hbtmc.edu.in

Ethics Committee



Location:-

Address:- Dept. of Pharmacology, 1st floor, New Building, HBTMC & Dr. RNCH, Bhaktivedanta Swami Marg, Juhu Scheme, Juhu, Vile Parle West Mumbai, Mumbai Suburban, Maharashtra – 400056.

Email:-[email protected]
Phone Number:-+917588367068

The Institutional Ethics Committee (IEC) have a primary duty to safeguard the rights, safety, and welfare of research participants. IEC convene regular meetings to assess research proposals, offering recommendations to investigators to ensure ethical standards before granting approval. Approval from IEC is mandatory for commencing any human research projects.

HBT Medical College & Dr R N Cooper Hospital Institutional Ethics Committee (HBTMC & RNCH IEC) is registered with Central Drugs Standard Control Organization (CDSCO) & Department of Health Research (DHR); in compliance with New Drugs and Clinical Trials Rules 2019 and National Ethical Guidelines for Biomedical and Health Research involving Human Participants (2017).

Registration No:

  • CDSCO- ECR/1654/Inst/MH/2022
  • DHR- EC/NEW/INST/2021/2272

Composition if IEC:

SR. NO. NAME ROLE IN IEC QUALIFICATION
1 Dr. Anand Thakur Chair Person M.S. (Orthopaedics)
2 Dr. Prasad Pandit Member Secretary M.D. (Pharmacology)
3 Dr. Neelam Redkar Clinician M.D. (Medicine)
4 Dr. Reena Wani Clinician M.D. (OBGY)
5 Dr. Satish Chandra Kale Clinician M.S. (Orthopaedics)
6 Dr. Renuka Munshi Medical Scientist D.M. (Clinical Pharmacology)
7 Dr. Vinay Patke Scientific Member M.Sc., Ph.D. (Biochemistry)
8 Ms. Vidula Patil Social Scientist B.A. (Major Psychology)
9 Mr. Sanjeev Kumar Agawane Legal Expert L.L.B.
10 Ms. Shubhada Salvi Legal Expert L.L.B.
11 Mr. Mukesh Garg Lay Person B.COM.

List of documents to be submitted for review:

Following documents need to be submitted to IEC for review of research study:

  1. Summary of study (To download the file, click here)
  2. Covering Letter addressing the Chairperson, IEC.
  3. Study Protocol document- which should include study title, introduction, review of literature, aims & objectives, study methodology (study design, site, duration, sample size, selection criteria, study procedures, data collection, statistical analysis plan), references and abbreviations.
  4. Case Record Form
  5. Informed Consent document (Patient Information Sheet & Informed Consent form) along with Translation certificate
  6. Investigator’s Brochure (if available)
  7. Financial disclosure
  8. CTRI registration (in case of interventional trials)
  9. DCGI approval letter (in case of interventional trials)
  10. Gantt Chart (Timeline Chart)
  11.  Annexure 1 & 2
    • For thesis (To download the file, click here).
    • For other research study (To download the file, click here
  12. GCP document of Investigator(s)
  13. Curriculum vitae of Investigator(s)
  14. IEC Exemption Review form (To download the file, click here)

Contact Details of IEC:

  • Address- Dept. of Pharmacology, 1st floor, New Building, HBTMC & Dr. RNCH, Bhaktivedanta Swami Marg, Juhu Scheme, Juhu, Vile Parle West Mumbai, Mumbai Suburban, Maharashtra – 400056
  • Email ID- [email protected]
  • Phone number – +917588367068
Brochure