Overview
Tata Memorial Centre- Institutional Ethics Committee –III
Re-registered with DCGI, Registration No. ECR/149/Inst/MH/2013/RR-24
Registered with DHR: EC/NEW/INST/2020/934
The TMC- Institutional Ethics Committee-III (IEC) was established in December 2009 as per the ICMR and ICH- GCP guidelines for Ethics Committees, with a mandate for combined scientific and ethics review of research projects being conducted at ACTREC and Tata Memorial Hospital. The Committee has currently accredited by the prestigious Association for the Accreditation of Human Research Protection Programs (AAHRPP).
Tata Memorial Centre, Institutional Ethics Committee has been accredited by National Accreditation Board for Hospitals and Healthcare Providers (NABH), a constituent board of Quality Council of India (QCI) in 2017 Validity: Dec 11, 2017 - Dec 10, 2020
The research studies which are eligible for review by this IEC and their categorization is as follows:
- Studies not involving living subjects:
Studies requiring Intra-Mural/Extra-Mural grant or those in collaboration with other sites/institutes will be reviewed by IEC. Such studies could be -
- In vitro study on established cell lines (other than embryonic stem cells)
- Physics / Equipment / Software R&D studies not involving animal or human subjects
- Studies involving Human subjects: Such studies could be
- Epidemiological, Molecular epidemiology or Pharmacological studies using questionnaires, with or without physical examination and or additional blood / saliva / urine / hair / nail / other samples or follow up.
- Biological studies on human tissues obtained as part of diagnostic or therapeutic procedures with or without physical examination and or additional blood / saliva / urine / hair / nail /other samples or follow up.
- Observational studies, surveys, questionnaires, audits for various demographic, symptoms, Quality of life , Knowledge Attitude Practice, dietary variable etc.
- Cross sectional or longitudinal cohort studies for response, toxicity and other outcomes in patients undergoing standard of care (as listed in TMH EBM guidelines).
- Human Clinical trials using experimental approaches or involving additional invasive intervention, including gene and cell based therapies.
TMC-ACTREC IEC will not review the following research studies (Investigators can seek IEC guidance about the possible routes of obtaining scientific and ethical approval at local and national level).
- Research on Embryonic Stem Cells.
- Experimental invasive studies on non human primates or healthy pets or other animals in captivity or wild that are not being investigated or treated as patients.
Meeting Schedule
The IEC-III meets (Virtual) on Third Friday of every month at 09.15 a.m (unless otherwise notified) in the Board Room, Paymaster Shodhika, 3rd Floor, ACTREC
IRB Processing fee for Pharma initiated projects
IEC processing fees (applicable for all pharmaceutical sponsored studies)
- Initial project submission - Rs. 40,000/- +applicable GST
- Protocol amendment (major) for ongoing study - Rs. 10,000/- + applicable GST
The fees will be accepted as cheque/demand draft drawn in favour of “Tata Memorial Centre".
Members IEC - III
Tata Memorial Centre- Institutional Ethics Committee –III have been reconstituted from 01st July 2020 for 2 years
| Sr. No. | Name & Position | Position | Affiliation | Gender | Expertise |
|---|---|---|---|---|---|
| 1. | Dr. Surekha Zingde | Chairperson | Trustee, Indian Women Scientists' Association (IWSA), Former Deputy Director, CRI, Scientific Officer ‘H’ | Female | Basic Scientist |
| 2. | Dr. Punit Jain | Member and Stem Cell expert | Consultant Hematologist/ Hemato-Oncologist & Bone Marrow Transplant Physician, Apollo Hospitals, Belapur, Navi Mumbai | Male | Clinician (Medical Oncology and stem cell expert) |
| 3. | Dr. Pravesh Golay | Member | Associate Professor, Department of Humanities and Social Sciences, Indian Institute of Technology Bombay, Powai, Mumbai - 400 076, India | Male | Philosopher |
| 4. | Dr. Sachin Punatar | Member Secretary | Professor ‘F’. Medical Oncology, (Adult Hematolymphoid) TMH, TMC | Male | Clinician (Medical Oncology) |
| 5. | Dr. Vaishali Thakare | Member | Professor, Department of Pharmacology, D.Y. Patil School of Medicine, Navi Mumbai | Female | Clinical Pharmacologist (Basic Medical Scientist) |
| 6. | Mrs. Josephine Machado | Member | Playgroup teacher and special educator, Bloomingdale Preschool, Nursery & Day Care, Kharghar, Navi Mumbai | Female | Layperson |
| 7. | Mr Akil Hirani | Member | Head of the Transactions Practice and Managing Partner Majmudar & Partners, International Lawyers, India | Male | Legal Expert |
| 8. | Ms. Bhavya Solanki | Member | Legal Associate, Majmudar & Partners, International Lawyers, India | Female | Legal Expert |
| 9. | Dr. Girish Maru | Member | Former Principal Investigator and Scientific Officer ‘H’, CRI. | Male | Basic Scientist |
| 10. | Dr. Syed Hasan | Member | Principal Investigator and Scientific Officer ‘E’ Hasan Lab, ACTREC, TMC | Male | Basic Scientist |
| 11. | Dr. Shwetabh Sinha | Member | Assistant Professor "E", Radiation Oncology, ACTREC, TMC | Male | Clinician (Radiation Oncology) |
| 12. | Dr. Anant Gokarn | Member | Professor ‘F’ Medical Oncology, (Adult Hematolymphoid) TMH, TMC | Male | Clinician (Medical Oncology) |
| 13. | Dr. Arjun Singh | Member | Assistant Professor ‘E’(Oral Surgery), ACTREC | Male | Clinician (Surgical oncology) |
| 14. | Dr. Prashant Tembhare | Member | Clinician Scientist and Prof in Hematopathology (SO F) ACTREC, TMC | Male | Basic Medical Scientist (Hemato Pathology) |
| 15. | Dr. Amit Janu | Member | Professor ‘F’ Radiodiagnosis, ACTREC | Male | Clinician (Radiodiagnosis) |
The mandate of the committee are as follows :
- Ensure the highest scientific and ethical standards of research at TMC
- Review and approve, proposals for clinical, basic or translational research projects (Intra and Extra mural) for scientific and ethical content
- Improve ethical standards and issue guidelines on ethical dilemmas related to patient care services
- To function as a forum to advise the administration in case of any ethical issues that may arise from patients, families or public
- To maintain our leadership as a national standard of reference in oncology and in allied specialties
- To issue and periodically, update and revise SOP s and guidelines for effective functioning of IEC as and when necessary
- Continuing education in clinical research bioethics and ethical aspects of clinical practice by seminars, workshops and interactive discussions for all categories of staff members including nursing and paramedical staff
- To initiate and commission research studies on ethical aspects of practice in TMC
The IEC-III will meet on third Friday of every month at 9.15 a.m (unless otherwise notified) in the Board Room, Paymaster Shodhika, 3rd Floor, ACTREC, Kharghar, Navi Mumbai. The Member Secretary of IEC -III will be Members of TRAC.
Research Review Committee (RRC)
The Research Review Committee (RRC) is a unit of the IEC comprising of clinicians of varied expertise from the hospital, supported by IEC staff with a primary responsibility to review serious adverse events, safety reports and annual status reports of the projects approved by the IEC. This unit reports to the IEC.
The Research Review Committee is a unit of the IEC essentially responsible for monitoring IEC approved projects, to ensure patient safety and assess data during the course of the study in a manner that contributes to the scientific and ethical integrity of the study.
RRC- I based in TMH will function as a unit of the IEC for TMH (IEC-I & II) and RRC-II based in ACTREC will function as a unit of the IEC for ACTREC (IEC-III).
RRC Members
TMC IEC-III, Research Review Committee (RRC) have been reconstituted from 01/06/2024 for 2 years.
| Sr. No. | Name & Position | Position | Affiliation | Gender | Expertise |
|---|---|---|---|---|---|
| 1. | Dr. Poonam Joshi | Chairperson | Professor, Department of Head and Neck Oncology, TMH | Female | Clinician (Head and neckl Oncology) |
| 2. | Dr. Arjun Singh | Co-Chairperson | Assistant Professor, Medical Officer "E" ACTREC | Male | Clinician (Medical Oncology) |
| 3. | Dr. Manjunath Nookala Krishnamurthy | Member Secretary | Scientific Officer F (Clinical Pharmacology) | Male | Clinical Pharmacologist |
| 4. | Dr. Anbarsan Sekar | Member | Assistant Professor, Department of Medical Oncology, ACTREC | Male | Clinician (Medical Oncology) |
| 5. | Dr. Jifmi Jose Manjali | Member | Assistant Professor, Department of Radiation Oncology, ACTREC | Female | Clinician (Radiation Oncology) |
| 6. | Dr. Sharath Arandkar | Member | Scientific Officer E Ramalingaswamy Re-entry fellow Assistant Professor, Homi Bhabha National Institute, CRI, ACTREC | Male | Basic Scientist (Tumor micro environment |
| 7. | Dr. Ashwini Rane | Member | Assistant Professor, Department of Anaesthesia, ACTREC | Female | Clinician( Anesthesia) |
| 8. | Dr. Rohan Khadilkar | Member | Scientific Officer D, ACTREC TMC | Male | Basic Scientist |
| 9. | Dr. Rohini Kulkarni | Member | Assistant Professor, Department of Surgical Oncology, ACTREC | Female | Clinician (Gyn Surgeon) |
| 10. | Dr. Anuj Kumar | Member | Assistant Professor, Department of Radiation Oncology, ACTREC | Male | Clinician (Medical Oncology) |
The mandate of the TMC-IEC III Research Review Committee (RRC) are to:
The Research Review Committee (RRC) perform the review of Serious Adverse Events (SAEs) and monitor research studies, as an institutional committee. The RRC functioning is overseen by the TMC-Research Administration Council (TRAC).
The committee does not address or interfere in matters of administration, nor does the committee function as a grievance cell for staff members.
The RRC will meet on the Second Friday of every month at 02.00 p.m (unless otherwise notified) in the Conference Room, Khalolkar Shodhika, 3 rd Floor, ACTREC, Kharghar, Navi Mumbai.
List of Forms for PIs / Research staff effective from 10.11.2023 for human study
Online Submission
Online submission of new projects through IEC web portal
TMC IEC has initiated online web portal for submission/review of research projects w.e.f. 01 Jan 2018
Link: https://www.iecportal.org/login.php
Contact person for creating Login ID:
Mr. Sandeep Kalsekar
Email id: sandeep.kalsekar@gmail.com
Contact No: 022 2417 7000 (Extn: 4267)
Note:
Link for IEC SOPs effective from Version 6.1 dated 10.11.2023Guidelines and Regulations
Link for guidelines and regulations:
1. NDCT guidelines 2019 NDCT 2019 (2021 amendment)
4. WMA Helsinki 2024 and Taipei 2016
Contact Us
Tata Memorial Centre
Advanced Centre for Treatment, Research & Education in Cancer,
Institutional Ethics Committee (TMC- IEC III),
Room no 128, Paymaster Shodhika, First floor,
ACTREC, Kharghar,
Sector 22 Navi Mumbai 410210
Phone: +91-22-27405154//27405126
Email- irb@actrec.gov.in