FEDERAL MEDICAL COLLEGE
Ethical Review Committee (ERC)
Application for approval of a Research Project involving Human Subjects
Date of Application:
1. Brief title of project:
2. Personnel involved
3. State your personal experience in this field in terms of extent and duration.
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PROJECT DETAILS
4. Purpose of investigation (please indicate what information you hope to obtain, and what you
believe will be the benefits).
5. Provide a concise description of what is to be done (the protocol).
6. State the potential hazards (if any), and precautions to be taken to meet them.
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7. State the degree of discomfort in terms of apprehension, pain and disturbance in terms of alteration
of subject's routine.
8. State the likely duration of the project.
9. Where will the project be done?
10. What individual benefit (if any) will a patient have if he participates in the study?
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PATIENTS/VOLUNTEERS
11. State the number, age and type of patients/subjects likely to be involved. Have you discussed the
methodology and number of subjects needed with a statistician? (If yes, please indicate with whom).
12. Do these include women who are pregnant or likely to become pregnant? How will pregnancy be
excluded (if relevant)?
13. How will patients/volunteers be recruited?
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14. Informed consent must be obtained in all cases: where written consent is sought, written
information should be provided for the patient/volunteer, and this must be included with the
application. Please indicate if consent will be:
(a) Oral
(b) Written
(c) Obtained in the presence of a disinterested 3rd person
15. Give details of any payment to be made to the patient/subject.
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COMMUNICATION
16. Please indicate what (if any) information will be sought from general practitioners/other doctors,
and what information will be supplied to them and in what form. Note that written information
should indicate how experimenters can be contacted by telephone in emergency.
17. When a drug is being administered will the patient/subject have on his person some means of this
being known in the case of a sudden illness/accident?
DRUGS
18. Please state briefly the known pharmacology of drugs to be used, indicating activity and I
mportant side-effects.
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SPONSORSHIP
19. Is this study being performed with commercial sponsorship, or sponsorship from some outside body
(e.g. the PMRC)? If so, please state from whom.
20. If this project involves participation/sponsorship by a pharmaceutical company, has indemnification
or no fault liability been obtained?
21. Is there any other form of indemnification?
22. In case of commercial sponsorship, is there any payment to be made to the
experimenters/department in addition to the actual cost of the study? If so, please give details.
Signature of Principal Investigator
Name: Designation:
Deptt:
Tel No Office: Mobile:
Emails
