YENEPOYA ETHICS COMMITTEE - 1 OFFICIAL WEBPAGE
Instructions to researchers in the current COVID-19 pandemic crisis
While we are also certain that you are taking the necessary precautions to keep your clinical trial participants safe, Yenepoya Ethics Committee - 1 responsibly reminds you to do all that is in your power to minimize the risk and mitigate the harm to your participants. Please look at the following and try to incorporate in your workplace:
1. Minimize interaction between the participants and research team members as well as with other patients and hospital staff.
2. Provide your clinical trial participants hand sanitizers and train them to use it frequently. Provide them with masks and teach them to use it correctly and dispose it appropriately.
3. Make sure they have the contact details of a responsible research team member who will respond to their calls 24x7, especially when they develop symptoms suggestive of coronavirus infection.
CONTINUE TO PRACTICE COVID APPROPRIATE BEHAVIOUR FOR A WHILE...STAY SAFE...STAY BLESSED
Issued by Yenepoya Ethics Committee -1 in public interest.
1. Minimize interaction between the participants and research team members as well as with other patients and hospital staff.
2. Provide your clinical trial participants hand sanitizers and train them to use it frequently. Provide them with masks and teach them to use it correctly and dispose it appropriately.
3. Make sure they have the contact details of a responsible research team member who will respond to their calls 24x7, especially when they develop symptoms suggestive of coronavirus infection.
CONTINUE TO PRACTICE COVID APPROPRIATE BEHAVIOUR FOR A WHILE...STAY SAFE...STAY BLESSED
Issued by Yenepoya Ethics Committee -1 in public interest.
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 (NABH)
3. Drugs Controller General of India (DCGI)
4. Department of Health Research (DHR)
5. Office for Human Research Protection (DHHS)
Yenepoya Ethics Committee - 1
YEC-1 Members
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
Ms. Sharika Rai B LLB, LLM External Legal expert
Fr. Siby Kaitharan MHA, BPh, BTh External Theologist
Dr. Shwetha Joyce Rasquinha MSW, MPhil, PhD External Social Scientist
Dr Mohammed Guthigar MSW, PhD Internal Social Scientist
Dr Nagapati Bhat MBBS, MD Internal Pharmacologist
Dr Pooja Harish 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 Ravi Vaswani MD, PG Dip Bioethics Internal Joint Secretary/Clinician/Bioethicist
Dr Uma Kulkarni DNB (Ophthal), DOMS, Internal Member-Secretary (9448150032)
PGDBEME, PGDCE
YEC-1 Members
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
Ms. Sharika Rai B LLB, LLM External Legal expert
Fr. Siby Kaitharan MHA, BPh, BTh External Theologist
Dr. Shwetha Joyce Rasquinha MSW, MPhil, PhD External Social Scientist
Dr Mohammed Guthigar MSW, PhD Internal Social Scientist
Dr Nagapati Bhat MBBS, MD Internal Pharmacologist
Dr Pooja Harish 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 Ravi Vaswani MD, PG Dip Bioethics Internal Joint Secretary/Clinician/Bioethicist
Dr Uma Kulkarni DNB (Ophthal), DOMS, Internal Member-Secretary (9448150032)
PGDBEME, PGDCE
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Serious Adverse Events Subcommittee of YEC-1:
Dr. Ravi Vaswani Chairperson Dr. Mohammed Guthigar Executive Secretary Dr. Nagapati Bhat Member Dr. Pooja Harish S Member Dr. Uma Kulkarni Ex-officio Member |
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SOP Subcommittee of YEC-1:
Dr. Uma Kulkarni Convenor
Dr. Ravi Vaswani Member
Dr. Pooja Harish S Member
Ms. Viji Prasad Member
Dr. Uma Kulkarni Convenor
Dr. Ravi Vaswani Member
Dr. Pooja Harish S Member
Ms. Viji Prasad Member
Important administrative documents of YEC-1
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Principal Investigator/Researcher/Sponsor Resource Centre
Standard Operating Procedure Manual of YEC-1 Version 3 Effective Date 3 October 2019
26 Chapters
| YEC-1 SOP Manual Version 3 (26 chapters) |
More details
Proposed dates of YEC-1 scheduled meetings for 2022
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Pre-approval forms and templates
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| Vulnerability checklist students employees v3.docx |
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Post-approval forms
| Serious Adverse Event reporting form V3 |
| Periodic/Continuing review app form v3.1.docx |
| Request for extension of YEC-1 approval.docx |
| Request for protocol amendment form.docx |
| Study completion reporting form V3.docx |
| Protocol deviation initial report.docx |
| Protocol deviation detailed report.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 Ethics Committee-1
3. All applications must be submitted in duplicate (print copies) and one soft copy 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, YEC-1, to clarify ethical doubts, either orally, or in writing or communicate by 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 YEC-1.
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 Ethics Committee-1
3. All applications must be submitted in duplicate (print copies) and one soft copy 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, YEC-1, to clarify ethical doubts, either orally, or in writing or communicate by 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 YEC-1.
12. Please download the checklist and the application form (above); print it, check the items included and submit along with the
application