KAUVERY INSTITUTIONAL

ETHICS COMMITTEE
(KIEC)
Constitution of Kauvery Institutional Ethics
Committee(KIEC)

SOP CODE : SOP02/V2 Date:

28/11/2016
Pages: 1 to 21
INTRODUCTION
Sprouting from an established foundation laid in 1999, Kauvery Hospital has
mushroomed to be 1200 bed strong, leading global, multispecialty tertiary
healthcare enterprise.

Our Medical and Non medical staffs unite at the Centers of Excellence, at each
location, to bring together healthcare professionals and state of the art medical
technology to serve communities across the globe

In keeping with our vision and consistent commitment, and sustained by our mission
Kauvery Hospital has been delivering preeminent medical care, setting world class
standards.

Our sophisticated and therapeutic care extends to all specialties and sub-specialties
of medicine and surgery.Located in the heart of Trichy(Tennur, Royal Road and
Alexandria Road-Cantonment), Chennai, Karaikudi,Hosur,Salem and Bangalore, the
hospital also renders adult and paediatric trauma care.

Kauvery Hospital is globally known for its multi-disciplinary services at the Centre of
Excellence and for its comprehensive, Avant garde technology, especially in
diagnostics and remedial care in heart diseases, transplantation, vascular and
neurosciences medicine.

Our Mission:

To make great healthcare affordable

Our Vision:

To be the most respected and trusted healthcare provider

Our Values:

C: Continual improvement

H: Heartfelt Personal Touch

E: Ethical

E: Empathetic Care

R: Real Accountability
S: Service Excellence

Kauvery Institutional Ethics Committee is an independent body constituted of

medical/scientific professionals and non-medical/non-scientific members whose
responsibility is to ensure the protection of the right, safety and well being of human
subjects involved in a trial and to provide public assurance of that protection

‘Kauvery Institutional Ethics Committee is constituted and operates as per ICMR

guidelines,Schedule Y and ICH-GCP’

The Kauvery Institutional Ethics Committee is responsible for the ethical review of all
applications submitted to it by their staff and through its international composition
ensures compliance of international consistency and completeness in ethical
approval is achieved

These Standard Operating Procedures provide a framework and guidance for the
KIEC.The following maybe called as Standard Operating Procedures for the Kauvery
Institutional Ethics Committee,Chennai

All proposals on biomedical research involving human subjects should be cleared by

Kauvery Institutional Ethics Committee, to safe guard the welfare of the rights of the
subject involved.

Kauvery Institutional Ethics Committee was registered with Drug Controller General
India.as the DCGI REGISTRATION Dated September 2017 is in the name of
Institutional Ethics Committee situated at Kauvery Hospital

KIEC-1 has Ethics Committee Registration No: ECR/966/Inst/TN/2017

issued under Rule 122DD of the Drugs and Cosmetics Act, 1940 and Rules 1945

PURPOSE

KIEC was established to formalize and specify institution’s commitment to the

promotion of high scientific and ethical standards in patient care, professional
education, clinical research and community interests
MANDATE

KIEC functions independently for maintaining a consistent scientific and ethical

framework for patient care and research and for integrating ethical values into
practice, policy relationships and organizational activities

The purpose of KIEC is to cultivate a pluralistic and democratic exchange of

scientific and ethical values and concerns, and to critically analyze them while
looking for opportunities to enhance the scientific and ethical integrity of Institution.

The mandate of KIEC essentially is to promote patient care through a scientific and
ethical approach to research and education.

The terms of reference for KIEC are as follows:

1. Ensure the highest scientific and ethical standards of research at Kauvery Hospital
2. Review and approve, proposals for clinical, basic or translational research
projects (Intra and Extra mural) for scientific and ethical content
3. Improve ethical standards and issue guidelines on ethical dilemmas related to
patient care services
4. To function as a forum to advise the administration in case of any ethical
issues that may arise from patients, families or public
5. To maintain our leadership as a national standard of reference in all fields
6. To issue and periodically, update and revise SOP s and guidelines for
effective functioning of KIEC as and when necessary
7. Continuing education in clinical research bioethics and ethical aspects of
clinical practice by seminars, workshops and interactive discussions for all
categories of staff members including nursing and paramedical staff
8. To initiate and commission research studies on ethical aspects of practice in
Kauvery Hospital
1. The KIEC endeavors to provide guidance on a broad range of topics such
as disclosures of diagnosis, diagnosis of brain death, indications for
stopping resuscitation, true informed consent, etc.
2. The committee does not address or interfere in matters of administration,
nor does the committee function as a grievance cell for staff members.
SCOPE
The SOP applies to the formation of KIEC

Responsibility
KIEC has the responsibility, within the Institution, for the following objectives:
a. To ensure the competent review and evaluation of all scientific and ethical
aspects of research projects received in compliance with the appropriate
laws, and welfare of subjects.
b. Consultations for clinical science and ethics;.
c. Education of professional, administrative, and support staff about ethical
issues.
d. Creation, development, revision and implementation of guidelines for the
KIECs (SOPs).
e. Initiate research studies in ethics.
f. Continuing education and training programs to ensure that KIEC members
are qualified to perform their specific duties

Scientific and Ethical Basis

1. The committee consists of members who collectively have the
qualifications and experience to review and evaluate the scientific, medical
and ethical aspects of a proposed research project.
2. KIEC recognizes that the protocols approved may also be approved by
national and/ or local ethics committees and concerned regulatory bodies
prior to their implementation in specific localities.
3. In evaluating protocols and ethical issues, KIEC is aware of the diversity
of laws, cultures and practices governing research and medical practices
in various countries around the world
4. KIEC also seeks to be informed, as appropriate, by national / other local
ethics committees and researchers of the impact of the research it has
approved.
5. KIEC is guided in its reflection, advice and decision by the
Ethical principles expressed in the Declaration of Helsinki (Adopted by
the 18th World Medical Assembly, Helsinki, Finland, June 1964, and
amended by the 29th World Medical Assembly, Tokyo, Japan, October
1975; 35th World Medical Assembly, Venice, Italy, October 1983; 41st
World Medical Assembly, Hong Kong, September 1989; 48th World
Medical Assembly, Somerset West, Republic of South Africa, October
1996; and the 52nd World Medical Assembly, Edinburgh, Scotland,
October 2000; Note of Clarification on Paragraph 29 added by the
World Medical Assembly, Washington 2002; Note of Clarification on
Paragraph 30 added by the World Medical Assembly, Tokyo 2004, 59th
WMA general Assembly, Seoul, October 2008)
It makes further reference to the International Ethical Guidelines for e.g.
The Nuremburg Code (1945), the Council of International Organizations of
Medical Sciences (CIOMS), the Belmont Report 1979, the International
Ethical Guidelines for Biomedical Research Involving Human Subjects
(Geneva 2002), and the European Convention on Human Rights and
Biomedicine 1977
The KIEC establishes its own Standard Operating Procedures based on the
ICMR guidelines (2017), Operational Guidelines for Ethics Committees
that Review Biomedical Research (WHO 2000), and ICH-GCP, 1996 and
the local regulations, CFR 45 (US FDA)
KIEC seeks to fulfil the requirements for international assurances and is
established and functions in accordance with the national law and
regulations
Composition
KIEC will be multidisciplinary and multi-sectorial such as scientific and non-scientific
members, clinicians and non - clinicians, a clinical pharmacologist, members of the
community, a lawyer-expert in ethics and a layperson to represent different points of
view.

The Committees will comprise of a Chairperson, a Member Secretary, and other

active members who represent an appropriate balance of professional, ethical, legal,
cultural, educational,and community interests

As far as possible, based on the requirement of research area such as

HIV, genetic disorder, etc., specific patient group may also be represented
in the Ethics Committee
The committee should have adequate representation of age, gender,
community, etc. to safeguard the interests and welfare of all sections of
the community / society. Members are expected to be aware of local,
social and cultural norms, as this is the most important social control
mechanism
The members should have various backgrounds to promote complete and
adequate review of research activities commonly conducted by Kauvery Hospital.
Composition of KIEC
The composition should be as follows:-
1. Chairperson (not – affiliated to Kauvery Hospital)
2. Member secretary (from Kauvery Hospital)
3.2 clinicians (from Kauvery Hospital)
4. Clinical Pharmacologist(from Kauvery Hospital)
5. One legal expert (not- affiliated to Kauvery Hospital)
6. One social scientist (not- affiliated to Kauvery Hospital)
7. One lay person from the community (not- affiliated to Kauvery Hospital)

Membership
The Executive Director, Kauvery Hospital appoints the Chairperson, KIEC and the
Member Secretary.
All other members will be appointed by the Executive Director, Kauvery Hospital in
consultation with the Chairperson and Member Secretary. The licensing authority
shall be informed in writing in case of any change in the membership or the
constitution of the Ethics Committee takes place.

Criteria for selection of members:

 Members are selected in their personal capacities, based on their interest,
ethical and/or scientific knowledge and expertise, experience in the domain field and
profile.
 The members representing medical scientist and clinicians should have post
graduate qualification & adequate experience in their respective fields
 Conflict of interest will be avoided while making appointments, but
where unavoidable, there will be transparency with regard to such
interests.
 Directors, Head of Institution, Administrative officers who are responsible for
business development will not serve as members or ex-officio members.
 New members will be identified according to the requirement and provided the
potential member fulfils the conditions of appointment as defined

The following qualities are sought in KIEC members:

 experience and education
 interest and motivation
 commitment and availability
 respect for divergent opinions
 integrity and diplomacy

Terms of Appointment

Duration
 The members of KIEC,Kauvery Hospital will be appointed for duration of five
years.
 The appointment procedure for membership will be followed so that it allows
for continuity, development and maintenance of expertise within KIEC, and
the regular input of fresh ideas and approaches.
 The members can be continued and there will be no limit on the number of
times the membership is extended. Extension of membership will be based on
the recommendation of the Chairperson and Member Secretary of KIECs.
 In case of the resignation/discontinuation of a Member Secretary, Chairperson
or member, a replacement may be newly appointed by the Executive Director,
Kauvery Hospital before the completion of the tenure of the existing appointed
committee
 This appointment will be effective for the remaining tenure of the existing
committee
Renewal
 The membership will be renewed after the stated term of 2 years.
 The process of renewal will be as follows :
i. Selection of Member Secretary and other members should be
done at least 3 months and 1 month in advance respectively.
 Member secretary designate should be inducted into the KIEC
as an observer before he/she takes on the mantle in the new
KIEC. Other members designate may attend the board meeting
as observers before starting their tenure as KIEC members.
ii. Designated members of the KIEC who wish to attend KIEC
meetings as observers should read, understand, accept and
sign the agreement contained in the Conflict of Interest form at
the beginning of the KIEC meeting and/or before scientific and
ethical review tasks of the KIEC commence
iii. If a regular member resigns, or ceases to be a member due to
disqualification, or death, a new member will be appointed for
the remaining term
Resignation / Replacement procedure
 The members who have resigned may be replaced at the discretion of the
Executive Director, Kauvery hospital
 KIEC members who decide to resign must provide the Executive Director,
Kauvery Hospital, and Chairperson, KIEC, the written notification of their
proposed resignation date at least 30 calendar days prior to the next
scheduled meeting.
 In case of resignation, Executive Director, Kauvery Hospital would appoint a
new member, falling in the same category of membership e.g. NGO
representative. Recommendations may be sought from the resigning member.
 Appointments may be made in consultation with the Member Secretary and
/or Chairperson
 Termination / Disqualification procedure
 A member may be relieved or terminated of his/her membership in case of
Conduct unbecoming for a member of KIEC
 Inability to participate in the meetings on any grounds
 Failure to attend more than 3 consecutive meetings of KIEC and subsequent
to review of the membership by KIEC; if deemed necessary, KIEC may decide
to terminate the membership and the Chairperson, KIEC may make a
recommendation to the Executive Director, Kauvery Hospital, for necessary
action.
  Relocation to another city or any such matter.
 In all such situations/circumstances, Executive Director, Kauvery Hospital, will
serve a letter of termination to the member.
 Documentation of the termination will be recorded in the minutes of the next
duly constituted KIEC meeting and KIEC membership roster and circulars will
be revised.
Conditions of Appointment
 Name, gender, profession, and affiliation of KIEC members will be publicized.
 Members must accept the appointment in writing.
 Members must submit a one page CV and training certificates in GCP &
NDCT 2019
 Conflict of interest, if any, must be disclosed.
 Members must apprise themselves of the NDCT 2019, GCP for clinical trials
in India, and the ICMR guidelines 2017 and KIEC SOPs.
 Members are required to sign the Confidentiality / Conflict of Interest
Agreement and Financial Disclosure at the start of their term. The
confidentiality agreement protects the privacy and confidentiality of all parties
whose information may be disclosed to the KIEC in the course of its work.
 All KIEC members shall disclose in writing to the KIEC all conflicts of interest
for themselves and their spouses/domestic partners and dependent children.
For purposes of this policy, a conflict of interest may be identified as either
financial in nature (such as when an KIEC member holds an economic
interest in the research) or non-financial in nature (such as when an KIEC
member or consultant participates in the research or will be included as a co-
author on a publication from the research), either of which could affect or
appear to affect the design, conduct, oversight, or reporting of the research
project.
 Financial interests that require disclosure include but are not limited to:
Ownership interest, stock options, or other economic interest related to the
research, Board, scientific officer, or executive relationship related to the
research, regardless of compensation for that position
 Non-financial interests that require disclosure include but are not limited to:
 (a) Participation in the research project as key personnel (PI, Co-PI,
subinvestigator);
(b) Co-Author on a publication of the research project’s results;
(c) Other relationships which may influence judgment of KIEC member
in reviewing the research project:
i. is a direct supervisor or trainee of the researcher(s)
ii. is related to a researcher whose protocol is under
consideration
iii. has a prominent role in a directly competing research
team or product
d has a close personal relationship with a researcher or for other
reasons feels unable to render a fair and unbiased review.
 An investigator can be a member of the KIEC. However, the investigator-as-
member cannot participate in the review and approval process for any project
in which he or she is present as a PI, Co-PI or CI or has any other potential
conflict of interest
 KIEC members are prohibited from participating in the review of a research
protocol or plan in which they have a conflict of interest, except to provide
information requested by the KIEC.
Independent Consultants
KIEC may call upon, or establish a standing list of, independent consultants
who may provide special expertise to KIEC on proposed research protocols,
when the Chairperson / Member secretary or KIEC members determine that a
study will involve procedures or information that is not within the area of expertise
of KIEC members. These consultants may be specialists in ethical or legal
aspects, specific diseases or methodologies (e.g. genetic disorders, stem cell
research etc.), or they may be representatives of communities, patients, or
special interest groups. These consultants must sign the confidentiality
agreement regarding meeting, deliberations, and related
matters. These consultants or subject experts cannot vote for a decision.
Directors, Head of Institution, Administrative officers who are
responsible for business development will not be appointed as independent
consultants.
Office Bearers
KIEC will have the following office bearers who have the expertise and professional
qualifications to review the proposals submitted.
Chairperson
KIEC Chairperson should be a highly respected individual from outside Kauvery
Hospital, fully capable of managing KIEC and the matters brought before it, with
fairness and impartiality. The task of making KIEC a respected part of the
institutional community will fall primarily on the shoulders of this individual. KIEC
must be perceived to be fair and impartial, immune from pressure either by Kauvery
Hospital's administration, the investigators whose protocols are brought before it, or
other professional and non-professional sources. KIEC Chairperson will respect the
diverse backgrounds, perspectives, and sources of expertise of all KIEC members,
especially the contributions of the non-scientists, and must have the
ability to foster such respect among KIEC members. The Chairperson should:
• Conduct EC meetings and be accountable for independent and efficient
functioning of the committee
• Ensure active participation of all members (particularly non-affiliated, non-medical/
non- technical) in all discussions and deliberations
• Ratify minutes of the previous meetings

• In case of anticipated absence of Chairperson at a planned meeting, the

Chairperson should nominate a committee member as Acting Chairperson or the
members present may elect an Acting Chairperson on the day of the meeting.
The Acting Chairperson should be a non-affiliated person and will have all the
powers of the Chairperson for that meeting.
• Seek COI declaration from members and ensure quorum and fair decision making

• Handle complaints against researchers, EC members, conflict of interest issues

and requests for use of EC data, etc.
Member Secretary
The Member Secretary will be a staff member of Kauvery Hospital, committed to the
task of coordinating and managing the activities of the committee. Should be able to
devote adequate time to this activity which should be protected by the institution.
He/she will be responsible for scheduling the meetings, describing the agenda and
ensuring that the function of the committee is conducted as per the norms and
policies described in this SOPs. The member secretary should:
• Organize an effective and efficient procedure for receiving, preparing, circulating
and maintaining each proposal for review
• Schedule EC meetings, prepare the agenda and minutes

• Organize EC documentation, communication and archiving

• Ensure training of EC secretariat and EC members

• Ensure SOPs are updated as and when required

• Ensure adherence of EC functioning to the SOPs

• Prepare for and respond to audits and inspections

• Ensure completeness of documentation at the time of receipt and timely

inclusion in agenda for EC review.
• Assess the need to obtain prior scientific review, invite independent consultant,
patient or community representatives.
• Ensure quorum during the meeting and record discussions and decisions.

• Assess the need for expedited review/ exemption from review or full review.

• In the absence of a Member Secretary of KIEC for scheduled KIEC meeting,

another member of KIEC will be nominated by the Chairperson for that meeting to
coordinate and manage the activities of the KIEC for that meeting.
• Member Secretary along with KIEC Chairperson shall review disclosures to
determine whether a conflict of interest exists and to determine appropriate
management of the conflict of interest.
Basic Medical Scientist- Clinical Pharmacologist
Non-medical or medical person with qualifications in basic medical sciences. In
case of EC reviewing clinical trials with drugs, the basic medical scientist should
preferably be a pharmacologist. The Clinical Pharmacologist should conduct
• Scientific and ethical review with special emphasis on the intervention, benefit-
risk analysis, research design, methodology and statistics, continuing review
process, SAE, protocol deviation, progress and completion report
• For clinical trials, pharmacologist to review the drug safety and
pharmacodynamics.
Clinicians
The clinicians in KIEC should be individual/s with recognized medical qualification,
expertise and training.Their role pertains to:
• Scientific review of protocols including review of the intervention, benefit-risk
analysis, research design, methodology, sample size, site of study and statistics
• Ongoing review of the protocol (SAE, protocol deviation or violation, progress and
completion report)

• Review medical care, facility and appropriateness of the principal investigator,

provision for medical car, management and compensation.

• Thorough review of protocol, investigators brochure (if applicable) and all other
protocol details and submitted documents.
Legal Expert
The legal expert in KIEC should have a basic degree in Law from a recognized
university, with experience. It would be added advantage if they have training in
medical law.The responsibility of the legal expert is to
• Ethical review of the proposal, ICD along with translations, MoU, Clinical Trial
Agreement (CTA), regulatory approval, insurance document, other site approvals,
researcher’s undertaking, protocol specific other permissions, such as, stem cell
committee for stem cell research, HMSC for international collaboration,
compliance with guidelines etc.
• Interpret and inform EC members about new regulations if any

Social Scientist
Should be an individual with social/ behavioural science/ philosophy/ religious
qualification and training and/or expertise and be sensitive to local cultural and moral
values. Can be from an NGO involved in health-related activities
• Ethical review of the proposal, ICD along with the translations.

• Assess impact on community involvement, socio–cultural context, religious or

philosophical context, if any

• Serve as a patient/participant/ societal / community representative and bring

in ethical and societal concerns
Lay person
 Should be a literate person from the public or community;has not pursued a
medical science/ health-related career in the last 5 years; may be a representative
of the community from which the participants are to be drawn; is aware of the local
language, cultural and moral values of the community. It is preferable if he/she is
involved in social and community welfare activities. The lay person will be
involved in the:
• Ethical review of the proposal,

• Evaluate benefits and risks from the participant’s perspective and opine whether
benefits justify the risks.
• Serve as a patient/participant/ community representative and bring in ethical and
societal concerns.
• Assess on societal aspects if any.
Duties of the administrative officer/s/staff:
1. Organizing an effective and efficient tracking procedure for each proposal
received.
2. Preparing, maintaining and distributing study files.
3. Organizing KIEC meetings regularly
4. Preparing the agenda and minutes of the meetings
5. Maintaining KIEC records and archives.
6. Communicating with KIEC members and PIs.
7. Arranging training for personnel and KIEC members
8. Providing necessary administrative support for KIEC related activities to the
Member Secretary, KIEC.
9. Receiving KIEC processing fees and issuing official receipts for the same.
10. Corresponding with KIEC members, external experts and investigators.
11. Making the pre and post arrangements of KIEC meetings.
12. Preparing the agenda and minutes of KIEC meetings.
13. Answering queries of the investigators.
14. Filing study related documents.
15. Archiving and maintaining the study files.
16. Preparation for accreditation, audits
17. Training for investigators, key study personnel, KIEC members, and KIEC staff.
18. Participate in the development and subsequent implementation of SOPs
19. Developing an effective and efficient tracking procedure

Roles and Responsibilities of KIEC members

 The members’ primary responsibilities will be determining the scientific and
ethical validity of the research and the protection of the safety, rights and
confidentiality of the research subjects.
 Participate in KIEC meeting.
 Review and discuss research proposals assigned for evaluation.
 Review progress reports and monitor ongoing studies.
 Monitor SAEs and recommend appropriate action(s).
 Maintain confidentiality of the documents and deliberations of KIEC meetings.
 Declare conflict of interest, if any - KIEC members shall disclose to KIEC all
conflicts of KIEC member, their spouse/domestic partner, and their dependent
children with regard to a research project involving human participants. Such
disclosure shall be sufficiently detailed and timely to allow KIEC administration
to transfer the project to another KIEC member or allow time for an alternate
member to attend KIEC meeting to meet quorum.
 KIEC member/consultant shall evaluate whether a conflict of interest exists,
and he/she shall disclose any identified conflicts to KIEC at the next KIEC
meeting. If an KIEC member discovers that he/she has a conflict of interest
during the conduct of a study over which KIEC provides oversight, KIEC
member/consultant shall report the conflict to KIEC. KIEC members shall
cooperate with KIEC and other officials in their review of the conflicts of
interest issues and shall comply with all requirements of KIEC.
 Carry out work delegated by the Chairperson and/or Member Secretary.
 Participate in continuing education activities in biomedical ethics and
biomedical research.
 Provide information and documents related to training obtained in biomedical
ethics and biomedical research to KIEC secretariat.
 Directors, Head of Institution, Administrative officers who are responsible for
business development will not be involved in the review process.
 In the absence of the Chairperson, a member who is independent of the
institution will chair the meeting as the Acting Chairperson.
Quorum Requirements
All research projects for approval by the full board of KIEC shall be reviewed at
convened meetings at which a majority of the members of KIEC are present. In
order for the research to be approved, it shall receive the approval of a majority of
those members present at the meeting. The presence of the following five (5)
members is required to form part of the quorum without which a meeting cannot be
convened and a decision regarding the project cannot be taken. These 5 members
should have the following representation:
(a) basic medical scientists (preferably one clinical pharmacologist);
(b) clinicians
(c) legal expert;
(d) social scientist or representative of non-governmental voluntary agency or
philosopher or ethicist or theologian or similar person;
(e) lay person from the community;
In addition to the above , the quorum must fulfill following criteriai)
A quorum should include at least one member whose primary area of expertise is in
a non-scientific area, a clinician, and at least one member who is independent of
Kauvery Hospital and has no immediate family member affiliated to Kauvery
Hospital.
ii) No quorum should consist entirely of members of one profession
or one gender.
iii) When an alternate member attends a meeting as a substitute for a
regular member, the alternate member’s participation counts
toward the quorum requirements. Alternate members will serve in
the same representative capacity as the member for whom they
substitute
Decision making
Decisions will be arrived at through consensus/unanimous or majority opinion
amongst the voting members of KIEC. The decision-making is thus concerned with
the process of deliberating and finalizing a decision. When a consensus is not
possible, the KIEC will vote.
Voting may be in the form of voice vote, show of hands, or by secret ballot, as
determined by the Chairperson, KIEC.
All members including the Chairperson are entitled to one vote. However, in case of
a tie, the Chairperson will have the casting vote.
KIEC minutes will document each alternate member’s status, vote, and
attendance as they relate to KIEC actions and quorum requirements.
Opinions of absent members that are transmitted by mail or telephone or fax may be
considered by the attending members during discussion. But absent member van
not be counted as voting member or quorum member for formally convened full
board meetings.
Any committee member with a conflicting interest in a proposal will abstain from
deliberations and in the decision making process on that proposal, except to provide
information as requested by the committee. Such abstentions will be recorded in the
minutes.
An KIEC member or consultant with either a financial or non-financial conflict of
interest in a research project involving human participants may not participate in the
KIEC review of that research. KIEC shall not approve a research protocol where a
conflict of interest is not eliminated, and it has the final authority to determine
whether a conflict of interest has been eliminated appropriately.

TERMS OF REFERENCE FOR ETHICS COMMITTEE MEMBERS

 The head of the institution should appoint all KIEC members, including the
chairperson
 The appointment letter issued to all members should specify the Terms of
References
 The letter issued by the head of the institution should include, at the minimum,
the following:
 Role and responsibility of the member in the committee
 Duration of appointment
 Conditions of appointment
 The term of EC membership is 5 years. 30% of KIEC members are changed on a
regular basis
 KIEC members are given an honorarium for attendance at the meeting
 Members to be appointed on the KIEC should be willing to fulfil the EC
requirements as mentioned below:
Every Kauvery Institutional Ethics Committee member must:
1. Provide a recent signed CV and training certificates on Good Clinical Practice
Guideline(GCP) and New drugs &Clinical Trial Rule 2019
2. They should be trained at the time of induction into the committee or must
undergo training and submit the training certificates within 6 months of
appointment
3. Be willing to undergo training or update their skills/knowledge during their
tenure as an Ethics Committee member
4. Be aware of relevant guidelines and regulations
5. Read, understand, accept and follow the Conflict of Interest policy framed by
KIEC and declare it when and wherever applicable
6. The confidentiality and conflict of interest agreement to be signed
7. Willingness to place their full name, profession and affiliation in the public
domain
8. To understand the need for research and be committed in imparting protection
to the research participants in research

CRITERIA FOR SELECTION OF MEMBERS FOR KIEC

 Members should be selected in their personal capacities based on

their qualifications, experience, interest, commitment and
willingness to volunteer the required time and effort for the EC.
 Members are appointed to the EC for a particular role. They
cannot substitute for the role of any other member who is absent
for a meeting.
 The role of Chairperson/ Member Secretary is an additional activity
to their primary responsibility based on their qualifications. Hence, if
the Chairperson is a lawyer, she or he can serve as both the lawyer
and the Chairperson.

Training
  Members should be trained in human research protection, EC
functions and SOPs, and should be conversant with ethical
guidelines, GCP guidelines (if applicable) and relevant regulations
of the country.
 KIEC members should undergo initial and continuing training in
human research protection, applicable EC SOPs and related
regulatory requirements. All trainings should be documented.
 Any change in the relevant guidelines or regulatory requirements
should be brought to the attention of all EC members.
 EC members should be aware of local, social and cultural norms
and emerging ethical issues.
Roles and responsibilities of KIEC

 The basic responsibility of KIEC is to ensure protection of the

dignity, rights, safety and well-being of the research participants.
 The KIEC ensures ethical conduct of research by the investigator team.
 The KIEC is responsible for declaration of conflicts of interest to the
Chairperson, if any, at each meeting and ensuring these are
recorded in the minutes.
 The KIEC should perform its function through competent initial and
continuing review of all scientific, ethical, medical and social
aspects of research proposals received by it in an objective, timely
and independent manner by attending meetings, participation in
discussion and deliberations.
 The KIEC must ensure that universal ethical values and
international scientific standards are followed in terms of local
community values and customs.
 The KIEC assists in the development and education of the research
community in the given institute (including researchers, clinicians,
students and others), responsive to local healthcare requirements
 Responsibilities of members is clearly defined as per the ICMR
Guidelines 2017. The SOPs are given to all KIEC members at the
time of their appointment.
  The privacy of the individua; and the confidentiality of the submitted
data at the KIEC is strictly adhered to at all times
 When and where ever applicable the KIEC provides suggestions
pertaining to the care of participants and other risk reducing
procedures
 The progress and final reports, adverse events and serious adverse
events are also reviewed by the KIEC
 Appropriate compensation for research related injury is
recommended by the KIEC wherever required
 The KIEC should carry out monitoring visits at study sites as and when
needed.
 The KIEC should participate in continuing education activities in
research ethics and get updated on relevant guidelines and
regulations.
 KIEC does not permit duplication of the same research and has
zero tolerance to the submission of the same research to different
funding agencies
Submission and review procedures

The research proposals are submitted as both hard and soft copies to the KIEC in
the prescribed format. The committee then prepares a checklist for the required
documents and this is subject to modifications. The entire process is given in the
subsequent SOPs