YENEPOYA ETHICS COMMITTEE - 1 OFFICIAL WEBPAGE
Instructions to researchers in the current COVID-19 pandemic crisis
Dear Principal Investigator,
We are sure that you are aware of the pandemic that is the scourge of the present day - COVID - 19 or the Coronavirus infection. 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. If you haven't started recruitment/enrollment.... don't. If you have.... then consider stopping.
2. Discourage participants from traveling for the sake of a follow up. If possible, take telephonic follow up.
3. Encourage admitted participants to get discharged as quickly as possible.
4. Minimize interaction of our participants and research team members with other patients and hospital staff.
5. 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.
6. Make them aware of how this virus spreads and teach them to avoid touching surfaces and shaking hands more than necessary.
7. 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. Please refer such patients to the Fever Clinic at Yenepoya Medical College Hospital.
STAY HOME...STAY SAFE...STAY BLESSED
Issued by Yenepoya Ethics Committee -1 in public interest.
We are sure that you are aware of the pandemic that is the scourge of the present day - COVID - 19 or the Coronavirus infection. 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. If you haven't started recruitment/enrollment.... don't. If you have.... then consider stopping.
2. Discourage participants from traveling for the sake of a follow up. If possible, take telephonic follow up.
3. Encourage admitted participants to get discharged as quickly as possible.
4. Minimize interaction of our participants and research team members with other patients and hospital staff.
5. 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.
6. Make them aware of how this virus spreads and teach them to avoid touching surfaces and shaking hands more than necessary.
7. 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. Please refer such patients to the Fever Clinic at Yenepoya Medical College Hospital.
STAY HOME...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
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 Member-Secretary (9448150032)
PGDBEME, PGDCE
Serious Adverse Events Subcommittee of the YEC-1:
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
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| DCGI re-registration YEC-1 2020-25.pdf |
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 2021
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Pre-approval forms and templates
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| Template for Informed consent form |
Post-approval forms
| Serious Adverse Event reporting form V3 |
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| 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