ANNEXURE 3B

FORMAT FOR SUBMISSION OF PROJECTS INVOLVING RESEARCH IN HUMAN SUBJECTS FOR CLEARANCE BY
ETHICS COMMITTEE OF AIIMS, PATNA

Submit one (1) hard copy of the Research Proposal along with Covering letter, a CD/DVD of
the proposal and a ‘soft copy’ along with the following information to the Member Secretary,
Institution Ethics Committee at the IEC office, AIIMS Patna.

No research project shall be / can be started unless ethics clearance/approval is obtained. Please
bear in mind that no retrospective / post facto ethical clearance can be provided to research
projects which were neither submitted nor vetted by the Institution Ethics Committee.

All submissions should be made in the prescribed Format of the IEC with signatures of all the
investigators. The submission must be accompanied with Participant Informed Consent Form
(PICF) and Participant Information Sheet (PIS), both in English and Hindi/Concerned local
Language, in a simple layman’s language, in a narrative form, directed to
Participant/LAR, covering all the points given, before it can be considered for placing
before the IEC. Also ensure that all the pages are numbered.

PROJECT SUBMISSION TIME: SUBMISSIONS WILL BE RECEIVED ON ALL WORKING DAYS.

PROPOSALS RECEIVED TILL 25th OF PRECEDING MONTH WILL BE PROCESSED IN THE COMING
INSTITUTION ETHICS COMMITTEE MEETING AND THOSE RECEIVED AFTER 25 th WILL BE
PROCESSED IN THE NEXT INSTITUTION ETHICS COMMITTEE MEETING. ALL MEETINGS OF
INSTITUTION ETHICS COMMITTEE WILL BE HELD AS FAR AS POSSIBLE ON LAST FRIDAY OF
EVERY MONTH. THE FREQUENCY WILL CHANGE DEPENDING UPON THE NUMBER OF
PROPOSALS AND WILL BE UPDATED.

While submitting replies to queries raised by the IEC, the candidates are advised to mention
the IEC reference number/s and also attach a copy of the comments of the IEC Moreover if the
approval is required in a particular format, the same may be submitted in a CD/DVD.

Amendment Submission: While submitting amendments in protocols a covering letter should

be provided clearly stating the changes and a certificate by the PI that the changes made in the
protocol will not hamper the safety of the subject in anyway.

(Kindly read the instructions carefully and do abide by the above.)

 FORM TO BE FILLED BY THE PRINCIPAL INVESTIGATOR FOR SUBMISSION TO
INSTITUTIONAL ETHICS COMMITTEE (IEC), AIIMS‐PATNA

(FOR ATTACHMENT TO EACH COPY OF THE PROPOSAL)

Serial No of IEC Management Office:

TITLE OF THE PROJECT: …………………………………………………………………………………………………...

…………………………………………………………………………………………………………………………………..

Name, Number of
Mobile No.
Designation, Projects already Signature
Email ID
Department with Investigator

Principal
Investigator

Co-PI’s

Name, Mobile Number and Email ID should be clearly written.

Sponsor Information :
Central State Institutional
1. Indian a) Government

b) Private
2. International Government Private UN agencies

3. Industry National Multinational

Contact Address of Sponsor:

Total Budget:
Who will bear the cost of investigation / implants 1.Patient 2.Project 3. Exempted
drugs / contrasts?
4. Other Agencies

1.Type of Study : Cross sectional case control cohort Clinical Trial Review

Participating Centre : Single center Multi-centric Others (Specify)

2. Status of Review: New Revised

Clinical Trials:

Drug /Vaccines/Device/Herbal Remedies:

i. Does the study involve use of:

Drug Devices

Indian Systems of Medicine/ Any other

Alternate System of Medicine

ii. Is it approved and marketed

In India UK & Europe USA

Other countries, specify

iii. Does it involve a change in use, dosage, route of administration? Yes No

If yes, whether DCGI’s /Any other Regulatory authority’s Permission Yes No
is obtained?
If yes, Date of permission :
iv. Is it an Investigational New Drug? Yes No

If yes, IND No:

a). Investigator’s Brochure submitted Yes No
b). In vitro studies data Yes No
c). Preclinical Studies done Yes No
d). Clinical Study is : Phase I Phase II Phase III Phase IV

e). Are you aware if this study/similar study is being done else-where? Yes No

If Yes, attach details

4. Brief description of the proposal – Introduction, review of literature, aim(s) & objectives,
justification for study, methodology describing the potential risks & benefits, outcome measures,
statistical analysis and whether it is of national significance with rationale (Attach sheet with
maximum 500 words):
5. Subject selection:

ii. Duration of study :

iii. Will subjects from both sexes be recruited Yes No

iv. Inclusion / exclusion criteria given Yes No

v. Type of subjects Volunteers Patients

vi. Vulnerable subjects Yes No

(Tick the appropriate boxes)

pregnant women children elderly

fetus illiterate handicapped

Mental terminally ill seriously ill

i. Special group subjects Yes No

(Tick the appropriate boxes)

captives institutionalized employees

students nurses/dependent armed

any other staff forces

6. Privacy and confidentiality

i. Study involves - Direct Identifiers

Indirect Identifiers/coded

Completely anonymised

ii. Confidential handling of data by staff Yes No

7. Use of biological/ hazardous materials Yes No

ii. Use of organs or body fluids Yes No

iii. Use of recombinant/gene therapy Yes No

If yes, has Department of Biotechnology (DBT) approval for rDNA Yes No

products been obtained?

iv. Use of pre-existing/stored/left over samples Yes No

v. Collection for banking/future research Yes No
vi. Use of ionizing radiation/radioisotopes Yes No

If yes, has Bhabha Atomic Research Centre (BARC) approval for Yes No
Radioactive Isotopes been obtained?

vii. Use of Infectious/bio hazardous specimens Yes No

viii. Proper disposal of material Yes No
ix. Will any samples collected from the patients be sent Yes No
abroad?

If Yes, justify with details of collaborators

a) Is the proposal being submitted for clearance from HealthYes No
Ministry’s Screening Committee (HMSC) for International
collaboration?

b) Sample will be sent abroad because (Tick appropriate box):

Facility not available in India

Facility in India inaccessible

Facility available but not being accessed.

If so, reasons…
8. Consent : *Written Oral Audio-visual

I. CONSENT FORM : (TICK THE INCLUDED ELEMENTS)

Understandable Alternatives to
language participation

Statement that study Confidentiality of

involves research records

Sponsor of study Contact information

Purpose and procedures Statement that consent

is voluntary

Risks & Discomforts Right to withdraw

Benefits Consent for future use
of biological material
Compensation for Benefits if any on
participation future
commercialization eg.
genetic basis for drug
development
Compensation for
study related injury

*if written consent is not obtained, give reasons.

ii. Who will obtain consent ? PI/Co-PI Nurse/Counsellor

 Research staff Any other

9. Will any advertising be done for recruitment of Subjects? Yes No

(posters, flyers, brochure, websites – if so kindly attach a copy)

10. Risks & Benefits:

Is the risk reasonable compared to the anticipated benefits
i toYes No
subjects / community / country?
ii. Is there physical / social / psychological risk / discomfort? Yes No

If Yes, Minimal or no risk

More than minimum risk
High risk

iii. Is there a benefit

a) to the subject?
Direct
Indirect

b) Benefit to society

11. Data Monitoring Yes No

I Is there a data & safety monitoring committee/ Board

(DSMB)?

ii. Is there a plan for reporting of adverse events? Yes No

If Yes, reporting is done to :

Ethics
Sponsor Committee DSMB

iii. Is there a plan for interim analysis of data? Yes No

vi. Are there plans for storage and maintenance of all trial database? Yes No
If Yes, for how long ?

12. Is there compensation for participation? Yes No

If Yes, Monetary In kind
 13. Is there compensation for injury? Yes No
If Yes, by Sponsor

14. Do you have conflict of interest? Yes No

(financial/nonfinancial) If Yes, specify :

Conflict of interest for any other investigator(s) (if yes, please 1 Yes

explain in brief No 2 Yes

15. Participant Information Sheet Attached English version

Attached Hindi version

(mark √ if yes)

16. Participant Informed Consent Form Attached English version

Attached Hindi version
(mark √ if yes)

17. Whether any work on this project has started or not? (mark √ if yes, X if no) (Please
Separate certificate to this effect).

18. In case of clinical trials CTRI status

 CHECKLIST FOR ATTACHED DOCUMENTS

*Covering letter, through proper channel forwarded by Head of Department . . . . . . . . . . . . . . . .

*Project proposal – 01 Copy ...............................................
*Curriculum Vitae of Investigators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
*Brief description of proposal ...............................................
*Patient information sheet (PIS) ...............................................
*Patient Informed Consent form (PICF). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
*Soft Copy of the Proposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Investigator’s brochure ...............................................
Copy of advertisements/Information brochures ...................................
Copy of clinical trial protocol and/or questionnaire . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HMSC/DCGI/DBT/BARC clearance (if required) ...................................
*Undertaking that the study shall be done in accordance with ICMR and GCP guidelines . . . . .
*Undertaking that Left over blood will be disposed off in controlled & regulated manner . . . . . .
*Undertaking of responsibility in case of adverse event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
In case of multi-centric study, IEC clearance of other centres must be provided . . . . . . . . . . . . .
Definite undertaking as to who will bear the expenditure of injury related to the project . . . . . . .
If an insurance cover is intended .......................................... .....
Insurance certificate must be provided (as per ICMR guidelines) . . . . . . . . . . . . . . . .. . . . . . . .
Permission to use copyrighted Questionnaire / Perform ..............................
Investigator should provide undertaking what they will do with the leftover sample tissue . . . . .
Certificate/undertaking as mentioned in column 17 .............................
Others .............................................................

[NOTE: REQUIRED DOCUMENTS MARKED WITH [ * ] ARE MENDATORY]

Please do not submit without required documentation.