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Yenepoya University Ethics Committee recognized by FERCAP

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Yenepoya University Ethics Committee
Renamed as Yenepoya Ethics Committee - 1 

YUEC Members from July 2017 - June 2019

Name                                          Qualifications                              Status                        Designation

Dr Vikram Shetty                        MBBS, MS (Ortho)                         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                      Basic Scientist


Ms Viji Prasad C                          MSc, PG Dip Bioethics                   Internal                       Nurse/Bioethicist

Mr Y Moideen Khurshid            MBA                                                 Internal                        Risk Assessor

Dr Uma Kulkarni                        DNB, DOMS, PGDBEME, PGDCE   Internal                       Secretary (9448150032)
Re-registration of YUEC DCGI.pdf
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YUEC Registrar notification.pdf
File Size: 493 kb
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Renaming of the ethics committees.pdf
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Notification SAE sub committee.pdf
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Serious Adverse Events Subcommittee of the YEC:
Dr. Ravi Vaswani                      Chairperson
Dr. Mohammed Guthigar       Executive Secretary
Dr. Nagapati Bhat                    Member 
Dr. Laxminarayan Sonde        Member
Dr. Uma Kulkarni                      Ex-officio Member

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Yenepoya University Ethics Committee underwent an accreditation recognition process by Forum for Ethics Review Committees of the Asia and Western Pacific Regions (FERCAP) in December 2015.  Following the recommendations of the FERCAP Survey Team our SOP has undergone extensive reconstruction.  We have used the FERCI templates and modified them to our requirements.  Our new SOP is effective from 1 August 2016.  We have uploaded our new SOP as approved by the Registrar, Yenepoya University.  Also attached are useful templates which a PI or PG is strongly encouraged to use, so that the protocol document package is processed quickly and time to ethical approval is minimized.  
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Chap 1: Preparation of SOP.pdf
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Chap 2: Constitution of YUEC.pdf
File Size: 394 kb
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Chap 3: Conflict of Interest.pdf
File Size: 421 kb
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Chap 4: Selection of Independent Consultant.pdf
File Size: 296 kb
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Chap 5: Guest Observer Procedure.pdf
File Size: 138 kb
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Chap 6: Protocol Submission Management.pdf
File Size: 617 kb
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Chap 7: Initial Review Categorization.pdf
File Size: 396 kb
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Chap 7A: Initial categorization: Full Review.pdf
File Size: 419 kb
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Chap 7B: Initial categorization: Expedited Review.pdf
File Size: 307 kb
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Chap 7C: Initial Categorization: Exemption Review.pdf
File Size: 291 kb
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Chap 8: Agenda, Meeting & Minutes.pdf
File Size: 245 kb
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Chap 9: Resubmissions & Protocol Amendments.pdf
File Size: 261 kb
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Chap 10; Continuing Review Process.pdf
File Size: 259 kb
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Chap 11: Handling of Protocol Deviations.pdf
File Size: 236 kb
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Chap 12: Serious Adverse Event.pdf
File Size: 443 kb
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Chap 13: Completion review.pdf
File Size: 283 kb
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Chap 14: Premature Termination of Protocol.pdf
File Size: 234 kb
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Chap 15: Informed Consent Waiver.pdf
File Size: 355 kb
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Chap 16: Site Monitoring.pdf
File Size: 376 kb
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Chap 17: Handling of Requests, Complaints & Queries.pdf
File Size: 290 kb
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Chap 18: Document Maintenance, Archival & Retrieval.pdf
File Size: 281 kb
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Chap 19: Vulnerable Populations.pdf
File Size: 417 kb
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Chap 20: Audits & Inspections.pdf
File Size: 314 kb
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Chap 21: Member Training.pdf
File Size: 289 kb
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Application Initial Submission Academic Dissertation Study.docx
File Size: 51 kb
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Application Initial Submission Sponsored Regulatory RCT.docx
File Size: 49 kb
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Checklist Protocol Submission RCT.docx
File Size: 69 kb
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YUEC 2018 meeting calendar.pdf
File Size: 201 kb
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Continuing review application form.docx
File Size: 52 kb
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Instruction for writing participant information sheet.docx
File Size: 14 kb
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Checklist and sample for informed consent
File Size: 33 kb
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Review exemption application form.docx
File Size: 49 kb
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Checklist for protocol submission.docx
File Size: 103 kb
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Waiver consent form.docx
File Size: 53 kb
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Request for amendment of protocol.docx
File Size: 217 kb
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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 University Ethics Committee
3.    All applications must be submitted in duplicate (print copies) and one soft copy (CD), 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, YUEC, to clarify ethical doubts, either orally, or in writing or communicate by e      
       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 YUEC. 
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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Academics
Center for Ethics is a unit of  Yenepoya (Deemed to be University), Mangalore. India. 
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