(Version 1.

1, September 2014)

ETHICAL REVIEW COMMITTEE,

FACULTY OF MEDICINE, UNIVERSITY
OF PERADENIYA
ETHICS REVIEW PROTOCOL SUBMISSION FORM
(For use by ERC, Faculty of Medicine, Universit y of Per adeniya only)

SECTION A GENERAL INFORMATION

1. TITLE OF RESEARCH PROJECT

2. INVESTIGATOR INFORMATION
Principal Investigator:
Title (e.g., Dr.,
Ms., etc.):

Name:

Department:
Mailing address:
Phone:

Institutional e-mail:

Alternate Contact (e.g., Research Coordinator):

Title:

Name:

Phone:

e-mail:

Co-Investigators:
Are co-investigators involved?
Title:

Yes

No

Name:

Institution/Department:
Mailing address:

Version Date: September 2014

12

Phone:

e-mail:

Title:

Name:

Institution/Department:
Mailing address:
Phone:

e-mail:

Please append additional pages with co-investigators names if necessary.

Please attach 03 hard copies of the detailed research proposal

3. FACULTY OF MEDICINE ETHICS REVIEW COMMITTEE:

Health Sciences

Social Sciences, Humanities and Education

CLINICAL

4. LOCATION(S) WHERE THE RESEARCH WILL BE CONDUCTED:

If the research is to be conducted at a site requiring administrative approval/consent (e.g., in a school),
please include all administrative consent letters. It is the responsibility of the researcher to determine what
other means of approval are required, and to obtain approval prior to starting the project.
University of Peradeniya
Hospital

specify site(s)

School/College

specify site(s)

Community

specify site(s)

International

specify site(s)

Other

specify site(s)

5. OTHER RESEARCH ETHICS BOARD APPROVAL(S)

(a) Does the research involve another institution or site?

Yes

No

(b) Has any other ERC approved this project?

Yes

No

If Yes, please provide a copy of the approval letter upon submission of this application.
If No, will any other ERC be asked for approval?
Yes

(please specify which ERC)

6. FUNDING OF THIS PROJECT

(a)

2 of 9

No

Funding Status

Source and Type

Details (number)

Agency:

Funded

Agency:
Applied for funding

Agency:

Submission date:

Agency:

Submission date:

Unfunded
If unfunded, please explain why no funding is needed:
(b) If one protocol is to cover more than one grant, please include all grant identification numbers:

7. CONTRACTS
Is this research to be carried out as a contract? Yes
No
If yes, is there a University of Peradeniya / Ministry of Health funding or non-funded agreement associated
with the research?
Yes
No
If Yes, please append a copy of the agreement with this application.
Is there any aspect of the contract that could put any member of the research team in a potential conflict of
interest? Yes
No
If yes, please elaborate under #10.

8. PROJECT START AND END DATES

Estimated start date for the component of this project that involves human participants or data:
Estimated completion date of involvement of human participants or data for this project:

9. SCHOLARLY REVIEW:
(a) Please check one:
I.

The research has undergone scholarly review by Higher Degrees Committee / Research
Committee of Faculty of Peradeniya or some other equivalent (Specify review type):

II.

The research will undergo scholarly review prior to funding

(Specify review committee):

III.

The research will not undergo scholarly review

(Please note that all research conducted for obtaining higher degrees should be approved by the
relevant higher degrees committee prior to ethical clearance )

IV.

If box I or II above was checked, please specify

The review was/will be specific to this protocol
The review was/will be part of a larger grant

3 of 9

10. CONFLICTS OF INTEREST

(a) Will the researcher(s), members of the research team, and/or their partners or immediate family
members:
(i) Receive any personal benefits (e.g., financial benefit such as remuneration, intellectual property
rights, rights of employment, consultancies, board membership, share ownership, stock options, etc.) as a
result of or in connection with this study? Yes
No
(ii) If Yes, please describe the benefits below. (Do not include conference and travel expense
coverage, or other benefits which are considered standard for the conduct of research.)

(b) Describe any restrictions regarding access to or disclosure of information (during or at the end of the
study) that have been placed on the investigator(s). These restrictions include controls placed by the
sponsor, funding body, advisory or steering committee.

(c) Where relevant, please explain any pre-existing relationship between the researcher(s) and the
researched (e.g., instructor-student; manager-employee; clinician-patient; minister-congregant). Please
pay special attention to relationships in which there may be a power differential actual or perceived.

(d) Please describe the decision-making processes for collaborative research studies. If Terms of
Reference exist, attach them. Collaborative research studies include those where a number of sites (e.g.
other universities, hospitals, etc.) are involved, as well as those that involve community agencies.

11. EXPERIENCE OF INVESTIGATORS WITH THIS TYPE OF RESEARCH

(a) Please provide a brief description of previous experience with this type of research by (i) the principal
investigator, (ii) the research team and (iii) the people who will have direct contact with the participants. If
there has not been previous experience, please describe how the principal investigator/research team will
be prepared.

(b) For projects that will involve community members (e.g., peer researchers) in the collection and/or
analysis of data, please describe their status within the research team (e.g., are they considered
employees, volunteers or participants?) and what kind of training they will receive?

12. HAVE YOU EVER DONE A TRAINING COURSE ON GOOD CLINICAL PRACTICE (GCP)?

4 of 9

13. HOW MAY RESEARCH STUDIES DO YOU CURRENTLY CARRYING OUT? (IN ADDITION TO
THIS STUDY)

14. RECRUITMENT OF PARTICIPANTS

Where there is recruitment, please describe how, by whom, and from where the participants will be
recruited
Where participant observation is to be used, please explain the form of insertion of the researcher into
the research setting (e.g., living in a community, visiting on a bi-weekly basis, attending organized
functions)
If relevant, describe any translation of recruitment materials, how this will occur and whether or not
those people responsible for recruitment will speak the language of the participants.
Attach a copy of all posters, advertisements, flyers, letters, e-mail text, or telephone scripts to
be used for recruitment.

15. COMPENSATION
(a) Will participants receive compensation for participation?
Financial

Yes

No

In-kind

Yes

No

Other

Yes

No

(b) If Yes, please provide details and justification for the amount or the value of the compensation offered.

(c) If No, please explain why compensation is not possible or appropriate.

(d) Where there is a withdrawal clause in the research procedure, if participants choose to withdraw, how
will compensation be affected?

SECTION B DESCRIPTION OF THE RISKS AND BENEFITS OF THE PROPOSED RESEARCH

16. POSSIBLE RISKS

5 of 9

(a) Please indicate all potential risks to participants as individuals or as members of a community that may
arise from this research:
(i) Physical risks (e.g., any bodily contact or administration of any substance):

Yes

No

(ii) Psychological/emotional risks (e.g., feeling uncomfortable, embarrassed, or upset):

Yes

No

(iii) Social risks (e.g., loss of status, privacy and/or reputation):

Yes

No

(iv) Legal risks (e.g., apprehension or arrest, subpoena):

Yes

No

(b) Please briefly describe each of the risks noted above and outline the steps that will be taken to manage
and/or minimize them.

17. POSSIBLE BENEFITS

Describe any potential direct benefits to participants from their involvement in the project
Describe any potential direct benefits to the community (e.g., capacity building)
Comment on the potential benefits to the scientific/scholarly community or society that would justify
involvement of participants in this study

SECTION C INFORMED CONSENT

18. CONSENT PROCESS
(a) Describe the process that will be used to obtain informed consent and explain how it will be recorded.
Please note that it is the quality of the consent, not the form that is important. The goal is to ensure that
potential participants understand to what they are consenting.
(b) If the research involves extraction or collection of personally identifiable information from or about a
research participant, please describe how consent from the individuals or authorization from the data
custodian (e.g., medical records department, district school board) will be obtained.

19. CONSENT DOCUMENTS

(a) Attach a copy of the Information Letter/Consent Form.
Additional documentation regarding consent should be provided such as:
-

screening materials introductory letters, letters of administrative consent or

authorization

(b) If any of the information collected in the screening process - prior to full informed consent to participate
in the study - is to be retained from those who are later excluded or refuse to participate in the study,

6 of 9

please state how potential participants will be informed of this course of action and whether they will have
the right to refuse to allow this information to be kept.

20. COMMUNITY AND/OR ORGANIZATIONAL CONSENT, OR CONSENT BY AN AUTHORIZED

PARTY
(a) If the research is taking place within a community or an organization which requires that formal
consent be sought prior to the involvement of individual participants, describe how consent will be
obtained and attach any relevant documentation. If consent will not be sought, please provide a
justification and describe any alternative forms of consultation that may take place.

(b) If any or all of the participants are children and/or others who are not competent to consent, describe
the process by which capacity/competency will be assessed, and the proposed alternate source of
consent.
i)

Submit a copy of the permission/information letter to be provided to the person(s) providing

the alternative consent

ii)

Describe the assent process for participants and attach the assent letter.

21. DEBRIEFING and DISSEMINATION

(a) If deception or intentional non-disclosure will be used in the study, provide justification. Please provide
a copy of the written debriefing form, if applicable.

(c) If participants and/or communities will be given the option of withdrawing their data following the
debriefing, please describe this process.

(d) Please describe what information/feedback will be provided to participants and/or communities after
their participation in the project is complete (e.g., report, poster presentation, pamphlet, etc.) and note how
participants will be able to access this information.

22. PARTICIPANT WITHDRAWAL

(a) Where applicable, please describe how participants will be informed of their right to withdraw from the
project and outline the procedures that will be followed to allow them to exercise this right.

(b) Indicate what will be done with the participants data and any consequences which withdrawal may
have on the participant.

7 of 9


(c) If participants will not have the right to withdraw from the project at all, or beyond a certain point,
please explain. Ensure this information is included in the consent process and consent form.

SECTION D CONFIDENTIALITY AND PRIVACY

23. CONFIDENTIALITY
Data security measures must be properly ensured. All identifiable electronic data that is being kept outside
of a secure server environment must be encrypted.
(a) Will the data be treated as confidential?

Yes

No

(b) Describe the procedures to be used to protect the confidentiality of participants or informants, where
applicable

(c) Describe any limitations to protecting the confidentiality of participants whether due to the law, the
methods used, or other reasons (e.g., a duty to report)

24. DATA SECURITY, RETENTION AND ACCESS

(a) Describe how data (including written records, video/audio recordings, artifacts and questionnaires) will
be protected during the conduct of the research and dissemination of results.

(b) Explain how long data will be retained. (If applicable, referring to the standard data retention practice
for your discipline) Provide details of their final disposal or storage. Provide a justification if you intend to
store your data for an indefinite length of time. If the data may have archival value, discuss how
participants will be informed of this possibility during the consent process.

(c) If participant anonymity or confidentiality is not appropriate to this research project, please explain.

(d) If data will be shared with other researchers or users, please describe how and where the data will be
stored and any restrictions that will be made regarding access.

SECTION E SIGNATURES
25. PRIVACY REGULATIONS

8 of 9

My signature as Principal Investigator, in Section G of this application form, confirms that I am

aware of, understand, and will comply with all relevant laws governing the collection and use of
personally identifiable information in research. I understand that for research involving extraction or
collection of personally identifiable information, Provincial, National and/or International laws may apply
and that any apparent mishandling of personally identifiable information must be reported to the Office of
Institutional Ethics Review Committee.
As the Principal Investigator on this project, my signature confirms that I will ensure that all procedures
performed will be conducted in accordance with all relevant University, Provincial, National and
International policies and regulations that govern research involving human participants. I understand that
if there is any significant deviation from the project as originally approved, I must submit an amendment to
the Institutional Ethics Review Committee for approval prior to implementing any change.

Signature of Principal Investigator:_____________________________________

Date:

As the head of the department/ institution, my signature confirms that I am aware of the requirements for
scholarly review and that the ethics protocol for this research has received/not-received appropriate
review prior to submission.

In addition, my institution/department unit will follow guidelines and procedures to ensure compliance with
all relevant University, Provincial, National or International policies and regulations that govern research
involving human participants. My signature also reflects the willingness of the department, faculty
institution or division to administer the research funds, if there are any, in accordance with University,
regulatory agency and sponsor agency policies.
Print Name of the Institution/Departmental Head(or designate) :

Signature of the Departmental Head/Institution: ____________________ Date:

(or designate)

9 of 9