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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.


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) 

Forum for Ethics Review Committees of the Asia and Western Pacific Region (FERCAP)  of Yenepoya Ethics Committee-1
Forum for Ethics Review Committees of the Asia and Western Pacific Region (FERCAP) recognition of Yenepoya Ethics Committee-1 2019
NABH accreditation YEC-1
NABH accreditation of Yenepoya Ethics Committee-1
Yenepoya Ethics Committee- 1 DCGI Registration Sept 2020
DHR Certificate YEC-1

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

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​
Reconstitution SAE Subcommittee 23 Oct 2021.pdf
File Size: 108 kb
File Type: pdf
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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

Important administrative documents of YEC-1

DCGI amended approval letter for YEC-1.pdf
File Size: 324 kb
File Type: pdf
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Registrar YU Notification.pdf
File Size: 174 kb
File Type: pdf
Download File

Re-registration of YUEC DCGI.pdf
File Size: 931 kb
File Type: pdf
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Notification SAE sub committee.pdf
File Size: 40 kb
File Type: pdf
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Renaming of the ethics committees.pdf
File Size: 30 kb
File Type: pdf
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Scope of YEC-1 and YEC-2.pdf
File Size: 155 kb
File Type: pdf
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DCGI re-registration YEC-1 2020-25.pdf
File Size: 174 kb
File Type: pdf
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DCGI approval change in YEC-1 composition
File Size: 302 kb
File Type: pdf
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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)
File Size: 6658 kb
File Type: pdf
Download File

More details 

Proposed dates of YEC-1 scheduled meetings for 2022
​        
Meeting No. 125             06 January 2022
        Meeting No. 126             03 February 2022
        Meeting No. 127             03 March 2022
        Meeting No. 128             07 April 2022
        
Meeting No. 129             05 May 2022
        Meeting No. 130             02 June 2022
        Meeting No. 131              07 July 2022
        Meeting No. 132             04 August 2022
        Meeting No. 133             01 September 2022
        Meeting No. 134             06 October 2022
        Meeting No. 135             03 November 2022
        Meeting No. 136             01 December 2022

YEC-1 Sitting Fee - 14 Aug 21.pdf
File Size: 346 kb
File Type: pdf
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Calendar YEC-1 Meetings 2022.pdf
File Size: 258 kb
File Type: pdf
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 Pre-approval forms and templates

Application form for protocol submission.docx
File Size: 149 kb
File Type: docx
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Template for building a research protocol
File Size: 98 kb
File Type: docx
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Review Exemption Application form.docx
File Size: 45 kb
File Type: docx
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Vulnerability checklist for studies recruiting minors.docx
File Size: 136 kb
File Type: docx
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Instruction for writing participant information sheet.docx
File Size: 14 kb
File Type: docx
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Vulnerability checklist cognitively impaired 22 July 2021.docx
File Size: 131 kb
File Type: docx
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Delegation and responsibility of study team.docx
File Size: 20 kb
File Type: docx
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Vulnerability checklist for studies involving genetic research.docx
File Size: 128 kb
File Type: docx
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Checklist for protocol submission.docx
File Size: 103 kb
File Type: docx
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Conflict of Interest researcher declaration v2
File Size: 95 kb
File Type: docx
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Waiver of consent.docx
File Size: 52 kb
File Type: docx
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Resubmission template v3
File Size: 412 kb
File Type: doc
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Vulnerability checklist students employees v3.docx
File Size: 13 kb
File Type: docx
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YEC-1 Template and Process for Informed Consent v2.docx
File Size: 40 kb
File Type: docx
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YEC-1 Research Participant Information Sheet Builder v2.docx
File Size: 18 kb
File Type: docx
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Post-approval forms 

Serious Adverse Event reporting form V3
File Size: 22 kb
File Type: docx
Download File

Periodic/Continuing review app form v3.1.docx
File Size: 18 kb
File Type: docx
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Request for extension of YEC-1 approval.docx
File Size: 15 kb
File Type: docx
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Request for protocol amendment form.docx
File Size: 104 kb
File Type: docx
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Study completion reporting form V3.docx
File Size: 16 kb
File Type: docx
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Protocol deviation initial report.docx
File Size: 12 kb
File Type: docx
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Protocol deviation detailed report.docx
File Size: 12 kb
File Type: docx
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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 
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About us
Academics
Center for Ethics is a unit of  Yenepoya (Deemed to be University), Mangalore. India. 
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