Yenepoya Ethics Committee - 1

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(Recognized by SIDCER-FERCAP and Registered with the office of DCGI)

YEC-1 Members from July 2017 - 2020

Name Qualifications Designation
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 Ravi Vaswani MD, PG Dip Bioethics Internal - Clinician, Bioethicist
Dr. Laxminarayana Sonde BDS, MDS Internal - Basic Scientist
Dr. Nagapati Bhat MD Internal - Pharmacologist
Dr. Mohd Guthigar MSW, PhD Internal - Social Scientist
Ms Viji Prasad C MSc, PG Dip Bioethics Internal - Nurse, Bioethicist
Mr Y Moideen Khurshid MBA Internal - Risk assessor
Dr. Vijayalakshmi Mogasale MBBS, MD (Ped) Internal - Clinician
Dr. Grrishma B MBBS, MD(Physio) Internal - Basic Scientist
Ms. Mudasir Rashid Baba BPT, MPT Internal - Physiotherapy
Dr. Kiran Kammar BAMS, MD (Ayur) Internal - AYUSH
Dr Uma Kulkarni DOMS, DNB (Oph),
PGDBEME, PGDCE

Internal – Member Secretary Clinician, Bioethicist

Intent of YEC - 1: "Enhancing quality of research through protection of research participants"

Renaming of the ethics committee

YEC-1 Notification July 2017

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

13.Review Completion

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

 

Registration of YEC-1 with DCGI

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

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