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YENEPOYA ETHICS COMMITTEE - 1 OFFICIAL WEBPAGE


Yenepoya Ethics Committee - 1 is recognized by/registered with/accredited by
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
NABH accreditation YEC-1
Yenepoya Ethics Committee- 1 DCGI Registration Sept 2020

Composition of YEC - 1 

YEC-1 Members from 04 September 2025 
          Name                                                    Qualifications                                           Status                       Designation
  1. Dr. Pratik Kumar Chatterjee                MBBS, MD                                                  External                   Chairperson                                
  2. Dr. Sripada G Mehandale                   MBBS, MD (Anesth),  PGDBEME            External                    Clinician                                             
  3. Mr. S Nandagopal                                BSc, MA (Sociology)                                 External                    Layperson        
  4. ​Ms. Sharika Rai B                                   LLB, LLM                                                     External                    Legal expert
  5. Mr. N Chethan Chakravarty                MSW, LLB                                                    External                    Legal expert
  6. Fr. Siby Kaitharan                                  MHA, BPh, BTh                                          External                    Theologist 
  7. Dr. Prakasha Amin                                 MSW, MBA, PhD                                       External                    Social Scientist
  8. Dr. Swathi Acharya                                MBBS, MD (Pharmacology)                    External                    Basic Medical Scientist
  9. Dr. Chaitra SR                                         MBBS, MD (Pharmacology)                    Internal                     Basic Medical Scientist
  10. ​Dr. Gladys Colaco                                  MSW, PhD                                                  Internal                     Social Scientist
  11. Dr. Malcolm Pinto                                  MBBS, MD (Dermat)                                 Internal                     Clinician
  12. Dr. Ravichandra Karkal                          MBBS, MD (Psychiatry)                            Internal                     Clinician 
  13. Dr. Poonam R Naik                                 MBBS, MD (Community), PGDBEME    Internal                     Clinician 
  14. Dr Pooja Harish                                      BDS, MDS,  PGDBEME, PGDCE             Internal                     Clinician/Joint Secretary 
  15. Dr. Rouchelle Tellis                                MBBS, MD, PGDBE,                                  Internal                     Member-Secretary (9380909464)
                                                  
Secretarial Support Staff: 
  1. Ms. Vindhya K
  2. Ms. Jainabu Mufeeda

YEC-1 Secretariat:
3rd floor, Academic Block, Yenepoya Medical College, Deralakatte, Mangalore 575018 Karnataka India
Office hours:
0900 - 1300 and 1400 - 1600 hours (except Sundays, third Saturdays and Yenepoya University declared holidays)
Contact details: 
Phone:
Office: +91(824)2206000-2055
Member-Secretary: +919380909464
Email: [email protected]

Serious Adverse Events Subcommittee of YEC-1:
  1. Dr. Pooja Harish                                Chairperson 
  2. Dr. Chaitra SR                                    Executive Secretary 
  3. Dr. Malcolm Pinto                             Member 
  4. Dr. Gladys Colaco                             Member
  5. Dr. Rouchelle C Tellis                       Ex-Officio member 

Reconstitution serious adverse events Sep 2025.pdf
File Size: 78 kb
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SOP Subcommittee of YEC-1:

Important administrative documents of YEC-1

DCGI amended approval letter for YEC-1.pdf
File Size: 324 kb
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Reconstitution of YEC-1 notification June 2025.pdf
File Size: 734 kb
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Re-registration of YUEC DCGI.pdf
File Size: 931 kb
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Reconstitution serious adverse events 2025.pdf
File Size: 78 kb
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Renaming of the ethics committees.pdf
File Size: 30 kb
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Approval of YEC-1 stem cell research independent consultants.pdf
File Size: 510 kb
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DCGI re-registration YEC-1 2020-25.pdf
File Size: 174 kb
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DCGI approval change in YEC-1 composition
File Size: 302 kb
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DCGI approval change in composition 2024-25.pdf
File Size: 629 kb
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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)

List of SOP v4 chapters.pdf
File Size: 999 kb
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Yen EC-1 SOP9A v4 Resubmission.pdf
File Size: 734 kb
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Yen EC-1 SOP01 4.1 SOP manual.pdf
File Size: 2530 kb
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Yen EC-1 SOP02 v4.1 Constitution.pdf
File Size: 2334 kb
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Yen EC-1 SOP3A v4 Conflict of Interest.pdf
File Size: 801 kb
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Yen EC-1 SOP3B v4 Confidentiality.pdf
File Size: 878 kb
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Yen EC-1 SOP04 v4 IC.pdf
File Size: 1204 kb
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Yen EC-1 SOP05 v4 Guest Observer.pdf
File Size: 778 kb
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Yen EC-1 SOP06 v4 Protocol submission.pdf
File Size: 923 kb
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Yen EC-1 SOP07 v4 Categroization.pdf
File Size: 724 kb
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Yen EC-1 SOP7A v4.1 Full Review.pdf
File Size: 2158 kb
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Yen EC-1 SOP7B v4 Expedited review.pdf
File Size: 689 kb
File Type: pdf
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Yen EC-1 SOP7C v4 Exemption.pdf
File Size: 743 kb
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Yen EC-1 SOP08 v4 Meetings.pdf
File Size: 875 kb
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Yen EC-1 SOP 9B v4 Amendment.pdf
File Size: 803 kb
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Yen EC-1 SOP10 v4 Periodic review.pdf
File Size: 855 kb
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Yen EC-1 SOP11 v4 Deviations.pdf
File Size: 769 kb
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Yen EC-1 SOP12 v4.1 SAE.pdf
File Size: 2028 kb
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Yen EC-1 SOP 13 v4 Completion.pdf
File Size: 758 kb
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Yen EC-1 SOP14 v4 Premature termination.pdf
File Size: 749 kb
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Yen EC-1 SOP15 v4 Waiver of consent.pdf
File Size: 738 kb
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Yen EC-1 SOP16 v4 SMV and protocol audit.pdf
File Size: 952 kb
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Yen EC-1 SOP17 v4 Requests.pdf
File Size: 1383 kb
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Yen EC-1 SOP18 v4 Maintenance.pdf
File Size: 845 kb
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Yen EC-1 SOP19 v4 Vulnerability.pdf
File Size: 959 kb
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Yen EC-1 SOP20 v4 Audit.pdf
File Size: 823 kb
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Yen EC-1 SOP21 v4.1.pdf
File Size: 1877 kb
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More details 

International and national guidelines
File Size: 505 kb
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Proposed dates - YEC-1 scheduled meetings for 2025
​        
Meeting No. 179              08 January 2026
        Meeting No. 180              05 February 2026
        Meeting No. 181               05 March 2026
        Meeting No. 182              02 April 2026
        
Meeting No. 183               07 May 2026
        Meeting No. 184              04 June 2026
        Meeting No. 185              02 July 2026
        Meeting No. 186              06 August 2026
        Meeting No. 187              03 September 2026
        Meeting No. 188              01 October 2026
        Meeting No. 189              05 November 2026
        Meeting No. 190              03 December 2026

YEC-1 Sitting Fee - 14 Aug 21.pdf
File Size: 346 kb
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Pre-approval forms and templates
Need EC approval for your research? Look here

Protocol template with instructions.pdf
File Size: 273 kb
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Vulnerable checklist - research on cognitively impaired.docx
File Size: 18 kb
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Postgraduate synopsis and research protocol template.docx
File Size: 127 kb
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Vulnerable checklist forn research involving pregnant women fetuses.docx
File Size: 18 kb
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Application form for academic and Regulated Clinical Trial Form 4.docx
File Size: 48 kb
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Vulnerable checklist research involving children 18 years.docx
File Size: 22 kb
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Application form for observational studies form 4A.docx
File Size: 28 kb
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Vulnerable checklist for considerations for genetic research v4.docx
File Size: 15 kb
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Application form for exemption from ethical review.docx
File Size: 16 kb
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Vulnerable checklist for research involving students employees.docx
File Size: 15 kb
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Template for curriculum vitae of investigators.docx
File Size: 15 kb
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YEC-1 template for informed consent_form_v2.docx
File Size: 42 kb
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COI declaration by Researcher v2.docx
File Size: 95 kb
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YEC-1 instructions for writting a participant information sheet.docx
File Size: 21 kb
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Application form requesting waiver of consent.docx
File Size: 24 kb
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Placebo justification checklist
File Size: 20 kb
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Post-approval forms:
Any issues with your research study after approval? Look here

Serious adverse event reporting form v4.docx
File Size: 21 kb
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Study completion reporting form.docx
File Size: 20 kb
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Application for extension of the research study.docx
File Size: 18 kb
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Application for protocol amendment.docx
File Size: 16 kb
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Periodic continuing review application form.docx
File Size: 23 kb
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Protocol deviation violation initial report.docx
File Size: 17 kb
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Protocol deviation violation detailed report.docx
File Size: 17 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 Member- Secretary, Yenepoya Ethics Committee-1
​3.    Please download and fill the application form for initial review for protocol and submit along with protocol 
4.    Please submit the protocol, participant information sheet and informed consent form as per the University approved template 
5.    Please submit updated signed CVs of all the investigators 
6.    All applications must be submitted in one hard copy (print) and one soft copy by email to [email protected] 
7.    Applications that are for full review if received (complete in all documents) at least 2 weeks before the scheduled meeting will be    
       eligible to be kept as agenda
8.    It is the PI's responsibility to submit the corrections advised within the stipulated time. 
9.    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.  Study completion report are mandatory. 
12. Changes in the title, objectives, methodology and/or analysis amount to protocol amendments and require reporting to the ethics committee

​        

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 [email protected]. In case the stakeholder is not satisfied with the response from YEC-1, please email your dissatisfaction to [email protected]
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Center for Ethics is a unit of  Yenepoya (Deemed to be University), Mangalore. India. 
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