Upcoming Events:
Yenepoya Ethics Committee - 1 to undergo FERCAP resurvey on 10-12 June 2019
Yenepoya Ethics Committee - 1 (YEC-1) has been providing protection to human research participants and enhancing the quality of biomedical research involving human subjects since 2008. In 2016 YEC-1 (then YUEC) voluntarily took the decision to undergo ethics committee recognition by FERCAP. FERCAP or Forum for Ethical Review Committees in the Asian & Western Pacific Regions is an international organization created under the WHO's Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) and its office is based in the Bangkok, Thailand. In 2016 when Yenepoya University Ethics Committee (now renamed YEC-1) underwent recognition by FERCAP it was only the tenth ethics committee in the country to get this recognition. At the close of three years we are now undergoing a re-survey.
Four assessors (two international and two Indian) will - along with 10 trainees - review the functioning of YEC-1 over three days and provide constructive feedback to improve the quality and standards of YEC-1.
The surveyor team consists of:
Dr. Prasad Ranatunga, Human Genetics Unit, Faculty of Medicine, University of Colombo, Sri Lanka
Dr. PHG Janaka Pushpakumara, Head, Department of Family Medicine, Faculty of Medicine & Allied Sciences, Rajarata University, Sri Lanka
Dr. Paul Kumaran, National Institute for Research in Tuberculosis, Madurai Unit, Madurai, Tamil Nadu
Dr. Swarnalakshmi, YR Gaitonde Centre for AIDS Research & Education (YRG CARE), Chennai
Yenepoya Ethics Committee - 1 (YEC-1) has been providing protection to human research participants and enhancing the quality of biomedical research involving human subjects since 2008. In 2016 YEC-1 (then YUEC) voluntarily took the decision to undergo ethics committee recognition by FERCAP. FERCAP or Forum for Ethical Review Committees in the Asian & Western Pacific Regions is an international organization created under the WHO's Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) and its office is based in the Bangkok, Thailand. In 2016 when Yenepoya University Ethics Committee (now renamed YEC-1) underwent recognition by FERCAP it was only the tenth ethics committee in the country to get this recognition. At the close of three years we are now undergoing a re-survey.
Four assessors (two international and two Indian) will - along with 10 trainees - review the functioning of YEC-1 over three days and provide constructive feedback to improve the quality and standards of YEC-1.
The surveyor team consists of:
Dr. Prasad Ranatunga, Human Genetics Unit, Faculty of Medicine, University of Colombo, Sri Lanka
Dr. PHG Janaka Pushpakumara, Head, Department of Family Medicine, Faculty of Medicine & Allied Sciences, Rajarata University, Sri Lanka
Dr. Paul Kumaran, National Institute for Research in Tuberculosis, Madurai Unit, Madurai, Tamil Nadu
Dr. Swarnalakshmi, YR Gaitonde Centre for AIDS Research & Education (YRG CARE), Chennai
Yenepoya Ethics Committee - 1 to undergo NABH accreditation on 3 June 2019
Yenepoya Ethics Committee - 1 (YEC-1) has been providing protection to human research participants and enhancing the quality of biomedical research involving human subjects since 2008. YEC-1 will undergo NABH accreditation for Ethics Committees on 3 June 2019. This is made mandatory by the Government of India, for ethics committees that review clinical trials. YEC-1 is recognized by Forum for Ethics Review Committees of the Asia-Pacific (FERCAP) under the WHO initiative Strategic Initiative for Development of Capacity in Ethics Review (SIDCER). YEC-1 is also registered with the Office of the Drugs Controller General of India. The Chairperson, Member-Secretary and all the members of YEC-1 wholeheartedly welcome the NABH EC assessor team.
Yenepoya Ethics Committee - 1 (YEC-1) has been providing protection to human research participants and enhancing the quality of biomedical research involving human subjects since 2008. YEC-1 will undergo NABH accreditation for Ethics Committees on 3 June 2019. This is made mandatory by the Government of India, for ethics committees that review clinical trials. YEC-1 is recognized by Forum for Ethics Review Committees of the Asia-Pacific (FERCAP) under the WHO initiative Strategic Initiative for Development of Capacity in Ethics Review (SIDCER). YEC-1 is also registered with the Office of the Drugs Controller General of India. The Chairperson, Member-Secretary and all the members of YEC-1 wholeheartedly welcome the NABH EC assessor team.
Yenepoya Ethics Committee - 1 recognized by Forum for Ethics Review Committees of the Asia and Western Pacific Region (FERCAP) under the SIDCER initiative of the WHO
Yenepoya University Ethics Committee
Renamed as Yenepoya Ethics Committee - 1
YEC-1 Members from July 2017 - June 2019
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 Y Moideen Khurshid MBA Internal Risk Assessor
Dr. Grrishma B MBBS, MD Internal Basic Scientist
Dr. Vijayalakshmi Mogasale MBBS, MD Internal Clinician
Ms. Kiran Kammar BHMS, MD (OBG) Internal Homeopathy
Ms. Mudassir Rashid Baba BPT, MPT Internal Physiotherapy
Dr Uma Kulkarni DNB (Ophthal), DOMS, Internal Secretary (9448150032)
PGDBEME, PGDCE
| DCGI amended approval letter for YEC-1.pdf |
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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 |
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Yenepoya University Ethics Committee underwent an accreditation recognition process by Forum for Ethics Review Committees of the Asia and Western Pacific Regions (FERCAP) in December 2015. Following the recommendations of the FERCAP Survey Team our SOP has undergone extensive reconstruction. We have used the FERCI templates and modified them to our requirements. Our new SOP is effective from 1 August 2016. We have uploaded our new SOP as approved by the Registrar, Yenepoya University. Also attached are useful templates which a PI or PG is strongly encouraged to use, so that the protocol document package is processed quickly and time to ethical approval is minimized.
Principal Investigator/Researcher/Sponsor Resource Centre
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| Checklist and sample for informed consent |
| Review exemption application form.docx |
| Checklist for protocol submission.docx |
| Waiver consent form.docx |
| Request for amendment of protocol.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