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. Encourage and motivate your participants to get vaccinated.
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. Encourage and motivate your participants to get vaccinated.
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)
Composition of YEC - 1
YEC-1 Members
Name Qualifications Status Designation
Dr Vikram Shetty MBBS, D. Ortho, DNB External Clinician (Chairperson)
Dr Sachidananda Adiga MBBS, MD External Basic Scientist (Co-Chairperson)
Dr Sayeegeetha PhD (Tulu Language) External Layperson
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 Ravi Vaswani MD, PG Dip Bioethics Internal Joint Secretary/Clinician/Bioethicist
Dr Uma Kulkarni DNB (Ophthal), DOMS, Internal Member-Secretary (9448150032)
PGDBEME, PGDCE
Secretarial Support Staff:
Ms. Vindhya K, Ms. Jainabu Mufeeda
YEC-1 Secretariat:
3rd floor, Academic Block, Yenepoya Medical College, Deralakatte, Mangalore 575018 Karnataka India
Office hours:
0900 - 1600 hours (except Sundays, third Saturdays and Yenepoya University declared holidays)
Contact details:
Phone:
Office: +91(824)2206000-2055
Member-Secretary: +919448150032
Email: ethcom@yenepoya.edu.in
Name Qualifications Status Designation
Dr Vikram Shetty MBBS, D. Ortho, DNB External Clinician (Chairperson)
Dr Sachidananda Adiga MBBS, MD External Basic Scientist (Co-Chairperson)
Dr Sayeegeetha PhD (Tulu Language) External Layperson
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 Ravi Vaswani MD, PG Dip Bioethics Internal Joint Secretary/Clinician/Bioethicist
Dr Uma Kulkarni DNB (Ophthal), DOMS, Internal Member-Secretary (9448150032)
PGDBEME, PGDCE
Secretarial Support Staff:
Ms. Vindhya K, Ms. Jainabu Mufeeda
YEC-1 Secretariat:
3rd floor, Academic Block, Yenepoya Medical College, Deralakatte, Mangalore 575018 Karnataka India
Office hours:
0900 - 1600 hours (except Sundays, third Saturdays and Yenepoya University declared holidays)
Contact details:
Phone:
Office: +91(824)2206000-2055
Member-Secretary: +919448150032
Email: ethcom@yenepoya.edu.in
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Serious Adverse Events Subcommittee of YEC-1:
Dr Ravi Vaswani Clinician Chairperson Dr Mohammed Guthigar Social Scientist Member Dr Nagapati Bhat Pharmacologist Executive Secretary Dr Pooja Harish S Clinician Member Dr Uma Kulkarni Clinician 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
How we function:
Standard Operating Procedure Manual of YEC-1 Version 4 Effective Date 01 July 2023 (All 26 Chapters)
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More details |
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Proposed dates - YEC-1 scheduled meetings for 2023
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Pre-approval forms and templates
Need EC approval for your research? Look here
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| Application form requesting waiver of consent.docx |
Post-approval forms:
Any issues with your research study after approval? Look here
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| Protocol deviation violation 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. Please download the initial application application form and conflict of interest declaration (above); submit along with the protocol documents
4. All applications must be submitted in one hard copy (print) and one soft copy by email to ethcom@yenepoya.edu.in
5. Applications that are eligible for expedited review will receive approval within 2-4 weeks of receipt of complete protocol package.
6. 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.
7. It is the PI's responsibility to submit the corrections advised within the stipulated time.
8. Incomplete forms are liable to undue delays.
10. 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.
11. Six-monthly progress reports and study closure report are mandatory.
11. 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 issue for ethical clearance is required or not.
12. Decisions on ethical waiver, expedited review or full review rest solely with the YEC-1.
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. Please download the initial application application form and conflict of interest declaration (above); submit along with the protocol documents
4. All applications must be submitted in one hard copy (print) and one soft copy by email to ethcom@yenepoya.edu.in
5. Applications that are eligible for expedited review will receive approval within 2-4 weeks of receipt of complete protocol package.
6. 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.
7. It is the PI's responsibility to submit the corrections advised within the stipulated time.
8. Incomplete forms are liable to undue delays.
10. 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.
11. Six-monthly progress reports and study closure report are mandatory.
11. 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 issue for ethical clearance is required or not.
12. Decisions on ethical waiver, expedited review or full review rest solely with the YEC-1.
GRIEVANCE REDRESSAL PROCEDURE:
If any stakeholder (researcher, sponsor, EC member or participant) has any complaints or wishes to express dissatisfaction towards any of the stakeholders, please send an email to ethcom@yenepoya.edu.in. In case the stakeholder is not satisfied with the response from YEC-1, please email your dissatisfaction to registrar@yenepoya.edu.in
If any stakeholder (researcher, sponsor, EC member or participant) has any complaints or wishes to express dissatisfaction towards any of the stakeholders, please send an email to ethcom@yenepoya.edu.in. In case the stakeholder is not satisfied with the response from YEC-1, please email your dissatisfaction to registrar@yenepoya.edu.in