MEDICAL ETHICS COMMITTEE
BHABHA ATOMIC RESEARCH CENTRE
MEDICAL DIVISION
B.A.R.C.HOSPITAL
ANUSHAKTI NAGAR, MUMBAI-400 094.
‘FACE SHEET’ of the Project for Ethical Review
1.
Title of the Project
(It should be concise & self explanatory)
To be filled by Office
_______________________________________
_____________________________________







Project No.
Date of Receipt
Date/s of Review
Status
Date of Start
Date of Close
Outcome
2.
Name, affiliation, official postal address, telephone nos., e-mail address of the
Principal Investigator / Co-ordinator. (if it is a multicentric study,
- who would be responsible for implementation of the project)
______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
____________________
3.
Name and address of the Institution /
Organization responsible for conduct /
coordination of the project.
4.
Name and address of the Funding / Sponsoring
4(a) Name and address of the Officer-inInstitution/CRO
Charge of the Funding / Sponsoring
institution
3(a)
Name and address of the Officer
responsible for institutional supervision
Page 1 of 9
5.
Name and address of the monitor / auditor of the Project, if any
6.
Comments / Recommendations of the SAC / Technical Experts : (Attach Minutes/Letter)
7.
Comments / Recommendations of the Statistician : (Attach letter)
8. To be answered / responded by the PI / Co-ordinator
a.
b.
c.
Does the protocol fall under exempt category?
(If yes, give reasons on separate sheet)
Is request made for obtaining waiver from informed
consent?
(If yes, give reasons on separate sheet)
Yes/No.
Does the protocol involve Human subjects
If yes, will it include
i) drawing of blood, body fluids, tissues etc.
(if yes, give details)
ii) administration of an investigational substance /
implantation of a device
(if yes, provide name of the drug / substance / device etc.
and its manufacture’s name and address) (Also,clearance
from the DCGI, if relevant)
iii) exposure to ionizing radiation
iv) use of genetically engineered products (if yes, give
details of
the product, and appropriate clearances from the DBT,
GEAC, DCGI, etc.)
Yes/No.
Yes/No.
Yes/No.
Yes/No.
Yes/No.
Page 2 of 9
d.
Does the protocol involve inclusion of vulnerable subjects
(If yes, special precautions proposed to safeguard their rights
and
interests shall be documented on separate sheet)
Yes/No.
It is certified that the statements made herein are true, complete and accurate to the best of
my/our knowledge. I am aware that any false, fictitious or fraudulent statements or claims may
subject me/us to criminal, civil, or administrative penalties. I/We agree to accept responsibility
for the scientific conduct of the project and to provide required progress reports if the
permission is granted as a result of this application.
Signature and assurance of the
Principal Investigator / Coordinator
responsible for conduct of the study _________________________________________________
Date
Place
(Stamp / Seal)
Signature and assurance of the
HOD / Chairperson of the
Department responsible for conduct _________________________________________________
of the study
Date
Place
(Stamp / Seal)
Signature and assurance of the
Head of the Institution / Authorized
person responsible for conduct of
the study
_________________________________________________
Date
Place
(Stamp / Seal)
Page 3 of 9
THESIS PROJECT PROTOCOL SHEET
Title of Project –
Aims & Objective –
Brief background of the Project –
Material & Methods –
References –
p.s.: if this page does not suffice please attach another sheet.
Page 4 of 9
FIFTEEN copies of all the Documents, neatly typed, numbered and bound shall be
submitted. All pages must be serially numbered and bear the title of the project.
1.
The documents shall include :
 Face sheet
 Signatures / Undertaking of all the Principal & Co-Investigators (Clinical &
Laboratory) of all Centres (if multicentric)
 Brief Biodata of all the investigators highlighting, competence and expertise to
carry out the study.
 Certification regarding conflict of interest
 Funding agency / Sponsor’s letter
 Information sheet and consent form in national and regional languages.
 Summary of protocol
 Detailed protocol
 Appraisal certificate from 1or 2 experts in the concerned field
 Any other relevant document
 All these above documents should be page numbered.
Page 5 of 9
UNDERTAKING BY INVESTIGATORS
(Separate sheet for each participating center / institution)
Protocol Title : ______________________________________________________________
__________________________________________________________________________
_____________________________________________
1.
We have read the ICMR’s Guidelines for ethical conduct of research involving
human subjects, and are familiar with our duties / obligations to ensure safety,
welfare of participants enrolled in the study and confidentiality of the data. The
study would start only after obtaining the approval of Institutional Ethics
Committee. We have also read the guidelines for good clinical practice issued by
the DGHS, Government of India and will follow them in our research on human
subjects. We would be responsible for obtaining the informed consent of
participants before enrolling them in the study.
2.
We will follow all the restrictions, if any, laid down by the Ethics Committee; and
seek its approval, if there is any deviation in the protocol / procedure of consent.
We will report all adverse events, which are required to be reported, and will
maintain all records as required. We will honour all obligations as accepted in the
consent form.
3.
There is no conflict of interest of any kind in carrying out the proposed study. We
will not receive any personal, direct or indirect financial benefit from the conduct of
this study.
4.
It is also certified that the statements made herein are true, complete and accurate
to the best of my/our knowledge. I am aware that any false, fictitious or fraudulent
statements or claims may subject me/us to criminal, civil, or administrative
penalties. I/We agree to accept responsibility for the scientific conduct of the
project and to provide required progress reports if the permission is granted as a
result of this application.
Signature of PI
Signature of Co-PI
Name
Address
Name
Address
Signature (any other)
Signature (any other)
Name :
Address :
Name :
Address :
Page 6 of 9
A consent form should include the following two parts(language should be as simple for the
potential subjects to understand clearly; translations into local languages will be required
Part I: (subject information sheet)
1. Name of the Institute with address
2. Title of study, including funding and other collaborating agencies
3. Name of the Principal Investigator
4. Why the study is being done
5. What we know about the issue/product
6. What is the product (Description)
7. How many subjects will take part in the study
8. What treatment will subject receive after inclusion in this study full details
with treatment and visit schedules, procedures, including interviews and
questionnaires and tests (give complete details of proposed tests)
9. Inclusion and exclusion criteria
10. Are there any risks involved in participating in the study
11. What are the benefits involved in participating in the study
12. What about confidentiality
13. What cost will subject have to bear by participating in the study, include any
reimbursements.
14. What are subjects rights as a participant, include right to withdraw anytime during the
study
15. What are subjects duties as a participant
16. Whom should subjects contact if they have any question or problem (PI, Ethics
committee chairperson, HOD with addresses and phone numbers)
Page 7 of 9
Part II:
CONSENT FORM
Name of the Institute with address
Title of study
I _______________________understand that the ‘Name of the Institute’ conducts
XYZ research in the area of _________. I hereby give my consent willingly to participate in
the study on “Title.”
I have been explained in detail in, the language I understand, about the purpose of the
study and my participation. I have been informed to my satisfaction the procedures to be
carried out by the study.
I am willing to follow the study procedures (clinical examination/interviews etc, as
applicable).
I have been explained the risks and benefits from my participation in the study.
I also understand that my participation in this study and information derived will be
kept confidential.
I am also aware of my right to withdraw from the study at any time without giving any
reason for doing so, but without any loss of benefits or utilization of the facilities offered at the
Institute.
I have discussed the study with my partner and he/she has agreed to my participation
in this study (If applicable).
Name and signature of witness
Date:
Name and Signature / Left hand thumb
impression of the subject/participant
Date:
Name and Signature of attending PI.
Date:
Page 8 of 9
CHECK LIST FOR DNB STUDENTS TO FOLLOW BEFORE SUBMISSION OF
PROJECTS
1.
Fill the face sheets covering all points.
2.
Project Details
3.
Subject information sheet in three languages (English, Hindi & Marathi).
4.
Consent form in three languages (English, Hindi & Marathi).
5.
Contact details of Investigators which should include the following:
a.
Local address
b.
Office address
c.
Telephone Numbers of Residence, Office and Mobile
d.
E mail id
6.
Number all the pages (Right bottom corner of page)
7.
To carry out corrections as per the instructions of Ethics Committee Members in
the meeting.
ALL ARE CALLED UPON TO STRICTLY ADHERE TO
THE DEADLINES ISSUED.
Page 9 of 9