FORMAT FOR SUBMISSION OF PROTOCOL INVOLVING RESEARCH IN HUMAN
SUBJECTS FOR CLEARANCE BY ETHICS SUB-COMMITTEE AND COMMITTEE
OF AIIMS FOR DM / M.Ch / Ph.D/ MD / MS / MHA / M.Sc / M.Biotech. STUDENTS
(FOR THESIS OR DISSERTATION)
12 copies of the Research Project along with Covering letter, copy of protocol and ‘soft copy’ on
CD with following information be submitted to the Member Secretary, Ethics Sub-committee at
Room No. 102/108, 1st Floor, Old OT Block, AIIMS, Tel No.4579. The submission must be
accompanied by informed consent and Patient Information Sheet in both English and Hindi
before it can be considered for placing for the Committee. The format is also available at
www.aiims.edu / www.aiims.ac.in
The research projects proposal submitted should be as follows:
1. Full Title of Study:
2. Name of Candidate / Department _______________________ Signature________________
Please Specify the degree M.Sc / M.Biotech / MD / MS / MHA /Ph.D / DM / MCh
3. Name of Faculty (Guide/Co-guide) Signatures (Should preferably be signed by at least two guides / co-guides)
(with designation & department)
3.1______________________________ 3.1_____________________________________________
3.2 _____________________________ 3.2 ____________________________________________
3.3 _____________________________ 3.3 ____________________________________________
3.4 _____________________________ 3.4 ____________________________________________
3.5______________________________ 3.5_____________________________________________
(Expand if any more co-guides)
4. Objectives of the study 4.1_____________________________________________
4.2_____________________________________________
4.3_____________________________________________
4.4_____________________________________________
4.5_____________________________________________
5. Justification for the conduct of the
study
6. Methodology 6.1. Number of Patients:
6.2. Inclusion criteria
a)______________________________________________
b)______________________________________________
c)______________________________________________
d)______________________________________________
6.3. Exclusion criteria
a)______________________________________________
b)______________________________________________
c)______________________________________________
d)______________________________________________
6.4. Control(s)
6.5. Study design
6.6. Dosages of drug
6.7. Duration of treatment
6.8. Investigation
6.9. Others
7. Permission from Drug Controller 1. Required 2. Not required
General of India (DCGI) 3. Received 4. Applied
when:_____________
8. Permission from DGFT 1. Required 2. Not required
if applicable 3. Received 4. Applied
when:_____________
9. a) Safety measures for proposed a)_____________________________________________
interventions
b) Results of relevant laboratory tests b)_____________________________________________
c) Result of studies in human c)_____________________________________________
10. Plans to withdraw standard therapy Yes No
During conduct of research
Remarks:_______________________________________
11. Plan for provision of coverage for
medical risk during the study period
12. How you will maintain
confidentiality of subject?
13. Costs Involved (Appx. in Rs.)
13.1 Investigations 13.1_____________________________________________
13.2 Disposables 13.2_____________________________________________
13.3 Implants 13.3_____________________________________________
13.4 Drugs / Contrast Media 13.4_____________________________________________
Who will bear the costs of the 1. Patient 2. Project 3. Exempted
requirements? 4. Other Agencies (Name)________________________
13. Patient Information Sheet (PIS)/ Informed Consent Form (ICF): The project must be accompanied
by the Patient Information Sheet addressed to patient. The Informed Consent Form to be used in the
study should be signed by two witness. While formulating the patient information sheet, investigator
must provide the subjects with the following information in simple language, which can be understood
by them both in English and Hindi:
i) Aims and methods of the research
ii) Expected duration of the subject participation
iii) The benefits to be expected from the research to the subject or to others
iv) Any risk to the subject associated with the study
v) Maintenance of confidentiality of records
vi) Provision of free treatment for research related injury
vii) Compensation of subjects for disability or death resulting from such injury
viii) Freedom of individual to participate and to withdraw from research at any time without
penalty or loss of benefits to which the subject would otherwise be entitled.
ix) Amount of blood sample or any other tissues an quantity to be taken should be mentioned
in PIS in ml
x) Costs and source of investigations, disposables, implants and drugs / contrast media must
be mentioned in the PIS.
xi) Telephone number/contact number of the candidate and one of the investigator must be
mentioned in the PIS at the top of the page.
xii) In case of the drug trials:
a. The chemical name of the drug, date of its manufacturing and batch number must be
mentioned.
b. Initial Bio-equivalent study of the drug/references should be avoided.
xiii) Informed Consent Form should state that the patient has been informed about the study and
agrees to a part of the study. It should have space for signatures by patient, doctors and two
witnesses (Annexure 1)
(Students are requested to prepare the translation in simple Hindi on their own for both PIS and ICF
should be enclosed herewith)
14.Attached documents 14.1________________________________________
(If any)
14.2________________________________________
14.3________________________________________
14.4________________________________________
Six monthly progress reports to be sent to the Dean’s office as given in the Annexure 2
INFORMED CONSENT FORM Annexure-I
Protocol / Study number:_____________________________________
Patient identification number for this trial: _______________________
Title of project:_____________________________________________
Name of Principal Investigator: _________________________Tel.No(s).__________________
The contents of the information sheet dated ……………….. (Version)…………….. that was
provided have been read carefully by me / explained in detail to me, in a language that I
comprehend, and I have fully understood the contents. I confirm that I have had the opportunity
to ask questions.
The nature and purpose of the study and its potential risks / benefits and expected duration of the
study, and other relevant details of the study have been explained to me in detail. I understand
that my participation is voluntary and that I am free to withdraw at any time, without giving any
reason, without my medical care or legal right being affected.
I understand that the information collected about me from my participation in this research and
sections of any of my medical notes may be looked at by responsible individuals from
……………………… (Company name) or from regulatory authorities where it is relevant to my
taking part in research. I give permission for these individuals to have access to my records.
I agree to take part in the above study.
--------------------------------------------- Date:
(Signature / Left Thumb Impression) Place:
Name of the Participant: ____________________________________
Son / Daughter / Spouse of:__________________________________
Complete postal address: _____________________________________
This is to certify that the above consent has been obtained in my presence.
------------------------------
Signature of the Principal Investigator Date:
Place:
1) Witness – 1 2) Witness – 2
------------------------------ --------------------------------
Signature Signature
Name: Name:
Address: Address:
NB Three copies should be made, for (1) patient, (2) researcher, (2) Institution
Six monthly progress of Project Annexure-II
1st
Progress:
Side Effect if any:
Amendments if any:
Discontinuation reasons:
Data Safety Monitoring Committee Report:
2nd Progress:
Side Effect if any:
Amendments if any:
Discontinuation reasons:
Data Safety Monitoring Committee Report:
3rd Progress:
Side Effect if any:
Amendments if any:
Discontinuation reasons:
Data Safety Monitoring Committee Report:
4th Progress:
Side Effect if any:
Amendments if any:
Discontinuation reasons:
Data Safety Monitoring Committee Report:
5th Progress:
Side Effect if any:
Amendments if any:
Discontinuation reasons:
Data Safety Monitoring Committee Report:
6th Progress:
Side Effect if any:
Amendments if any:
Discontinuation reasons:
Data Safety Monitoring Committee Report:
