YEC-1 Members from July 2017 - 2020
|Dr. Vikram Shetty||MBBS, MS (Ortho)||External - Chairperson|
|Mr. Saduddin Salihi||LLB, LLM||External - Legal|
|Dr. Sayeegeetha||PhD Tulu language||External - Layperson|
|Fr. Teji Thomas||B.Ph, B.Th, GNM (Nursing)||External - Priest|
|Dr. Sachidananda Adiga||MD||External - Basic Scientist|
|Dr. Ravi Vaswani||MD, PG Dip Bioethics||Internal - Clinician, Bioethicist|
|Dr. Laxminarayan Sonde||BDS, MDS||Internal - Basic Scientist|
|Mr. Y M Khurshid||MBA||External - Layperson|
|Dr. Nagapati Bhat||MD||Internal - Pharmacologist|
|Dr. Mohammed Guthigar||MSW, PhD||Internal - Social Scientist|
|Ms Viji Prasad||MSc, PG Dip Bioethics||Internal - Nurse, Bioethicist|
|Dr Uma Kulkarni||DOMS, DNB (Oph),
Internal - Member Secretary Clinician, Bioethicist
Intent of YEC - 1: "Enhancing quality of research through protection of research participants"
Standard Operating Procedure Manual of Yenepoya Ethics Committee-1 (To download all SOP's and relevant templates click here)
1. Preparation of SOP
2. Constitution of EC
3. Conflict of Interest
4. Selection Independent Consultant
5. Guest observer procedure
6. Protocol submission management
7. Initial review categories
7A. Initial Full Review
7B. Expedited review
7C. Exemption review
8. Agenda meeting minutes
9. Resubmissions amendments
10. Continuing review
11. Continuing review_1
12. Serious Adverse Event reporting
14. Premature termination
15. Waiver IC
16. Site monitoring
17. Requests Complaints Queries
18. Maintenance archival retrieval
19. Vulnerable populations
20. Audit inspections
21. YEC-1 training
How to submit a proposal for ethical clearance:
1. All applications must be signed by all investigators, and other relevant authorities of the university as applicable.
2. Applications must be addressed to the Secretary, Yenepoya University Ethics Committee
3. All applications must be submitted in duplicate (print copies) and one soft copy (CD). Email submissions will not be accepted.
4. Applications received only fifteen days before the scheduled meeting will be eligible to be heard
5. It is the PI's responsibility to submit the corrections advised within the stipulated time.
6. Incomplete forms are liable to undue delays.
7. If required, the PI may be invited by the Secretary, YUEC, to clarify ethical doubts, either orally, or in writing or in the form of a presentation. In such an event, the PI personally has to make himself/herself available for the clarifications. In the unusual event that the PI is unable to be present he/she can send his/her representative along with a letter highlighting reasons for absence.
8. Six-monthly progress reports and study closure report are mandatory.
9. Changes in the title, objectives, methodology and/or analysis requires reporting to the ethics committee, which will decide on whether fresh application for ethical clearance is required.
10. Decisions on ethical waiver, expedited review or full review rest solely with the YUEC.
Please download this checklist; print it, check the items included and submit along with the application
Application form initial submission sponsored regulatory rct
Application initial submission academic or dissertation study
Check list for protocol submission rct
Checklist and sample for informed consent for pg pi
Checklist for protocol submission academic dissertation study