Institutional ethics committee form

1. Institutional Ethics Committee
S. C. B. Medical College & Hospital, Cuttack
Proforma to be filled by the Principal Investigator (PI) for submission to the Institutional Ethics
Committee (IEC) (for attachment to each copy of proposal)
Proposal Title (in Capital Letters) :
Name, Qualifications & Designation Address, Tel. & Fax No.s, Email Id Signature
Principal
Investigator
Prof. Dr. Daityari Routray, MD
Anaesthesiology
Professor & Head
P.G. Dept. of Anaesthesiology
& Critical Care
S. C. B. Medical College & Hospital
Cuttack
P.G. Dept. of Anaesthesiology
& Critical Care
At:- S. C. B. Medical College & Hospital,
P.O.:- S. C. B. Medical S. O.,
Dist:- Cuttack, State:- Odisha,
Pin:- 753007
Tel. No.:- (+91)
dr.daityariroutray@gmail.com
Co-Investigator
Prof. Dr. Daityari Routray, MD
Anaesthesiology
Professor & Head
P.G. Dept. of Anaesthesiology
& Critical Care
S. C. B. Medical College & Hospital
Cuttack
P.G. Dept. of Anaesthesiology
& Critical Care
At:- S. C. B. Medical College & Hospital,
P.O.:- S. C. B. Medical S. O.,
Dist:- Cuttack, State:- Odisha,
Pin:- 753007
Tel. No.:- (+91)
dr.daityariroutray@gmail.com
Co-Investigator
Prof. Dr. Daityari Routray, MD
Anaesthesiology
Professor & Head
P.G. Dept. of Anaesthesiology
& Critical Care
S. C. B. Medical College & Hospital
Cuttack
P.G. Dept. of Anaesthesiology
& Critical Care
At:- S. C. B. Medical College & Hospital,
P.O.:- S. C. B. Medical S. O.,
Dist:- Cuttack, State:- Odisha,
Pin:- 753007
Tel. No.:- (+91)
dr.daityariroutray@gmail.com
Please attach detailed Curriculum Vitae of all Investigators (with subject specific publications limited to
previous five (5) years). The Investigators should sign their CVs.
Tick Appropriately
Sponsorship Information
☐ Sponsored Study ☐ Non-Sponsored Study
If Sponsored Study, whether
☐ Indian ☐ Government ☐ Private ☐ Institutional
☐ International ☐ Government ☐ Private ☐ UN Agencies
☐ Industry ☐ National ☐ Multinational
Name & Address of
Sponsor :

2. Total Budget : Rs. _______________ (in words ____________________________________) only
Research Fund will be deposited in (please specify) _______________________.
Please give details of allocation of budget in attachment.
1. Type of Study : ☐ Prospective ☐ Retrospective
☐ Epidemiological ☐ Basic Sciences ☐ Behavioural ☐ Clinical
☐ Single Center ☐ Multicentric If multicentric, how many centers :
2. Status of Review : ☐ New ☐ Revised
3. Clinical Trials Drug/ Vaccine/ Device/ Herbal Medicine
a) Does the study involve use of : ☐ Drug / Vaccine ☐ Device
☐ Alternative Medicine ☐ Any other, please specify ____________________ ☐ Not Applicable
b) Is it approved & marketed in ☐ India ☐ UK
☐ Europe ☐ USA ☐ Other Countries, Specify :
If marketed in India, please attach package insert ☐ Yes ☐ No
If not marketed in India, please attach Drugs Controller General (India) [DCG(I)] permission
c) Is the drug an Investigational New Drug (IND)? ☐ Yes ☐ No
If yes, please submit Investigator’s Brochure which contains data of pre-clinical and/or clinical studies.
If IND, please mention IND No. ____________________ and also attach DCG(I) permission.
d) Does the drug involve a change in Use, Dosage, and Route of Administration?
☐ Yes ☐ No
If yes, whether DCGI’s/Any other Regulatory Authority’s Permission is obtained?
☐ Yes ☐ No
If yes, please attach a copy of DCG(I) permission ☐ Yes, copy attached ☐ No, copy not attached
e) Clinical Study is :
☐ Phase I ☐ Phase II ☐ Phase III ☐ Phase IV
4. Objectives of the Study :
1)
2)
3)
4)
5)
5. Justification for Conduct of this Study
6. Methodology

3. a) Number of Patients :
b) Inclusion Criteria :
c) Exclusion Criteria :
d) Controls :
e) Study Design :
f) Dosage of drug
g) Duration of
treatment :
h) Investigation
specifically related
to projects :
i) Permission to use
copyrighted
Questionnaire/
Proforma
j) Others :
7. Subject Selection :
a) Duration of 1) Study : 2) Subject Participation :
b) Will subjects from both sexes be recruited ☐ Yes ☐ No
c) Inclusion/exclusion criteria given ☐ Yes ☐ No
d) Types of Subjects ☐ Volunteers ☐ Patients
b) Vulnerable Subjects (tick the appropriate boxes) ☐ Yes ☐ No
☐ Pregnant Women ☐ Children ☐ Elderly ☐ Foetus
☐ Illiterate ☐ Handicapped ☐ Seriously Ill ☐ Mentally Challenged
☐ Economically & Socially Backward ☐ Any Other, please specify :
c) Special Group Subjects (tick the appropriate boxes) ☐ Yes ☐ No
☐ Captives ☐ Institutionalised ☐ Employees ☐ Students
☐ Nurses/Staffs ☐ Armed Forces ☐ Any Other, please specify :
8. Privacy and Confidentiality ☐ Direct Identifiers
a) Study Involves ☐ Indirect Identifiers/Coded
☐ Completely Anonymised/Delinked
b) Confidentiality Handling of Data by Staff ☐ Yes ☐ No
9. Use of Biological/Hazardous Materials
a) Use of fetal tissue or abortus. If yes provide details ☐ Yes ☐ No

4. b) Use of organs or body fluids. If yes provide details ☐ Yes ☐ No
c) Use of recombinant/gene therapy products ☐ Yes ☐ No
d) If yes, has Department of Biotechnology (DBT) approval for r DNA products
been obtained?
☐ Yes ☐ No
e) Use of pre-existing/stored/left over samples ☐ Yes ☐ No
f) Collection for banking/future research ☐ Yes ☐ No
g) Use of ionizing radiation/radioisotopes ☐ Yes ☐ No
h) If yes, has Bhabha Atomic Research Centre (BARC) approval for Radioactive
Isotopes been obtained?
☐ Yes ☐ No
i) Use of Infectious/Biohazardous Specimens ☐ Yes ☐ No
j) Proper Disposal of Material ☐ Yes ☐ No
k) Will any sample collected from the patients be sent abroad? ☐ Yes ☐ No
If yes, give details and address of collaborators ☐ Yes ☐ No
A. Sample will be sent abroad because (tick the appropriate box)
☐ Facility not available in India ☐ Facility in India inaccessible
☐ Facility available but not being accessed If so, reasons
B. Has necessary clearance been obtained ☐ Yes ☐ No
10. Consent
☐ Written ☐ Oral ☐ Audio-Visual
a) Patient Information Sheet attached : (Tick the included elements) ☐ Yes ☐ No
☐ Understandable language
☐ Statement that study involves research
☐ Sponsor of study
☐ Purpose and procedures
☐ Risks & discomforts
☐ Benefits
☐ Compensation for participation
☐ Compensation for study related injury
☐ Translation of Information Sheet in Local
Language
☐ Alternatives to participation
☐ Confidentiality of records
☐ Contact information
☐ Statement that consent is voluntary
☐ Right to withdraw
☐ Consent for future use of material biological
☐ Benefits if any on future commercialization e.g.
Genetic basis for drug development
☐ Cost of Management of Adverse
☐ Effects will be borne by Sponsor
b) If healthy volunteers will be included, information sheet for them attached ☐ Yes ☐ No
c) Consent Form ☐ in English ☐ in Regional Languages

5. d) Who will obtain consent? ☐ PI/Co-PI ☐ Nurse/Counsellor
☐ Research Staff ☐ Any Other
*If written consent is not obtained, give reasons
11. Will any advertising be done for recruitment of Subjects? (Posters,
Flyers, Brochure, Websites – if so attach a copy)
☐ Yes ☐ No
12. Risks & Benefits
a) Is the risk reasonable compared to the anticipated benefits to subjects/
community/ country?
☐ Yes ☐ No
b) Is there physical/social/psychological risk/discomfort?
If yes, ☐ Minimal Or No Risk ☐ > Minimum Risk ☐ High Risk
c) Is there benefit a) to the subject? ☐ Yes ☐ No ☐ Direct ☐ Indirect
b) to the society ☐ Yes ☐ No
13. Data Monitoring
a) Is there a Data & Safety Monitoring Committee/Board (DSMB)? ☐ Yes ☐ No
b) Is there a plan for reporting of adverse events? ☐ Yes ☐ No
If yes, reporting will be done to ☐ Sponsor ☐ IEC ☐ DSMB
c) Is there a plan for interim analysis of data? ☐ Yes ☐ No
14. Is there compensation for injury? ☐ Yes ☐ No
If yes, by ☐ Sponsor ☐ Investigator ☐ Insurance Company
☐ Any Other
15. Do you have conflict of interest? (Financial/Non-financial) ☐ Yes ☐ No
If yes, specify
16. Insurance Policy for the following is available?
Patient/Participant ☐ Yes ☐ No Company/Sponsor ☐ Yes ☐ No
Investigator/s & Team ☐ Yes ☐ No Institute/Committees ☐ Yes ☐ No
Check List for attached Documents
Project Proposal-15 copies
Curriculum Vitae of Investigators ☐
Brief description of proposal/summary ☐
Copy of the Protocol/Project and questionnaire (if any) ☐
Investigator’s Brochure ☐
Copy of Patient Information Sheet & Consent form in Local Language ☐
Copy of Advertisements/Information Brochures ☐

6. HMSC/DCGI/DBT/BARC clearance if obtained ☐
Copy of Insurance Policy ☐
Copy of Clinical Trial Agreement ☐
Copy of IEC Proforma ☐
Copy of PI Undertaking ☐
Copy of Case Report Form ☐
Curriculum Vitae of Investigators ☐
We hereby declare the information given above is true and that we do not have any financial or non -
financial conflict of interest.
Signature of Principal Investigator
with Date & Seal
Signature of Co-Investigator
with Date & Seal
Signature of Head of the Department
with Date & Seal