IHEC

Annexure – 5

Investigator’s Undertaking

  1. We certify that, we have determined that the proposal herein is not unnecessarily duplicative of previously reported research.
  2. We certify that, we are qualified by education, training and have enough experience to do such a study.
  3. For procedures listed under proposal, we certify that we have reviewed the pertinent scientific literature and have found no valid alternative to any procedure described herein which may cause less pain or distress to the patient.
  4. We certified that, study will be initiated only upon review and approval of scientific intent by IHEC GMERS Medical College and Hospital Gotri, Vadodara and getting a certificate from IHEC.
  5. We will do necessary changes in our study protocol as per the suggestions given by respected IHEC members during meeting before getting approval letter and bound to submit the changes to IHEC. We will obtain approval from the IHEC GMERS Medical College and Hospital Gotri, Vadodara, before making any significant changes in this study. Institutional Biosafety Committee’s (IBC) certification of review and concurrence will be taken (Required for studies utilizing DNA agents of human pathogens).
  6. We will do our study according to ICH-GCP guidelines and maintain all the study related records. Whenever asked, we are bound to produce to IHEC GMERS Medical College and Hospital Gotri, Vadodara.
  7. We will report adverse drug reaction to Pharmacovigilance Cell & IHEC whenever, we come across the adverse drug reaction while doing research work. (If Applicable)
  8. We certify that, we will follow the recommendations of IHEC and Govt. of Gujarat rules and regulation issued from time to time.
  9. We certify that, record of all premature termination of a study with a summary of the reasons/final report after completion of the study including microfilms, CDs and Video recordings, will submit to the IHEC GMERS Medical College and Hospital Gotri, Vadodara.

Institutional Human Ethics Committee (Institutional Review Board)

(Registration No. ECR/28/Inst./GJ/2013/ dated 16th April 2013 approved upto 15th April 2016)

(Re-registration approved on 08/06/2017 effective from 16 April 2016 to 15th April 2019)

GMERS Medical College & Hospital, Gotri, Vadodara – 390021, Gujarat, India

Phone: (0265) 2398008, Fax: (0265) 2398009,

Email: ihecmcgv@gmail.com

List of Members

No Member Gender Position
1 Dr. Indiraben Parmar, MD (Paediatrics) Professor – Pediatric Parul Institute of Medical Science & Research, Waghodia, Vadodara Email:drindiraparmar@gmail.com Female Chairman (Clinician)
2 Dr. Premnath Hiryur, MD (Pathology) Professor – Pathology Parul Institute of Medical Science & Research, Waghodia, Vadodara Email:phiryur@yahoo.co.in Male Co-chairman (Basic Science)
3 Dr. Minoobhai Patel, MS (General Surgery) Professor and Head – Surgery, Medical Superintendent G. M. E. R. S. Medical College & General Hospital, Gotri, Vadodara Email:minoorustom@yahoo.com Male Co-chairman (Clinician)
4 Dr. Anand K. Patel, MD (TB & Chest) Associate Professor – Respiratory Medicine G. M. E. R. S. Medical College & General Hospital, Gotri, Vadodara Email:dranandkpatel@gmail.com Male Member Secretary
5 Dr. Manoj Kumar Saurabh Professor & Head – Pharmacology G. M. E. R. S. Medical College & General Hospital, Gotri, Vadodara Email:manojkumarsaurabh@yahoo.co.in Male Basic Science Member
6 Dr. Sandip Shah, MD (Psychiatry) Professor – Psychiatry, G. M. E. R. S. Medical College & General Hospital, Gotri, Vadodara Email: Male Philosopher Member
7 Mr. Kevalsaran N. Prajapati, BA, LLB Email:Prajapati.keval44@gmail.com Male Legal Expert Member
8 Brijal Patel Email: Female Community Member (Lay Person)
9 Sureshbhai Shah Hari Om Seva Trust Email: Male Social Scientist Member (NGO)
10 Dr. Tejas K. Patel Assistant Professor – Pharmacology G. M. E. R. S. Medical College & General Hospital, Gotri, Vadodara Email: Male Joint Member Secretary

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Contact Info

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Phone

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