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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. 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/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 
Name                                           Qualifications                              Status                        Designation
Dr 
Sachidananda Adiga           MBBS, MD                                   External                    Basic Scientist (Chairperson)                                  
Dr Sripada G Mehandale         MBBS, MD (Anesth)                   External                    Clinician
                                                      PGDBEME
Dr Sayeegeetha                         PhD (Tulu Language)                 External                    Layperson  
Ms Shilpa                                    BA (Secretarial Practice)            External                    Layperson        
​
Ms. Sharika Rai B                        LLB, LLM                                      External                    Legal expert
Mr. N Chethan Chakravarty      MSW, LLB                                    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 Malcolm Pinto                       MBBS, MD (Dermat)                 Internal                      Clinician
Dr Pooja Harish                          BDS, MDS                                    Internal                     Clinician

Ms Viji Prasad C                         MSc, PG Dip Bioethics              Internal                     Nurse/Bioethicist
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 - 1300 and 1400 - 1600 hours (except Sundays, third Saturdays and Yenepoya University declared holidays)
Contact details: 
Phone:
Office: +91(824)2206000-2055
Member-Secretary: +919448150032
Email: [email protected]

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​
20220520 Renotification SAE Subcommitte.pdf
File Size: 133 kb
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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
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YEC-1 Reconstitution March 2024
File Size: 109 kb
File Type: pdf
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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
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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
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

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
File Type: pdf
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Yen EC-1 SOP9A v4 Resubmission.pdf
File Size: 734 kb
File Type: pdf
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Yen EC-1 SOP01 4.1 SOP manual.pdf
File Size: 2530 kb
File Type: pdf
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Yen EC-1 SOP02 v4.1 Constitution.pdf
File Size: 2334 kb
File Type: pdf
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Yen EC-1 SOP3A v4 Conflict of Interest.pdf
File Size: 801 kb
File Type: pdf
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Yen EC-1 SOP3B v4 Confidentiality.pdf
File Size: 878 kb
File Type: pdf
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Yen EC-1 SOP04 v4 IC.pdf
File Size: 1204 kb
File Type: pdf
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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
File Type: pdf
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Yen EC-1 SOP07 v4 Categroization.pdf
File Size: 724 kb
File Type: pdf
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Yen EC-1 SOP7A v4.1 Full Review.pdf
File Size: 2158 kb
File Type: pdf
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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
File Type: pdf
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Yen EC-1 SOP08 v4 Meetings.pdf
File Size: 875 kb
File Type: pdf
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Yen EC-1 SOP 9B v4 Amendment.pdf
File Size: 803 kb
File Type: pdf
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Yen EC-1 SOP10 v4 Periodic review.pdf
File Size: 855 kb
File Type: pdf
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Yen EC-1 SOP11 v4 Deviations.pdf
File Size: 769 kb
File Type: pdf
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Yen EC-1 SOP12 v4.1 SAE.pdf
File Size: 2028 kb
File Type: pdf
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Yen EC-1 SOP 13 v4 Completion.pdf
File Size: 758 kb
File Type: pdf
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Yen EC-1 SOP14 v4 Premature termination.pdf
File Size: 749 kb
File Type: pdf
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Yen EC-1 SOP15 v4 Waiver of consent.pdf
File Size: 738 kb
File Type: pdf
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Yen EC-1 SOP16 v4 SMV and protocol audit.pdf
File Size: 952 kb
File Type: pdf
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Yen EC-1 SOP17 v4 Requests.pdf
File Size: 1383 kb
File Type: pdf
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Yen EC-1 SOP18 v4 Maintenance.pdf
File Size: 845 kb
File Type: pdf
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Yen EC-1 SOP19 v4 Vulnerability.pdf
File Size: 959 kb
File Type: pdf
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Yen EC-1 SOP20 v4 Audit.pdf
File Size: 823 kb
File Type: pdf
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Yen EC-1 SOP21 v4.1.pdf
File Size: 1877 kb
File Type: pdf
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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. 167              09 January 2025
        Meeting No. 168              06 February 2025
        Meeting No. 169              06 March 2025
        Meeting No. 170              03 April 2025
        
Meeting No. 171               08 May 2025
        Meeting No. 172              05 June 2025
        Meeting No. 173              03 July 2025
        Meeting No. 174              07 August 2025
        Meeting No. 175              04 September 2025
        Meeting No. 176              09 October 2025
        Meeting No. 177              06 November 2025
        Meeting No. 178              04 December 2025

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
File Type: pdf
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Vulnerable checklist - research on cognitively impaired.docx
File Size: 18 kb
File Type: docx
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Research protocol/synopsis template.docx
File Size: 93 kb
File Type: docx
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Vulnerable checklist forn research involving pregnant women fetuses.docx
File Size: 18 kb
File Type: docx
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Application form for initial review for all protocols v4.docx
File Size: 48 kb
File Type: docx
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Vulnerable checklist research involving children 18 years.docx
File Size: 22 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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Vulnerable checklist for considerations for genetic research v4.docx
File Size: 15 kb
File Type: docx
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Application form for exemption of research protocols from ethical review.docx
File Size: 16 kb
File Type: docx
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Vulnerable checklist for research involving students employees.docx
File Size: 15 kb
File Type: docx
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Template for curriculum vitae of investigators.docx
File Size: 15 kb
File Type: docx
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YEC-1 template for informed consent form.docx
File Size: 42 kb
File Type: docx
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Application for resubmission.docx
File Size: 14 kb
File Type: docx
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YEC-1 instructions for writting a participant information sheet.docx
File Size: 21 kb
File Type: docx
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Application form requesting waiver of consent.docx
File Size: 24 kb
File Type: docx
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Placebo justification checklist
File Size: 20 kb
File Type: docx
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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
File Type: docx
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Study completion reporting form.docx
File Size: 20 kb
File Type: docx
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Application for extension of the research study.docx
File Size: 18 kb
File Type: docx
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Application for protocol amendment.docx
File Size: 16 kb
File Type: docx
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Periodic continuing review application form.docx
File Size: 23 kb
File Type: docx
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Protocol deviation violation initial report.docx
File Size: 17 kb
File Type: docx
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Protocol deviation violation detailed report.docx
File Size: 17 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.    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 [email protected] 
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 [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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About us
Academics
Center for Ethics is a unit of  Yenepoya (Deemed to be University), Mangalore. India. 
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