institutional-ethics-committee

Institutional Ethics Committee

Medical Research

KDAH Doctor View Doctors

Find A Specialist

Institutional Ethics Committee (IEC)

Institutional Ethics Committee is an independent body constituted of medical, non-medical, scientific and non-scientific members whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in the trial by, among other things, reviewing, approving and providing continuing review of trial protocols and amendments.

Timely reviews and safeguarding of high ethical standards formed the basis of the IEC review process which are essential for clinical research including student research, investigator initiated research and multi-centric multinational research.  

KDAH-IEC became functional in Sept-2009. KDAH-IEC is registered with Drug Controller General of India. This is periodically renewed as per regulations.

Ethics Committee Re-Registration Number: ECR/141/Inst/MH/2013/RR-19

IEC is accredited with NABH (National Accreditation Board for Hospitals and Healthcare providers) with Certificate Number = EC-CT-2017-0003.

INSTITUTIONAL ETHICS COMMITTEE MEMBERS LIST
No. Name Member Details IEC Designation Affiliation to Institution
1 Dr.  Renuka Munshi Qualification :  M.B.B.S., M.D. (Pharmacology), DNB (Clinical Pharmacology) Chairperson No
2 Dr. Varsha Vadera Qualification: MD (Pathology) Member Secretary Basic Medical Scientist Yes
3 Dr. Bijal Kulkarni Qualification: M.B.B.S., M.D. (Pathology) Medical Scientist Yes
4 Dr. N. R. Shetty Qualification: M. B. B. S., MD (Medicine) Clinician Yes
5 Mr. Ravindra Dalal Qualification: B.com. Lay Person No
6 Mr. Nitin Sheth Qualification: B.Tech (Civil) from IIT Mumbai Lay Person No
7 Dr. Navita Purohit Qualification: MBBS, MD, DNB, CIPS (USA) Clinician Yes
8 Mr. Sanjay R. Singh Qualification: B. Sc., LL. B, LL.M Legal Expert No
9 Mr. Rajiv Kamlakar Patil Qualification: M.A. Social Scientist No
10 Mr. Nupur Yatin Chaudhari Qualification: B.A., Master in Social Work Social Worker No
11 Dr. Manjusha Kudre Qualification: BAMS, LLB Legal Expert No
12 Dr. Kapil Adwani Qualification: PharmD (Doctor of Pharmacy), RPh Scientific Member Yes
13 Dr. Shalmali Inamdar Qualification: MBBS, DNB Medicine, Fellowship Infectious Diseases Clinician Yes

Communication details of IEC:

Mailing Address IEC:

Institutional Ethics Committee

2nd Floor, Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute,

Rao Saheb Achutrao Patwardhan Marg, Four bungalows, Andheri West, Mumbai 400 053.

Tel.: 022 3097 0213 E mail: iseb@kokilabenhospitals.com

IEC Review Process

Investigator need to submit documents to Institutional Ethics Committee (IEC) at least three weeks prior to IEC meeting. IEC Secretariat will check the Project Application Proforma for completeness of the information and signatures of the Principal Investigator.

The Institutional Ethics Committee member will consider the following criteria when performing the review of the study protocol:

  • Minimize risks to participants
  • Risks must be reasonable in relation to anticipated benefits
  • Participants are selected equitably
  • Informed consent is adequate, easy to understand and properly documented
  • The research plan makes adequate provision for monitoring the data collected to ensure the safety of participants, where appropriate;
  • There are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data, where appropriate; and
  • Appropriate safeguards are included to protect vulnerable participants.
  • Ensure that the advertisements regarding the research project do not induce the participants to be lured into the clinical trials and that Research doctor has a recruitment policy to ensure unbiased selection of adequate number of suitable subjects according to the protocol.