YENEPOYA ETHICS COMMITTEE - 1 OFFICIAL WEBPAGE
Yenepoya Ethics Committee - 1 is recognized by/ registered with
1. Forum for Ethics Review Committees of the Asia and Western Pacific Region (FERCAP) under the SIDCER initiative of the WHO
2. National Accreditation Board of Hospitals and healthcare providers
3. Drugs Controller General of India (DCGI)
Yenepoya Ethics Committee - 1
YEC-1 Members from July 2017 - September 2020
Name Qualifications Status Designation
Dr Vikram Shetty MBBS, D. Ortho, DNB External Chairperson
Dr Sayeegeetha PhD (Tulu Language) External Layperson
Mr Saduddin Salihi LLB, LLM External Legal expert
Fr Teji Thomas B.Ph, B.Th, GNM (Nursing) External Priest/Theologian
Dr Ravi Vaswani MD, PG Dip Bioethics Internal Clinician/Bioethicist
Dr Mohammed Guthigar MSW, PhD Internal Social Scientist
Dr Nagapati Bhat MBBS, MD Internal Pharmacologist
Dr Laxminarayan Sonde BDS, MDS Internal Clinician
Ms Viji Prasad C MSc, PG Dip Bioethics Internal Nurse/Bioethicist
Mr YM Khurshid MBA External Layperson
Dr. Sachidananda Adiga MBBS, MD External Basic Scientist
Dr Uma Kulkarni DNB (Ophthal), DOMS, Internal Secretary (9448150032)
PGDBEME, PGDCE
Serious Adverse Events Subcommittee of the YEC:
Dr. Ravi Vaswani Chairperson
Dr. Mohammed Guthigar Executive Secretary
Dr. Nagapati Bhat Member
Dr. Laxminarayan Sonde Member
Dr. Uma Kulkarni Ex-officio Member
Dr. Ravi Vaswani Chairperson
Dr. Mohammed Guthigar Executive Secretary
Dr. Nagapati Bhat Member
Dr. Laxminarayan Sonde Member
Dr. Uma Kulkarni Ex-officio Member
Important administrative documents of YEC-1
|
| ||||
|
| ||||
|
| ||||
Principal Investigator/Researcher/Sponsor Resource Centre
Standard Operating Procedure Manual of YEC-1 Version 3 Effective Date 3 October 2019
26 Chapters
|
| ||||
|
| ||||
|
| ||||
|
| ||||
|
| ||||
|
| ||||
|
| ||||
|
| ||||
|
| ||||
|
| ||||
|
| ||||
|
| ||||
More detailsProposed dates of YEC-1 meetings
|
| ||||
|
| ||||
|
| ||||
|
| ||||
| Checklist for protocol submission.docx |
| Waiver consent form.docx |
| Checklist and sample for informed consent |
Post-approval forms
| Serious Adverse Event reporting form V3 |
| Periodic or continuing review application form V3.docx |
| Request for amendment of protocol V3.docx |
| Study completion reporting form V3.docx |
General information for submission for ethical approval:
1. All applications must be signed by all investigators, and other relevant authorities of the university as applicable.
2. Applications must be addressed in a covering letter to the Secretary, Yenepoya University Ethics Committee
3. All applications must be submitted in duplicate (print copies) and one soft copy (CD), by email to ethcom@yenepoya.edu.in
4. Applications that are eligible for expedited review will receive approval within 2-4 weeks of receipt of complete protocol package.
5. Applications that are for full review if received (complete in all documents) at least 4 weeks before the scheduled meeting will be
eligible to be kept as agenda, and approval letter (if approved) will be issued within 2 weeks of the meeting.
6. It is the PI's responsibility to submit the corrections advised within the stipulated time.
7. Incomplete forms are liable to undue delays.
8. If required, the PI may be invited by the Secretary, YUEC, to clarify ethical doubts, either orally, or in writing or communicate by e
email. 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.
9. Six-monthly progress reports and study closure report are mandatory.
10. Changes in the title, objectives, methodology and/or analysis amount to protocol amendments and require reporting to the ethics
committee, which will decide on whether fresh issual for ethical clearance is required or not.
11. Decisions on ethical waiver, expedited review or full review rest solely with the YUEC.
12. Please download the checklist and the application form (above); print it, check the items included and submit along with the
application
1. All applications must be signed by all investigators, and other relevant authorities of the university as applicable.
2. Applications must be addressed in a covering letter to the Secretary, Yenepoya University Ethics Committee
3. All applications must be submitted in duplicate (print copies) and one soft copy (CD), by email to ethcom@yenepoya.edu.in
4. Applications that are eligible for expedited review will receive approval within 2-4 weeks of receipt of complete protocol package.
5. Applications that are for full review if received (complete in all documents) at least 4 weeks before the scheduled meeting will be
eligible to be kept as agenda, and approval letter (if approved) will be issued within 2 weeks of the meeting.
6. It is the PI's responsibility to submit the corrections advised within the stipulated time.
7. Incomplete forms are liable to undue delays.
8. If required, the PI may be invited by the Secretary, YUEC, to clarify ethical doubts, either orally, or in writing or communicate by e
email. 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.
9. Six-monthly progress reports and study closure report are mandatory.
10. Changes in the title, objectives, methodology and/or analysis amount to protocol amendments and require reporting to the ethics
committee, which will decide on whether fresh issual for ethical clearance is required or not.
11. Decisions on ethical waiver, expedited review or full review rest solely with the YUEC.
12. Please download the checklist and the application form (above); print it, check the items included and submit along with the
application