Ethics Committee
Location
Address:
Dept. of Pharmacology, 1st Floor, New Building, HBT Medical College & Dr. R. N. Cooper Hospital, Bhaktivedanta Swami Marg,
Juhu Scheme, Juhu, Vile Parle West, Mumbai Suburban, Maharashtra – 400056.
Email:
The Institutional Ethics Committee (IEC) has a primary duty to safeguard the rights, safety, and welfare of research participants. The IEC convenes regular meetings to assess research proposals, offering recommendations to investigators to ensure ethical standards before granting approval. Approval from the IEC is mandatory before commencing any human research project.
HBT Medical College & Dr. R. N. Cooper Hospital Institutional Ethics Committee (HBTMC & RNCH IEC) is registered with the Central Drugs Standard Control Organization (CDSCO) and the Department of Health Research (DHR), in compliance with the New Drugs and Clinical Trials Rules, 2019 and the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017).
Registration Numbers
| Authority | Registration Number |
|---|---|
| CDSCO | ECR/1654/Inst/MH/2022 |
| DHR | EC/NEW/INST/2021/2272 |
Composition of IEC
| Sr. No. | Name | Role in IEC | Qualification |
|---|---|---|---|
| 1 | Dr. Anand J. 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 | Mrs. Vidula Patil | Social Scientist | B.A. (Major Psychology) |
| 7 | Adv. Sanjeev Kumar Agawane | Legal Expert | LL.B. |
| 8 | Mr. Mukesh Garg | Lay Person | B.Com. |
| 9 | Dr. Renuka Munshi | Basic Medical Scientist | D.M. (Clinical Pharmacology) |
| 10 | Dr. Vinay Patke | Basic Medical Scientist | M.Sc., Ph.D. (Biochemistry) |
| 11 | Ms. Shubhada Salvi | Legal Expert | LL.B. |
List of Documents to be Submitted for Review
Following documents need to be submitted to the IEC for review of a research study:
- Summary of Study
- Covering Letter addressed to the Chairperson, IEC.
- Study Protocol including:
- Study Title
- Introduction
- Review of Literature
- Aims & Objectives
- Study Methodology
- Study Design
- Study Site
- Study Duration
- Sample Size
- Selection Criteria
- Study Procedures
- Data Collection
- Statistical Analysis Plan
- References
- Abbreviations
- Case Record Form
- Informed Consent Document (Patient Information Sheet & Informed Consent Form) along with Translation Certificate.
- Investigator's Brochure (if available).
- Financial Disclosure.
- CTRI Registration (for interventional trials).
- DCGI Approval Letter (for interventional trials).
- Gantt Chart (Timeline Chart).
- Annexure 1 & 2.
- For Thesis
- For Other Research Study
- GCP Document of Investigator(s).
- Curriculum Vitae of Investigator(s).
- IEC Exemption Review Form
Contact Details
Address:
Dept. of Pharmacology, 1st Floor, New Building, HBT Medical College & Dr. R. N. Cooper Hospital, Bhaktivedanta Swami Marg,
Juhu Scheme, Juhu, Vile Parle West, Mumbai Suburban, Maharashtra – 400056.