Overview
Tata Memorial Centre- Institutional Ethics Committee –III
Re-registered with DCGI, Registration No. ECR/149/Inst/MH/2013/RR-19
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 09.30 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
| Sr. No. | Name & 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 Sudhir Nair Member Secretary | Prof. Head and Neck Surgical Oncology, ACTREC., TMC | Male | Clinician (Surgical oncology) |
| 3. | Dr Shona Nag Member | Director, Oncology, Sahyadri Super Speciality Hospitals, Hadapsar, Survey No. 163, Bhosale Nagar, Pune, 400 028, Maharashtra | Female | Clinician (Medical Oncology) |
| 4. | Dr. Pravesh Golay Member | Associate Professor, Department of Humanities and Social Sciences, Indian Institute of Technology Bombay, Powai, Mumbai - 400 076, India | Male | Philosopher |
| 5. | Dr. Sangita Sukumaran Member | Prof and Head, Department of Pharmacology, Terna Medical College Navi Mumbai, 400706 | Female | Clinical Pharmacologist(Basic Medical Scientist) |
| 6. | Mrs. Deepa Ramani Member | Zenith Spinners Ltd. Ex-play group teacher, store and purchase in-charge, Zenith Spinners Ltd., Member of IC-SCR, ACTREC | Female | Layperson |
| 7. | Mr Akil Hirani Member | Head of the Transactions Practice and Managing Partner Majmudar & Partners, International Lawyers, India | Male | Legal Expert |
| 8. | Dr. Girish Maru Member | Former Principal Investigator and Scientific Officer ‘H’, CRI. | Male | Basic Scientist |
| 9. | Dr. Syed Hasan Member | Principal Investigator and Scientific Officer ‘E’, ACTREC, TMC | Male | Basic Scientist |
| 10. | Dr Naveen Mummudi Member | Associate Professor, Dept. of Radiation Oncology, Tata Memorial Hospital, TMC. | Male | Clinician (Radiation Oncology) |
| 11. | Dr. Sachin Punatar Member and DSMU Secretary | Prof. Medical Oncology, E (Adult Hematolymphoid), ACTREC, TMC | Male | Clinician (Medical Oncology) |
| 12. | Dr. Shalaka Joshi Member | Prof. Dept. of Surgery, Tata Memorial Hospital, TMC | Female | Clinician (Surgical oncology) |
| 13. | Dr. Prashant Tembhare Member | Clinician Scientist and Prof in Hematopathology Laboratory (SO F), ACTREC, TMC | Male | Basic Medical Scientist (Hemato Pathology) |
| 14. | Dr. Nitin S Shetty Member | Prof. Interventional Radiology, Tata Memorial Hospital, TMC | Male | Clinician (Interventional Radiology) |
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 10.00 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.
Data Safety and Monitoring Unit (DSMU)
The Data Safety Monitoring Unit (DSMU) 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 Data Safety Monitoring Unit 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.
DSMU- I based in TMH will function as a unit of the IEC for TMH (IEC-I & II) and DSMU-II based in ACTREC will function as a unit of the IEC for ACTREC (IEC-III).
DSMU Members
TMC IEC-III, Data Safety and Monitoring Unit (DSMU) have been reconstituted from 1st April 2022 for 2 years.
| Sr. No. | Name & Position | Affiliation | Gender | Expertise |
|---|---|---|---|---|
| 1. | Dr. Sachin Punatar, Member and DSMU Secretary | Prof. Medical Oncology, E (Adult Hematolymphoid) ACTREC, TMC | Male | Clinician (Medical Oncology) |
| 2. | Dr. Manjunath Nookala Krishnamurthy, Joint Secretary | Scientific Officer F (Clinical Pharmacology) | Male | Clinical Pharmacologist |
| 3. | Dr Anant Gokarn, Member | Prof. Medical Oncology, E (Adult Hematolymphoid) ACTREC, TMC | Male | Clinician (Medical Oncology) |
| 4. | Dr Shwetabh Sinha, Member | Asst. Professor, Dept. of Radiation Oncology, ACTREC, TMC | Male | Clinician (Radiation Oncology) |
| 5. | Dr Madhura Sharma, Member | Asst. Professor. ( Dental AND Prosthetic Surgeon ) | Female | Clinician (Dental Surgeon) |
| 6. | Dr, Sejal Patwardhan, Member | Scientific Officer D, ACTREC TMC | Female | Basic Scientist |
| 7. | Dr. Debashree Lahiri, Member | Asst. Professor, Anesthesia, TMH TMC | Female | Clinician( Anesthesia) |
| 8. | Dr. Rohan Khadilkar, Member | Scientific Officer D, ACTREC TMC | Male | Basic Scientist |
| 9. | Mrs. Reena Devi Phurailatpam, Member | Scietific Officer 'E' Medical Physicist 'E' Radiation Oncology, ACTREC TMC | Female | Medical Physicist |
| 10. | Dr.Sumeet Mirgh, Member | Asst. Prof. Medical Oncology, (Adult Hematolymphoid) ACTREC, TMC | Male | Clinician (Medical Oncology) |
The mandate of the TMC-IEC III Data Safety and Monitoring Unit (TMC IEC-III, DSMU) are to:
As a national cancer centre, the TMC needs to ensure that research data generated by the investigators are of high quality, reliable and verifiable. To accomplish this objective, the DSMU is charged with the mission of developing and implementing quality assurance procedures to monitor the overall progress of institutional clinical trials and ensuring adherence to procedural requirements.
This includes -
- Review of overall progress of IEC approved clinical trials/studies to ensure the safety of participants.
- Checking the enrollment to ensure that the projected accrual goals are met on a timely basis and do not fall below minimum acceptable standards.
- Serious adverse events and off-site serious adverse events are appropriately monitored and reported to the IEC.
- Ensure that eligibility criteria are followed as per IEC approved study protocol and risk-benefit ratio to the patient remains acceptable.
- Enhance the quality of the research by providing the investigator with constructive criticism.
- Provide regular reports to the Institutional Ethics Committee.
The DSMU will meet on third Wednesday of every month at 02.00 p.m (unless otherwise notified) in the Conference Room, Khalolkar Shodhika, 3rd Floor, ACTREC, Kharghar, Navi Mumbai.
List of Forms for PIs / Research staff effective from 28.04.2021 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:
IEC SOPs effective from 28.04.2021- Kindly request (irb @actrec.gov.in) IRB to provide copy of IEC SOP.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