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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.


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

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

​

Important administrative documents of YEC-1

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

YEC-1 Notification April 2019.pdf
File Size: 660 kb
File Type: pdf
Download File

Re-registration of YUEC DCGI.pdf
File Size: 931 kb
File Type: pdf
Download File

Notification SAE sub committee.pdf
File Size: 40 kb
File Type: pdf
Download File

Renaming of the ethics committees.pdf
File Size: 30 kb
File Type: pdf
Download File

Scope of YEC-1 and YEC-2.pdf
File Size: 155 kb
File Type: pdf
Download File

DCGI re-registration YEC-1 2020-25.pdf
File Size: 174 kb
File Type: pdf
Download File

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 meetings
​        (First Thursday of every month)

        Meeting No. 99             2 January 2020
        Meeting No. 100           6 February 2020
        Meeting No. 101             5 March 2020
        Meeting No. 102            9 April 2020
        (On account of COVID-19 nation-wide lockdown
        the April meeting will be conducted online)

        Meeting No. 103            7 May 2020
        Meeting No. 104           4 June 2020
        Meeting No. 105            2 July 2020
        Meeting No. 106            6 August 2020
        Meeting No. 107            3 September 2020
        Meeting No. 108            1 October 2020
        Meeting No. 109            5 November 2020
        Meeting No. 110             3 December 2020

Clinical trial Review Fee YEC-1.pdf
File Size: 333 kb
File Type: pdf
Download File

 Pre-approval forms and templates

Application form for protocol submission.docx
File Size: 38 kb
File Type: docx
Download File

Template for building a research protocol
File Size: 98 kb
File Type: docx
Download File

Review Exemption Application form.docx
File Size: 45 kb
File Type: docx
Download File

Vulnerability checklist for studies recruiting minors.docx
File Size: 136 kb
File Type: docx
Download File

Instruction for writing participant information sheet.docx
File Size: 14 kb
File Type: docx
Download File

Vulnerability checklist for studies recruiting cognitively impaired.docx
File Size: 129 kb
File Type: docx
Download File

Delegation and responsibility of study team.docx
File Size: 20 kb
File Type: docx
Download File

Vulnerability checklist for studies involving genetic research.docx
File Size: 128 kb
File Type: docx
Download File

Checklist for protocol submission.docx
File Size: 103 kb
File Type: docx
Download File

Conflict of Interest researcher declaration v2
File Size: 95 kb
File Type: docx
Download File

Waiver of consent.docx
File Size: 52 kb
File Type: docx
Download File

Template for Informed consent form
File Size: 33 kb
File Type: docx
Download File

Post-approval forms 

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

Extension request v3.docx
File Size: 15 kb
File Type: docx
Download File

Periodic continuing review app form v3.1.docx
File Size: 18 kb
File Type: docx
Download File

Request for protocol amendment form.docx
File Size: 104 kb
File Type: docx
Download File

Study completion reporting form V3.docx
File Size: 16 kb
File Type: docx
Download File

Protocol deviation initial report.docx
File Size: 12 kb
File Type: docx
Download File

Protocol deviation detailed report.docx
File Size: 12 kb
File Type: docx
Download File

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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Center for Ethics is a unit of  Yenepoya (Deemed to be University), Mangalore. India. 
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