Introduction
In September 2000, the Indian Council of Medical Research (ICMR) introduced new ‘Ethical Guidelines for Biomedical Research on Human Subjects’. All research organisations engaged in biomedical research, and recognised by the Government of India’s Department of Scientific and Industrial Research (DSIR), are required to follow these guidelines.
The KEMHRC Ethics Committee (EC), under the Chairmanship of Dr. S. Sivaram, was registered under the Drugs Controller General of India (DCGI) in 2013; the registration was renewed in 2016, and 2022. Currently the KEMHRC EC, under the Chairmanship of Dr. Mandeep Chadha, is registered under the DCGI from 31st January 2022 to 30th January 2027. The KEMHRC EC was accredited by National Accreditation Board for Hospitals (NABH) on 27th July 2018; the accreditation was subsequently renewed on 27th July 2021 up to 26th July 2024.
The Ethics Committee held its first meeting on 19th April 2001, with former Chief Justice of India, Justice Y.V. Chandrachud, appointed as the first Chairperson. Justice Chandrachud served as Chairperson for five years, and was succeeded by Dr. A. S. Nanivadekar and Dr. Y.K. Kazi, who held the position for one year. Dr. Swaminathan Sivaram, presently a Senior INSA Scientist and Honorary Professor at Indian Institute of Science Education and Research, took over as Chairperson in 2006 and continued till 2019. He was succeeded by Professor Mohan Gupte who initiated and established the National Institute of Epidemiology and ICMR School of Public Health in India.
The current Chairperson of KEMHRC EC is Dr. Mandeep Chadha, MBBS, MD (General Medicine), Ex-Scientist G/ Director Grade Scientist, ICMR-National Institute of Virology, Pune.
Archival Facility
Crown Worldwide Private Limited, with its headquarters in Navi Mumbai, is the outsourced archival facility of KEMHRC.
Crown Information Management
M/S Shubham Warehousing,
Gate no. 307, 308 Pune Nagar Highway,
Village-Karegaon,
Taluka-Shirur,
Pune District – 412220
Scope and Role
The KEMHRC EC plays a vital role in ensuring that all research conducted by the Centre upholds the highest standards of ethics, integrity, and respect for human dignity. It serves as an independent body that reviews and monitors research involving human participants to safeguard their rights, safety, and well-being. Its presence ensures that KEMHRC maintains a trustworthy, ethical, and compliant research environment.
The EC is engaged in the following activities:
- Review of Research Proposals: The EC evaluates research protocols to ensure ethical and scientific soundness, in line with national and international guidelines such as those from the Indian Council of Medical Research (ICMR) and the Declaration of
- Participant Protection: Particular attention is given to informed consent, risk–benefit balance, privacy, and confidentiality, especially in studies involving vulnerable
- Ongoing Oversight: The EC monitors approved research projects through regular updates and reports, and is empowered to recommend modifications or suspend studies if ethical concerns arise.
- Support for Researchers: The EC provides guidance to researchers on the ethical aspects of study design and implementation, fostering a culture of responsibility and transparency in scientific work.
- Capacity Building: Periodic workshops and training sessions are held to build awareness and strengthen ethical practices among investigators, students, and staff.
Members
External
| Sr.No. | Name | Qualification | Category | Designation | Current Organisation |
|---|---|---|---|---|---|
| 01 | Dr. Mandeep Chadha | MBBS, MD (General Medicine) | Ex-Scientist G/ Director Grade Scientist | Chairperson | ICMR-National Institute of Virology, Pune |
| 02 | Dr. Sudha Kanitkar | MBBS, MD (Pharmacology) | Basic Medical Scientist | Member | Former Assoc. Professor of Pharmacology B. J. Medical. College, Pune |
| 03 | Dr. Kalpana Shah | MBBS, MD (Pharmacology) | Basic Medical Scientist | Member | Former Professor & HOD of Pharmacology B. J. Medical College, Pune |
| 04 | Dr. Uma Divate | MBBS, MD (Medicine) | Clinician | Member | Director, HCJMR Institute, Pune |
| 05 | Adv. Naresh Singh | BSL, LLB | Legal Expert | Member | Former Advocate, WNS Global Services, Pune |
| 06 | Dr. Deepa Paturkar | Ph. D. and LLM, Pune University, Diploma in Journalism, Pune University | Legal Expert | Member | Vice Principal and Professor, ILS Law College, Pune |
| 07 | Mrs. Perveen Bharucha | BA, MA (Medical Social Work) | Woman Member | Member | Retired Head of Department of Medical Social Work at KEM Hospital, Pune |
| 08 | Ms. Savita Kanade | M.Sc. (Anthropology), Masters in Population Sciences | Social Scientist | Member | Community & Outreach Coordinator, and CAB Liaison, BJMC-CTU, Pune |
| 09 | Mrs. Sanghamitra Bhattacharjee | BA, Graduate with English | Lay Person | Member | Teacher (Premier Institutes) |
| 10 | Mrs. Shilpa Karvande | Ph.D. Public Health | Social Scientist | Member | Senior Research Officer, Foundation for Medical Research, Mumbai |
| 11 | Mrs. Veena Thadani | M.Sc. (Zoology), B.Ed. (Science & English) | Lay Person | Member | Education Counsellor at St. Mary’s School and Junior College, Pune |
Internal
| Sr.No. | Name | Qualification | Category | Designation | Current Organisation |
|---|---|---|---|---|---|
| 01 | Dr. Valentine Lobo | MBBS, MD (Medicine), DNB (Nephrology) | Clinician | Member | Associate Consultant, KEM Hospital, Pune |
| 02 | Dr. Ranjana Mundhe | M.D. (Hom), PGDCR | Research Scientist | Member Secretary | Research Scientist, KEMHRC, Pune |
Panel of Experts
| Expert Advisors of KEMHRC- EC | |||||
|---|---|---|---|---|---|
| 01 | Dr. Sanjay Bafna | Male | Paediatrician | Expert Advisor | Jehangir Hospital Consultant |
| 02 | Dr. Mita Pawar | Female | Paediatrician | Expert Advisor | Consultant Dept. Of Paediatrics, Jehangir Hospital |
| 03 | Dr. Rajendra Bhujbal | Male | Paediatrician | Expert Advisor | Ankur Hospital Talegaon |
| 04 | Dr. Aarti Kamat | Female | Paediatrician | Expert Advisor | Sahyadri Hospital Ped. Consultant, Jehangir Hospital Panel Consultant |
| 05 | Dr. Satyajit Pathak | Male | Paediatrician | Expert Advisor | Suman Nursing Home |
| 06 | Dr. Sandeep Kadam | Male | Paediatrician | Expert Advisor | KEM Hospital Pune |
| 07 | Dr. Ambrish kumar Mishra | Male | Paediatrician | Expert Advisor | KEM Hospital Pune |
| 08 | Dr. Pramod Kulkarni | Male | Paediatrician | Expert Advisor | KEM Hospital Pune |
| 09 | Dr. Sheela Bhave | Female | Paediatrician | Expert Advisor | KEM Hospital Pune |
| 10 | Dr. Vasudeo Paralikar | Male | Psychiatrist | Expert Advisor | KEM Hospital Consultant & HOD Psychiatry Dept. |
| 11 | Dr. D. M. Dhavale | Male | Psychiatrist | Expert Advisor | Poona Hospital and Research Centre Pune (Consultant) |
| 12 | Dr. Vanita Patwardhan | Female | Psychiatrist | Expert Advisor | Jnana Prabodhini 510 Sadashiv Peth, Pune |
| 13 | Dr. Arvind Panchnandikar | Male | Psychiatrist | Expert Advisor | KEM Hospital Pune |
| 14 | Dr. Nita Mawar | Female | Social & Behavioural Researcher | Expert Advisor | Freelance Consulting Consultant in Texela American University |
| 15 | Dr. Seema Sahay | Female | Social & Behavioural Researcher | Expert Advisor | National AIDS Research Institute |
| 16 | Dr. Madhuri Thakar | Female | Immunology | Expert Advisor | Scientist E, National AIDS Research Institute (NARI) |
| 17 | Dr. Paresh Shah | Male | Immunology | Expert Advisor | National Institute of Virology Pune |
| 18 | Dr. V. A. Pandit | Female | Pharmacology | Expert Advisor | Prof & HOD Dept. of Pharmacology Bharti Vidyapeeth Deemed University Medical College Pune |
Contact Details of EC Members
Ethics Committee Chairperson
Dr. Mandeep Chadha,MBBS,MD (General Medicine)
Ex Scientist G/ Director Grade Scientist, ICMR- National Institute of Virology, Pune
Email ID – mscniv@gmail.com
Mob:9860038654, 020-66037335
Member Secretary
Dr. Ranjana Mundhe, MD (Hom),PGDCR Research Scientist, KEMHRC, Pune.
Email ID – ethics@kemhrcpune.org
Mob:9552541275, 020-66037335
Department Of Health Research
Archival Details
Archival of closed study files
The archival is located a
“Crown Worldwide Private Limited,
Gate No. 294, Khandale, Pune-Nagar Road, Taluka-Shirur,
Near Suruchi Dairy, Pune-412209, Maharashtra, India”
FAQs
The KEMHRC Ethics Committee (KEMHRC-EC) charges a fee of Rs. 1,00,000/- (Rupees One Lakh Only) for reviewing a Regulatory research proposal. For Non-regulatory research proposals, the fee is Rs. 50,000/- (Rupees Fifty Thousand Only). These charges include the review process as well as monitoring the progress of the approved project until its completion, closure, or termination.
In case of any amendments to the approved research proposal, an additional fee of Rs. 5,000/- (Rupees Five Thousand Only) will be applicable for each document.
No; 18% GST is required to be paid over and above the EC fees.
The cheque should be drawn in favour of ‘The Director, KEM Hospital Research Centre, Pune’, and submitted along with the research proposal.
In case of any amendments to the approved research proposal, an additional fee of Rs. 5,000/- (Rupees Five Thousand Only) will be applicable for each document.
Yes, expedited meetings are conducted. The KEMHRC Ethics Committee (KEMHRC-EC) charges a fee of Rs. 1,50,000/- (Rupees One Lakh Fifty Thousand Only) for reviewing a Regulatory research proposal. For Non-regulatory research proposals, the fee is Rs. 75,000/- (Rupees Seventy-five Thousand Only). These charges include the review process, as well as monitoring the progress of the approved project until its completion, closure, or termination.
Eight hard copies of the research proposal document (please refer to SOP-3) along with a soft copy must be submitted for consideration by the KEMHRC Ethics Committee (KEMHRCEC).
The approval letter is issued two weeks after the EC meeting.
Yes. Please refer to the website. www.kemhrcpune.org
Yes. Please refer to the website. www.kemhrcpune.org
The archival facility, Crown Records Management (www.crownrms.com), is located at M/S Shubham Warehousing, Gate no. 307, 308, Pune Nagar Highway, Village-Karegaon, Taluka-Shirur, Pune District – 412220. Charges amount to Rs. 1,20,000 for 15 years and Rs. 2,00,000 /- for 25 years.