointment
Form ##: Confidentiality and Conflict of Interest Disclosure Agreement Form

8. History of SOP

Indicate the date of the first draft and the authors, date of approval of the final draft, and the
approving authority. If this is not the first time, then it should include information on the previous
versions (see SOP on Writing and Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC First draft

2 2013 May 01 DEF Added of criteria for selection

of Independent Consultants

3 2018 June 03 GHI Changed terms of reference

9. References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)?

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

13
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 04
Date of Approval: Expedited Review
Date of Effectivity :

1. Policy Statement

The policy statement should provide guidance on the type of research that will require expedited
review by the REC and how long it should take. Sample policy statement, “An expedited review
shall be conducted for study protocols that (1) do not entail more than minimal risk to the study
participants, and (2) do not have study participants belonging to a vulnerable group, and (3) the
study procedures do not generate vulnerability. The results of the initial review shall be released
to principal investigator within four weeks after the submission of all the required documents.
The study protocol that underwent expedited review and approved shall be reported in the
subsequent regular committee meeting.”

2. Objective of the Activity

The objective of the activity is the intended outcome of expedited review. For example,
“Expedited Review aims to demonstrate due diligence and high standards in the system of
protection of human participants.”

3. Scope

RECs may exempt submitted protocols from review or decide to conduct an expedited or full
review. This SOP is about the conduct of expedited review. What are the limits of applicability of
this SOP? For example, “This SOP applies to initial review of protocols and post-approval
submissions which do not entail more than minimal risk to study participants, whose participants
do not belong to vulnerable groups, and where vulnerability issues do not arise. This SOP begins
with the assignment of reviewers or independent consultant/s and ends with the inclusion of the
review in the agenda of the next meeting.”

4. Workflow

What are the different steps involved in the conduct of an expedited review? Who are responsible
in each of these steps? For example:

ACTIVITY RESPONSIBILITY

Step 1: Assignment of Reviewers or Independent Consultant/s Chair

(SOP#___ Appointment of Independent Consultants)

Step 2: Notification of Reviewers or Independent Consultant/s Staff

14
 Step 3: Provision of study documents and evaluation forms (Form Staff
___) to reviewers

Step 4: Accomplishment and submission of evaluation forms Reviewers

Step 5: Finalization of review results Chair

Step 6: Communication of review results to the researcher (SOP# Chair and Staff
______Communicating REC Decisions)

Step 7: Filing of documents in the protocol file (SOP # Staff

____Management of Active Files)

Step 8: Inclusion of the Review in the Agenda of the next meeting Chair and Staff
(SOP# ___ Preparing the Meeting Agenda)

5. Description of Procedures

Step 1 - Assignment of Reviewers or Independent Consultant/s: What expertise is necessary for

an adequate review of the study protocol? Is the expertise present among the REC members? Is it
necessary to designate an independent consultant (see SOP on Appointment of Independent
Consultants (SOP#__))?

Step 2 – Notification of Reviewers or Independent Consultant/s: How soon should the reviewers
be notified? Prompt notification provides an opportunity to assess conflict of interest, availability,
and suitability of reviewers. Usually, the response from the assigned reviewers should be received
within two days after notice.

Step 3 - Provision of documents and evaluation form to reviewers: Who provides the documents
and forms to the reviewers? The REC Staff gathers the pertinent documents (for example, for
initial submissions: the complete submission package; for post approval submissions: the
pertinent information from the retrieved protocol and the report itself). How will these be sent
(e.g. by email, courier, or post)?

Step 4 -Accomplishment and Submission of Evaluation forms: Are the reviewers trained in
completing the assessment forms in a most comprehensive and informative manner? What is the
timeline given to the reviewers? How will the reviewers submit the completed forms?

Step 5 - Consolidation and Finalization of the review results: Who will consolidate the review
results? How will the review results be finalized? Usually, it is the Chair that consolidates and
finalizes the review results. What procedures will be used in order to harmonize differing opinions?
If the 2 reviewers considerably differ in opinion about the study, the Chair may have the final say.

Step 6 - Communication of review results to the researcher: See SOP on Communicating REC
Decisions (SOP#__)

Step 7 - Filing of documents in the protocol file: See SOP on Managing Active Files (SOP#__)

15
Step 8 - Inclusion of the Review in the Agenda of the next REC regular meeting: See SOP on
Preparing the Meeting Agenda (SOP#__)

6. Glossary

What terms/abbreviations used in this SOP need to be defined for effective implementation?
Examples:

Decision – the result of the deliberations of the REC in the review of a protocol or other
submissions.
Exempt from Review - a decision made by the REC Chair or designated member of the
committee regarding a submitted study proposal based on criteria in the NEGHHR
2017 The Research Ethics Review Process Guideline 3.1. This means that the
protocol will not undergo an expedited nor a full review.
Expedited Review – is the ethical evaluation of a research proposal and other protocol-
related documents, a resubmission and after-approval submissions, conducted by
only 2-3 members of the committee without involvement of the whole
committee.
Full Review- Full Review – is the ethical evaluation of a research proposal and other
protocol-related documents, a resubmission and after-approval submissions,
conducted by the research ethics committee en banc, in the presence of a
quorum, using established technical and ethical criteria.
Vulnerable Groups – participants or potential participants of a research study who may
not have the full capacity to protect their interests and may be relatively or
absolutely incapable of deciding for themselves whether or not to participate in
the research. They may also be at a higher risk of being harmed or to be taken
advantage.
Minimal Risk – term used when the probability and magnitude of harm or discomfort
anticipated in a research are not greater, in and of themselves, than those
encountered in daily life or during the performance of routine physical or
psychological examinations or tests.
More than Minimal Risk - term used when the probability and magnitude of harm or
discomfort anticipated in a research are greater, in and of themselves, than those
encountered in daily life or during the performance of routine physical or
psychological examinations or tests.
Reviewer- a regular member of the Research Ethics Committee who is assigned to assess
a research protocol, the Informed Consent, and other research-related
submissions based on technical and ethical criteria established by the committee.
Independent Consultant- Resource person who is not a member of the Research Ethics
Committee, whose expertise is needed in the review of a research
protocol/proposal and who may be invited to attend a committee meeting but is
non-voting during the deliberations.

7. Forms

What forms/templates/tools are used in the implementation of this SOP? Example:

Form ## Protocol Evaluation Worksheet

Form ## Informed Consent Evaluation Worksheet

16
 Form ## Decision letter template

8. History of SOP

Is this the first time that this SOP is being prepared? If yes, then indicate the date of the first draft
and the authors, date of approval of the final draft, and the approving authority. If this is not the
first time, then it should include information on the previous versions (see SOP on Writing and
Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC First draft

2 2013 May 01 DEF Included list of types of studies

that may fall under expedited
review

3 2018 June 03 GHI Revised the evaluation form

9. References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)?

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

17
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 05
Date of Approval: Full Review
Date of Effectivity :

1. Policy Statement

The policy statement shall indicate which protocols undergo full review. For example: ““A full
review shall be conducted when a proposed study entails more than minimal risk to study
participants or when study participants belong to vulnerable groups or when a study generates
vulnerability to participants. Does the committee use the primary reviewer system? Will the
researcher/proponent be invited to the meeting? Will there be provisions for the presence of
resource persons or independent consultants? What is the maximum period for a full review to be
accomplished after submission of a complete set of documents? For example, “Only protocols
submitted for, at least, 2 weeks before a scheduled meeting shall be included in the agenda for
full review. Full review shall be conducted through a primary reviewer system. If necessary,
independent consultants and or the proponents shall be invited during the meeting to clarify
certain issues. The decision shall be communicated to the proponent within six weeks after
submission of required documents.

2. Objective of the Activity

The objective of the activity specifies the intended outcome of the activity. For example, “A full
review aims to ensure compliance with technical and ethical standards in the conduct of
researches involving human participants and identifiable human data and materials.”

3. Scope

RECs may exempt submitted protocols from review or decide to conduct an expedited or full
review. This SOP is about the conduct of full review. For example, “This SOP applies to initial,
resubmissions and post-approval submissions which are classified as entailing more than minimal
risk to study participants or whose participants belong to vulnerable groups. This SOP begins with
the assignment of primary reviewers or independent consultant/s and ends with the filing of
protocol-related documents.”

4. Workflow

What are the different steps involved in the conduct of a full review? Who are responsible in each
of these steps? For example:

ACTIVITY RESPONSIBILITY

Step 1: Assignment of primary reviewers or Independent Chair

Consultant/s (SOP on Appointment of Independent Consultants
(SOP#__))
18
 Step 2: Notification of primary reviewers or Independent Staff
Consultants

Step 3: Provision of protocol and protocol-related documents Staff

and assessment forms to reviewers

Step 4: Provision of protocol and protocol-related documents to Staff

the rest of the committee members

Step 5: Presentation of review findings and recommendations Primary Reviewers

during a Committee meeting (SOP on Conduct of Meeting
(SOP#__))

Step 6: Discussion of technical and ethical issues Committee members

Step 7: Summary of issues and resolutions Chair

Step 8: Committee action Committee members

and Chair

Step 9: Documentation of Committee deliberation and action Staff

(SOP on Preparing the Meeting Minutes (SOP#__))

Step 10: Communication of Committee Action to the researcher Chair and Staff
(SOP Communicating REC Decisions (SOP#__))

Step 11: Filing of protocol-related documents and Updating of Staff

the Protocol Database

5. Description of Procedures

Step 1 - Assignment of primary reviewers or Independent Consultants. How are the primary
reviewers assigned? Who does this? What criteria will be used? What expertise is necessary for an
adequate review of the study protocol? Is the expertise present in the REC membership? Is it
necessary to designate an independent consultant (see SOP on Appointment of Independent
Consultants (SOP#__)? Sample statements, The Chair assigns members who have the necessary
expertise as primary reviewers (designates an independent consultant in case such expertise is
not present among the members) including a non-scientist member to review the Informed
Consent Process and Form.

Step 2 - Notification of primary reviewers and/or Independent Consultants: How will the
primary reviewers and/or independent consultants be notified about their assignment? Who will
do this? Sample statement: The Staff notifies the assigned primary reviewers and/or independent
consultants about their assignment by email with a request that they confirm their acceptance
and availability within 3 days

Step 3 - Provision of protocol and protocol-related documents and assessment forms to

primary reviewers/independent consultants: Will all the committee members be provided with
the full protocol and the assessment forms? Sample statement: Upon receipt of

19
confirmation/acceptance, the staff prepares copies of the protocol and/or protocol-related
documents and assessment forms for delivery to the primary reviewers and/or independent
consultants.

Step 4 - Provision of protocol and protocol-related documents to the rest of the committee
members: What documents will be provided to the rest of the REC members? Sample statement:
The staff provides the rest of the members of the REC with an executive summary of the study
proposal (included among the submitted documents in the Application package, Form ##
Application Form) three (3) days before the committee meeting, at the latest.

Step 5 - Presentation of review findings and recommendations during a committee meeting:

Do the primary reviewers need to be present during the meeting? Will the presentations be guided
by the assessment form? For example, The primary reviewers submit their findings and
recommendations (Form ## Protocol evaluation worksheet and Form ## ICF evaluation worksheet)
to the chair 3 days before the meeting and present these during the actual meeting. If a primary
reviewer cannot attend the meeting, the Chair exercises his/her prerogative to take over the
role of the primary reviewer so that the meeting can proceed.

Step 6 - Discussion of technical and ethical issues: How does the chair manage the discussion?
Which technical and ethical issues should be highlighted during the meeting? Will the independent
consultant and/or the proponent be present for clarificatory interview/s? Example: The chair
leads the discussion of the technical and ethical issues using the protocol assessment check list
(Form ##) and the Informed Consent Assessment checklist (Form ##) and the assessment of the
primary reviewers as guides for an orderly exchange of ideas.

Step 7 - Summary of issues and resolutions: How are issues summarized in order to guide the
decision making process? For example, “The Chair summarizes the technical and ethical issues
that were identified, the issues that were resolved /not resolved, including the recommendations
for the issues that were not resolved.”

Step 8 - Committee action: What are the possible actions for a specific submission (e.g. approval,
minor modifications, major modifications, disapproval)? How will the final decisions be settled?
RECs often decide by voting and the majority decision is adopted. Other RECs do it by consensus
such that as long as there is a strong objection, the deliberation continues the strong objector is
convinced.

Step 9 - Documentation of committee deliberation and action: How will the committee
deliberation be documented? See SOP on Preparing the Meeting Minutes (SOP#__).

Step 10 - Communication of Committee Action to the researcher: See SOP on Communicating

REC Decisions (SOP#__)

Step 11 - Filing of protocol-related documents and Updating of the Protocol Database: See SOP
on Managing Active Files (SOP#__)

6. Glossary

What terms/abbreviations used in this SOP need to be defined for better for effective
implementation? Examples:
20
Full Review – is the ethical evaluation of a research proposal and other protocol-related
documents, a resubmission and after-approval submissions, conducted by the
research ethics committee en banc, in the presence of a quorum, using
established technical and ethical criteria.
Vulnerable Groups – participants or potential participants of a research study who may
not have the full capacity to protect their interests and may be relatively or
absolutely incapable of deciding for themselves whether or not to participate in
the research. They may also be at a higher risk of being harmed or to be taken
advantage.
Minimal Risk – term used when the probability and magnitude of harm or discomfort
anticipated in a research are not greater, in and of themselves, than those
encountered in daily life or during the performance of routine physical or
psychological examinations or tests.
More than Minimal Risk - term used when the probability and magnitude of harm or
discomfort anticipated in a research are greater, in and of themselves, than those
encountered in daily life or during the performance of routine physical or
psychological examinations or tests.
Independent Consultant- Resource person who is not a member of the Research Ethics
Committee, whose expertise is needed in the review of a research
protocol/proposal and who may be invited to attend a committee meeting but is
non-voting during the deliberations.
Primary Reviewers – are members of the Research Ethics Committee (usually a scientist
and a non-scientist) assigned to do an in-depth evaluation of the research-related
documents using technical and ethical criteria established by the committee. The
non-scientist member shall focus on the review of the Informed Consent process
and form and reflect on community values, culture and tradition in order to
recommend acceptance, non-acceptance or improvement of the informed consent
process and form. The primary reviewers shall present their findings and
recommendations during the meeting for discussion.
Major Modification – is a recommended revision of significant aspects/s of the study (e.g.,
study objectives, recruitment of participants, exclusion/inclusion criteria,
collection of data statistical analysis, mitigation of risks, protection of
vulnerability, etc.) that impact on potential risks/harms to participants and on
the integrity of the research.
Minor Modification - – is a recommended revision of particular aspect/s of the study or
related documents that do not impact on potential risks/harms to participants
and on the integrity of the research, e.g. incomplete documentation, incomplete
IC elements, unsatisfactory IC format)
Resubmissions - revised study proposals that are submitted after the initial review.
Protocol-related Documents- consists of all other documents aside from the
proposal/protocol itself that required to be submitted for review, e.g., Informed
Consent Form, Survey Questionnaire, CV of proponent, advertisements, In-depth
Interview Guide Questions,
Decision – the result of the deliberations of the REC in the review of a protocol or other
submissions.
Voting – the act of expressing opinions or making choices usually by casting ballots, spoken
word or hand raising. The rule is majority wins.
Consensus – a collective agreement.

21
7. Forms

What forms/templates/tools are used in the implementation of this SOP? Example:

Form ## Protocol Evaluation Worksheet

Form ## Informed Consent Evaluation Worksheet

Form ## Decision letter template

8. History of SOP

Is this the first time that this SOP is being prepared? If yes, then indicate the date of the first draft
and the authors, date of approval of the final draft, and the approving authority. If this is not the
first time, then it should include information on the previous versions (see SOP on Writing and
Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC First draft

2 2013 May 01 DEF Revised assessment form

3 2018 June 03 GHI Changed timeline for full

review

9. References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)?

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

22
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 06
Date of Approval: Management of Initial Submissions
Date of Effectivity :

1. Policy Statement

The REC receives applications for ethical review through several modes (e.g. hand-carried by the
researcher, via messenger or email). Shall the REC limit submissions to a particular mode? What
documents shall be required in an application for ethics review? How will these be recorded and
identified? Management of Initial Submissions includes the determination of whether or not it is
exempted from review and the type of review it shall undergo. An example of a policy statement
can be “The REC shall require the submission of a set of pertinent documents for an application
for ethical review to be accepted. A preliminary evaluation shall determine whether a research
proposal is exempted from or needs to undergo ethical review based on the NEGHHR 2017 The
Research Ethics Review Process Guideline 3.1. Subsequent amendments to a protocol that was
exempted from review shall be submitted for a preliminary evaluation to determine whether the
revised protocol can still be “exempted from review”.

2. Objective of the Activity

The objective of the activity specifies the intended outcomes of managing initial submissions. For
example, “Management of Initial Submissions ensures that study documents are complete,
properly recorded, and properly evaluated to determine appropriate action or type of review.”

3. Scope

The scope of this SOP must be consistent with the mandate given to the REC that is described in
the Overview section. Shall the REC review only study protocols submitted by the faculty? How
about those from students and administrative staff? How about study protocols from faculty of
other institutions that will be implemented in the site? How about studies in other institutions
that do not have their own RECs? Procedure-wise, it includes the first and last steps in the
Workflow. For example, “The REC shall accept for initial review only study protocol submitted
by the faculty, staff, and students of the institution. This SOP begins with the receipt of study
documents for initial review and ends with entry of protocol information in the database.”

4. Workflow

What are the different steps involved in the process of management of initial submissions?

For example:

23
 ACTIVITY RESPONSIBILITY

Step 1: Receipt of study documents for initial review and Staff

determination of completeness of submission .

Step 2: Entry into the logbook Staff

Step 3: Coding Staff and Member

Secretary

Step 4: Determination of type of Action/ Type of Review Chair

a. Exemption from Review
b. Expedited Review (SOP on Expedited Review (SOP#__))
c. Full Review (SOP on Full Review (SOP#__))

Step 5: Preparation of a protocol folder Staff

Step 6: Entry into the database Staff

5. Description of Procedures

Each of the identified steps in the workflow should be described in detail.

Step 1 - Receipt of study documents for initial review and determination of completeness of
submission: Who receives documents? Will there be forms (checklists) to determine completeness
of the package? What will be done if the package is incomplete? Example, The REC office is open
from 8:00 AM to 5:00 PM during which the Staff accepts study documents. The Staff checks
completeness of the documents based on the checklist (Form ##). If incomplete, the Staff informs
the proponent of the missing documents.

Step 2 - Entry into logbook: The REC logbook is an official document of having received particular
documents on a specific date and time. It includes information on (1) title of the study, (2) name
of proponent, (3) date of submission, (4) name of receiver and (5) Action. It is also good to include
the name and signature of the individual who actually submitted the documents in case s/he is
not the proponent.

Step 3 - Coding: The usual code includes information on the year of submission and series number,
For example, If the documents are determined to be complete, the staff with the supervision of
the member secretary assigns a protocol code such that if , for example, Mr. Juan De la Cruz
submitted a protocol on HIV in 2015 and it was the 5th study protocol received for the year, then
the code for the documents will be 2015-05. This code is the ID number of the protocol and
cannot be assigned to any other protocol. When referring to the protocol in communications or
presentations, the code is lengthened to include the proponent and topic as follows, 2015-05 -
DelaCruz-HIV, to become more informative.

Step 4 - Determination of type of Review/Action: The Chair conducts a preliminary review of

the protocol to determine whether it is Exempted from Review or for review as Expedited or Full.

24
If the Chair decides that the protocol is exempted from review, s/he directs the REC staff to follow
the procedure to communicate the decision to the researcher (SOP #___ Communicating REC
Decisions).

If the Chair determines that the protocol should undergo either Full or Expedited review, then
the REC staff proceeds to follow either SOP # ___Expedited Review or SOP # ____ Full Review.

Step 5 - Preparation of a Protocol Folder: The staff files the protocol documents in a protocol
folder and labels it accordingly. (SOP #______ Managing Active Files)

Step 6 - Entry into the database: In the latter case, there will be a need for subsequent entries
in a database as described in SOP # ____ Managing Active Files.

6. Glossary

What terms/abbreviations used in this SOP needs to be defined? Examples:

Initial Submission – a set of documents consisting of the full proposal and other study-
related documents that need to be submitted so that review can be conducted.
Study Documents- include all materials (protocol, forms, certificates, research tools)
pertinent to a research proposal that have to be submitted to the REC for review.
Initial Review –ethical and technical review conducted on the initially-submitted study
documents. It may be expedited or full.
Amendment – a change in /revision of the protocol made after its approval.
Coding - a unique number assigned to a protocol indicating the year and series it was
received.
Logbook – a real-time, chronological record of incoming protocols that includes the Date
/Time of Receipt, Title of the Document, Name of the Proponent, Name and
Signature of the Submitting Entity, Name and Signture of the Receiving Person
and Action done.
Database – a collection of information that is structured and organized so that this can
easily be accessed, managed, intepreted, analyzed and updated. It is usually in
an electronic platform used for tracking and monitoring the implementation of a
study.
Exemption from Review – a decision made by the REC Chair or designated member of the
committee regarding a submitted study proposal based on criteria in the NEGHHR
2017 The Research Ethics Review Process Guideline 3.1.
Full Review– is the ethical evaluation of a research proposal and other protocol-related
documents, a resubmission and after-approval submissions, conducted by the
research ethics committee en banc, in the presence of a quorum, using
established technical and ethical criteria.
Expedited Review – is the ethical evaluation of a research proposal and other protocol-
related documents, a resubmission and after-approval submissions, conducted by
only 2-3 members of the committee without involvement of the whole
committee.

7. Forms: What forms/templates/tools are used in the implementation of this SOP? Examples:

Form ## Application Form

Logbook
25
8. History of SOP

Indicate the date of the first draft and the authors, date of approval of the final draft, and the
approving authority. If this is not the first time, then it should include information on the previous
versions (see SOP on Writing and Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC First draft

2 2013 May 01 DEF Added requirements in the

checklist

3 2018 June 03 GHI Added information in the

coding system

9. References

What references were used in the preparation of this SOP (e.g. other institutional SOPs,
institutional policies, institutional documents, local regulations)? Examples:

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

26
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 07
Date of Approval: Management of Resubmissions
Date of Effectivity :

1. Policy Statement

The policy statement guides the REC in the management of resubmissions including the
determination of the level of review and the required timeline. Example of a policy statement
can be “The REC shall require a resubmission of a protocol that requires either minor or major
modification/s not later than 4 weeks after receipt of the Decision Letter. Minor modifications
shall undergo expedited review while major modifications shall undergo full review.”

2. Objective of the Activity

The objective of the activity specifies the intended outcome of managing resubmissions. For
example, “Management of resubmission ensures that the researcher addressed the required
modifications before approval of the protocol.”

3. Scope

This SOP pertains to the resubmission of revised or modified protocols that have been previously
reviewed by the REC. The procedure begins with the receipt of the revised protocol documents
and ends with filing of the documents in the protocol file and the entry of the submission in the
protocol database.

4. Workflow

What are the different steps involved in the management of resubmissions? Who are the
responsible persons?

For example:

ACTIVITY RESPONSIBLE PERSONS

Step 1: Receipt and Entry in the Logbook Staff

Step 2: Coding of Resubmitted Protocol Documents Staff

Step 3: Evaluation by the Chair or Notification of Reviewers Chair and Staff

and Reviewers

Step 4: Review of the Resubmission Assigned Reviewers

a. Expedited Review (SOP#___ Expedited Review)
b. Full Review (SOP#___ Full Review)

Step 5: Communication of Decision Staff

27
 Step 6: Filing of Documents in the Protocol File and Update of Staff
the database
5. Description of Procedures

Each of the identified steps in the workflow should be described in detail.

Step 1 - Receipt and Entry in the Logbook: As in the SOP on Initial Submissions (SOP 06), who
receives the resubmission documents? What procedures are done to record the receipt of
documents? For Example, The Staff receives study document, checks the nature of the document
and ensures that the submission is properly logged.

Step 2 - Coding of Resubmitted Protocol Documents: The staff stamps/indicates the code
assigned to the protocol when it was initially submitted and the date of receipt on all the
documents.

Step 3 - Notification of the Chair and Reviewers: The staff retrieves the Decision Letter
(Form#_______) that pertains to the original protocol and informs the Chair about the
resubmission and about the nature of the modifications required from the researcher. Given the
necessary information, the Chair either evaluates the resubmitted protocol at his/her level or
directs the staff to inform the reviewers concerned and to forward to them the necessary
documents.

Step 4 - Review of the Resubmission: The assigned reviewers conduct review of the resubmitted
protocol by referring to the resubmission form noting the different recommendations made by
the REC and evaluating whether these were satisfactorily addressed in the resubmitted protocol.
The reviewers submit the report to the Chair for inclusion in the next regular meeting.

Step 5 - Communication of Decision: For Resubmissions approved at the level of the Chair: the
Chair dictates his/her decision to staff for preparation of the draft letter, finalization and
sending to the researcher. For the resubmissions that underwent Full Review, refer to SOP #
_____ Communicating Committee Decisions.

Step 6 - Filing of Documents in the Protocol Folder and update of the database: The staff
gathers all the pertinent documents related to the resubmission (revised protocol, assessment
forms, excerpts of minutes, approval letter,) and enters the relevant information on
resubmission in the appropriate protocol database.

6.Glossary

What terms/abbreviations used in this SOP needs to be defined? Examples:

Initial Submission – refers to the first (initial) package of study documents forwarded to
the REC for review.
Resubmission – the revised study proposal that is re-forwarded to the REC followiing the
recommendations from the initial review.

Study Documents – include all materials (protocol, forms, certificates, research tools)
pertinent to a research proposal that have to be submitted to the REC for a
comprehensive review.
Initial Review – the ethical assessment of the first complete set of study documents
submitted to the REC so that review can be conducted

28
 Coding- a unique number assigned to a protocol indicating the year and series it was
received.
Logbook – a real-time chronological record of incoming protocols that includes the Date
/Time of Receipt, Title of the Document, Name of the Proponent, Name and
Signature of the Submitting Entity, Name and Signture of the Receiving Person
and Action done.
Protocol Database – Significant nformation about protocols that are organized
systemaically so that these can easily be accessed, managed, intepreted, analyzed
and updated. It is usually in an electronic platform used for tracking and
monitoring the implementation of a study.
Full Review – is the ethical evaluation of a research proposal and other protocol-related
documents, a resubmission and after-approval submissions, conducted by the
research ethics committee en banc, in the presence of a quorum, using established
technical and ethical criteria.
Expedited Review – is the ethical evaluation of a research proposal and other protocol-
related documents, a resubmission and after-approval submissions, conducted by
only 2-3 members of the committee without involvement of the whole committee.

7.Forms: What forms/templates/tools are used in the implementation of this SOP? Examples:

Form ## Decision Letter

Form ## Resubmission Form

Form ## Approval Letter

8.History of SOP

Indicate the date of the first draft and the authors, date of approval of the final draft, and the
approving authority. If this is not the first time, then it should include information on the previous
versions (see SOP on Writing and Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2018 July 15 ABC

9.References

What references did you use in the preparation of this SOP (e.g. other institutional SOPs,
institutional policies, institutional documents, local regulations)? Examples:

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

29
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 08
Date of Approval: Review of Progress Report
Date of Effectivity :

1. Policy Statement

What policy does the REC have regarding submission of progress reports? For example, “The REC
shall require the submission of progress reports at a frequency based on the level of risk of the
study. This requirement shall be explicitly stated in the Approval Letter.

2. Objective of the Activity

The objective of the study specifies the intended outcomes of reviewing progress reports. For
example, “This activity aims to ensure that the conduct of the study is in compliance with the
approved protocol and that the safety and welfare of study participants are promoted.”

3. Scope

The scope of the SOP defines the limits of the review procedures with regard to progress report.
For example, “This SOP applies to the management and review of progress submitted by the
proponent while the study is on-going or has ended. This SOP begins with the receipt and entry
to logbook of incoming documents and the protocol database and ends with filing of progress
report and committee decision in the protocol file.”

4. Workflow

What are the different steps involved in the process of review of progress report? Who will be
responsible in each of these steps?

For example:

ACTIVITY RESPONSIBILITY

Step 1: Receipt and entry into logbook of the progress report (SOP on Staff
Management of Active Files (SOP#__))

Step 2: Retrieval of pertinent protocol file Staff

Step 3: Notification of Chair and Primary Reviewers Staff

Step 4: Determination of type of review: expedited (SOP on Expedited Chair and Primary
Review (SOP#__)) or full review (SOP on Full Review (SOP#__)) Reviewers

Step 5: Communication of committee action (SOP on Communication REC Chair

Decisions (SOP#__))

Step 6: Filing of Progress report and decision letter and update of the Staff
protocol database. SOP on Management of Active Files (SOP#__))

30
5. Description of Procedures

Each of the identified steps in the workflow should be described in detail.

Step 1 - Receipt and entry to logbook: Does the REC have specific forms for progress report
submission? How will these be recorded? Example, The Staff receives the progress report written
in the Progress Report Form ## and enters the date and pertinent information in the logbook of
incoming documents (See SOP 21: Management of Active files).

Step 2 - Retrieval of pertinent protocol file: Which pertinent document will be retrieved (e.g.
approved protocol)? Example, The Staff retrieves the corresponding protocol file for reference
and guidance of the Chair and Reviewers.

Step 3 - Notification of Chair and Primary Reviewers: How (by SMS, email etc.) and when will
the Chair and the Primary Reviewers be notified about the submission? Example, Within two days
after receipt of the progress report, the Staff notifies and sends the pertinent protocol file to
the Chair and the previously assigned Primary Reviewers.

Step 4 - Determination of type of review: expedited or full review: Usually, the Primary
Reviewer recommends the type of review to the Chair and the Chair will determine the final type
of review. Example, The Chair and the Primary Reviewers, together, decide the type of review
and proceed accordingly. For Expedited review, see SOP 4: and for Full review, see SOP 5.

Step 5 - Communication of committee decision: The REC communicates the committee action,
see SOP 19: Communicating REC Decisions. For progress reports, the committee action may be
“approved” or “additional information required” or “specific action/s required from the
researcher”. Staff prepares a draft of the committee decision based on either an expedited
review report or minutes of a meeting. The Chair signs the decision letter as follows: Approval,
request for additional information or specific action/s.

Step 6 – Filing of Progress Report and committee decision and update of the database: For
example, The Staff files the progress report and a copy of the committee decision in the
appropriate protocol folder. S/he proceeds to update the pertinent protocol database.

6. Glossary

What terms/abbreviations used in this SOP for review of progress report? Examples:
Progress Report – description of how the implementation of the study is moving forward.
This is done by accomplishing the Progress Report Form ##. The frequency of
submissioin (e.g., quarterly, semi-annually or annually) is determined by the REC
based on the level of risk.
Primary Reviewer – a member of the Research Ethics Committee (usually a scientist and a
non-scientist) assigned to do an in-depth evaluation of the research-related
documents using technical and ethical criteria established by the committee.
Expedited Review – is the ethical evaluation of a research proposal and other protocol-
related documents, a resubmission and after-approval submissions, conducted by
only 2-3 members of the committee without involvement of the whole
committee.
Full Review – is the ethical evaluation of a research proposal and other protocol-related

31
 documents, a resubmission and after-approval submissions, conducted by the
research ethics committee en banc, in the presence of a quorum, using established
technical and ethical criteria.
Logbook – a real-time chronological record of incoming protocols that includes the Date
/Time of Receipt, Title of the Document, Name of the Proponent, Name and
Signature of the Submitting Entity, Name and Signture of the Receiving Person and
Action done.
Database– a collection of information (e.g. regarding protocols) that is structured and
organized so that this can easily be accessed, managed, intepreted, analyzed and
updated. It is usually in an electronic platform used for tracking and monitoring
the implementation of a study.

7. Forms

What forms/templates/tools are used in the implementation of this SOP? Examples:

Form ## Progress Report Form
Form ## Decision letter template

Logbook

Database

8. History

Is this the first time that this SOP is being prepared? If yes, then indicate the date of the first draft
and the authors, date of approval of the final draft, and the approving authority. If this is not the
first time, then it should include information on the previous versions (see SOP on Writing and
Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC

2 2013 May 01 DEF Change of timeline for

submission of progress reports

3 2018 June 03 GHI Change of entries in the

progress report form

9. References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)?

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020
32
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 09
Date of Approval: Review of Amendments
Date of Effectivity :

1. Policy Statement

What policy does the REC have regarding submission of amendments? For example, “The REC
shall require the submission of proposed amendments for review and approval before their
implementation. This requirement shall be explicitly stated in the Approval Letter.

2. Objective of the Activity

The objective of the study specifies the intended amendments outcomes of reviewing
amendments. For example, “This activity aims to ensure that the conduct of the study is in
compliance with the approved protocol such that any change such as amendments does not impact
safety and welfare of study participants.”

3. Scope

The scope of the SOP defines the limits of the review procedures with regard to amendments. For
example, “This SOP applies to the management and review of protocol amendments submitted
by the proponent while the study is on-going. This SOP begins with the receipt and entry of the
submission of amendment to logbook of incoming documents and the protocol database and ends
with filing of the amendments and committee decision in the protocol file.”

4. Workflow

What are the different steps involved in the process of review of progress report? Who will be
responsible in each of these steps?

For example:

ACTIVITY RESPONSIBILITY

Step 1: Receipt and entry into logbook of the submission of amendments Staff
(SOP # on Management of Active Files).

Step 2: Retrieval of pertinent protocol file Staff

Step 3: Notification of Chair and Primary Reviewer Staff

Step 4: Determination of type of review: expedited (SOP# on Expedited Chair and Primary
Review) or full review (SOP# on Full Review) Reviewer

Step 5: Communication of committee action (SOP# on Communication Chair

REC Decisions)

33
 Step 6: Filing of Amendments and decision letter and update of the Staff
protocol database. SOP# on Management of Active Files)

5. Description of Procedures

Each of the identified steps in the workflow should be described in detail.

Step 1 - Receipt and entry to logbook: Does the REC have specific forms for submission of
amendments? How will these be recorded? Example, The Staff receives Application for Review of
Amendments Form ## and enters the date and pertinent information in the logbook of incoming
documents (See SOP 21: Management of Active files).

Step 2 - Retrieval of pertinent protocol file: Which pertinent document will be retrieved (e.g.
approved protocol)? Example, The Staff retrieves the corresponding protocol file for reference
and guidance of the Chair and Reviewers.

Step 3 - Notification of Chair and Primary Reviewer: How (by SMS, email etc.) and when will the
Chair and the Primary Reviewer be notified about the submission? Example, Within two days after
receipt of the Application for Review of Amendments, the Staff notifies and sends the pertinent
protocol file to the Chair and the previously assigned Primary Reviewers.

Step 4 - Determination of type of review: expedited or full review: Usually, the Primary
Reviewer recommends the type of review to the Chair and the Chair will determine the final type
of review. Example, The Chair and the Primary Reviewer, together, decide the type of review
and proceed accordingly. For Expedited review, see SOP 4: and for Full review, see SOP 5.

Step 5 - Communication of committee decision: The REC communicates the committee action,
see SOP 19: Communicating REC Decisions. For amendments, the committee action may be any of
the following “approved”, “additional justification/information required”, “reconsent required”
or disapproved. Staff prepares a draft of the committee decision based on either an expedited
review report or minutes of a meeting. The Chair signs the decision letter as follows: Approval,
request for additional justification/information or specific action/s e.g. reconsent required or
disapproved.

Step 6 – Filing of Amendment documents and committee decision and update of the database:
For example, The Staff files the Amendment and a copy of the committee decision in the
appropriate protocol folder. S/he proceeds to update the pertinent protocol database.

6. Glossary

What terms/abbreviations used in this SOP for review of progress report? Examples:
Amendment – Any change or revision in the protocol made after its approval.
Primary Reviewer – a member of the Research Ethics Committee (usually a scientist and a
non-scientist) assigned to do an in-depth evaluation of the research-related
documents using technical and ethical criteria established by the committee.
Expedited Review – is the ethical evaluation of a research proposal and other protocol-
related documents, a resubmission and after-approval submissions, conducted by
only 2-3 members of the committee without involvement of the whole committee.
Full Review – is the ethical evaluation of a research proposal and other protocol-related

34
 documents, a resubmission and after-approval submissions, conducted by the
research ethics committee en banc, in the presence of a quorum, using established
technical and ethical criteria.
Logbook – a real-time chronological record of incoming protocols that includes the Date
/Time of Receipt, Title of the Document, Name of the Proponent, Name and
Signature of the Submitting Entity, Name and Signture of the Receiving Person and
Action done
Database– a collection of information (e.g. regarding protocols) that is structured and
organized so that this can easily be accessed, managed, intepreted, analyzed and
updated. It is usually in an electronic platform used for tracking and monitoring
the implementation of a study.

7. Forms

What forms/templates/tools are used in the implementation of this SOP? Examples:

Form ## Amendment Form
Form ## Decision letter template
Logbook
Database

8. History

Is this the first time that this SOP is being prepared? If yes, then indicate the date of the first draft
and the authors, date of approval of the final draft, and the approving authority. If this is not the
first time, then it should include information on the previous versions (see SOP on Writing and
Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC

2 2013 May 01 DEF Inclusion of the updating of the

protocol database as a final
step.

3 2018 June 03 GHI Inclusion. of “additional

justification/information
required” as a possible REC
action

9. References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)?

35
CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

36
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 10
Date of Approval: Management of Protocol Deviation and Violation
Date of Effectivity : Report

1. Policy Statement

Protocol deviations and violations impact safety and welfare of the research participants and
integrity of data. In sponsored clinical trials, the ICH-GCP guidelines shall be followed in reporting
protocol deviations and violations which are usually done by clinical monitors and auditors.
However, in researcher-initiated studies, what should be the policy of the REC in reporting
protocol deviations or violations? For example, “Researchers shall report protocol deviations and
violations in the conduct of approved researches within a week from the detection of the protocol
violation/deviation. Major protocol violations undergo full review.”

2. Objective of the Activity

What are the intended outcomes of review of protocol deviations and violations? For example,
“Review of protocol deviations and violations aims to ensure that the safety and welfare of
human participants in the study are safeguarded and that the credibility and integrity of data
are maintained.”

3. Scope

The scope of this SOP includes the procedures done to effectively address the issue of protocol
deviation/violation. For example, “This SOP applies to the review of reports of protocol
deviations or violations in the conduct of previously approved studies. This begins with the
receipt and documentation of the report of protocol violations and deviations in the logbook and
ends with the filing of all related documents and update of the database.”

4. Workflow

What are the different steps involved in the review of report of protocol violations and deviations?
Who are responsible in each of these steps?

For example:

ACTIVITY RESPONSIBILITY

Step 1: Receipt and documentation of report of protocol violations Staff

and deviations in the logbook.

Step 2: Retrieval of pertinent protocol file Staff

37
 Step 3: Notification of Chair and primary reviewers. Staff

Step 4: Determination of type of review: expedited (SOP on Expedited Chair

Review (SOP#__)), full review (SOP on Full Review (SOP#__))

Step 5: Inclusion of report in the agenda of the next REC regular Staff and Chair
meeting (SOP on Preparing the Meeting Agenda (SOP#__); SOP on
Conduct of Meeting (SOP#__))

Step 6: Communication of decision to the Principal Staff and Chair

Investigator/researcher (SOP on Communicating REC Decisions
(SOP#__))

Step 7: Filing of all related documents and update of the protocol Staff
database (SOP on Managing Active Files (SOP#__))

5. Description of Procedures

What are the detailed steps involved in review? What documents and forms are needed in the
review process?

Step 1 - Receipt and documentation of report of protocol violations and deviations in the
logbook/database: Does REC require a specific report form? What information about the
submission will be entered in the log? Example, The Staff receives the report on protocol deviation
or violation in the appropriate report form (Form ##) and records this in the logbook for incoming
documents.

Step 2 - Retrieval of pertinent protocol file. Which pertinent information about corresponding
protocol will be retrieved (e.g. identity of primary reviewers and all other earlier reports).
Example, The Staff retrieves the approved protocol and checks the identity of the primary
reviewers for reference and guidance of the Chair in the selection/ designation of reviewers.

Step 3 - Notification of Chair and primary reviewers. For example, The Staff notifies and sends
the protocol deviation or violation report and together with the retrieved pertinent documents
to the Chair and the primary reviewers.

Step 4 - Determination of type of review: expedited or full review: Who will determine whether
the violation or deviation is minor or major? How will this be done? For example, The Chair and
primary reviewers determine the type of review such that major protocol violations undergo full
review. Otherwise, the protocol deviation undergoes expedited review. See SOP##: Expedited
Review and SOP ##: Full Review.

Step 5 - Inclusion of report in the agenda of the next REC regular meeting. See SOP on Preparing
the Meeting Agenda and SOP on Conduct of Meetings. Example, The Chair includes the report on
protocol deviation and violation in the Agenda of the next meeting if it is for Full review or the
decision report if Expedited review.

Step 6 - Communication of Decision to the Principal Investigator/researcher: See SOP on

Communicating REC Decisions. What are the possible actions of REC on reports of protocol
38
violations and deviations? For example, The Staff prepares the draft decision based on the report
of the expedited review or the minutes of the meeting in the full review. Possible decisions
include one or several of the following: (1) submission of additional information, (2) submission
of corrective action, (3) invitation to a clarificatory interview, (4) Requirement for an
amendment (5) site visit, (6) suspension of recruitment, and (7) withdrawal of ethical clearance.

Step 7 - Filing of all related documents and update of the protocol database. See SOP on
Managing Active Files (SOP#__). Example, The Staff collates and files the retrieved protocol
documents, the report on protocol deviation and violation and the decision letter in the
appropriate protocol file and updates the protocol database with the relevant information.

6. Glossary

What terms/abbreviations used in this SOP need to be defined for effective implementation?
Examples:
Protocol Deviation – non-compliance with the approved protocol that does not increase
risk or decrease benefit to participants or does not significantly affect their
rights, safety or welfare or the integrity of data.Example: missed visit, non-
submission of a food diary on time.
Protocol Violation - non-compliance with the approved protocol that increases risk or
decreases benefit to participants or significantly affects their rights, safety or
welfare orthe integrity of data. Example: incorrect treatment, non-compliance
with inclusion/exclusion criteria.
Principal Investigator- the lead person selected by the sponsor to be primarily responsible
for the implementation of a sponsor-initiated clinical drug trial.
Researcher- is the individual primarily responsible for the conceptualization,
planning and implementation of a study.
Sponsored Clinical Trials – are clinical studies on investigational drugs.
Clinical Monitor- an individual who oversees the progress of a clinical trial.
Clinical Auditor – an individual who systematically and independently examines trial
related activities and documents at a particular period.
Regular Meeting – a periodically scheduled assembly of the REC.
Drug or device – health product used for diagnosis or treatment.
Protocol File – is an organized physical or electronic compilation of all documents related
to a Protocol
Full Review - is the ethical evaluation of a research proposal and other protocol-related
documents, a resubmission and after-approval submissions, conducted by the
research ethics committee en banc, in the presence of a quorum, using established
technical and ethical criteria.
Expedited Review- is the ethical evaluation of a research proposal and other protocol-
related documents, a resubmission and after-approval submissions, conducted by
only 2-3 members of the committee without involvement of the whole committee.
Site Visit – is an activity of the REC where an assigned team goes to the research site or
office for specific monitoring purposes.
Clarificatory Interview/meeting – is a meeting or consultation of the REC with the
researcher for the purpose of obtaining explanations or clarity regarding some
research issues identified by the REC.

7. Forms
39
What forms/templates/tools are used in the implementation of this SOP? Examples:
Form ## Protocol Deviation/Violation Report Form
Form ## Decision Letter Template

8. History of SOP

Is this the first time that this SOP is being prepared? If yes, then indicate the date of the first draft
and the authors, date of approval of the final draft, and the approving authority. If this is not the
first time, then it should include information on the previous versions (see SOP on Writing and
Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC First draft

2 2013 May 01 DEF Change in the definition of

major protocol
deviation/violation

3 2018 June 03 GHI Change in the definition of

minor protocol deviation

9. References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)?

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

40
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 11A
Date of Approval: Review of Reportable Negative Events Reports
Date of Effectivity :

1. Policy Statement

Reportable Negative events are occurrences during the implementation of a research that impact
safety, dignity and well-being of participants and /or the study team and the integrity of data.
These events need to be reported to the REC as essential to the continuing concern for a favorable
balance of risks and benefits from the study. An example of a policy statement is as follows:“ The
REC shall require the submission of RNE reports, at the latest three (3) days after the event has
come to the attention of the researcher. A special meeting shall be considered depending on the
level of risk involved.

2. Objective of the Activity

The objective of the activity specifies the intended outcomes of reviewing the reports on negative
events. For example, “Review of RNE reports aims to ensure that the safety and welfare of human
participants and the research team are safeguarded and that information on RNEs are properly
documented and evaluated.”

3. Scope

Review of Reportable Negative Events is an important responsibility of RECs in non-drug-

therapeutic studies e.g., social science studies. For example, “This SOP applies to the review of
RNE reports. This SOP begins with the receipt and documentation of submission of RNE report in
the logbook and ends with the filing of all related documents and update of the protocol
database.”

4. Workflow

What are the different steps involved in the process of review of RNE reports? Who will be
responsible in each of these steps?

For example:

ACTIVITY RESPONSIBILITY

Step 1: Receipt and documentation of submission of RNE report in the Staff

logbook.

Step 2: Retrieval of pertinent protocol file Staff

Step 3: Notification of Chair Staff

41
 Step 4: Call for a Special Meeting Chair

Step 5: Deliberation on the RNE REC members

Step 6: Communication of REC action to the researcher (SOP ##on Chair

Communication of REC Decisions) and to the Institutional authority

Step 7: Filing of all related documents (SOP ## Management of Active Staff

Files) and Update of the protocol database

5. Description of Procedures

Step 1 - Receipt and documentation of submission of the RNE report in the logbook/database:
Does REC require a specific RNE report form? Was the form properly accomplished? Was the date
of submission within the required timeline? What information about the submission will be entered
in the log? For example, The Staff receives the accomplished RNE report form (Form ##) and
enters the submission into the logbook. The Staff notes whether the submission is within the
required timeline.

Step 2 - Retrieval of pertinent protocol file: Which pertinent information about corresponding
protocol will be retrieved (e.g. identity of primary reviewers)? For example, The Staff retrieves
the approved protocol file and checks the identity of the primary reviewers.

Step 3 - Notification of Chair: How and when will the Chair or designated officer be notified about
the submission? For example, The Staff notifies and sends the report and the retrieved documents
to the Chair who may decide to call for a special meeting.

Step 4 - Call for a Special Meeting. The staff prepares for a special meeting (SOP ##). The
researcher and other members of the study team may be invited for a clarificatory meeting.

Step 5 - Conduct of the Special Meeting. The Chair leads the discussion of the special meeting,
summarizes the RNE report and informs the REC members regarding the presence of the research
team for clarificatory meeting. The safety issues are evaluated, i.e., identification of risks to
the participants / research team, nature and effectivity of preliminary interventions with or
without the help of community constituents/authority, impact on integrity of data and
completion of the research. The Research team is excused and the REC members deliberate on
possible options, as follows:
- recommend suspension of the study until risk is resolved.
- withdrawal of ethical clearance
- submission of a plan to mitigate risk/harm
- require an amendment to the protocol
- uphold original ethical clearance

Step 6 - Communication of REC recommendation to the researcher: See SOP ## on

Communicating REC decisions.

Step 7 - Filing of all related documents and update of the protocol database: See SOP## on
Managing Active Files (SOP#__).
42
6. Glossary

What terms/abbreviations used in this SOP need to be defined for effective implementation?
Examples:

Study Site - physical location of where the study is being conducted, e.g., community,
institutional facility.
Reportable Negative Events (RNE) - are occurrences in the study site that indicate risks or actual
harms to participants and to members of the research team and to integrity of data.
Examples are brewing hostilities in the research community, natural calamities,
unleashed dogs, threats of harassment, etc.,
Special meeting – an assembly of the Committee outside of the regular schedule of meetings for
a specific purpose, usually to decide on an urgent matter like selection of officer,
approval of a revised or new SOP, report of critical research problem that requires
immediate action
Clarificatory Meeting/ Interview – is a face-to-face meeting or consultation of the REC with the
researcher for the purpose of obtaining explanations or clarity regarding some research
issues identified by the REC.

7. Forms

What forms/templates/tools are used in the implementation of this SOP? Examples:

Form ## RNE Report

Form## Notice of Meeting

Form ## REC Decision Letter

8. History of SOP

Is this the first time that this SOP is being prepared? If yes, then indicate the date of the first draft
and the authors, date of approval of the final draft, and the approving authority. If this is not the
first time, then it should include information on the previous versions (SOP on Writing and Revising
SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC First draft

2 2013 May 01 DEF Constitution of a SAE

Subcommittee

3 2018 June 03 GHI Revision of SAE/SUSAR Report

Form

9. References

43
What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)?

Examples:

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

44
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 11B
Date of Approval: Review of SAEs and SUSARs
Date of Effectivity :

1. Policy Statement

Serious Adverse Events (SAEs) and Suspected, Unexpected, Serious Adverse Reactions (SUSARs) are
important issues in sponsored clinical trials. Reporting SAEs and SUSARs is the responsibility of the
sponsor who collects such reports from all its study sites. This report is sent to the individual
principal investigators for submission to their institutional REC. Review of these reports is an
important function of Level 3 RECs. There is need to consult international and national guidelines
and local regulations for specific details such as timelines for safety reports. What may be
applicable in this SOP would be the ICH-GCP Guideline E2A which the Philippine FDA has adopted.

What is the policy of the REC regarding the submission of reports of SAEs and SUSARs? For example,
“The REC shall require the submission of reports of SAEs and SUSARs within 4 weeks after the
event has come to the attention of the researcher.” Does the REC have a separate subcommittee
or point person to analyze SAEs and SUSARs? If so, then a related policy should be stated in this
section. For example, “The evaluation of the SAEs and SUSARs shall be conducted by the
Subcommittee on SAEs and SUSARs whose recommendation shall be submitted to the REC for final
action.

2. Objective of the Activity

The objective of the activity specifies the intended outcome of reviewing SAEs and SUSARs. For
example, “Review of SAE and SUSAR reports aims to ensure that the safety and welfare of human
participants in the study site are safeguarded and that information on SAEs and SUSARs are
properly documented and evaluated.”

3. Scope

For example, “This SOP applies to the review of reports of SAEs in various studies and SUSARs in
clinical trials. This SOP begins with the receipt and documentation of submission of report of
SAEs and SUSARs in the logbook and ends with the filing of all related documents and update of
the protocol database.”

4. Workflow

What are the different steps involved in the process of review of SAE and SUSAR reports? Who will
be responsible in each of these steps?

For example:

45
 ACTIVITY RESPONSIBILITY

Step 1: Receipt and documentation of submission of report of SAEs and Staff

SUSARs in the logbook.

Step 2: Retrieval of pertinent protocol file Staff

Step 3: Notification of Chair Staff

Step 4: Submission of report to the SAE Subcommittee Staff

Step 5: Inclusion of report of Subcommittee in the agenda of the next Staff and Chair
regular REC meeting

Step 6: Communication of REC action to the Principal Staff and Chair

Investigator/researcher (SOP on Communication of REC Decisions
(SOP#__))

Step 7: Filing of all related documents (SOP ## Management of Active Staff

Files) and Update of the protocol database

5.Description of Procedures

Step 1 - Receipt and documentation of submission of report of SAEs and SUSARs in the
logbook/database: Does REC require a specific SAEs and SUSARs report form? Was the form
properly accomplished? Was the date of submission within the required timeline? What information
about the submission will be entered in the log? For example, The Staff receives the accomplished
SAE/SUSARs report forms (Form ##) and enters the submission into the logbook. The Staff notes
whether the submission is within the required timeline.

Step 2 - Retrieval of pertinent protocol file: Which pertinent information about corresponding
protocol will be retrieved (e.g. identity of primary reviewers and earlier reports on SAEs and
SUSARs)? For example, The Staff retrieves the identity of the primary reviewers (if there is no
SAE/SUSAR subcommittee) and a tabulation of earlier SAE/SUSAR reports.

Step 3 - Notification of Chair: How (by SMS, e-mail, memo, etc.) and when will the Chair or
designated officer be notified about the submission? For example, The Staff notifies and sends
the report and the retrieved documents to the Chair.

Step 4 - Submission of report to SAE Subcommittee or point person: How and when will the SAE
Subcommittee or point person be informed about the submission? Are there forms to be used? How
much time is allotted to the subcommittee to act on the report? Will the Subcommittee or point
person use an REC form? The Chair forwards the report and pertinent documents to the primary
reviewers (or to the SAE/SUSAR Subcommittee) for action which should not be later than 3 days
prior to the next committee meeting.

Step 5 - Inclusion of report of SAE Subcommittee or point person in REC meeting agenda: What
are the possible actions of REC on SAE and SUSAR report? For example, The suggested
action/decision of either the primary reviewer or the SAE/SUSAR Subcommittee is included in
the Agenda of the next meeting (see SOP on Preparing the Meeting Agenda). for ratification or
46
discussion and final decision. Possible actions include: notation with no further action required,
further information or action required or suspension of recruitment.

Step 6 - Communication of REC recommendation to the Principal Investigator/researcher: See

SOP on Communicating REC decisions.

Step 7 - Filing of all related documents and update of the protocol database: See SOP on
Managing Active Files (SOP#__).

6.Glossary

What terms/abbreviations used in this SOP need to be defined for effective implementation?
Examples:

SAE (Serious Adverse Events) - – is an event observed during the implementation of a study where
the outcome is any of the following
o Death
o Life thereatening
o Hospitalization (initial or prolonged)
o Disability or permanent damage
o Congenital anomaly/ birth defect
o Required intervention to prevent permanent impairment or damage (devices)
o Other serious (important medical) events
whether or not it is related to the study intervention.
SUSAR (Suspected Unexpected Serious Adverse Reactions)- is a noxious response to a drug that is
not described in the Investigator’s Brochure nor in the drug insert.
SAE Subcommittee – a group of individuals with the necessary expertise, assigned by the REC to
review SAEs and SUSARs and provide the pertinent recommendation for action of the
REC.
Principal Investigator - the lead person selected by the sponsor to be primarily responsible for
the implementation of a sponsor-initiated clinical drug trial.
Sponsor- an individual, company, institution or organization which takes responsibility for the
initiation, management, and financing of a clinical trial.
Researcher-Initiated Studies – are research activities whose conceptualization, protocol
development and implementation are done by a researcher or group of individuals who
may request for external funding support.
Sponsored-Clinical Trials – are a systematic study on pharmaceutical products in human subjects
(including research participants and other volunteers), whose conceptualization,
protocol development and support for their conduct are the responsibilities of sponsors
who manufactured the products, in compliance with the requirements of regulatory
authorities.

7.Forms

What forms/templates/tools are or used in the implementation of this SOP? Example:

Form ## SAE/SUSAR Report

Form ## Evaluation of SAE/SUSAR Reports

Form ## REC Decision Letter

47
8.History of SOP

Is this the first time that this SOP is being prepared? If yes, then indicate the date of the first draft
and the authors, date of approval of the final draft, and the approving authority. If this is not the
first time, then it should include information on the previous versions (SOP on Writing and Revising
SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC First draft

2 2013 May 01 DEF Constitution of a SAE

Subcommittee

3 2018 June 03 GHI Revision of SAE/SUSAR Report

Form

9.References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)?

Examples:

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

48
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 12
Date of Approval: Management of An Application for Continuing
Date of Effectivity : Review

1. Policy Statement

A sample policy could be: “The REC shall require the submission of an application for Continuing
Review at least 4 weeks before the expiration of the ethical clearance of a protocol. Protocols
that underwent Full review in its initial submission shall undergo Full review in its application
for Continuing review. Similarly, protocols that underwent Expedited review shall undergo
Expedited review in its application for Continuing review.”

2. Objective of the Activity

The objective specifies the intended outcomes in the management of an application for continuing
review. For example, “This activity aims to ensure that the conduct of the study is in compliance
with the approved protocol and that the safety and welfare of study participants are promoted
and the integrity of data protected beyond the period of initial ethical clearance and up to the
end of the study.”

3. Scope

The scope defines the management of an application for Continuing Review in preparation for
expiration of the initial ethical clearance. For example, “This SOP applies to the management of
an application for Continuing review submitted by the proponent while the study is still on-going
but whose ethical clearance is about to expire. This SOP begins with the receipt of an application
for continuing review and ends with the entry to logbook and protocol database.”

4. Workflow

What are the different steps involved in the management of an application for Continuing review?
Who will be responsible in each of these steps?

For example:

ACTIVITY RESPONSIBILITY

Step 1: Receipt of the application for Continuing Review and entry to Staff
logbook(SOP ## Management of Active Files)

Step 2: Retrieval of pertinent protocol files Staff

Step 3: Notification of Chair and Primary Reviewers Staff

Step 4: Determination of type of review: expedited (SOP ## Expedited Chair and Primary
Review ) or full review (SOP ## Full Review) Reviewers

49
 Step 5: Communication of committee action (SOP on Communication REC Chair
Decisions (SOP#__))

Step 6: Filing of documents in the appropriate protocol folder and Staff

Update of the Protocol Database

5. Description of Procedures

Each of the identified steps in the workflow should be described in detail.

Step 1 - Receipt of the application for continuing review and entry to logbook: Does the REC
have specific form for an application for continuing review? Was the form adequately
accomplished? Example, The Staff receives, logs and enters in the protocol database the
information included in the application for Continuing review (Form ##: Application for
Continuing Review).

Step 2 - Retrieval of pertinent protocol file: Which pertinent documents will be retrieved (e.g.
approved protocol and Informed Consent Form versions, related past submissions)? Example, The
Staff retrieves the approved protocol and prepares a summary of the progress reports, protocol
deviation/violation reports, SAE/SUSAR reports, report of negative events (RNEs) and
corresponding decisions including the type of initial review during the period of effectivity of the
initial ethical clearance.

Step 3 - Notification of Chair and Primary Reviewers: How (by SMS, email etc.) and when will
the Chair and the Primary Reviewers be notified about the submission? Example. The Staff notifies
the Chair and the Primary Reviewers regarding the submission and the summary of the reports
submitted and decisions made during the period of effectivity of initial ethical clearance.

Step 4 - Determination of type of review: expedited or full review: For example, The Chair
shall determine the type of review based on the policy that protocols that underwent Full review
in its initial submission shall undergo Full review in its application for Continuing review.
Similarly, protocols underwent Expedited review shall undergo Expedited review in its
application for Continuing review (see SOP 4: Expedited Review and SOP5: Full Review).

Step 5 - Communication of committee action: For example, The Staff prepares the draft decision
based on the report of the expedited review or the minutes of the meeting in the full review.
The Chair finalizes and signs the decision letter (Form ##). Possible decisions include the
following: Approval, Additional information required, submission of an explanation for failure to
submit required reports or disapproval.

Step 6 – Filing of documents in the appropriate protocol folder: For example, The Staff files
the application for Continuing review, the recommendations of the reviewers and decision letter
in the appropriate protocol folder.

6. Glossary

What are the terms/abbreviations used in this SOP for review of progress, final, and early
termination reports and protocol amendments that need to be defined? Examples:
Continuing Review - is the decision of the REC to extend the ethical clearance of a study
based on an assessment that the research is proceeding according to the approved
protocol and there is reasonable expectation of its completion.

50
Progress Report – A description of how the implementation of the study is moving forward.
This is done by accomplishing the Progress Report Form ##. The frequency of
submissioin (e.g., quarterly, semi-annually or annually) is determined by the REC
based on the level of risk.
Amendment – a change in /revision of the protocol made after it has been approved.

Protocol Deviation– non-compliance with the approved protocol that does not increase risk
or decrease benefit to participants or does not significantly affect their rights,
safety or welfare or the integrity of data.Example: missed visit, non-submission
of a food diary on time.
Protocol Violation - non-compliance with the approved protocol that increases risk or
decreases benefit to participants or significantly affects their rights, safety or
welfare or the integrity of data. Example: incorrect treatment, non-compliance
with inclusion/exclusion criteria.
SAE – a Serious Adverse Event – is an event where the outcome observed in a study is any
of the following, whether or not it is related to the study intervention
o Death
o Life threatening
o Hospitalization (initial or prolonged)
o Disability or permanent damage
o Congenital anomaly/ birth defect
o Required intervention to prevent permanent impairment or damage (devices)
o Other serious (important medical) events
SUSAR – Suspected Unexpected Serious Adverse Reaction – is a noxious response to a drug
that is not described in the Investigator’s Brochure nor in the drug insert
RNE – an occurrence in the study site that indicates risks or actual harms to participants
and to members of the research team. Examples are brewing hostilities in the
research community, natural calamities, unleashed dogs, threats of harassment,
etc.,
Primary Reviewers – are members of the Research Ethics Committee (usually a scientist
and a non-scientist) assigned to do an in-depth evaluation of the research-related
documents using technical and ethical criteria established by the committee.
Expedited Review – is the ethical evaluation of a research proposal and other
protocol-related documents, a resubmission and after-approval submissions,
conducted by only 2-3 members of the committee without involvement of the
whole committee.
Full Review – is the ethical evaluation of a research proposal and other protocol-related
documents, a resubmission and after-approval submissions, conducted by the
research ethics committee en banc, in the presence of a quorum, using established
technical and ethical criteria.
Logbook – a real-time chronological record of incoming protocols that includes the Date
/Time of Receipt, Title of the Document, Name of the Proponent, Name and
Signature of the Submitting Entity, Name and Signture of the Receiving Person and
Action done.
Database– a collection of information (e.g. regarding protocols) that is structured and
organized so that this can easily be accessed, managed, intepreted, analyzed and
updated. It is usually in an electronic platform used for tracking and monitoring
the implementation of a study.
51
7. Forms

What forms/templates/tools are used in the implementation of this SOP? Examples:

Form ##: Continuing Review Application Form
Logbook
Database
Form ##: Decision letter template

8. History

Is this the first time that this SOP is being prepared? If yes, then indicate the date of the first draft
and the authors, date of approval of the final draft, and the approving authority. If this is not the
first time, then it should include information on the previous versions (see SOP on Writing and
Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC

2 2013 May 01 DEF Change of timeline for

submission of application for
continuing review

3 2015 June 03 ABC Change of entries in the

DEF application form

9. References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)? Examples are:

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

52
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 13
Date of Approval: Review of Final Report
Date of Effectivity :

1. Policy Statement

Submission and review of final reports signal the completion of the study and its acceptance by
the research ethics committee. This is an important step in the timeline of the study, on which
will depend other researcher/institutional/funding agency decisions regarding the study, e.g.,
student/trainee graduation, publication/ release of final funding tranche. The Final Report Form
is useful in checking the consistency of study implementation with the approved protocol and the
knowledge gained from the endeavor. What is the policy of the REC regarding submission of final
reports? For example, “The REC shall require the submission of the final report not later than 8
weeks after the end of the study. Final reports shall undergo either expedited or full review.”

2. Objective of the Activity

The objective specifies the intended outcomes of the review of final reports. For example, “This
activity aims to ensure that the conduct of the study was in compliance with the approved
protocol and that the safety and welfare of study participants were promoted and the integrity
of data protected until the end of the study.”

3. Scope

The SOP on management of Review of Final reports defines the steps taken in the process guided
by the policy statement. For example, “This SOP applies to the management and review of final
reports submitted by proponents at the end of the study. This SOP begins with the receipt and
entry of the final report into the logbook and ends with an update of the protocol database.”

4. Workflow

What are the different steps involved in the process of review of the final report? Who will be
responsible in each of these steps?

For example:

ACTIVITY RESPONSIBILITY

Step 1: Receipt of final report and entry into logbook (SOP on Staff
Management of Active Files (SOP#__))

Step 2: Retrieval of pertinent protocol file Staff

Step 3: Notification of Chair and Primary Reviewer Staff

53
 Step 4: Full review (SOP ## on Full Review) Chair, Primary
Reviewer,
Committee Members

Step 5: Communication of committee action (SOP on Communication Chair

REC Decisions (SOP#__)

Step 6: Filing of the Final Report and related documents and update of Staff
the protocol files.

5. Description of Procedures
Each of the identified steps in the workflow should be described in detail.

Step 1 - Receipt and entry of final report into logbook : Does the REC have specific form for
final report (Form ##)? Example, The Staff receives and enters the date of receipt of the final
report into the logbook.

Step 2 - Retrieval of pertinent protocol file: Which pertinent documents will be retrieved (e.g.
approved protocol and Informed Consent Form versions, related past submissions)? For example:
“The staff retrieves the corresponding protocol file as reference in the review of the Final
Report.”

Step 3 - Notification of Chair and Primary Reviewer: For example: “The staff notifies the Chair
and the primary reviewers of the receipt of the Final Report and awaits further instructions.”

Step 4 - Full review: “The Chair instructs the staff to include the report in the agenda of the
next meeting and to ensure that the primary reviewer is given the necessary documents so that
s/he can prepare the presentation during the next meeting (SOP ## Full Review).

Step 5 - Communication of committee action (SOP ## Communicating REC Decisions): It is

suggested that the REC consider the following decisions in the review of a final report: acceptance
of the Final Report or to require resubmission with corrections.

Step 6 - Filing of the Final Report and related documents and update of the protocol database:

The REC Staff files the Final Report and related documents in the appropriate folder and updates
the protocol database.

6. Glossary
What are the terms/abbreviations used in this SOP for review of progress, final, and early
termination reports and protocol amendments that need to be defined? Examples:

Final Report– is a summary of the outputs and outcomes (including documented risks and
benefits) of the study upon its completion, as well as the status of all
participants. The REC requires the accomplishment of the Final Report form
within a reasonable period after the end of the study.
Primary Reviewers- are members of the Research Ethics Committee (usually a scientist
and a non-scientist) assigned to do an in-depth evaluation of the research-related
documents using technical and ethical criteria established by the committee.
Risks – summary of probable negative or unfavorable outcomes ranging from
inconvenience, discomfort, or physical harm based on the protocol

54
 Benefits – summary of probable positive or favorable outcomes ranging from benefit to
the community (or society), indirect gains such as education, or direct
therapeutic value
Status of participants – summary of what happened to (condition of) participants recruited
to the study, including those that completed the study, those that dropped out,
or those withdrawn for specific reasons in accordance with the protocol
Full Review - is the ethical evaluation of a research proposal and other protocol-related
documents, a resubmission and after-approval submissions, conducted by the
research ethics committee en banc, in the presence of a quorum, using established
technical and ethical criteria.
Expedited Review - is the ethical evaluation of a research proposal and other protocol-
related documents, a resubmission and after-approval submissions, conducted by
only 2-3 members of the committee without involvement of the whole committee.
Agenda - the list of topics or items to be taken up in a meeting arranged in a sequential
manner. It is an outline of the meeting procedure and starts with a “Call to Order”.
Logbook – a real-time, chronological record of incoming protocols that includes the Date
/Time of Receipt, Title of the Document, Name of the Proponent, Name and
Signature of the Submitting Entity, Name and Signature of the Receiver and Action
done.
Database – a collection of information that is structured and organized so that this can
easily be accessed, managed, intepreted, analyzed and updated.

7. Forms

What forms/templates/tools are used in the implementation of this SOP? Examples:

Final Report Form

Decision Letter

8. History
Is this the first time that this SOP is being prepared? If yes, then indicate the date of the first draft
and the authors, date of approval of the final draft, and the approving authority. If this is not the
first time, then it should include information on the previous versions (see SOP on Writing and
Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC

Change of timeline for

2 2013 May 01 DEF
submission of final reports

Revision of the Final Report

3 2018 June 03 GHI
Form

9. References

55
What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)? Examples:

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health-Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

56
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 14
Date of Approval: Review of Early Termination Reports
Date of Effectivity :

1. Policy Statement

Early termination may be a decision of the researcher/investigator or the sponsor for reasons that
make the continuation of the research untenable, e.g. poor recruitment, high number of SUSARs,
lack of funding. In some occasions the REC may recommend early termination of the study when,
based on its assessment, the participants and/or the study team may be at high risk of harm that
cannot be mitigated. The REC policy regarding early termination of the research maybe, for
example, “When a decision for early termination of the research has been made, the well-being
and safety of study participants that have already been recruited shall be a primary consideration
and the plan for termination shall reflect this concern. Early termination reports shall undergo
full review”

2. Objective of the Activity

The objective specifies the intended outcome/s of reviewing early termination reports. For
example, “Review of early termination reports aims to ensure that the decision takes into
consideration the safety and welfare of study participants that have already been recruited and
that there is adherence to the principle of fairness for all concerned.”

3. Scope

This SOP describes the steps involved in the review of early termination reports. For example,
“This SOP applies to the review of early termination reports. This SOP begins with the receipt
and entry to logbook of the early termination reports and ends with the communication of
committee action to the researcher/investigator and updating of the protocol database.”

4. Workflow

What are the different steps involved in the review of early termination reports? Who will be
responsible in each of these steps?

For example:

ACTIVITY RESPONSIBILITY

Step 1: Receipt of the early termination report and entry into the Staff
logbook (SOP## Management of Active Files)

Step 2: Retrieval of pertinent protocol file Staff

Step 3: Notification of Chair and Primary Reviewers Staff

57
 Step 4: Full review (SOP on Full Review (SOP#__)) Primary Reviewers
and Members

Step 5: Communication of committee action (SOP## Communicating REC Chair, Staff

Decisions) and update of the protocol database (SOP ## Management of
Active Files)

5. Description of Procedures

Each of the identified steps in the workflow should be described in detail.

Step 1 - Receipt and entry to the logbook and database of early termination reports, for
review: The REC staff receives the early termination report and enters the appropriate
information into the log book (SOP ## Management of Active Files)

Step 2 - Retrieval of pertinent protocol file: Which pertinent documents will be retrieved (e.g.
approved protocol and Informed Consent Form versions, related past submissions)? The REC Staff
retrieves the protocol folder and summarizes the documents that have been submitted.

Step 3 - Notification of Chair and Primary Reviewers: How (by SMS, email etc.) and when will
the Chair and the Primary Reviewers be notified about the submission? The REC staff informs the
Chair and the primary reviewers by email about the report and the summary of documents that
have been submitted. S/he waits for further instructions.

Step 4 - Full review: The Chair instructs the staff to include the report in the agenda of the next
meeting and to ensure that the primary reviewers are given the necessary documents so that s/he
can prepare the presentation during the next meeting (SOP ## Full Review). The review should
ensure implication of the early termination on the rights, safety, and welfare of the study
participants, in the form of a termination package with a set of procedures. The procedures may
include adapting specific provisions for continued access to protective mechanisms and
information by the study participants.

Step 5 - Communication of committee action and Update of the Protocol Database: The REC
considers the following possible decisions in the review of an early termination report:
acceptance of the decision with no further action; request for additional information; or
requirement for further action. The staff prepares a draft of the committee decision based on
the minutes of the meeting (SOP ## Communicating REC Decisions) for signature of the Chair.
S/he updates the protocol database accordingly.

6. Glossary

What are the terms/abbreviations used in this SOP for review of progress, final, and early
termination reports and protocol amendments that need to be defined? Examples:

Early Termination - refers to the decision of the researcher, principal investigator, the
institution, or sponsor to end the implementation of a study before its
completion.
Termination package - refers to the entitlements of study participants in the event of
discontinuance of the study, which can come in the form of access to the study
intervention, treatment, or information, for purposes of adherence to the
principle of fairness for all concerned
58
 Primary Reviewers – are members of the Research Ethics Committee (usually a scientist
and a non-scientist) assigned to do an in-depth evaluation of the research-related
documents using technical and ethical criteria established by the committee.
Full Review – is the ethical evaluation of a research proposal and other protocol-related
documents, a resubmission and after-approval submissions, conducted by the
research ethics committee en banc, in the presence of a quorum, using established
technical and ethical criteria.
Logbook – a real-time, chronological record of incoming protocols that includes the Date
/Time of Receipt, Title of the Document, Name of the Proponent, Name and
Signature of the Submitting Entity, Name and Signature of the Receiver and Action
done.
Database – a collection of information (e.g. regarding a protocol/s) that is structured and
organized so that this can easily be accessed, managed, intepreted, analyzed and
updated. It is usually in an electronic platform used for tracking and monitoring
the implementation of a study.

7. Forms

What forms/templates/tools are used in the implementation of this SOP? Examples:

Form ## Early Termination Report Form

Form ## Decision Letter Template

Logbook

Database

8. History

Is this the first time that this SOP is being prepared? If yes, then indicate the date of the first draft
and the authors, date of approval of the final draft, and the approving authority. If this is not the
first time, then it should include information on the previous versions (see SOP on Writing and
Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC

2 2013 May 01 DEF Policy to conduct Full Review

for all early termination
reports.

3 2018 June 03 GHI Development of an Early

Termination Report Form

59
9. References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)? Examples:

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

60
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 15
Date of Approval: Management of Appeals
Date of Effectivity :

1. Policy Statement

Appeals are requests from researchers (sometimes, from sponsors or funding agencies) for
reconsideration of a decision or action of the research ethics committee with regard the protocol
or related documents. Consideration of appeals is a reflection of the open-mindedness of REC
members and their adherence to the principles of transparency and fairness. Here is a sample
policy statement: “The REC shall consider the perspective of the researcher regarding the
feasibility and acceptability of REC recommendations including its disapproval. Appeals of
researchers shall undergo full review and shall be resolved within six weeks (24 working days)
upon receipt of the fully documented appeal.”

2. Objective of the Activity

The objective specifies the intended outcome/s of management of appeals. For example:
Management of appeals ensures fairness, transparency and comprehensiveness of ethics review
that takes into consideration the perspective of the researcher.

3. Scope

The SOP on Management of Appeals covers procedures that begin with the receipt of the appeal
and ends with communicating the committee’s action to the researcher and updating of the
protocol

4. Workflow

ACTIVITY RESPONSIBILITY

Step 1: Receipt of an appeal Staff

Step 2: Retrieval of pertinent protocol file Staff

Step 3: Notification of Chair and Primary Reviewer/s Staff

Step 4: Inclusion in Agenda of the next regular Chair and Primary Reviewer
meeting

Step 5: Discussion of and deliberation on the appeal Chair and REC Members

Step 6: Communication of committee action (SOP## Chair

Communicating REC Decisions)

61
 Step 7: Filing of documents and updating of the Staff
protocol database

5. Description of Procedures

Each of the identified steps in the workflow shall be described in detail.

Step 1 - Receipt of an Appeal: The staff receives the letter of appeal and enters the pertinent
information into the logbook.

Step 2: Retrieval of pertinent protocol file: The staff retrieves the pertinent file for reference
in the review. The file includes the initially submitted protocol, ICF, research tools and other
related documents.

Step 3: Notification of Chair and Primary reviewers: The staff notifies the Chair and the primary
reviewers about the letter of appeal and awaits further instructions.

Step 4. Inclusion in the Agenda of the next regular meeting: The Chair instructs the staff to
include the appeal in the agenda of the next meeting, to ensure that the retrieved protocol and
related documents are available during the meeting and to inform the researcher to be available
on the scheduled meeting in case there is a need for further clarification.

Step 5: Discussion of and Deliberation on the Appeal: The primary reviewer summarizes the
protocol and the previous discussion of the issues in the protocol as background to the appeal.
The Chair presents the contents of the appeal and leads discussion. The researcher may be called
in for further clarification of issues. The researcher is asked to step out after the committee has
taken up the issues for clarification. The committee then decides (by consensus) whether to
accept any or all of the points raised in the appeal.

Step 6: Communication of Committee Action: Based on the deliberations, the Chair summarizes
the decision points and instructs the REC staff to prepare the draft decision letter (Form ##
Decision Letter Template) for his/her finalization and forwarding to the researcher. (SOP ##
Communicating REC Decisions):

Step 7: Filing of Documents and Update of Protocol Database: The staff files all the documents
into the appropriate folder and updates the protocol database accordingly.

6. Glossary

Appeal – a request of a researcher/ investigator for a reconsideration of the REC

recommendation.
Primary reviewer – is a member of the REC who is assigned to do an in-depth evaluation
of research-related documents using technical and ethical criteria established by
the committee.
Protocol File/Folder – is an organized compilation of all documents (in physical or
electronic form) related to a study.
Protocol database - a collection of information (e.g. regarding protocols) that is
structured and organized so that this can easily be accessed, managed,
intepreted, analyzed and updated. It is usually in an electronic platform used for
tracking and monitoring the implementation of a study.

62
7. Forms

Form ## Decision Letter Template

8. History

Is this the first time that this SOP is being prepared? If yes, then indicate the date of the first draft
and the authors, date of approval of the final draft, and the approving authority. If this is not the
first time, then it should include information on the previous versions (see SOP on Writing and
Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2018 July 15 ABC New SOP

9. References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)? Examples:

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

63
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 16
Date of Approval: Conduct of Site Visits
Date of Effectivity :

1. Policy Statement

Site visits are important REC action that can be done in the performance of their oversight and
monitoring responsibilities. Relative to this action, the REC shall establish criteria that shall help
determine whether a site should be visited. Examples of such criteria are - high risk studies,
significant deviation reports and participant complaints. Thus, the policy statement could be as
follows: “The ERC shall conduct visits of selected sites of approved protocols that fall within the
following established criteria for such visits: (a) high risk studies, (b) receipt of significant
number of protocol violations, (c) receipt of complaints from participants and families, (d) non-
receipt of required after-approval reports from the and (e) multiple studies conducted by a
researcher.”

2. Objective of the Activity

The objective specifies the intended outcomes of the procedures involved in site visits. For
example, “Site visits are mechanisms with which the REC monitors compliance with approved
protocols, ICF process and continuing protection and promotion of participant’s dignity, rights
and well-being.”

3. Scope

This SOP covers criteria for site visits, notification, conduct of the visit, documentation,
presentation of results to the REC, and communication of REC action to the researcher for
example, “This SOP includes the steps in conducting visits to study sites for reasons set by the
REC. It begins with the selection of the site to be visited and ends with filing of Site-Visit Reports
in the protocol folder and updating of the protocol database

4. Workflow

What are the different steps involved in the process of site visits? Who are the persons responsible
in each of these steps?
For example:

ACTIVITY RESPONSIBILITY

Step 1: Selection of site to visit ERC Members

Step 2: Notification of researcher ERC Staff

Step 3: Creation of Site Visit Team Chair

64
 Step 4: Conduct of site visit Site Visit Team (members)

Step 5: Draft of report and presentation of report during Site Visit Team (members)
meeting and discussion for recommendations

Step 6: Transmittal of Final Report and Recommendations Chair/ Staff

to the Researcher/Investigator

Step 7: Filing of Site-Visit Reports in the protocol folder Staff

and update of Protocol database

5. Description of Procedures

Step 1 - Selection of site to visit: How does the REC decide of which research site to visit?
Examples of criteria are high risk studies, consistent non-submission or failure to submit after-
approval submission requirements, reports of major protocol noncompliance, significant number
of serious adverse events, reports of complaints from study participants. If the ERC has a Serious
Adverse Event Committee or Subcommittee, does this committee have a role in selecting sites?
How does the ERC arrive at a decision to do a site visit (e.g. during a committee meeting)?

Step 2 - Notification of researcher: How much lead time is given to the investigator or researcher
before the visit (e.g. two weeks before the scheduled visit)? How is the investigator informed (e.g.
through a letter)? What information is provided (e.g. visit details, documents to prepare)?

Step 3 - Creation of Site Visit Team: Who creates the Site Visit team? What is the composition?
How do the members of the team prepare to do their task? What documents do they need to be
familiar with (e.g. Site Visit Report Form)? What documents do they need to review ahead of time?

Step 4 - Conduct of Site Visit: How is the Site Visit Report Form used? What are the points of
observation on the documents in the study site? Will there be a debriefing with the researcher
and research staff at the end of the site visit?

Typically, important points to cover during the site visit include:

▪ Study protocol version
▪ Informed consent documents: verify if the site is using the most recently approved version
▪ Post-approval documents: verify if these have been submitted to and approved by the
REC.
▪ Security, privacy, and confidentiality of the documents at the study site
▪ Facilities in the study site
▪ Determination of the protection of the rights, safety, and welfare of human participants
in the study

Step 5 - Draft of report and presentation of report during meeting and discussion for
recommendations: How does the team complete the Site Visit Report Form? What is the timeline
for this process, including cut off dates for inclusion in the agenda of the next meeting? How is
this process documented? Who among the team members will make the presentation during the
REC meeting? How does the committee make a determination of action?

65
Step 6: Transmittal of the Final Report and Recommendations to the Researcher/ Investigator:
The staff prepares a summary of the findings and recommendations of the REC based on the
deliberations during the meeting. The Chair finalizes the draft for transmittal to the Researcher/
investigator. (SOP ## Communicating REC Decisions)

Step 7: Filing of the Site Visit documents and update of the Protocol database: The staff files
the Site Visit Report and the recommendations in the appropriate folder and updates the protocol
database accordingly. (SOP## Management of Active Files)

6. Glossary

What terms/abbreviations used in this SOP need to be defined for effective implementation?
Examples:

Site Visit -is an action of the REC (based on established criteria) in which an assigned team
goes to the research site or office for specific monitoring purposes.
After-approval reports – are reports, e.g. progress report, protocol deviation/violation
report, amendment, early termination report, final report, application for
continuing review, required by the REC for submission by the
researcher/investigator after the study has been approved for implementation.
Protocol Violation- non-compliance with the approved protocol that may result in an
increased risk or decreased benefit to participants or significantly affects their
rights, safety or welfare or the integrity of data. Example: incorrect treatment,
non-compliance with inclusion/exclusion criteria.
High Risk Studies – research where harm or danger resulting from the study intervention
is very likely for participants.
Primary Reviewer– a member of the Research Ethics assigned to do an in-depth evaluation
of the research-related documents using technical and ethical criteria established
by the committee.
Full Review – is the ethical evaluation of a research proposal and other protocol-related
documents, a resubmission and after-approval submissions, conducted by the
research ethics committee en banc, in the presence of a quorum, using established
technical and ethical criteria.
Decision - the result of the deliberations of the REC in the review of a protocol or other
submissions.
Protocol File/Folder – is an organized compilation of all documents (physical or electronic
form) related to a study.
Protocol Database - a collection of information regarding protocols that is structured and
organized so that this can easily be accessed, managed, intepreted, analyzed and
updated.

7. Forms

What forms/templates/tools are used in the implementation of this SOP? Example:

Form ## Site Visit Report Form

8. History of SOP

66
Is this the first time that this SOP is being prepared? If yes, then indicate the date of the first draft
and the authors, date of approval of the final draft, and the approving authority. If this is not the
first time, then it should include information on the previous versions (see SOP on Writing and
Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC First draft

2 2013 May 01 DEF Added criteria for site visit

3 2018 June 03 GHI Revised Site Visit Report Form

9. References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)? Examples:

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

67
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 17
Date of Approval: Preparing for a Meeting
Date of Effectivity :

1. Policy Statement

Meetings are one of the major activities of the research ethics committee. They are venues for
deliberations and decision-making regarding ethical evaluation of study proposals and are
opportunities for RECs to be informed, and to be updated regarding its operations and relevant
administrative matters. It is important that the REC have regular meetings. How often does the
REC meet? Does it hold special meetings? For example, “The REC shall have a regular schedule of
meetings every 2nd Friday of the month. All meetings shall be held within the premises of the
institution. Special meetings shall be held to resolve issues that require immediate attention,
e.g. safety of participants, protocol violation that impact research integrity.”

2. Objective of the Activity

The objective specifies the intended outcomes in preparing for a meeting. For example,
“Preparing for a meeting aims to contribute to a smooth, orderly, and efficient conduct of
meetings.”

3. Scope

What is covered by this SOP? For example, “This SOP covers all activities prior to the conduct of
an REC meeting. This SOP begins with the preparation of the agenda and ends with the
notification of REC Members and confirmation of attendance.”

4. Workflow

What are the different steps involved in the process of preparing for a meeting? Who are
responsible in each of these steps?
For example:

ACTIVITY RESPONSIBILITY

Step 1: Preparation of the agenda (SOP## Preparing the Meeting REC Staff and Member
Agenda ) Secretary

Step 2: Coordination with the physical plant division REC Staff

Step 3: Assembly of materials and documents needed for the meeting REC Staff

Step 4: Preparation of presentation and recording equipment, food

REC Staff
arrangements for the meeting

68
 Member Secretary and
Step 5: Notification of REC Members and confirmation of attendance
REC Staff

5. Description of Procedures

What are the detailed steps involved in the SOP and documents and forms that must be included
in the meeting?

Step 1 - Preparation of the agenda: What are the usual items included in the agenda of a meeting?
How are they identified? (See SOP ## Preparing the Meeting Agenda)

Step 2 - Coordination with the physical plant division: How does the REC ensure that the venue
for the meeting will be available on the scheduled date? Does the REC have a conference room of
its own? For example: The REC staff notifies the Physical Plant Division (or its equivalent)
regarding the upcoming meeting of the REC (date, time, appropriate conference room) one week
before the schedule.

Step 3 - Assembly of materials and documents needed for the meeting: What documents should
be prepared and be made available during the meeting? Typically, these includes the meeting
agenda, minutes of the previous meeting, relevant protocol folders, memorandums,
administrative documents, etc. How many copies should be provided? For example: ‘The staff
gathers the documents and materials for the meeting based on the provisional agenda, e.g. copies
of the provisional agenda, provisional minutes of the previous meeting, protocols and related
documents submitted, at least 2 weeks before the meeting, post-approval reports, expedited
review reports, administrative memos, etc.’

Step 4 - Preparation of presentation and recording equipment, food arrangements for the
meeting: What equipment is needed for the meeting? Will the time and duration of the meeting
require provision for meals or food? Will there be a need for the presence of support staff? If the
members receive honorarium for meetings, how will payments be ensured? For example: The staff
ensures that the following are prepared and available for the meeting: laptop (2), projector,
and screen, microphones (3), adequate food and drinks/water depending on the expected
duration of the meeting, respective honoraria of committee members.

Step 5 - Notification of REC Members and confirmation of attendance: When and how will the
REC members be notified? What information should be included in the notice of meeting? How will
the attendance be confirmed? How soon? How will a lack of quorum be managed? When and how
will the alternate members be invited? For example: The member secretary supervises the staff
in the preparation of the Notice of Meeting (Form ##) that includes the provisional agenda. The
staff sends the notice of meeting to the members of the committee, at least, one week before
the schedule and follows-up the confirmation of attendance to ensure quorum. In case, quorum
cannot be met, the staff informs the Chair and the member secretary so that alternate members
may be called in.

6. Glossary

What terms/abbreviations used in this SOP need to be defined for effective implementation?
Examples:

69
 Quorum – presence of the majority of the REC members including the non-affiliated and
the non-scientist members.
Support Staff – institutional personnel assigned by administration to assist in the
operations of the REC.
Regular Meeting - a periodically scheduled assembly of the REC
Special Meeting - an assembly of the Committee outside of the regular schedule of
meetings for a specific purpose, usually to decide on an urgent matter like
selection of officer, approval of a revised or new SOP, report of critical research
problem that requires immediate action
Administrative Documents – documents that pertain to the operations of the REC and are
not directly related to a study or protocol.
Honorarium- monetary payment for specific professional services.
Physical Plant Division – unit within the institution that is in charge of the maintenance
and use of physical facilities.
Agenda- the list of topics or items to be taken up in a meeting arranged in a sequential
manner. It is an outline of the meeting procedure and starts with a “Call to
Order”.
Alternate Members – individuals who possess qualifications of specified regular members.
They are called to attend a meeting and substitute for regular members to comply
with the quorum requirement when the latter cannot attend the meeting.

7. Forms

What forms/templates/tools are used in the implementation of this SOP? Examples:

Form ## Notice of Meeting

Form ## Attendance Confirmation Form

Form ## Agenda Template

8. History of SOP

Is this the first time that this SOP is being prepared? If yes, then indicate the date of the first draft
and the authors, date of approval of the final draft, and the approving authority. If this is not the
first time, then it should include information on the previous versions (see SOP on Writing and
Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC First draft

2 2013 May 01 DEF Revised notice of meeting form

3 2018 June 03 GHI Inclusion of preparation of

honoraria of members

70
9. References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)? Examples:

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

71
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 18
Date of Approval: Preparing the Meeting Agenda
Date of Effectivity :

1. Policy Statement

The meeting agenda is the guide in the conduct of a meeting. It ensures order and completeness
of topics for discussion. It is recommended that the agenda template includes the following: date,
time, and venue of the meeting; titles of protocols for full review; titles of protocols that
underwent expedited review, after approval reports, administrative issuances and operations. An
example of a policy statement would be, “The meeting agenda shall be based on the submissions
received, at the latest, two (2) weeks before the scheduled regular meeting. It shall follow an
established template for meeting agenda. The provisional agenda shall be included in the Notice
of Meeting.”

2. Objective/s of the Activity

What are the intended outcomes of the procedures involved in the preparation of meeting agenda?
For example, “The preparation of the meeting agenda aims to ensure a smooth, orderly,
inclusive, and efficient conduct of meetings.”

3. Scope

The SOP covers procedures that are needed to generate the Meeting Agenda. For example, “This
SOP describes how the REC determines what items are to be included in the agenda of regular
and special meetings. This SOP begins with the preparation of the draft meeting agenda and ends
with the filing of the final meeting agenda.”

4. Workflow

What are the different steps involved? Who are the persons responsible in each of these steps?
For example:

ACTIVITY RESPONSIBILITY

Step 1: Preparation of the draft meeting agenda Staff and Member Secretary

Step 2: Preparation of the provisional meeting agenda Chair

Step 3: Distribution of the provisional meeting agenda (SOP REC Staff

## Preparing for a Meeting)

Step 4: Approval of the provisional meeting agenda REC Members

72
 Step 5: Filing of the final meeting agenda (SOP ## on REC Staff
Management of Active Files)

5. Detailed Procedures

What are the detailed steps involved in the SOP and documents and forms that must be included
in the review process?

Step 1 - Preparation of the draft meeting agenda: Does the REC use a meeting agenda template
or form? How and when is the template completed? What information should the REC Staff use to
accomplish this form (e.g. new protocols for full review, expedited review reports, post-approval
reports, administrative issuances, etc.)? What kind of supervision is needed by the REC Staff to
complete this task? For Example: The staff under the supervision of the Member Secretary
prepares the draft agenda two (2) weeks before the scheduled meeting, using the Meeting Agenda
Template (Form ##______). The agenda includes the following:

1. Call to Order
2. Declaration of Quorum
3. Approval of the Provisional Agenda
4. Disclosure of Conflict of Interest
5. Review and Approval of the Minutes of the Previous Meeting
6. Business Arising from the Minutes
7. New Business:
7.1. Initial Review of Protocols
7.2. Review of Resubmissions
7.3. Review of After Approval Submissions
7.4. Report on Expedited Review of Protocols
7.5. Report on Expedited Review of After-Approval Submissions
7.6. Report of Site Visits
8. Other Matters

Step 2 - Preparation of the provisional meeting agenda: Who approves the draft meeting agenda?
How long is this process and how is it initiated and concluded? It is important to cite specific
timelines to properly guide REC staff. The Chair reviews the draft agenda (within 2 days) as the
basis of preparing the provisional agenda for inclusion in the Notice of Meeting.

Step 3 - Distribution of the provisional meeting agenda: What is the method of distribution of
the provisional meeting agenda to members? It is important to cite specific timelines to properly
guide REC Staff. Note that this step is related to the SOP on Preparing for a Meeting. The
provisional agenda is included in the Notice of Meeting (SOP ## Preparing for a Meeting).

Step 4 - Approval of the provisional meeting agenda: When is the provisional meeting agenda
approved and finalized? The REC members approves the provisional agenda during the meeting.
(SOP ## Conduct of Meeting).

Step 5 - Filing of the final meeting agenda: It is recommended that the REC maintain a central
file of all final meeting agenda by year to facilitate retrieval. The staff files the final (approved)

73
meeting agenda in a special folder that contains all meeting agenda in a chronological order. See
SOP ## Managing Active Files).

6. Glossary

What terms/abbreviations used in this SOP need to be defined for better compliance? Examples:

Draft Meeting Agenda – the order of business that includes the list of topics or items
recommended for discussion in a meeting. This is endorsed to the REC Chair for
his/her approval.
Provisional Meeting Agenda – is the order of business that includes the list of topics or
items approved for discussion in a meeting by the REC Chair.
Final Meeting Agenda - is the order of business that includes the list of topics or items
approved for discussion in a meeting by the REC Members in a regular or special
meeting.
Quorum– the minimum number (i.e., majority of the members) and type of members of
the REC that are required to be present in any meeting for the proceedings to be
considered valid. International and national guidelines require the presence of
at least 5 regular members including the non-affiliated and the non-scientist
members.
Conflict of Interest - a situation in which aims or concerns of two (primary and secondary)
different roles or duties are not compatible such that decisions may adversely
affect the official/primary duty.
Protocols for Full Review – Study proposals that require an en banc ethical assessment
because they entail more than minimal risks to the participants and/or that
participation generates vulnerability issues.
Exemption Report – a list of protocols submitted for review that were deemed not to
require the conduct of either expedited or full review. This report is presented
during a regular committee meeting or as required by the institutional authority.
Expedited Review Reports – is an enumeration of protocols (including titles, code number,
proponent, submission date, names of reviewers and decisions) that underwent
expedited review for information of the REC members and for record viewers.
Post-approval Reports – are accounts of the ongoing implementation of an approved study
(e.g., progress report, amendment, safety report, protocol deviation/violation,
early termination, final report, or application for continuing review) that are
required be submitted by the researcher to the REC for monitoring purposes.
Administrative Issuance – official communications or announcements from institutional
authorities.

7. Forms:

What forms/templates/tools are used in the implementation of this SOP? Examples:

Form ## Meeting Agenda Template
Form ## Notice of Meeting

8. History of SOP

Is this the first time that this SOP is being prepared? If yes, then indicate the date of the first draft
and the authors, date of approval of the final draft, and the approving authority. If this is not the
74
first time, then it should include information on the previous versions (see SOP on Writing and
Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC First draft

2 2013 May 01 DEF Included the Invocation in the

Meeting Agenda Template

3 2018 June 03 GHI Removed the Invocation in the

Meeting Agenda Template

9. References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)? Examples:

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

75
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 19
Date of Approval: Conduct of Meetings
Date of Effectivity :

1. Policy Statement

The policy statement should include the rule on quorum, presiding officer, conflict of interest,
and adherence to the agenda. For example, “Meetings shall be presided by the chair or designated
substitute, shall proceed only when quorum is declared, and shall be guided by the approved
agenda. The presence of a conflict of interest among the members shall be disclosed prior to the
discussion of protocols for review.”

2. Objective/s of the Activity

The objective specifies the intended outcomes of conducting meetings. For example, “Meetings
are conducted to provide an opportunity for the REC to arrive at collegial decisions regarding
study protocols and REC operations and to be informed of pertinent administrative matters.”

3. Scope

The SOP on the Conduct of Meeting covers activities required for an effective and efficient conduct
of a meeting. For example, “This SOP describes the manner by which the REC conducts all its
meetings. It covers REC actions and activities from the time the meeting is called to order and
quorum is declared to the time the meeting is adjourned. This SOP begins with the distribution
of meeting materials and ends with the collection, storage, and disposal of meeting materials.”

4. Workflow

What are the different steps involved in the conduct of meeting? Who are the persons responsible
in each of these steps?
For example:

ACTIVITY RESPONSIBILITY
Step 1: Distribution of meeting materials REC Staff

Step 2: Declaration of quorum (formal start) Member Secretary or Chair

Step 3: Approval of the provisional agenda REC Members

76
Step 4: Declaration of conflict of interest (COI) REC Members (who have COI)

Step 5: Approval of minutes of the previous meeting REC Members

Step 6: Discussion of “Business arising from the minutes” REC Members

Step 7: Review of protocols and protocol-related submissions

REC Chair and Members
(SOP on Full Review (SOP#__))

Step 8: Report of results of expedited review (SOP on

Designated Reviewers
Expedited Review (SOP#__))

Step 9: Discussion of operations-related matters REC Chair and Members

Step 10: Adjournment Chair

Step 11: Collection, storage, and disposal of meeting

Staff
materials

5. Description of Procedures

What are the detailed steps involved in the SOP and documents and forms that must be included
in the review process?

Step 1 - Distribution of meeting materials: What documents need to be made available during
the meeting? These documents should have been prepared ahead in accordance with SOP on
Preparing for a Meeting. How many copies are needed? Who are responsible for preparation? It is
recommended that these documents be available already before the start of the meeting.

Step 2 – Declaration of quorum: What is the policy regarding quorum? Who is in charge of
declaring quorum? How is quorum manifested to signal the formal start of the meeting?

Step 3 - Approval of the provisional agenda: How is the provisional agenda approved? Usually the
Chair invites the members to examine the provisional agenda and to propose addition or deletion
of items.

Step 4 - Declaration of Conflict of Interest: How does the REC define conflict of interest in a
meeting? How does the committee manage a disclosure of conflict of interest? For example, some
RECs prefer to declare COI early in the meeting so that the Chair will note it and implement the
policy on conflict of interest management (e.g. conflicted member stepping out of the room or
non-participation in the decision making process).

Step 5 - Approval of minutes of previous meeting: How is the review of the minutes of the
previous meeting done? Who leads in this review? How are questions or objections about the
minutes managed? How are corrections managed? How is approval declared?

Step 6 - Discussion of “Business arising from the minutes”: Who reports on “business arising
from the minutes”? How are issues on “business arising from the minutes” resolved?

77
Step 7 - Review of protocols and protocol-related submissions: Does the REC require
researchers/principal investigators to make a presentation? Are they invited for a clarificatory
interview? If so, how is this managed or facilitated in the discussion? What is the role of the
independent consultant during the meeting?

What is the sequence of review? It is recommended that the discussion is structured in the
following order: technical issues, ethical issues, and informed consent process/form issues. The
primary reviewers should be guided by the assessment form in their presentations. See SOP ## Full
Review.

How does the REC arrive at a decision (e.g. voting, consensus)? For REC’s that require voting, how
is the voting done (e.g. by secret ballot or raising hands)?

Step 8 - Report of results of expedited review: Who presents the results of expedited review to
the members? What do members do with the information? In practice, expedited review results
are for the information of the REC members, only, as well as for the documentation of the review
results.

Step 9 - Discussion of operations-related matters: What are the usual items that fall under
operations-related matters? Which of these items will need to be deliberated upon and approved
by the members? Which are for information only?

Step 10 - Adjournment: What policies cover adjournment of the meeting? How is adjournment
declared? For example, “Meeting must be adjourned after all items in the agenda have been
discussed and/or resolved. A member must move for the adjournment of the meeting, and
seconded, for it to be declared.” Sometimes, meetings are adjourned based on a strict timeframe,
whether or not all items in the agenda have been discussed.

Step 11 - Collection, storage, and disposal of meeting materials: How does the REC staff sort
the documents distributed during the meeting? Are they returned to the shelves? Are extra copies
disposed of? What is the manner of disposal? How does the REC staff keep track of meeting
documents? See SOPs on Managing Active Files (SOP#__) and SOP ## Preparation of Agenda

6. Glossary

What terms/abbreviations used in this SOP need to be defined for effective implementation?
Examples:
Quorum– the minimum number (i.e., majority of the members) and type of members of
the REC that are required to be present in any meeting for the proceedings to
be considered valid. International and national guidelines require the presence
of at least 5 regular members including the non-affiliated and the non-scientist
members.
Conflict of Interest - a situation in which aims or concerns of two (primary and secondary)
different interests are not compatible such that decisions may adversely affect
the official/primary duties.
Agenda - the list of topics or items to be taken up in a meeting arranged in a sequential
manner. It is an outline of the meeting procedure and starts with a “Call to
Order”.
Adjournment – Formal closure of the meeting. Motion for adjournment and record of the
time are minuted.

78
 Voting – act of formally manifesting a choice in a meeting.

Ballot – voting (indicating the choice) by writing the choice on a form for the purpose.
Ballots are subsequently counted to determine how the majority of members
voted for decision-making.
Consensus – the process of arriving at a decision without voting but by generating the over
all sentiment of a group such that deliberations continue until no more strong
objection is registered.
Collegial Decision – a course of action arrived at after a group deliberation where
members were considered of equal authority such that the course of action is
considered a group action and is not ascribed to any one member.
Meeting Minutes - – the official narration and record of the proceedings of the assembly
of REC Members, based on the agenda.
REC Operations- the overall activities of the REC that reflect performance of its functions
and responsibilities.
Protocol – documentation of the study proposal that includes a presentation of the
rationale and significance of the study, background and review of literature,
study objectives, study design and methodology, data collection, dummy tables,
plan for analysis of data, ethical consideration, and dissemination plan.
Protocol-related submissions– other documents that are included (required) in the
submission of the protocol, e.g., Informed Consent Forms, study tools (Interview
guide, survey questionnaire, FGD guide) and CVs of the proponents and
certificates of training.
Business Arising from the Minutes – are matters generated from the discussions in the
previous meeting that need continuing attention and require reporting.
Operations-related Matters – are items included in the agenda that are not directly related
to any protocol under review.
Clarificatory Interview/meeting – is a face-to-face consultation between the REC and the
researcher for the purpose of obtaining explanations or clarity regarding some
research issues identified by the REC to make these issues less confusing or more
comprehensible.

7. Forms

What forms/templates/tools are used in the implementation of this SOP? Examples:

Form ## Attendance Sheet
Form ## Secret Ballot Form
Form ## Protocol Assessment Form
Form ## ICF Assessment Form
Form ## REC Decision Form

8. History of SOP

Is this the first time that this SOP is being prepared? If yes, then indicate the date of the first draft
and the authors, date of approval of the final draft, and the approving authority. If this is not the
first time, then it should include information on the previous versions (see SOP on Writing and
Revising SOPs (SOP#__)).

79
 Version No. Date Authors Main Change

1 2010 July 15 ABC First draft

2 2013 May 01 DEF Included the independent

consultant in the meeting
attendance

3 2018 June 03 GHI Included an adjournment policy

9. References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)? Examples:

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

80
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 20
Date of Approval: Preparation of the Minutes of Meetings
Date of Effectivity :

1. Policy Statement

The minutes are the official documentation of the proceedings of an REC meeting. They represent
the evidence for transparency and integrity of the decision-making process. They are guided by
the approved agenda. A sample policy statement may be as follows, “The meeting minutes shall
be based on the approved agenda and shall be the basis of the decision letter on protocols.”

2. Objective of the Activity

The objective specifies the intended outcomes of the procedures involved in preparing the
meeting minutes. For example, “The preparation of the minutes of the meeting ensures the
proper documentation of the procedures and decisions in an REC meeting.”

3. Scope

This SOP on Preparation of Minutes of Meetings covers procedures to document the proceedings
of the meeting especially pertaining to the deliberations in the full review of protocols. For
example, “This SOP includes REC actions related to the documentation of the proceedings of a
meeting, the final output of which is the minutes of the meeting. This SOP begins with the entry
of preliminary information on the minutes template and ends with the filing of the approved
minutes.” Does the REC have special requirements for this type of document? Most RECs typically
use a template for meeting minutes

4. Workflow

What are the different steps involved in the process of preparing the minutes of the meeting? Who
are the persons responsible in each of these steps?

For example:

ACTIVITY RESPONSIBILITY

Step 1: Entry of preliminary information on the minutes template REC Staff

Step 2: Preparation of the draft minutes REC Staff and Member

Secretary

Step 3: Notation of the draft minutes Chair

81
 Step 4: Approval of the minutes in the next REC meeting Chair and Members

Step 5: Filing of the approved minutes (SOP on Managing Active REC Staff
Files (SOP#__))

5. Description of Procedures

What are the detailed steps involved in the SOP and documents and forms that must be included
in the review process?

Step 1- Entry of preliminary information on the minute’s template: Does the REC use a minute’s
template? Does the REC have a system to organize this document ahead of the meeting date such
as filling it out with preliminary or relevant information ahead of the meeting (e.g. protocol-
related information, other matters)? Who supervises the REC Staff in fulfilling this task?

Step 2 - Preparation of the draft minutes: How does the REC prepare the draft minutes? During
the meeting, the REC Staff is tasked with documentation of proceedings in accordance with the
agenda. How does the REC Staff document all board opinions and actions (e.g. take down notes,
project the template on screen and do real-time note-taking) in all specific sections of the agenda?
How does the REC ensure that the REC staff documents the discussion as the agenda is developed
and discussed, with respective reasons for protocol-related actions? What information is
mandatory to be included from the discussion (e.g. comments and recommendations on the
scientific issues, ethical issues, and informed consent form issues)? Note that opinions and actions
included in the minutes are understood to be collective and need not be attributed to specific
members? How much time is needed for this task? Who has oversight on the fulfilment of this task
by the REC Staff?

Step 3 - Notation of the draft minutes: How will the draft minutes be completed? How soon
should the draft minutes be prepared for notation of the Chair? What does the REC Staff do after
completing the draft of the minutes? To whom does the REC Staff submit the draft (e.g. Member
Secretary or Chair)? In how many days after the meeting should the REC complete, correct, and
finalize the draft? In general, the following items are included in the minutes of the meeting:

o Date and venue of meeting

o Members attendance (members present and absent)
o Presence of Independent consultants, primary investigators, guests, and
observer’s attendance (if any)
o Time when the meeting was called to order
o Declaration of Quorum
o Name of Presiding officer
o Conflict of Interest (COI) declaration
o Items discussed, issues raised, and resolutions
o REC decisions and recommendations
o Name and signature of person who prepared the minutes
o Name and signature of the Chair and date of notation

82
Step 4 - Approval of the minutes in the next REC meeting: How is the approval of the
provisional minutes signified? For example, approval of the minutes is done through a formal
motion from any member of the committee and seconded accordingly.

Step 5 - Storage of the approved minutes: What type of storage system does the REC have for
the final minutes of meeting? What kind of documentation is necessary to complete this task? It
is recommended that the REC maintain a central file of all meeting minutes by year to facilitate
retrieval. See SOP on Managing Active Files (SOP#__).

6. Glossary

What terms/abbreviations used in this SOP need to be defined for effective implementation?
Examples:
Meeting Agenda- the list of topics or items to be taken up in a meeting arranged in a
sequential manner. It is an outline of the meeting procedure and starts with a
“Call to Order”.
Draft Meeting Minutes – Proceedings of the meeting prepared by the Secretariat under the
supervision of the Member-Secretry.
Provisional Meeting Minutes – Proceedings of the meeting that have been noted or
approved by the Presiding officer.
Final Meeting Minutes – Proceedings of the meeting that have been approved by the REC
members.
Real-time Recording – the process of documenting the minutes of the meeting as the
meeting proceeds simultaneously.
Conflict of Interest – a situation in which aims or concerns of two (primary and secondary)
different interests are not compatible such that decisions may adversely affect
the official/primary duties.
7. Forms

What forms/templates/tools are used in the implementation of this SOP? Example:

Form ## Minutes Template

8. History of SOP

Is this the first time that this SOP is being prepared? If yes, then indicate the date of the first
draft and the authors, date of approval of the final draft, and the approving authority. If this is
not the first time, then it should include information on the previous versions (see SOP on
Writing and Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC First draft

2 2013 May 01 DEF Revised the procedure in

preparing the draft minutes
from audio recording to real-
time note taking

83
 3 2018 June 03 GHI Revised the timeline in
approving meeting minutes

9. References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)? Examples:

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

84
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 21
Date of Approval: Communicating REC Decisions
Date of Effectivity :

1. Policy Statement

The REC must be clear, informative and timely in communicating its decisions. An example of a
policy, in this regard, may be as follows, “The REC shall communicate its decisions to the
researcher within ___ (reasonable timeframe not later than six weeks) after the receipt of
complete set of submission documents. The communication document shall include clear
instructions/recommendations for guidance of the researcher, must be written on an official
stationery of the REC and signed by the chair.”

2. Objective of the Activity

The objective specifies the intended outcome of managing the communication of REC decisions.
For example, “The management of communicating REC decisions ensures that all stakeholders
are appropriately, accurately and promptly informed of the results of deliberations of the REC.”

3. Scope

The scope of the SOP on communicating REC decisions covers procedures and special requirements
for notification of researchers/investigators of decisions or actions of the REC. Usually the REC
uses either a Notification Form or an Approval Form to summarize required modifications in the
protocol or to its approval respectively. For example, “This SOP covers REC actions related to the
communicating REC decisions (e.g. actions to applications submitted to the REC). This SOP begins
with the finalization of recommendations of the committee or the reviewers and ends with the
filing of the decision document in the protocol file.”

4. Workflow

What are the different steps involved in communicating REC decisions? Who are the persons
responsible in each of these steps?
For example:

ACTIVITY RESPONSIBILITY

Step 1: Finalization of recommendations of the committee (in Chair

case of full review) (SOP ## Full Review) ) or Finalization of
recommendations of reviewers (in case of expedited review) (SOP
## Expedited Review)

Step 2: Transfer of information from meeting minutes or reports REC Staff, Member
to REC decision forms or templates Secretary
85
Step 3: Approval of the REC decision document Chair

Step 4: Transmittal of REC decision to researcher REC Staff

Step 5: Filing of the decision document in the protocol file (SOP REC Staff
## Managing Active Files ) and Update of Protocol Database

5. Description of Procedures

What are the detailed steps involved in the SOP and documents and forms that must be included
in the review process?

Step 1 - Finalization of recommendations of the committee (in case of full review) or reviewers
(in case of expedited review): For finalization of Committee’s Recommendations See SOP## on
Full Review or for finalization of Reviewers’ Recommendations, see SOP ## Expedited Review).

Step 2 - Transfer of information from meeting minutes to REC decision forms or templates:
Upon approval of the draft minutes, or finalization of the reviewers’ recommendations, how does
the REC relay the information to the researchers? Does the REC have an Approval Letter or
Notification Letter to send to the researcher, as the case may be? Who drafts the document? Who
oversees this process? How long should this process take?

Step 3 - Approval of the REC decision document: Who reviews and approves the decision
documents? How is this approval signified? How long does this process take?

Step 4 - Transmittal of REC decision to researcher: How do researchers get the results of the
review (e.g. email or hand-delivered or pick up at the REC office)? How long does this process
take? Who oversees this process?

Step 5 - Filing of the decision document in the protocol file and Update of the Protocol
Database: It is recommended that the REC maintains all protocol related decisions or actions in
the protocol folder to facilitate retrieval. The action should also be noted in the protocol
database. What type of storage system does the REC have for protocols? What kind of
documentation is necessary to complete this task (e.g. protocol index, database)? See SOP on
Managing Active Files (SOP#__).

6. Glossary

What terms/abbreviations used in this SOP need to be defined for effective implementation?
Examples:

Expedited Review is the ethical evaluation of a research proposal and other protocol-
related documents, a resubmission and after-approval submissions, conducted by
only 2-3 members of the committee without involvement of the whole
committee.
Full Review– is the ethical evaluation of a research proposal and other protocol-related
documents, a resubmission and after-approval submissions, conducted by the
research ethics committee en banc, in the presence of a quorum, using established
technical and ethical criteria.

86
 Protocol Index – is a chronological record of the documents in the protocol file. The
protocol index is in table form indicating the date of filing, the nature of the
document filed, the name and signature of the person who filed and an extra
column to record any movement of the document. The index is pasted inside the
cover page of the protocol file/folder for easy reference and checking,
Protocol Database - a collection of information about protocols that is structured and
organized for easy access, management, intepretation, analysis and updating. It
is usually in an electronic platform used for tracking and monitoring the
implementation of a study.
Active Files – are documents pertaining to protocols which are currently being assessed,
managed or monitored by the REC.

7. Forms

What forms/templates/tools are used in the implementation of this SOP? Example:

Form ## Decision Form/Letter

Form ## Approval Form/Letter

8. History of SOP

Is this the first time that this SOP is being prepared? If yes, then indicate the date of the first
draft and the authors, date of approval of the final draft, and the approving authority. If this is
not the first time, then it should include information on the previous versions (see SOP on
Writing and Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC First draft

2 2013 May 01 DEF Revised template of

notification

3 2018 June 03 GHI Use of the protocol database

9. References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)? Examples:

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

87
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 22
Date of Approval: Management of Incoming and Outgoing
Date of Effectivity : Communications

1. Policy Statement

Incoming and outgoing communications need to be recorded for monitoring and tracking purposes
as evidence of quality service and efficient operations of the REC. The policy may be stated as,
“All communications shall be recorded accurately and appropriately in a physical log book and
electronic database. Protocol-related communications are separated from administrative
communications. Incoming communications shall be acted upon promptly.”

2. Objective/s of the Activity

The objectives specify the intended outcomes of the procedures involved in managing REC
incoming and outgoing communications? For example, “The management of REC incoming and
outgoing documents/communications aims to establish accountability and an efficient and
effective tracking system.”

3. Scope

The SOP on Management of Incoming and Outgoing Communications covers procedures involved in
receiving, processing and filing communications. For example, “This SOP covers REC actions
related to organizing incoming and outgoing documents and ensuring an appropriate REC
response. This SOP begins with the sorting of incoming/outgoing communications and ends with
the storing or filing of incoming/outgoing communications.” Does the REC have special
requirements for this type of document? Most RECs use a scheme to systematically sort and store
documents.

4. Workflow

What are the different steps involved in managing REC incoming and outgoing communications?
Who are the persons responsible in each of these steps? For example:

ACTIVITY RESPONSIBILITY

Step 1: Sorting of incoming/outgoing communications REC Staff

Step 2: Recording of incoming/outgoing communications REC Staff

Step 3: Acting on incoming communications Chair or Member

Secretary

Step 4: Filing of incoming/outgoing communications and Updating of REC Staff

respective Databases

88
5. Description of Procedures

What are the detailed steps involved in the SOP and documents and forms that must be included
in the review process?

Step 1 - Sorting of incoming/outgoing communications: What kind of communications is received

by the REC (e.g. letters, official memoranda, or emails)? Does the REC differentiate procedures
depending on source (e.g. researchers, sponsors, regulators)? What procedures are in place to
organize these communications so that they are addressed in a relevant and timely manner (e.g.
separating protocol-related from process-related communication)? Who is responsible for this
action? Who oversees this process?

Step 2 - Recording of incoming/outgoing communications: How does the REC record the
incoming/outgoing communications? Does the REC have a recording system that documents the
date received, source (person who sent communication), subject, person who received
communication, action taken (with details of who received it from the REC), such as logbook or
log of submissions? Who is responsible for this action? Who oversees this process?

Step 3 - Acting on communications: Who is responsible for initiating response on incoming

communications? Who finalizes these responses? Who is the usual signatory for outgoing
communications?

Step 4 - Storing or filing of incoming/outgoing communication: What storage system does the
REC have for incoming/outgoing communications? What is the practice of the REC related to filing
of communications (e.g. protocol-related communications are filed in the study protocol file while
non-protocol-related documents are filed in the appropriate administrative file)? Does the REC
use an indexing system for file of communications, and if so, how does it work? Who is responsible
for this action? Who oversees this process?

6. Glossary

What terms/abbreviations used in this SOP need to be defined for effective implementation?
Examples:
Incoming Communications – are documents which are directed to and received at the REC
office.
Outgoing Communications – are documents generated within the REC office intended for
individuals or offices related to the operations of the REC.
Administrative Documents - documents that pertain to the operations of the REC and are
not directly related to a study or protocol. Examples include the SOPs,
Membership files, Agenda and minutes files, administrative issuances.
Protocol-related File/ Documents - consist of all other documents aside from the
proposal/protocol itself that are required to be submitted for review, e.g.,
Informed Consent Form, Survey Questionnaire, CV of proponent, advertisements,
In-depth Interview Guide Questions Indexing System.

7. Forms

What forms/templates/tools are used in the implementation of this SOP? Examples:

89
 Logbook for Incoming Communications
Logbook for Outgoing Communications
Form ## Index of Protocol File
8. History of the SOP

Is this the first time that this SOP is being prepared? If yes, then indicate the date of the first draft
and the authors, date of approval of the final draft, and the approving authority. If this is not the
first time, then it should include information on the previous versions (see SOP on Writing and
Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC First draft

2 2013 May 01 DEF Included “Topic” as entry on

Logbook for Outgoing
Communications

3 2018 June 03 GHI Included Member Secretary as

alternate signatory for
outgoing communications

9. References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)? Examples:

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

90
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 23
Date of Approval: Management of Active Files
Date of Effectivity :

1. Policy Statement

The REC needs to classify its protocol files into active or inactive. Considerations include proper
labelling and manner of storage. An example of a policy may be as follows, “Active files shall be
kept in a secured cabinet, arranged in an orderly manner that shall allow easy identification and
retrieval. Access to the active files shall be governed by SOP on Managing Access to Confidential
Files (SOP#__)”

2. Objective/s of the Activity

The objective specifies the intended outcomes of managing active files. For example, “The
management of active files ensures accessibility, easy retrieval of current files, and protection
of those that require confidentiality.”

3. Scope

The SOP on Management of Active Files covers storage of files and access procedures. For
example, “This SOP covers procedures done related to protocols accepted for review, undergoing
review, or has been approved by the REC. This SOP begins with the classification and coding of
active files and ends with the periodic updating of the file.”

4. Workflow

What are the different steps involved in the process of managing active files? Who are the persons
responsible in each of these steps?

ACTIVITY RESPONSIBILITY

Step 1: Classification and coding of Active Files Member Secretary and Staff

Step 2.: Preparation of the Protocol Folder Staff

Step 3: Periodic updating of the Protocol File Member Secretary and Staff

5. Description of Procedure

Step 1. Classification and coding of active files: The staff under the supervision of the member
secretary classifies active files as follows:
o Initial Submission
o Resubmission

91
 o Progress Report

o Amendment
o Protocol Deviation
o Protocol Violation
o SAE Serious Adverse Event (SAE
o SUSAR – Suspected Unexpected Serious Adverse Reaction –
o Early Termination –
o Continuing Review
o Final Report/ Close Out Report
The staff assigns a code to the Initial Submission and indicates the same for the rest of the
submissions related to the initial submission. The code consists of the year and the serial member
that indicate the sequence order of receipt. For example, a protocol received in 2019 as the 10th
submission in that year will be coded as 2019-010.
Step 2. Preparation of the Protocol Folder: The staff files all documents pertaining to a study
in a vertical folder that is labelled on the front cover and along the spine with: Protocol Code-
Study Title - Proponent’s Family Name - Sponsor or Funding Agency. The staff attaches a protocol
index on the inside front cover that indicates the contents of the folder.

Step 3. Periodic Updating of the Protocol File: The staff ensures that the documents are filed
in chronological order such that the most recent documents are topmost. These documents
include the following:

o Protocol (Original and Revised) versions

o Informed consent (Original and Revised) versions
o Reports: Progress, Protocol Deviation/Violation, SAE/SUSAR, Final, Amendment,
Early Termination, Site Visit Reports
o Assessment Forms for each of the submitted and reviewed reports which should be
signed and dated
o Excerpts of Minutes of Meetings when the protocol and reports were included in
the agenda
o Decision and Approval Letters
o Communications
The staff updates the protocol index each time a new document is added to the file. The protocol
folder is periodically checked for orderliness and completeness.

6. Glossary

Initial Submission - a set of documents consisting of the full proposal and other study-
related documents that is received by the REC so that ethical review can be done.
Resubmission- the revised study proposalth at is forwarded to the REC in response to the
recommendations given during the initial review.
Progress Reports- A systematized description of how the implementation of the study is
moving forward. This is done by accomplishing the Progress Report Form ##. The
frequency of submission (e.g., quarterly, semi-annually or annually) is
determined by the REC based on the level of risk.
Amendments- a change in or revision of the protocol made after it has been approved.
Protocol Deviation– non-compliance with the approved protocol that does not increase risk

92
 nor decrease benefit to participants and does not significantly affect their rights,
safety or welfare or the integrity of data.Example: missed visit, non-submission
of a food diary on time.
Protocol Violation- non-compliance with the approved protocol that may result in an
increased risk or decreased benefit to participants or significantly affect their
rights, safety or welfare or the integrity of data. Example: incorrect treatment,
non-compliance with inclusion/exclusion criteria.
Serious Adverse Event (SAE) – is an event observed during the implementation of a study
where the outcome is any of the
following
o Death
o Life threatening
o Hospitalization (initial or prolonged)
o Disability or permanent damage
o Congenital anomaly/ birth defect
o Required intervention to prevent permanent impairment or damage (devices)
o Other serious (important medical) events whether or not it is related to the
study intervention.
Suspected Unexpected Serious Adverse Reaction (SUSAR) - is a noxious response to a drug
that is not described in the Investigator’s Brochure nor in the drug insert.
Early Termination- is ending the implementation of a study before its completion. This is
a decision made by the sponsor or a regulatory authority and/or recommended by
the Data Safety Monitoring Board, researcher/investigator in consideration of
participant safety, funding issues, protocol violations, and data integrity issues.
Continuing Review - is the decision of the REC to extend ethical clearance of a study
beyond the initial period of effectivity based on an appreciation that the research
is proceeding according to the approved protocol and there is reasonable
expectation of its completion.
Final Reports/ Close Out Reports – is a summary of the outputs and outcomes of the study
upon its completion. The REC requires the accomplishment of the Final Report
form within a reasonable period after the end of the study.
Protocol Index - is a chronological record of the documents in the protocol file. The
protocol index is in table form indicating the date of filing, the nature of the
document filed, the name and signature of the person who filed and an extra
column to record any movement of the document. The index is pasted inside the
cover page of the protocol file/folder for easy reference and checking.
Assessment Form – evaluation tool accomplished by the reviewers when appraising the
protocol or the informed consent form.
7. Forms:

Form ## Protocol Index

8. History of SOP

Is this the first time that this SOP is being prepared? If yes, then indicate the date of the first draft
and the authors, date of approval of the final draft, and the approving authority. If this is not the
first time, then it should include information on the previous versions (see SOP on Writing and
Revising SOPs (SOP#__)).

93
 Version No. Date Authors Main Change

1 2010 July 15 ABC First draft

2 2013 May 01 DEF Revised Coding System

3 2018 June 03 GHI Revised List of documents to be

included in the protocol File

9. References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)? Examples:

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

94
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 24
Date of Approval: Archiving
Date of Effectivity :

1. Policy Statement

Protocols for archiving include those (a) with approved/ accepted Final Reports, (b) with approved
Early Termination reports and (c) whose proponent/researcher/investigator has not submitted a
response to the REC recommendation after 3 months (or as specified by the REC). What
institutional policies or standards exist which are relevant to archiving research files (e.g. ISO
coding system, database management)? Will these apply to REC documents? How? What is the
policy on retrieval of archived files?

The prescriptions of the WHO Operational Guidelines/CIOMS Guidelines/ICH GCP and the National
Ethical Guidelines need to be followed, including security of file storage and access, document
control, and document tracking.

Example: “Files of studies which have been terminated or completed or declared inactive shall
be kept in a separate storage for 3 years. Studies of Researchers who have not resubmitted their
proposals within 3 months after receiving the Notification Letter (Form ##) shall be considered
inactive.”

2. Objective/s of the Activity

The objective/s specify the intended outcomes of archiving terminated, inactive, and completed
protocols? For example, “Archiving inactive, terminated, or completed protocols ensures efficient
retrieval of information from the files for reference and compliance with national and
international guidelines.”

3. Scope

The SOP on archiving covers procedures in identifying documents to be archived, securing their
storage, and providing access when necessary. For example, “This SOP includes procedures
related to storage and retrieval of protocols that are classified as inactive, terminated or
completed. This SOP begins with the acceptance of final or early termination reports and
identification of a protocol as inactive and ends with the inclusion of the files in the archives and
update of the protocol database.”

4. Workflow

What are the different steps involved in the process of archiving of terminated, inactive, and
completed files? Who are the persons responsible in each of these steps?
For example:

95
 ACTIVITY RESPONSIBILITY

Step 1: Acceptance of Final or Early Termination Reports (SOP## REC Members, Chair
on Review of Final Reports, SOP ## Review of Early Termination
Reports, and Identification of a Protocol as Inactive.

Step 2: Updating of corresponding protocol folder REC Staff

Step 3: Transfer of the protocol folder in the archives and Update REC Staff
of the Protocol Database

5. Description of Procedures

What are the detailed steps involved in the SOP and documents and forms that must be included
in the review process?

Step 1 - Acceptance of Final or Early Termination Reports and Identification of an Inactive

File: The Committee members approve or accept the final report or early termination report
during a meeting (SOP## Review of Final, Report; SOP ## Review of an Early Termination Report).
In the identification of an Inactive File, the staff informs the Member Secretary of the failure of
a concerned researcher/ proponent/ investigator to respond to the recommendations of the REC
in the last 3 months during which time the researcher/proponent/investigator has been
appropriately reminded of the requirement. This is included in the agenda of the next meeting
where the protocol is declared inactive.

Step 2 - Updating of the corresponding active file: The staff files the Final or Early termination
report in the corresponding protocol folder, including the excerpts of the minutes that approved
the report or declared the protocol as inactive.

Step 3 - Transfer of the Protocol Folder in the Archives and Update of the Protocol Database:
The staff checks whether the documents listed in the protocol file index are complete and removes
extraneous documents. Thence, the staff transfers the folder to the archive section and updates
the protocol database.

6. Glossary

What terms/abbreviations used in this SOP need to be defined for effective implementation?
Examples:
Final Report – is a summary of the outputs and outcomes of the study upon its
completion. The REC requires the accomplishment of the Final Report form
within a reasonable period after the end of the study.
Early Termination - ending the implementation of a study before its completion.
Inactive Study – a study whose proponent has not communicated with the REC with regard
to issues pertaining to the approval or implementation of the study – within a
period of time required by the REC.
Active Study – is an ongoing study, implementation of which is within the period covered
by ethics clearance.

96
 Archiving- is the systematic keeping of protocol files in storage after the studies have
been completed with final reports accepted, or terminated or declared inactive.
Confidentiality of Documents – pertains to the recognition and awareness that certain
documents that have been entrusted or submitted to the REC must not be freely
shared or disclosed.
Controlled document – pertains to the document that have been entrusted or submitted
to the REC that must not be freely shared or disclosed such that it is appropriately
tagged and its distribution carefully tracked, monitored and appropriately
recorded.

7. Forms

What forms/templates/tools are used in the implementation of this SOP? Example:

Form ## Borrower’s Log

8. History of SOP

Is this the first time that this SOP is being prepared? If yes, then indicate the date of the first draft
and the authors, date of approval of the final draft, and the approving authority. If this is not the
first time, then it should include information on the previous versions (see SOP on Writing and
Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC First draft

2 2013 May 01 DEF Changed timeline for keeping

inactive files

3 2018 June 03 GHI Added policy on access to

inactive files

9. References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)? Examples:

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

97
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 25
Date of Approval: Management of Access to Confidential Files
Date of Effectivity :

1. Policy Statement

It is the responsibility of the REC to keep particular documents in its custody confidential. This is
to protect the intellectual property rights of research proponents and to protect REC members
from unnecessary scrutiny and pressure from non-authorized individuals. In the Philippines,
personally identifiable documents entered into a database system are subject to protections under
the Data Privacy Act of 2012, emphasizing the need to lay down policies authorizing access to such
documents. Confidential files include study protocol-related documents (e.g. protocols, case
report forms, informed consent documents, scientific documents, expert opinions or reviews),
meeting minutes, decisions, action letters/notification of committee decision, approval letters,
and study protocol-related communications. Generally, institutions have in-house policies or
standards to promote confidentiality of institutional files. RECs must make an effort to be familiar
with these policies and procedures so that these can be adopted by the REC. For example: who
determines confidentiality of documents? Who can have access to these files (e.g. REC members,
institutional authorities, regulatory agencies, sponsors)? Does the REC have a policy regarding the
use of confidential files for training purposes? Who will be responsible for anonymization? The
prescriptions of the WHO Operational Guidelines/CIOMS Guidelines/ICH GCP and the National
Ethical Guidelines need to be followed for security, storage, and access of files.

For example: Access to the REC confidential files shall be regulated and limited to REC members
and staff. Other persons with legitimate interest in these files (e.g. institutional authorities,
regulatory agencies, sponsors) shall be allowed to access specific files with proper justification.
Researchers/Investigators shall be allowed access only to their own protocol files upon request.

2. Objectives of the Activity

The objectives specify the intended outcomes of the procedures involved in managing requests
for access to confidential files. For example, “Management of access to confidential files helps
protect the intellectual property rights of researchers and enhances the credibility and integrity
of the REC.”

3. Scope

The scope of this SOP includes all the procedures necessary to control access to confidential files.
For example, “This SOP consists of procedures for accessing confidential files including document
handling and distribution. This SOP begins with the receipt of the request to access and ends with
the return of the documents to the protocol folder.

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4. Workflow

What are the different steps involved in maintaining the confidentiality of study files? Who are
the persons responsible in each of these steps?
For example:

ACTIVITY RESPONSIBILITY

Step 1: Receipt and logging of request for access to Staff

confidential files

Step 2: Approval of requests for access and retrieval of Member Secretary or Chair
documents

Step 3: Supervision of use of retrieved document Staff

Step 4: Return of document to the files Staff

5. Description of Procedures

What are the detailed steps involved in the SOP and documents and forms that must be included
in the review process?

Step 1 - Receipt and logging of request for access to confidential files: For example: The staff
receives the request (Form ##) to access specific files and refers this to the Chair or Member
Secretary.

Step 2 - Approval of requests for access and retrieval of documents: What are the requirements
for approval of requests for access to confidential files (e.g. authority of the requesting individual,
reason for the request, and signing of confidentiality agreement)? The Chair or Member Secretary
considers the indicated reason for the request and when found satisfactory approves it. The staff
asks the individual requesting to sign the confidentiality agreement and proceeds to retrieve the
pertinent document.

Step 3 - Supervision of use of retrieved document: How will the REC supervise the use of the
retrieved documents? The staff asks the user to sign the logbook, enforces the restriction to
room-use of documents and limits photocopying to concerned researchers/principal investigators.

Step 4 - Return of document to the files: Who is responsible in ensuring that the document is
returned to the proper file? The staff returns the retrieved files to the protocol file.

6. Glossary

What terms/abbreviations used in this SOP need to be defined for effective implementation?
Examples:
Confidentiality - is the duty to refrain from freely disclosing private/ research information
entrusted to an individual or organization.
Study-related Communications – documents that refer to an exchange of information or
opinions regarding a study, usually between the REC and the researcher.

99
 Sponsor- an individual, company, institution or organization which takes responsibility for
the initiation, management, and financing of a clinical trial.
Intellectual property –refers to intangible creations of the human mind (such as
inventions, literary and artistic works, designs, and symbols, names and images
used in commerce, that are considered as owned by the one who thought of it.
Intellectual property includes information and intellectual goods.
Intellectual property right – the exclusive right given to persons over the use of the
creations of his/her mind for a certain period of time.
Meeting Minutes – narration of the proceedings of the assembly of REC members.
Regulatory Authorities – refer to government agencies or institutions that have oversight
or control over the conduct of research, e.g., Department of Health, Food and
Drug Administration, Research Institutions.
Conflict of Interest -a situation in which aims or concerns of two (primary and secondary)
different interests are not compatible such that decisions may adversely affect
the official/primary duties.
Anonymization – process of removing the link between the research participant and the
personally identifiable data, in such a way that the research participant cannot
be determined nor traced.
Room-use Restriction – the rule that limits the use of a document within the designated
premises.

7. Forms

What forms/templates/tools are used in the implementation of this SOP? Examples:

Form ## Request Form
Form ## Log of Requests
Form ## Log of Access

8. History of SOP

Is this the first time that this SOP is being prepared? If yes, then indicate the date of the first draft
and the authors, date of approval of the final draft, and the approving authority. If this is not the
first time, then it should include information on the previous versions (see SOP on Writing and
Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC First draft

2 2013 May 01 DEF Revised policy on photocopying

3 2018 June 03 GHI Added “reason for access” in

the request form

9. References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)? Examples:

100
CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

101
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 26
Date of Approval: Management of Queries and Complaints
Date of Effectivity :

1. Policy Statement

Queries and complaints may come from various stakeholders but the responsibility of the REC is
highest for those coming from research participants and their families. Nevertheless, all queries
and complaints must be addressed as promptly, diligently, and appropriately as possible. An
example of a policy statement would be, “Queries and complaints from clients, patients, or
research participants shall be attended to promptly and appropriately while exercising due
diligence. The nature of queries shall determine whether they can be answered by the REC staff
or referred to the primary reviewers of the specific protocol. All complaints shall be referred to
the Chair who shall determine the level of risk involved. Complaints of minimal risk shall be
referred to the primary reviewers for resolution. Complaints of more than minimal risk shall be
taken up in a special meeting within 48 hours for deliberation by the committee en banc with
the primary reviewers leading the discussion.”

2. Objective/s of the Activity

The objectives specify the intended outcomes in managing queries and complaints. For example,
“Managing queries and complaints aims to promote public trust and confidence in the institution,
especially in the REC and to ensure that the rights and well-being of participants are attended
to.

3. Scope

The scope of this SOP includes all the procedures for receiving and appropriately responding to
queries and complaints. For example, “This SOP is limited to queries and complaints of research
participants, or their families, in studies that have been issued an ethical approval by the REC.
This SOP begins with the receipt, logging, and acknowledgement of queries and complaints and
ends with the logging of the response and inclusion in the agenda of the REC meeting.”

4. Workflow

For example:

ACTIVITY RESPONSIBILITY

Step 1: Receipt, logging, and acknowledgement of queries and REC Staff

complaints (SOP on Managing REC Incoming and Outgoing
Communications)

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 Step 2: Referral of query or complaint to competent authority. REC Staff

2.1 Referral of protocol-related query to primary reviewers.

2.2. Referral of all complaints to the REC Chair

Step 3: Formulation of response

3.1. Protocol-related queries Primary Reviewers

3.2. Minimal-risk complaints Primary Reviewers

3.3. More than minimal risk complaints : en-banc committee Chair and REC members

Step 4: Communication of response (SOP on Communicating REC REC Staff

Decisions (SOP#__))

Step 5: Logging of the response (SOP on Managing REC Incoming REC Staff
and Outgoing Communications (SOP#__)) and inclusion in the
agenda of the REC meeting (SOP on Preparing the Meeting Agenda
(SOP#__))

6. Description of Procedures

Based on the workflow (see above) describe each step. For example:

Step 1 - Receipt, logging, and acknowledgement of queries and complaints: Does the REC have
a logbook dedicated to queries and complaints? What information is included in the logbook? For
example, date, time, name of concerned party, specific study, nature of query or complaint.

Step 2 - Referral of query or complaint to competent authority: Does the REC have an algorithm
that guides the staff on who can respond to general/usual queries and complaints?
2.1. The staff refers queries related to specific protocols approved by the REC to the primary
reviewers.
2.2. On the other hand, the staff refers all complaints to the REC chair who determines the level
of risk effected by the issue.
2.2.1. Minimal risk complaints are referred to the primary reviewers of the concerned
protocol.
2.2.2. Complaints that involve more than minimal risk are referred to the Committee
through a special meeting that shall be called within 48 hours. The staff notifies the
concerned primary reviewers that they will lead the discussion such that pertinent
materials are provided to them as reference.

Step 3 - Formulation of response: Does the REC have a special form for documenting responses
to queries and complaints?
3.1. For queries, the primary reviewers accomplish the Form ## Query Reply.

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3.2. For minimal risk complaints, the primary reviewers accomplish Form ## Complaints
Resolution.
3.3. For more than minimal risk, the committee may choose any of the following options:
3.3.1. Constitute a site visiting team to gather more information, verification and
clarification regarding the source and cause/s of the complaint for its early resolution.
3.3.2. Designate the primary reviewers to meet with the complainants and the researcher
(preferably separately) for clarification of issues and obtain suggestions for resolution.
3.3.3. Formulate recommendation if satisfied with the adequacy of information –
- request for explanation/justification from researcher
- accept request/demand of participant
- suspension of further recruitment
- amendment of protocol and re-consent of participants
- others

Step 4 - Communication of response: Is there a special form for communicating the response to
queries and complaints? Who prepares this? Who signs? See SOP on Communicating REC Decisions
(SOP#__).

Step 5 – Logging of the response and inclusion in the agenda of the REC meeting: How will the
response be documented? See SOPs on Managing REC Incoming/Outgoing Communications (SOP#__)
and Preparing the Meeting Agenda (SOP#__).

5. Glossary

What terms/abbreviations used in this SOP need to be defined for better for effective
implementation? Examples:
Query – the act of asking for information or clarification about a study.
Complaint – the act of expressing discontent or unease about certain events or
arrangements in connection with a study.
Regular Meeting– a periodically scheduled assembly of the REC.
Special Meeting - an assembly of the Committee outside of the regular schedule of
meetings for aspecific purpose.
Competent Authority –designated officer or member of the REC with the authority to
respond to queries and complaints regarding studies approved by the REC.
Primary Reviewers– are members of the Research Ethics Committee (usually a scientist
and a non-scientist) assigned to do an in-depth evaluation of the research-related
documents using technical and ethical criteria established by the committee.
Site Visiting Team– members/staff of the REC (2-4 members) assigned by the REC Chair to
formally go to the research site, meet with the research team and evaluate
compliance with the approved protocol and Informed Consent Form and Process,
including other related research procedures to ensure promotion of the rights,
dignity and well-being of participants and protection of integrity of data.

6. Forms:What forms/templates/tools are used in the implementation of this SOP? Examples:

Form ## Query/Complaint Form

Form ##Query/Complaint Response Form

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7. History of SOP: Is this the first time that this SOP is being prepared? If yes, then indicate the
date of the first draft and the authors, date of approval of the final draft, and the approving
authority. If this is not the first time, then it should include information on the previous
versions (see SOP on Writing and Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC First draft

2 2013 May 01 DEF Designated competent

authority

3 2018 June 03 ABC Revised the Query/Complaint

DEF Response Form

8. References

What references did you use in the preparation of this SOP (e.g. guidelines, other institutional
SOPs, institutional policies, institutional documents, local regulations)? Examples:

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

105
 Name of the REC
e.g. Research Ethics Committee,
Name and
Ethics Review Committee,
Logo of Institution
Institutional Ethics Review Committee,
Institutional Review Board
Version No: SOP No. 27
Date of Approval: Writing and Revising SOPs
Date of Effectivity :

1. Policy Statement

SOPs ensure efficiency, transparency, and consistency of REC operations. The SOP manual needs
to be periodically reviewed to determine the need for revision or new SOPs in order to respond to
emerging operational issues of the REC. A policy statement could be stated as, “The REC shall
designate a team to annually review its set of SOPs to determine its continuing relevance and
effectiveness to its operations.”

2. Objective of the Activity

The objective specifies the intended outcome of writing and revising SOPs. For example, “Writing
and revising SOPs ensures continuing quality assurance of REC functions.”

3. Scope

This SOP on Writing and Revising SOPs covers the procedures the REC has put in place in order to
be able to develop new and relevant SOPs and to revise and update old SOPs. For example, “This
SOP applies to all REC activities involved in the development of its SOPs and their revisions as
published and distributed by the institution. This SOP begins with the proposal and approval for
revision or writing of a new SOP and ends with the inclusion of the new or revised SOP in the SOP
Manual and its dissemination.”

4. Workflow

What are the different steps involved in the process of writing, reviewing, approving and
disseminating SOPs of the REC? Who are the persons responsible in each of these steps?
For example:

ACTIVITY RESPONSIBILITY

Step 1: Proposal and approval for revision or writing of a new SOP Any REC Member or
Staff

Step 2: Designation of the SOP Team Chair

Step 3: Drafting of the revision or new SOP SOP Team

Step 4: Review and finalization of SOP REC Members

Step 5. Submission of finalized SOP to the institutional authority Chair

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 Step 6: Inclusion of the new or revised SOP in the SOP Manual and REC Staff
its dissemination

5. Description of Procedures

What are the detailed steps involved in the writing, reviewing, approving of SOPs and documents
and forms that must be included in this process?

Step 1 - Proposal for a revision of an SOP or a new SOP and its approval: Who can propose?
What is the procedure for initiation of a request for new SOPs and amendments to existing ones?
What process for approval is used (e.g. in a regular meeting, special meeting, or referendum)?

Step 2 - Designation of the SOP Team: How will the members of the SOP Team be selected? Who
will select?

Step 3 - Drafting of the revision or new SOP: Does the REC use an SOP template? This would
greatly harmonize the writing of SOPs. In designing this template, the following contents are
recommended:

(a) Title, which is descriptive of contents

(b) Policy statement

(c) Objective/s of the activity, which defines the purpose and intended outcome

(d) Scope, which defines the extent of coverage of the SOP and its limitations

(e) Workflow provides a graphic representation of the essential steps to implement

the SOP and the responsible person for each step.

(f) Detailed instructions, which elaborates the steps listed in workflow

(g) Glossary – acronyms and terms which need to be defined

(h) Forms, documents to be accomplished by different parties as required by the SOP,

(i) Document history which tabulates the different versions (from draft to final
versions) of the document by author, version, date, and description of main
changes

(j) References, which lists the instruments use to draft the Guideline such as other
SOPs, guidelines, or policies

How does the REC code SOPs? For example, SOP XX/YY where XX can refer to the SOP number, YY
the Version of the SOP (starting from 01),

Step 4 - Review and approval of SOP: What happens to the draft version once ready? Is it
submitted by a specific person to a committee/person/office? Does the review require an REC
meeting? Or an assembly of specific people designated to do this task? Does the review require
deliberation, collection of comments, or voting? What are the details involved (e.g. determination
107
of favorable action, deferment, documentation of action)? Is there a timeline? Is it possible to
have unfavorable outcomes in these procedures? If so, how will they be managed? These issues
should be presented in steps, and the outcome should be a form of functional approval by the REC
of the draft SOP.

When will the new or revised SOP be effective? Who approves the final version (e.g. signature
and date of signing by head of institute on)? This procedure should end with a formal approval,
indicated by an action (such as a signature).

Step 5 – Submission of the SOP to the institutional authority

Step 6 - Inclusion of the new or revised SOP in the SOP Manual and its dissemination: How will
the SOP be made available? Hard copy? E-copy? Is there a timeline from approval to dissemination
(e.g. within thirty (30) days of approval by the head of institution for hard copies and immediately
for e-copies)? Who is the custodian of the official approved copy? Is there a procedure for
reproducing the approved SOP? In case of amended or revised SOP, how is the old version retired
or superseded and stored separately from the new version? This step should end with filing of
approved SOP.

6. Glossary

What terms/abbreviations used in this SOP need to be defined for effective implementation?
Examples:
Standard Operating Procedures - are the step-by-step description of the different
procedures done to accomplish the objective of an activity. They consist of clear,
unambiguous instructions for ethical review to ensure quality and consistency.
Coding – unique number assigned to a particular SOP that reflects its serial position among
the SOPs and version number to indicate the number of times it has been revised.
Format- general style or layout of the document
Date of Effectivity – date when the guidelines shall be enforced.

7. Forms

What forms/templates/tools are used in the implementation of this SOP? Examples:

Form ## Request for Creation/Revision of an SOP
Form ##SOP Template

8. History of SOP

Is this the first time that this SOP is being prepared? If yes, then indicate the date of the first draft
and the authors, date of approval of the final draft, and the approving authority. If this is not the
first time, then it should include information on the previous versions (see SOP on Writing and
Revising SOPs (SOP#__)).

Version No. Date Authors Main Change

1 2010 July 15 ABC First draft

2 2013 May 01 DEF Added criteria for proposing a

new SOP

108
 3 2015 June 03 ABC Revised the layout/format of
DEF SOP Template

9. References

What references did you use in the preparation of this SOP: guidelines, other institutional SOPs,
institutional policies, institutional documents, local regulations?

Examples:

CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
2016
WHO Standards and Operational Guidance for Ethics Review of Health Related Research with
Human Participants 2011
National Ethical Guidelines for Health and Health-related Research 2017
Philippine Health Research Ethics Board Standard Operating Procedures 2020

109
Glossary

Active Files – are documents pertaining to protocols which are currently being assessed,
managed or monitored by the REC.

Active Study – is an ongoing study, implementation of which is within the period covered
by ethics clearance.

Adjournment – Formal closure of the meeting. Motion for adjournment and record of the
time are minuted.

Administrative Documents/File – documents that pertain to the operations of the REC and
are not directly related to a study or protocol. Examples include the SOPs, Membership
files, Agenda and minutes files, administrative issuances.

Administrative Issuance – official communications or announcements from institutional

authorities

After-approval reports – are reports, e.g. progress report, protocol deviation/violation

report, amendment, early termination report, final report, application for continuing
review, required by the REC for submission by the researcher/investigator after the study
has been approved for implementation.

Agenda - the list of topics or items to be taken up in a meeting arranged in a sequential

manner. It is an outline of the meeting procedure and starts with a “Call to Order”.

Alternate Members – individuals who possess the qualifications of specified regular

members. They are called to attend a meeting and substitute for regular members to
comply with the quorum requirement when the latter cannot attend the meeting.

Amendment – a change in or revision of the protocol made after it has been approved.

Anonymization – process of removing the link between the research participant and the
personally identifiable data, in such a way that the research participant cannot be
determined nor traced.
Appeal – a request of a researcher/ investigator for a reconsideration of REC
recommendation.
Appointing authority - the institutional official that has the power to designate or appoint
individuals to specific offices or roles.

Archiving- is the systematic keeping of protocol files in storage after the studies have
been completed with final reports accepted, or terminated or declared inactive.

Assessment Form– evaluation tool accomplished by the reviewers when appraising the
protocol or the informed consent form.

Ballot – voting (indicating a choice) by writing the choice on a form for the purpose. Ballots
are subsequently counted to determine how the majority of members voted for decision-
making.

Benefits – summary of probable positive or favorable outcomes ranging from benefit to

the community (or society), indirect gains such as education, or direct therapeutic value
110
Business Arising from the Minutes – are matters generated from the discussions in the
previous meeting that need continuing attention and require reporting.

Clarificatory Interview/meeting – is a face-to-face consultation between the REC and the

researcher for the purpose of obtaining explanations or clarity regarding some research
issues identified by the REC.

Clinical Auditor – an individual who systematically and independently examines trial

related activities and documents at a particular period as a significant step in quality
control.

Clinical Monitor- an individual who oversees the progress of a clinical trial.

Clinical Trial – a systematic study on pharmaceutical products in human subjects (including

research participants and other volunteers in order to discover or verify the effects of
and/or identify and adverse reactions to investigational products with the object of
ascertaining their efficacy and safety.

Coding- a unique number assigned to a document. A protocol code indicates the year and
order of receipt. The SOP code indicates its serial position among the other SOPs and its
version number.

Collegial Decision – a course of action arrived at after a group deliberation where

members were considered of equal authority such that the course of action is considered
as a group action and is not ascribed to any one member.

Complaint – the act of expressing discontent or unease about certain events or

arrangements in connection with a study.

Confidentiality – is the duty to refrain from freely disclosing private/ research information
entrusted to an individual or organization.

Confidentiality of Documents – pertains to the recognition and awareness that certain

documents that have been entrusted or submitted to the REC must not be freely shared
or disclosed.

Conflict of Interest – a situation in which aims or concerns of two (primary and secondary)
different interests are not compatible such that decisions may adversely affect the
official/primary duties.

Conforme- an indication of acceptance of or agreement to an assignment or designation

Consensus – a collective agreement.

- the process of arriving at a decision without voting but by generating the
over all sentiment of a group such that deliberations continue until no more strong
objections are registered.

Continuing Review - is the decision of the REC to extend ethical clearance of a study
beyond the initial period of effectivity based on an appreciation that the research is
proceeding according to the approved protocol and there is reasonable expectation of its
completion.
111
Controlled document – pertains to the document that have been entrusted or submitted
to the REC that must not be freely shared or disclosed such that it is appropriately tagged
and its distribution carefully tracked, monitored and appropriately recorded. .

Database – a collection of information that is structured and organized so that this can
easily be accessed, managed, intepreted, analyzed and updated.

Date of Effectivity – date when the guidelines shall be enforced.

Decision – the result of the deliberations of the REC in the review of a protocol or other
submissions.

Draft Meeting Agenda – the order of business that includes the list of topics or items
recommended for discussion in a meeting. This is endorsed to the REC Chair for his/her
approval.

Draft Meeting Minutes – Proceedings of the meeting prepared by the Secretariat.

Drug or device – health product used for diagnosis or treatment.

Early Termination - is ending the implementation of a study before its completion.

This is a decision made by the sponsor or a regulatory authority and/or recommended by
the Data Safety Monitoring Board, researcher/investigator in consideration of participant
safety, funding issues, protocol violations, and data integrity issues.

Exempt from Review – a decision made by the REC Chair or designated member of the
committee regarding a submitted study proposal based on criteria in the NEGHHR 2017
The Research Ethics Review Process Guideline 3.1. This means that the protocol will not
undergo an expedited nor a full review.

Exemption Report – a list of protocols submitted for review that were deemed not to
require the conduct of either expedited or full review. This report is presented during a
regular committee meeting or as required by the institutional authority.

Expedited Review – is the ethical evaluation of a research proposal and other protocol-
related documents, a resubmission and after-approval submissions, conducted by only 2-
3 members of the committee without involvement of the whole committee.

Expedited Review Reports – is an enumeration of protocols (including titles, code number,

proponent, submission date, names of reviewers and decisions) that underwent expedited
review presented during a regular REC meeting for information of the REC members and
for record purposes.

Final Meeting Agenda - is the order of business that includes the list of topics or items
approved for discussion in a meeting by the REC Members in a regular or special meeting.

Final Meeting Minutes – Proceedings of the meeting that have been approved by the REC
members.

Final Reports/ Close Out Reports – is a summary of the outputs and outcomes (including
documented risks and benefits) of the study upon its completion, as well as the status of

112
all participants. The REC requires the accomplishment of the Final Report form within a
reasonable period after the end of the study.
Format- general style or layout of the document

Full Review – is the ethical evaluation of a research proposal and other protocol-related
documents, a resubmission and after-approval submissions, conducted by the research
ethics committee en banc, in the presence of a quorum, using established technical and
ethical criteria.

Honorarium- monetary payment for a specific professional service.

Inactive Study – a study whose proponent has not communicated with the REC with regard
to issues pertaining to the approval or implementation of the study – within a period of
time required by the REC.

Incoming Communications – are documents which are directed to and received at the REC
office.

Independent consultants - individuals who are not members of the Research

Ethics Committee, but whose expertise is needed in the review of a research
protocol/proposal and who may be invited to attend a committee meeting but are non-
voting during the deliberation.

Initial Review – the ethical assessment of the first complete set of study documents
submitted to the REC for assessment that can be expedited or full review

Initial Submission – a set of documents consisting of the full proposal and other study-
related documents that is received by the REC so that ethical review can be done.

Intellectual property –refers to intangible creations of the human mind (such as

inventions, literary and artistic works, designs, and symbols, names and images used in
commerce, that are considered as owned by the one who thought of it. Intellectual
property includes information and intellectual goods.

Intellectual property right – the exclusive right given to persons over the use of the
creations of his/her mind for a certain period of time.

Logbook – a real-time, chronological record of incoming protocols that includes the Date
/Time of Receipt, Title of the Document, Name of the Proponent, Name and Signature of
the Submitting Entity, Name and Signture of the Receiving Person and Action done.

Major Modification – is a recommended revision of significant aspects/s of the study (e.g.,

study objectives, recruitment of participants, exclusion/inclusion criteria, collection of
data,statistical analysis, mitigation of risks, protection of vulnerability, etc.) that impact
on potential risks/harms to participants and on the integrity of the research.

Majority rule- is a policy based on the principle that the decision made by the greater
number should be carried/accepted.

Meeting Minutes – the official narration and record of the proceedings of the assembly of
REC Members, based on the agenda.

113
Medical Members – are individuals with academic degrees in the medical profession and a
master’s in the nursing profession.

Minimal Risk – term used when the probability and magnitude of harm or discomfort
anticipated in a research are not greater, in and of themselves, than those encountered
in daily life or during the performance of routine physical or psychological examinations
or tests.

Minor Modification - – is a recommended revision of particular aspect/s of the study or

related documents that do not impact on potential risks/harms to participants and on the
integrity of the research, e.g. incomplete documentation, incomplete IC elements,
unsatisfactory IC format )

More than Minimal Risk - term used when the probability and magnitude of harm or
discomfort anticipated in a research are greater, in and of themselves, than those
encountered in daily life or during the performance of routine physical or psychological
examinations or tests.

Non-affiliated Member/s – are regular members who are not in the roster of personnel or
staff of the Institution. They are not employees of the institution since they do not receive
regular salary or stipend from the institution.

Non-medical members- are individuals without academic degrees in the medical profession
nor a master’s degree in the nursing profession.

Non-Scientists – are individuals whose primary interest is not in any of the natural,
physical and Social sciences and whose highest formal education is a bachelor’s degree.

Operations-related Matters – are items included in the agenda that are not directly related
to any protocol under review.

Outgoing Communications – are documents generated within the REC office intended for
individuals or offices related to the operations of the REC.

Physical Plant Division – unit within the institution that is in charge of the maintenance
and use of physical facilities.

Post-approval Reports – are accounts of the ongoing implementation of an approved study

(e.g., progress report, amendment, safety report, protocol deviation/violation, early
termination, final report, or application for continuing review ) that are required be
submitted by the researcher to the REC for monitoring purposes.

Primary Reviewers – are members of the Research Ethics Committee (usually a scientist
and a non-scientist) assigned to do an in-depth evaluation of the research-related
documents using technical and ethical criteria established by the committee. The non-
scientist member shall focus on the review of the Informed Consent process and form and
reflect on community values, culture and tradition in order to recommend acceptance,
non-acceptance or improvement of the informed consent process and form. The primary
reviewers shall present their findings and recommendations during the meeting for
discussion.

Principal Investigator - the lead person selected by the sponsor to be primarily responsible
for the implementation of a sponsor-initiated clinical drug trial
114
Progress Report – A systematized description of how the implementation of the study is
moving forward. This is done by accomplishing the Progress Report Form ##. The frequency
of submissioin (e.g., quarterly, semi-annually or annually) is determined by the REC based
on the level of risk.

Protocol – the documentation of the study proposal that includes a presentation of the
rationale and significance of the study, background and review of literature, study
objectives, study design and methodology, data collection, dummy tables, plan for
analysis of data, ethical consideration, and dissemination plan.

Protocol database - a collection of information about protocols that is structured and

organized for easy access, management, intepretation, analysis and updating. It is usually
in an electronic platform used for tracking and monitoring the implementation of a study.

Protocol Deviation – non-compliance with the approved protocol that does not increase
risk nor decrease benefit to participants and does not significantly affect their rights,
safety or welfare or the integrity of data. Example: missed visit, non-submission of a
food diary on time.

Protocol File/Folder – is an organized compilation of all documents (physical or electronic

form) related to a study.

Protocols for Full Review – Study proposals that require an en banc ethical because they
entail more than minimal risks to the participants and/or that participation generates
vulnerability issues.

Protocol Index – is a chronological record of the documents in the protocol file. The
protocol index is in table form indicating the date of filing, the nature of the document
filed, the name and signature of the person who filed and an extra column to record any
movement of the document. The index is pasted inside the cover page of the protocol
file/folder for easy reference and checking.

Protocol-related Documents- consist of all other documents aside from the

proposal/protocol itself that are required to be submitted for review, e.g., Informed
Consent Form ,Survey Questionnaire, CV of proponent, advertisements, In-depth Interview
Guide Questions.

Protocol Violation- non-compliance with the approved protocol that may result in an
increased risk or decreased benefit to participants or significantly affect their rights,
safety or welfare or the integrity of data. Example: incorrect treatment, non-compliance
with inclusion/exclusion criteria.

Provisional Meeting Agenda – is the order of business that includes the list of topics or
items approved for discussion in a meeting by the REC Chair.

Provisional Meeting Minutes – Proceedings of the meeting that have been noted or
approved by Presiding officer.

Query – the act of asking for information or clarification about a study.

Quorum – the minimum number (i.e., majority of the members) and type of members of
the REC that are required to be present in any meeting for the proceedings to be

115
considered valid. International and national guidelines require the presence of at least 5
regular members including the non-affiliated and the non-scientist members.

Real-time Recording – the process of documenting the minutes of the meeting as the
meeting proceeds simultaneously.

REC Operations- the overall activities of the REC that reflect performance of its functions
and responsibilities.

Regular Meeting – a periodically scheduled assembly of the REC.

Regular Members – are members constituting the research to ethics committee, who
receive official appointments from the institutional authority with specific terms and
responsibilities including review of research proposals and attendance of meetings.

Regulatory Authorities – refer to government agencies or institutions that have oversight

or control over the conduct of research, e.g., Department of Health, Food and Drug
Administration, Research
Institutions

Reportable Negative Events (RNE) - are occurrences in the study site that indicate risks or
actual harms to participants and to members of the research team. Examples are brewing
hostilities in the research community, natural calamities, unleashed dogs, threats of
harassment, etc.,

Researcher- is the individual primarily responsible for the conceptualization,

planning and implementation of a study.

Researcher-Initiated Studies – are research activities whose conceptualization, protocol

development and implementation are done by a researcher or group of individuals who
may request for external funding support.

Resubmissions- the revised study proposals that are forwarded to the REC in response to
the recommendations given during the initial review.

Reviewer- a regular member of the Research Ethics Committee who is assigned to assess
a research protocol, the Informed Consent, and other research-related submissions based
on technical and ethical criteria established by the committee.

Risks – summary of probable negative or unfavorable outcomes ranging from

inconvenience, discomfort, or physical harm based on the protocol.

Room-use Restriction – the rule that limits the use of a document within the designated
premises.

Secret Ballot – is a system of casting votes (opinions or choices) such that the voters are
not identified or are anonymous.

Scientists – are individuals whose formal education is at least a master’s degree in a

scientificdiscipline, e.g. biology, physics, social science, etc.

Serious Adverse Event (SAE) – is an event observed during the implementation of a study
where the outcome is any of the following:
o Death
116
 o Life threatening
o Hospitalization (initial or prolonged)
o Disability or permanent damage
o Congenital anomaly/ birth defect
o Required intervention to prevent permanent impairment or damage (devices)
o Other serious (important medical) events
whether or not it is related to the study intervention .

Site Visit – is an action of the REC (based on established criteria) in which an assigned
team goes to the research site or office for specific monitoring purposes.

Site Visiting Team – members/staff of the REC (2-4 members) assigned by the REC Chair
to formally go to the research site, meet with the research team and evaluate compliance
with the approved protocol and Informed Consent Form and Process, including other
related research procedures to ensure promotion of the rights, dignity and well-being of
participants and protection of integrity of data.

Special meeting – an assembly of the Committee outside of the regular schedule of

meetings for a specific purpose, usually to decide on an urgent matter like selection of
officer, approval of a revised or new SOP, report of critical research problem that requires
immediate action.

Sponsor- an individual, company, institution or organization which takes responsibility for

the initiation, management, and financing of a clinical trial.

Sponsored Clinical Trials – are a systematic studies on pharmaceutical products in human

subjects (including research participants and other volunteers), whose conceptualization,
protocol development and support for their conduct are the responsibilities of sponsors
who manufactured the products, in compliance with the requirements of regulatory
authorities.

Standard Operating Procedures - are the step-by-step description of the different

procedures done to accomplish the objective of an activity.

Status of participants – summary of what happened to (condition of) participants recruited

to the study, including those that completed the study, those that dropped out, or those
withdrawn for specific reasons in accordance with the protocol.

Study Documents – include all materials (protocol, forms, certificates, research tools)
pertinent to a research proposal that have to be submitted to the REC for review.

Study-related Communications – documents that refer to an exchange of information or

opinions regarding a study, usually between the REC and the researcher.

Study Site - physical location of where the study is being conducted, e.g., community,
institutional facility.

SUSAR – Suspected Unexpected Serious Adverse Reaction – is a noxious response to a drug

that is not described in the Investigator’s Brochure nor in the drug insert.

SAE Subcommittee – a group of experts designated to analyze SAE/SUSAR reports and make
the necessary recommendations to the REC. The experts may or may not be members of
the REC.

117
Termination package refers to the entitlements of study participants in the event of
discontinuance of the study, which can come in the form of access to the study
intervention, treatment, or information, for purposes of adherence to the principle of
fairness for all concerned.

Term of office – the specified length of time that a person serves in a particular
designation /role.

Voting – the act of expressing opinions or making choices usually by casting ballots, spoken
word or hand raising. The rule is majority wins.
Vulnerable Groups – participants or potential participants of a research study who may
not have the full capacity to protect their interests and may be relatively or absolutely
incapable of deciding for themselves whether or not to participate in the research. They
may also be at a higher risk of being harmed or to be taken advantage.

118
SAMPLE FORMS

119
GROUP A

120
 RESEARCH ETHICS COMMITTEE
Name and logo
of institution REC Form No.
Version No.
CURICULUM VITAE FORM
Date of
Effectivity

1. General Information
Name Date of birth:

Address: Contact number:

Email address:

Affiliation: Name of Department: Name of Institution:

Position: Specialty:

Highest Name of Institution: Course/Degree: Year/s attended:

Educational
Attainment :
Research Name of Course: Offered by: Year:
Related 1. 1. 1.
Trainings
including
Research Ethics:

Name and signature: Date:

121
 RESEARCH ETHICS COMMITTEE
Name and logo
of institutioin REC Form No.
Version No.
NOMINATION FORM
Date of
Effectivity

1. General Information
Name of
Nominee
Affiliation: Name of Department: Name o Institution:

Position:

Highest Name of Institution: Year/s attended: Course/Degree:

Educational
Attainment :
Research Name of Course: Offered by: Year:
Related 1.
Trainings
including
Research Ethics:

Acceptance of Nomination:

Signature of Nominee
Date:

Name and signature of Nominator: Date:

Position:
Institution:

Received by: ___________

Date: _________________

122
GROUP B

123
APPOINTMENT OF MEMBER TEMPLATE

Name and logo of Institution

Date

NAME
Department and Position
Institutional Affiliation

Subject: Appointment as ________

Dear Name:

You are hereby appointed as ____________ of the Research Ethics Committee (REC) effective
(from) to (to). As member/ independent consultant, your responsibilities are as follows:

(As member)
1. Attend REC meetings consistently.
2. Participate in the ethical review of research proposals and other related reports. The
non-scientific member shall give special attention to the Informed Consent Form and
process to ensure that these are comprehensible by ordinary persons and are considerate
of community values.
3. Participate in the after-review activities, e.g., continuing review, site visits, etc.
4. Declare any conflict of interest (COI) in the review of research proposals.
5. Maintain confidentiality of the documents and deliberations of the REC meetings.
6. Attend continuing ethics education and other related activities.

We look forward to partnering with you in ensuring that all health researches conform to local,
national, and international ethical principles and standards towards respect for the rights, well-
being and dignity of persons.

Thank you for accepting the invitation to be the member / Independent Consultant of the Research
Ethics Committee. Kindly signify your acceptance by signing the conforme below.

Very truly yours,

INSTITUTIONAL AUTHORITY

Conforme:

________________________________
Name and signature of Appointee

124
APPOINTMENT OF REC OFFICER TEMPLATE

Name and logo of Institution

Date

NAME
Department and Position
Institutional Affiliation

Subject: Appointment as Chair/Vice Chair/Member Secretary_______

Dear Name:

You are hereby appointed as Chair/Vice Chair/Member Secretary of the Research Ethics
Committee (REC) effective (from) to (to). As Chair/Vice Chair/Member Secretary, your
responsibilities are as follows:

(As Chair)
Over and above duties as a Member, the Chair shall have the following responsibilitie:

1. Represent the REC in internal and external meetings and conferences.

2. Preside over REC Meeting.
3. Oversee review of protocols.
4. Assign Primary Reviewers of protocols based on expertise and experience.
5. Supervise development and revisions of SOPs.
6. Prepare and submit annual budget of the REC.
7. Prepare and submit annual report of the REC to the office of the Institutional Authority and
to PHREB.
8. Ensure initial and continuing research ethics trainings of members and staff.

(As Vice Chair)

Over and above duties as a Member, the Vice Chair shall have the following responsibilities:

1. Perform duties of Chair in his/her absence.

2. Perform tasks assigned by Chair Participate in the review of research proposals and other
related reports when requested.

(As Secretary)
Over and above duties as a Member, the Member Secretary shall have the following
responsibilities:

1. Supervise the administrative Staff in the daily operations of the REC.

a. Receipt of protocol documents
b. Preparation of protocol files and folders
c. Preparation of draft of communications
d. Preparation of draft Agenda and Minutes
e. Updating of records
2. Assist the Chair in assigning Primary Reviewers.
3. Assist the Chair in the preparation of the Agenda, Annual Report, and budget.

125
We look forward to partnering with you in ensuring that all health researches conform to local,
national, and international ethical principles and standards towards respect for the rights, well-
being and dignity of persons.

Thank you for accepting the invitation to be the Chair/Vice Chair/Member Secretary of the
Research Ethics Committee. Kindly signify your acceptance by signing the conforme below.

Very truly yours,

INSTITUTIONAL AUTHORITY

Conforme:

________________________________
Name and signature of Appointee

126
APPOINTMENT OF INDENDENT CONSULTANT TEMPLATE

Name and logo of Institution

Date

NAME
Department and Position
Institutional Affiliation

Subject: Appointment as Independent Consultant

Dear Name:

You are hereby appointed as Independent Consultant of the Research Ethics Committee (REC)
effective (from) to (to). As member/ independent consultant, your responsibilities are as follows:

1. Attend REC meeting when requested.

2. Participate in the review of research proposals and other related reports when requested.
3. Declare any conflict of interest (COI) in the review of research proposals.
4. Maintain confidentiality of the documents and deliberations of the REC meetings.

We look forward to partnering with you in ensuring that all health researches conform to local,
national, and international ethical principles and standards towards respect for the rights, well-
being and dignity of persons.

Thank you for accepting the invitation to be the member / Independent Consultant of the Research
Ethics Committee. Kindly signify your acceptance by signing the conforme below.

Very truly yours,

INSTITUTIONAL AUTHORITY

Conforme:

________________________________
Name and signature of Appointee

127
GROUP C

128
DECISION LETTER TEMPLATE

Name and Logo of the Institution

(Date)

(NAME OF PROPONENT)
(Designation)
(Institution)
(Address)

RE: (Title of project/study)

REC code:

Subject: (Nature of action requested, e.g. ethical clearance extension, acceptance of report,
etc.)

Dear (Name of proponent):

This is to acknowledge receipt of your request and the following supporting documents
dated________.

 _
 _
 _
 _
 _

The above documents underwent full/expedited review which generated the following:

(List of findings)

(List of recommendations)

(Specific instructions to the proponent, if any)

Very truly yours,

(Signature)
(Name)
Chair

129
ETHICAL CLEARANCE TEMPLATE

Name and logo of the Instittion

(Date)

(NAME OF PROPONENT/RESEARCHER)
(Designation)
(Institution)
(Address)

RE: (Title of project/study)

REC code:

Subject: Ethical Clearance

Dear (Name of proponent)

(Acknowledgment of request (date of letter) and submitted documents with version numbers and
dates)

 _
 _
 _
 _
 _

(Information on type of review and date of meeting, if full review)

(Validity of ethical clearance)

(Provisions for post-approval submissions)

Very truly yours,

(Signature)
(Name)
Chair

130
CERTIFICATE OF EXEMPTION FROM REVIEW TEMPLATE

Name and Logo of the Institution

(Date)

(NAME OF PROPONENT)
(Designation)
(Institution)
(Address)

RE: (Title of project/study)

EC code:

Subject: Certificate of Exemption from Review

Dear (Title and Family name of proponent)

This is to acknowledge submission of the following documents (include version numbers and dates)

 _
 _
 _
 _
 _

After a preliminary review of the above documents, the Research Ethics Committee deemed it
appropriate that the above proposal be EXEMPTED FROM REVIEW.

This means that the study may be implemented without undergoing an expedited or full review.
Neither will the proponents be required to submit further documents to the committee as long as
there is no amendment nor alteration in the protocol that will change the nature of the study nor
the level of risk involved.

Very truly yours,

(Signature)
(Name)
Chair

131
GROUP D

132
 Ethics Committee
Logo and
Confidentiality Agreement EC Form No.
name of
Version No.
insstitution (For Members, Observers or Guests of the
National Ethics Committee) Date of
Effectivity

I sign this document as _________________ of the Ethics Committee for Human Research
and voluntarily agree not to disclose or reproduce any confidential information and/or research
protocols under consideration during the course of my activities with the Committee, or anytime
afterwards.

Confidentiality covers information or materials prepared by the investigators, and/or

sponsors for the ethics committee review either in written or verbal forms. This information
includes technical and scientific data, financial and personal information concerning wages,
remunerations, salaries and benefits. I agree to return the related data or document to the office
of EC after the completion of the activity.

In case I have to disclose the confidential information by court order, I will so inform the
committee within two days after notification.

Signature ____________________

Name __________________________________

Institutional Affiliation ______________________________________

Address_________________________________________________

Noted

______________________
EC Chair

Date ____________________

133
 ETHICS COMMITTEE
STANDARD OPERATING PROCEDURES
Logo and DISCLOSURE OF CONFLICT OF INTEREST REC Form No.
name of AGREEMENT Version No.
institution
(For Members and Consultants of the Date of
Research Ethics Committee) Effectivity

In general, Conflict of Interest occurs when there is conflict (actual, potential or perceived)
between an individual’s duties and his/her personal or private interest. Conflict of Interest
impairs one’s abilities to exercise objectivity in the performance of official duties.

The Members (including the Chair) of the National Ethics Committee and its consultants shall sign
this agreement to disclose any Conflict of Interest that they may have in the review of research
protocols and other related documents.

The following can be used as a guide to determining whether he/she has Conflict of Interest.

INSTRUCTIONS TO NEC MEMBERS OR CONSULTANTS

Before affixing your signature below, please consider each of the following statements in relation
to: 1) all your past and current official positions; and 2) all your immediate family members,
especially spouse and children. Then, check (√) your answer in the ‘yes’ or the ‘no’ column.

STATEMENTS YES NO
 I/My family have owned stocks and shares in the proponent
organization(s).
 I/My family have received a salary, an honorarium, a compensation,
concessions and gifts from the proponent organization(s).
 I/My family have served as an officer, director, advisor, trustee,
consultant or an active participant in the activities of the proponent
organization(s).
 I/My family/my other organizations have had research work
experience with the principal investigator(s).
 I/My family/my other organizations have a long-standing issue against
the principal investigator(s), the proponent organization(s), or the
funding agency.
 I/My family have regular social activities, such as parties, home visits
and sports events, with the principal investigator(s).
 I/my family/my other organizations have an interest in or an
ownership issue against the proposed topic.
As a member/consultant of the National Ethics Committee I shall disclose any conflict of interest
that I may have in connection with the review of specific research protocols and related
documents.
I shall do this before or during any deliberations so that I may not participate in the decision
regarding the said protocol.
____________________________________ _____________________________
SIGNATURE OVER PRINTED NAME DATE
________________________________________________
INSTITUTIONAL AFFILIATION

______________________________________________________________________________
ADDRESS

134
GROUP E

135
 RESEARCH ETHICS COMMITTEE
Name and logo of REC Form No.
Institution
Version No.
PROTOCOL REVIEWER WORKSHEET
Date of
Effectivity

Title of Study

Type of
REC Code
Review
Project Leader Institution

Primary
Reviewer Date
reviewer ☐ Yes ☐No
Received
Guide questions for reviewing the proposal / protocol
Does the study have social value? ☐ Unable to Assess ☐ Yes ☐ No
Comment: (e.g. scientific value, relevance to
national /community needs)
Is the study background adequate? ☐ Unable to Assess ☐ Yes ☐ No

Comment:
Are the research questions supported by the Review ☐ Unable to Assess ☐ Yes ☐ No
of Literature?

Comment:
Are the study objectives Specific, Measurable, ☐ Unable to Assess ☐ Yes ☐ No
Attainable, Realistic, Time-bound?

Comment:
Is the research design appropriate?
 Is the population identified and defined? ☐ Unable to Assess ☐ Yes ☐ No

 Is the selection of study participants described? ☐ Unable to Assess ☐ Yes ☐ No

 Is the sample size justified? ☐ Unable to Assess ☐ Yes ☐ No

 Is the plan for data analysis described? ☐ Unable to Assess ☐ Yes ☐ No

Are there dummy tables?

Comment:

Does the research need to be carried out with human ☐ Unable to Assess ☐ Yes ☐ No
participants?

Comment:

Does the study have a vulnerability issue? ☐ Unable to Assess ☐ Yes ☐ No

Comment:
136
Are appropriate mechanisms/interventions in place to address the vulnerability issue/s?

☐ Unable to Assess ☐ Yes ☐ No

Comment:

Are there risks/ probable harms to the human participants in the study?

☐ Unable to Assess ☐Yes ☐ No

Comment:

Are there measures to mitigate the risks? ☐ Unable to Assess ☐ Yes ☐ No

Comment:

Is the informed consent procedure / form ade ☐ Unable to Assess ☐ Yes ☐ No

and culturally appropriate?

Comment:

Is/are the investigator/s adequately trained and do ☐ Unable to assess ☐ Yes ☐ No

they have sufficient experience to undertake the study?

Comment:

Is there a disclosure of conflict of interest? ☐ Unable to assess ☐ Yes ☐ No

Comment:

Are the research facilities adequate? ☐ Unable to assess ☐ Yes ☐ No

Comment:

Are there any other concerns in the study?

Recommendation: ☐ Approved
☐ Minor revision/s required

_____________________________________________________

_____________________________________________________

☐ Major revision/s required

_____________________________________________________

137
 _____________________________________________________

☐ Disapproved

Reasons for disapproval:

_____________________________________________________

_____________________________________________________

______________________________________ ______________________
Name and Signature of Reviewer Review Date

138
 RESEARCH ETHICS COMMITTEE

Logo and name REC Form No.

of institution Version No.
INFORMED CONSENT CHECKLIST
Date of
Effectivity

Title of Study

Type of
REC Code
Review
Instituti
Proponent
on
Primary
Reviewer reviewe ☐ Yes ☐ No
r
Guide questions for reviewing the informed consent process and form
Is it necessary to seek the informed consent of the participants? ☐ Unable to Assess ☐
Yes ☐ No
If NO, please explain.

If YES, are the participants provided with sufficient information

regarding:
 Purpose of the study? ☐ Yes ☐No
 Expected duration of participation? ☐ Yes ☐No
 Procedures to be carried out? ☐Yes ☐No
 Discomforts and inconveniences? ☐ Yes ☐ No
 Risks (including possible discrimination)? ☐ Yes ☐ No
☐ Not applicable ☐ Yes
 Random assignment to the trial treatments?
☐ No
 Benefits to the participants? ☐ Yes ☐ No
☐ Not applicable ☐ Yes
 Alternative treatments/ procedures?
☐ No
 Compensation and/or medical treatments in case of injury? ☐ Yes ☐ No
 Who to contact for pertinent questions and / or for
☐ Yes ☐ No
assistance in a research- related injury?
 Refusal to participate or discontinuance at any time will
involve penalty or loss of benefits to which the subject is ☐ Yes ☐ No
entitled?
 Extent of confidentiality? ☐ Yes ☐ No
Is the informed consent written or presented in simple ☐ Yes
☐ No
language that participants can understand?
Does the protocol include an adequate process for ☐ Yes
☐ No
ensuring that consent is voluntary?

139
Do you have any other concerns?

Recommendation: ☐ Approved
☐ Minor revisions required

_____________________________________________________

_____________________________________________________

_____________________________________________________

☐ Major revisions required

_____________________________________________________

_____________________________________________________

_____________________________________________________

_____________________________________________________

☐ Disapproved

Reasons for disapproval:

_____________________________________________________

_____________________________________________________

_____________________________________________________

_____________________________________________________

________________________________ ________________________
Name and Signature of Reviewer Review Date

140
 ETHICS COMMITTEE

Logo and name

REC Form No.
of institution PROTOCOL REVIEWER WORKSHEET
Version No.
(FOR STEM CELL RESEARCH)
Date of Effectivity

Title of the Study

NEC Code Type of Review

Proponent

Institution Has an ERC/IRB? ____yes ____no

Sponsor

Funding Agency

Name of Reviewer Primary Reviewer ____yes ____no

GUIDE QUESTIONS

Is there comprehensive literature review and information?

that describes the development of the stem cell therapy
in this study? _____ yes _____ no

Comment:

Nature of Stem Cell Use: ____ Clinical Trial ___ Phase 1 ____ Phase 2 ____ Phase 3
____ Experimental Therapy
____ Established Therapy for new indications/formulation

Source of Stem Cells: ____ Human (adult) ____ autologous ____ allogeneic
____ Human (embryonic)
____ cellular reprogramming
____ Animal (pls. identify_________________)
____ Plant (pls. identify ___________________)
____ Others (pls. describe _____________________________________)

Will the stem cells be directly transplanted to the human recipient? ______yes ______no
If YES, where? _____ outside the Philippines, pls specify _________________
_____ locally, pls. specify _____________________________

141
 If NOT, will the stem cells be
stored? ____yes ____no _____not indicated
processed? ____yes ____no _____not indicated
cultured? ____yes ____no _____not indicated
expanded? ____yes ____no _____not indicated
or genetically modified? ____yes ____no _____not indicated

Is the laboratory GMP/GLP certified? _____ yes _____ no ____not indicated

Is the hospital accredited by the DOH Bureau of Health
Facilities and Services (DOH-BHSF) for stem cell use? _____ yes _____ no ____not indicated

Will animal serum/feeder cells be used? _____ yes _____ no ____not indicated
Are release criteria described/indicated? _____ yes _____ no ____not indicated
Which stem cell markers will be used? ________________________________________________
Comment:

What is the route of administration/transplantation?

__________ intravenous
__________ intrathecal
__________ subdermal
__________ intramuscular
__________ direct to the target organ , ______________________

Are indicators of clinical efficacy described?

Are there homing indicators? _____ yes _____ no
Are there functional indicators? _____ yes _____ no
Are there persistence indicators? _____ yes _____ no

Comment:

Does the study design address the study objectives? _____ yes _____ no

Comment:

Is the selection of patients fair and equitable? _____ yes _____ no

142
Comment

Do the participants/ subjects belong to vulnerable groups? _____ yes _____ no

Is vulnerability addressed? _____ yes _____ no

Comment:

Are the benefits adequately described? _____ yes _____ no

Comment:

Will surrogate markers for good outcomes be used? _____ yes _____ no ____ not indicated

What are these?

Are the risks identified? _____ yes _____ no

Comment:

Do the benefits outweigh the risks? _____ yes _____ no

Comment:

Is the process for obtaining informed consent described?

in the protocol? _____ yes _____ no

Who will obtain the informed consent? ______ attending physician ______ project leader
______ principal investigator _______ nurse
______ others, pls. identify _____________________

Will standard health care be provided? _____ yes _____ no ____ not indicated
Comment:

Are financial arrangements reasonable and fair? _____ yes _____ no ____ not indicated
Comment:

143
 Is there a potential conflict of interest? _____ yes _____ no

Comment:

Is the training and practice of the researcher/principal/

investigator adequate and appropriate to ensure safe and
competent conduct of the study and care of the participants? _____ yes _____ no
Comment:

Is there a commitment to publish study results? _____ yes _____ no _____ not indicated
Comment:

Recommendation:  Approved
 Minor revisions required

_____________________________________________________

_____________________________________________________

 Major revisions required

_____________________________________________________

_____________________________________________________

_____________________________________________________

 Disapproved

Reasons for disapproval:

_____________________________________________________

_____________________________________________________

________________________________ ________________________
Name and Signature of Reviewer Review Date

144
 RESEARCH ETHICS COMMITTEE
Logo and
name of REC Form No.
institution INFORMED CONSENT CHECKLIST
Version No.
(FOR STEM CELL RESEARCH)
Date of Effectivity

Title of the Study

REC Code Type of Review

Proponent

Name of Reviewer Primary Reviewer ____yes ____no

GUIDE QUESTIONS

Is there a separate document for patient information and informed consent?

_____ yes _____ no
Comment:

Is the participant/patient provided with sufficient information

with regard to each of the following items?

 Purpose of the study _____ yes _____ no

 Unproven and experimental aspects of cell-based
intervention _____ yes _____ no
 Clarification of therapeutic misconception _____ yes _____ no
 Expected duration of participation _____ yes _____ no
 Permanency of stem cell therapy _____ yes _____ no
 Discomforts and inconveniences _____ yes _____ no
 Alternative care _____ yes _____ no
 Risks (nature and likelihood) _____ yes _____ no
 Benefits (nature and likelihood) _____ yes _____ no
 Confidentiality / Protection of Privacy _____ yes _____ no
 Voluntary withdrawal _____ yes _____ no
 Financial arrangements _____ yes _____ no
 Compensation ______ yes _____ no
 Provision of standard of care ______ yes _____ no
 Contact information of person/s in-charge ______ yes _____ no

Comments:

145
Recommendation:  Approved
 Minor revisions required

_____________________________________________________

_____________________________________________________

_____________________________________________________

 Major revisions required

_____________________________________________________

_____________________________________________________

_____________________________________________________

_____________________________________________________

 Disapproved

Reasons for disapproval:

_____________________________________________________

_____________________________________________________

_____________________________________________________

_____________________________________________________

________________________________ ________________________
Name and Signature of Reviewer Review Date

146
GROUP F

147
 RESEARCH ETHICS COMMITTEE
Name and logo of
Institution REC Form No.
APPLICATION FOR ETHICS REVIEW OF A NEW Version No.
PROTOCOL Date of
Effectivity

Instructions to the Researcher: Please accomplish this form and ensure that you have
included in your submission the documents that you checked below (in Section 3. Checklist
of Documents).

1. General Information

*Title of Study

*REC Code
(To be provided *Study Site
by REC)
*Name of *Tel No:
Researcher) Contact *Mobile No:
*Co-researcher Information Fax No:
(if any) *Email:
*Institution
*Address of
Institution
☐ Clinical Trial
(Sponsored)
☐ Clinical Trials ☐ Biomedical research (Retrospective,
(Researcher-initiated) Prospective and diagnostic studies)
☐ Health Operations
☐ Stem Cell Research
Research (Health
☐ Genetic Research
Programs and Policies)
☐ Social / Behavioral ☐ Others ______________________________
*Type of Study
Research
☐ Public Health /
Epidemiologic Research
☐ Others
____________________________________________________________
☐ Multicenter
☐ Multicenter (National) ☐ Single Site
(International)
☐ Self-funded ☐ Sponsored by a Pharmaceutical Company
☐Government-Funded Specify: _____________________________
☐ Scholarship/Research Grant ☐ Institution-Funded
*Source of
Funding ☐ Others
____________________________________________________________

*Duration of Start date: No. of study

the study End date: participants

148
*Has the Research undergone Technical ☐ Yes (please attach technical review results)
Review? ☐ No
*Has the Research been submitted to
another REC? ☐ Yes ☐ No
2. Brief Description of the study

3. Checklist of Documents
Basic requirements:
Supplementary Documents:
☐ Letter request for review
☐ Endorsement/Referral Letter ☐ Questionnaire (if applicable)
☐ Full proposal / study protocol ☐ Data Collection Forms (if applicable)
☐ Technical Review Approval ☐ Product Brochure (if applicable)
☐ Curriculum Vitae of Researcher/s ☐ Philippine FDA Marketing Authorization or
☐ Informed Consent Form Import License (if applicable)
☐ English version ☐ Filipino ☐ Permit/s for special populations (please
version specify)
________________________________________
☐ Others _________________
________________________________________
☐Assent Form (if applicable) ☐ Others (please specify)
☐ English version ☐ Filipino ________________________________________
version ________________________________________
☐ Others: _________________

Accomplish
______________________________
Signature
Date submitted
---------------------- To be filled by the REC Secretariat ----------------------
Completeness of ☐ Complete
Document ☐ Incomplete

Remarks

Date Received
(place stamp here)
Received by

149
 RESEARCH ETHICS COMMITTEE
Logo and name
of institution REC Form No.
Version No.
RESUBMISSION FORM
Date of
Effectivity

General Information

*Title of Study

Version
number/date
*REC Code
(To be provided *Study Site
by NEC)
*Name of *Tel No:
Researcher *Mobile No:
Contact
*Co- Fax No:
Information
researcher/s (if
*Email:
any)
*Institution of
researcher
*Address of
Institution

Section and page

REC Recommendations Response of Researcher number of
revisions

Signature of Researcher: ______________________

Date: ______________

150
 ETHICS COMMITTEE
Logo and name of
institution EC Form No.
APPLICATION FOR ETHICS REVIEW OF Version No.
AMENDMENTS Date of
Effectivity

General Information

*Title of Study

Version
number/date of
the EC approved
protocol
*EC Code
(To be provided *Study Site
by EC)
*Name of *Tel No:
Researcher *Mobile No:
Contact
*Co- Fax No:
Information
researcher/s (if
*Email:
any)
*Institution of
researcher
*Address of
Institution
Effective period From To
of ethical
clearance

Procedure/provisions
to be amended (Use Original Proposed Amendment/s
Justification
additional sheets if Procedure/Provision
necessary)

Signature of Researcher: ______________________

Date: _________________

151
 RESEARCH ETHICS COMMITTEE
Logo and name
of instution REC Form No.
APPLICATION FOR ETHICS REVIEW OF Version No.
PROGRESS REPORTS Date of
Effectivity

Instructions to the Researcher: Please accomplish this form and ensure that you have
included in your submission the documents that you checked below (in Section 3. Checklist
of Documents).

General Information

*Title of Study

*REC Code
(To be provided *Study Site
by REC)
*Name of *Tel No:
Contact
Researcher) *Mobile No:
Informatio
*Co-researcher Fax No:
n
(if any) *Email:
*Institution
*Address of
Institution
Ethical
clearance
effectivity
period
Progress Report
1. Start of study 2. Expected end of study
3. Number of enrolled participants 4. Number of required participants
5. Number of participants who withdrew
7. New information (literature or in the
6. Deviations from the approved protocol conduct of the study) that may
significantly change the risk-benefit
ratio

8. Issues/problems encountered

152
 RESEARCH ETHICS COMMITTEE
Name and logo
of institution REC Form No.
Version No.
PROTOCOL VIOLATION/DEVIATION REPORT
Date of
Effectivity

Instructions to the Researcher: Please accomplish this form and ensure that you have
included in your submission the documents that you checked in Section 3. Checklist of
Documents.

General Information

*Title of Study

*REC Code
(To be provided *Study Site
by REC)
*Name of *Tel No:
Researcher) Contact *Mobile No:
*Co-researcher Information Fax No:
(if any) *Email:
*Institution
*Address of
Institution
Ethical
clearance
effectivity
period
Progress Report
1. Start of study 2. Expected end of study
3. Number of enrolled participants 4. Number of required participants
5. Number of participants who withdrew
7. Explanation for deviation/violation
6. Deviations from the approved protocol

8. Impact of deviation/violation on 9. Actions taken to prevent future

participants’ risks/harms and integrity deviation/violation
of data

153
 RESEARCH ETHICS COMMITTEE
Name and logo
of institution REC Form No.
Version No.
REPORTABLE NEGATIVE EVENT REPORT
Date of
Effectivity

Instructions to the Researcher: Please accomplish this form and ensure that you have
included in your submission the documents that you checked in Section 3. Checklist of
Documents.

General Information

*Title of Study

*REC Code
(To be provided *Study Site
by REC)
*Name of *Tel No:
Contact
Researcher) *Mobile No:
Informatio
*Co-researcher Fax No:
n
(if any) *Email:
*Institution
*Address of
Institution
Ethical
clearance
effectivity
period
RNE Report
1. Start of study 2. Expected end of study
3. Number of enrolled participants 4. Number of required participants
5. Description of Negative (harms, risks) 6. Actions taken to prevent future RNEs,
Events interventions and Outcomes

a. Involving Participants

b. Involving members of the Study Team

c. Involving Data safety and integrity

7. Recommendations

154
 RESEARCH ETHICS COMMITTEE
Logo and name
of institution REC Form No.
Version No.
APPLICATION FOR CONTINUING REVIEW
Date of
Effectivity

Instructions to the Researcher: Please accomplish this form and ensure that you have
included in your submission the documents that you checked in Section 3. Checklist of
Documents.

General Information

*Title of Study

*REC Code
(To be provided *Study Site
by REC)
*Name of *Tel No:
Contact
Researcher) *Mobile No:
Informatio
*Co-researcher Fax No:
n
(if any) *Email:
*Institution
*Address of
Institution
Ethical
clearance
effectivity
period
Progress Report
1. Start of study 2. Expected end of study
3. Number of enrolled participants 4. Number of required participants
5. Number of participants who withdrew
6. Deviations from the approved protocol 7. New information (literature or in the
conduct of the study) that may
significantly change the risk-benefit
ratio

8. Issues/problems encountered

9. Justification for application for Continuing Review

155
 RESEARCH ETHICS COMMITTEE
Logo and name
of institution REC Form No.
Version No.
SITE VISIT REPORT
Date of
Effectivity

Instructions to the Researcher: Please accomplish this form and ensure that you have
included in your submission the documents that you checked in Section 3. Checklist of
Documents.

General Information

*Title of Study

*REC Code
(To be provided *Study Site
by REC)
*Name of *Tel No:
Researcher) Contact *Mobile No:
*Co-researcher Information Fax No:
(if any) *Email:
*Institution
*Address of
Institution
Ethical
clearance
effectivity
period
Site Visit Report
1. Start of study 2. Expected end of study
3. Number of enrolled participants 4. Number of required participants
5. Reasons for Site Visit 6. Person/s present during visit

7. Findings 8. Recommendations

Site Visit Team

1. –
2. –
3. –
Report submitted by:
______________________
Name and signature
Date:

156
 ETHICS COMMITTEE
Name and logo
of institution NEC Form No.
Version No.
EARLY TERMINATION REPORT
Date of
Effectivity

Instructions to the Researcher: Please accomplish this form and ensure that you have
included in your submission the documents that you checked in Section 3. Checklist of
Documents.

General Information

*Title of Study

*REC Code
(To be provided *Study Site
by REC)
*Name of *Tel No:
Contact
Researcher) *Mobile No:
Informatio
*Co-researcher Fax No:
n
(if any) *Email:
*Institution
*Address of
Institution
Ethical
clearance
effectivity
period
Recommended (e.g. Sponsor, Funding Agency, Data Safety Monitoring Board,
by: Researcher/Proponent)
Early Termination Report
1. Start of study 2. Expected end of study
3. Number of enrolled participants 4. Number of required participants
5. Reason/s for termination 6. Support mechanisms/Interventions for
Enrolled Participants

7. Post-Termination Actions

__________________________
Name and signature of Proponent
Date:

Received by:
Date:

157
 RESEARCH ETHICS COMMITTEE
Logo and name
of institution REC Form No.
Version No.
FINAL REPORT FORM
Date of
Effectivity

General Information

*Title of Study

Version
number/date of
the EC approved
protocol
*REC Code
(To be provided *Study Site
by REC)
*Name of *Tel No:
Researcher Contact *Mobile No:
*Co- Informatio Fax No:
researcher/s (if n
*Email:
any)
*Institution of
researcher
*Address of
Institution
Effective period From: To:
of ethical
clearance

Final Report
1. Start of study 2. End of study
3. Number of enrolled participants 4. Number of required participants
5. Number of participants who withdrew
6. Deviations from the approved protocol 7. Issues/problems encountered

8. Summary of findings:

9. Conclusions:

10. Actions for dissemination of study results:

Signature of Researcher: _____________________

Date: ________________
158
GROUP G

159
 RESEARCH ETHICS COMMITTEE

Name and logo

REC Form No.
of institutioin
Version No. 1
NOTICE OF MEETING
Effectivity Date

Date of Notice:
Date of Meeting:
Venue:
Time:

Items for Discussion:

1. Full Review of New Proposals (Initial)

1.1. REC Code - Title
1.2. REC Code - Title
2. Report on Expedited Review of Proposals
2.1. REC Code - Title
2.2. REC Code - Title
3. Updates on Full Review of Proposals (Resubmission)
3.1. REC Code - Title
3.2. REC Code - Title
4. Updates on Expedited Review of Proposals (Resubmissions)
4.1. REC Code - Title
4.2. REC Code - Title
5. Updates on Approved, Ongoing Researches
5.1. REC Code - Title
5.2. REC Code - Title
6. Other Matters

160
 RESEARCH ETHICS COMMITTEE

Name and logo REC Form No.

of institution
Version No.
PROVISIONAL AGENDA
Date of
Effectivity

Venue:
Date: Time:

1. Call to Order
2. Declaration of Quorum
3. Disclosure of Conflict of Interest
4. Approval of the Provisional Agenda
5. Review and Approval of the Minutes of the Previous Meeting
6. Business Arising
7. New Business
8. Full Review of New Proposals (Initial)
8.1. REC Code - Title
8.2. REC Code - Title
9. Report on Expedited Review of Proposals
9.1. REC Code - Title
9.2. REC Code - Title
10. Updates on Full Review of Proposals (Resubmission)
10.1. REC Code - Title
10.2. REC Code - Title
11. Updates on Expedited Review of Proposals (Resubmissions)
11.1. REC Code - Title
11.2. REC Code - Title
12. Updates on Approved, Ongoing Researches
12.1. REC Code - Title
12.2. REC Code - Title
13. Other Matters
14. Adjournment

161
 RESEARCH ETHICS COMMITTEE

Logo and name REC Form No.

of institution Version No.
MINUTES OF THE MEETING
Date of
Effectivity

Type of Meeting:
Date:
Time:
Venue:

Attendance:
Present
Name Office

Also Present
Name Office

Absent
Name Office

1. Call to Order

2. Declaration of Quorum

3. Disclosure of Conflict of Interest

4. Approval of the Provisional Agenda

5. Review and Approval of the Minutes of the Previous Meeting (Date)

6. Business arising from the minutes of the meeting

7. Full Review of Proposals (Initial)

162
 7.1.
NEC Code:
Title:
Researcher/s:
Submission date
Reviewers:
Discussion/Comments:

Scientific Soundness:

Ethical Considerations
-Social Value
-Vulnerability issue
-Measures to protect vulnerability population
-Risk/benefit ratio
-Measures to mitigate risks
-Confidentiality and privacy
-Informed Consent process, form and content

Recommendations:
Decision:
Decision letter
date

8. Report on Expedited Review of Proposals (Initial)

8.1.
NEC Code:
Title:
Researcher/s:
Reviewers:
Submission Date
Discussion/Comments/Recommendations:

Decision:
Decision letter
date

9. Updates on Full Review of Proposals (Resubmissions)

9.1.
NEC Code:
Title:
Researcher/s:
Submission date
Reviewers:
Discussion/Comments/Recommendations:

Decision:
Decision letter
date

10. Updates on Expedited Review of Proposals (Resubmissions)

10.1.
NEC Code:
163
 Title:
Researcher/s:
Submission date
Reviewers:
Discussion/Comments/Recommendations:

Decision:
Decision letter
date

11. Updates on Approved, Ongoing Researches

11.1.
NEC Code:
Title:
Researcher/s:
Submission date
Approval letter
sent
Amendment/Repo
rt submission date
Lead Reviewers
Discussion/Comments/Recommendations:

Decision:
Decision letter
date

12. Other Matters

13. Adjournment

Prepared by:

Date:

Noted : (Chair)

Date:

164
GROUP H

165
 RESEARCH ETHICS COMMITTEE

Logo and name of

REC Form No.
institution
Version No.
LOGBOOK OF OUTGOING COMMUNICATIONS
Date of Effectivity

YEAR: ________

Date Nature of document Signatory Addressee Received by Delivered by

(Decision letter, (Name and Signature of (Name and Signature)
Approval letter, Recipient)
Invitation, Notice of
Meeting, etc.)
1.
2.

166
 RESEARCH ETHICS COMMITTEE

Name and logo of

Institution REC Form No.
Version No.
LOGBOOK OF PROTOCOL SUBMISSIONS
Date of Effectivity

YEAR: _________

Date of Submission Code Number Title Proponent Submitted by Received by Action

(Name and (Name and
Signature) Signature)

1.
2.

167
 RESEARCH ETHICS COMMITTEE

Logo and name of

REC Form No.
institution
Version No.
PROTOCOL FOLDER INDEX
Date of Effectivity

Date of Filing Nature of document Name and signature of Date Document Withdrawn Name and Signature of Staff
(Initial Submission of Protocol and related Filer Member-in-charge
documents version number, Excerpts of Minutes,
Protocol and ICF Assessment, Decision letter,
Approval letter, Post-Approval submissions,
Communications from Researchers, Final Report,
etc.)
1.

2.

168
169