TMC-IEC III (ACTREC IEC)

Registered with DCGI, Registration No. ECR/149/Inst./MH/2013

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 prestigious Association for the Accreditation of Human Research Protection Programs (AAHRPP).

The research studies which are eligible for review by this IEC and their categorization is as follows:

1. 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 -

a. In vitro study on established cell lines (other than embryonic stem cells)

b. Physics / Equipment / Software R&D studies not involving animal or human subjects

2. Studies involving Human subjects: Such studies could be

a. 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.

b. 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.

c. Observational studies, surveys, questionnaires, audits for various demographic, symptoms, Quality of life , Knowledge Attitude Practice, dietary variable etc.

d. Cross sectional or longitudinal cohort studies for response, toxicity and other outcomes in patients undergoing standard of care (as listed in TMH EBM guidelines).

e. 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).

  1. Research on Embryonic Stem Cells.
  2. 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.

Name and Address of the IEC:

Tata Memorial Centre- Advanced Centre for Treatment, Research & Education in Cancer Institutional Ethics committee (TMC-IEC III),

Paymaster Shodhika, First floor,

ACTREC,  Kharghar, Sector 22

Navi Mumbai 410210

Contact no: 27405154,   email id: irb@actrec.gov.in

 

As per DCGI registration dated 20th April 2013, Institutional Review Boards (IRBs) are renamed as “Institutional Ethics Committees” and are reconstituted from 1st April 2016 till 31st March 2018

List of Members (IEC-IEC III)  01.04.2016 to 31.03.2018

Sr. No.

IEC-III
Registration No. ECR/149/Inst/MH/2013

Affiliation

Gender

Expertise

1. 

Dr. Rita Mulherkar

Chairperson

A/ 103, Park-Dew, Plot no 73, Sector 20, Kharghar, Navi Mumbai 410210

Female

Basic Scientist

2. 

Dr. Nobhojit Roy
Co-Chairperson

Head, Dept of Surgery,  BARC Hospital, Mumbai 94

Male

Surgeon

3. 

Dr. Vedang Murthy

Member Secretary

Associate Professor, Dept. of Radiation Oncology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

Male

Radiation Oncologist

4. 

Dr. Padmaja Marathe

Member

Prof, Dept of Pharmacology and Therapeutics,Seth GS Medical College and KEM Hospital

Female

Clinical Pharmacologist (Basic Medical Scientist)

5. 

Mrs. Deepa Ramani
Member

Ex-play group teacher, store and purchase in-charge, Kharghar

Female

Layperson

6. 

Mrs. Lakshmi. R.

Member

Co-ordinator, Sanjeevani  life beyond cancer, Mumbai. Trust

Female

Social Scientist

7. 

Dr. B.B. Singh

Member

Advocate, Mumbai High Court

Male

Legal Expert

8. 

Dr. Sanjeev Waghmare

Member

Scientific Officer ‘E’ & Principal Investigator, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

Male

Basic Scientist

9. 

Dr. Tejpal Gupta

Member

Associate Professor, Dept. of Radiation Oncology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

Male

Radiation Oncologist

10. 

Dr. Prafulla Parikh
Member

Assistant Professor,General Medicine, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

Female

Physician

11. 

Dr. Amita Maheshwari
Member

Associate Professor, Dept of Gynecology, Tata Memorial Hospital

Male

Surgeon

12. 

Dr. Gaurav Narula
Member

Professor, Pediatric Oncology, Convener Pediatric Hematolymphoid Group, Tata Memorial Hospital

Male

Medical Oncologist

13. 

Dr. Bharat Reiki
Member

Professor, Dept of Pathology, Tata  Memorial  Hospital, Mumbai.

Male

Pathologist

14. 

Dr. Pritha Ray

Member

Scientific Officer ‘F’ & Principal Investigator, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

Female

Basic Scientist

15. 

Dr. Navin Khattry
Member

Professor,  Dept of  Medical Oncology, ACTREC

Male

Medical oncologist

 

The mandate of the committee is as follows :

  1. Ensure the highest scientific and ethical standards of research at TMC
  2. Review and approve, proposals for clinical, basic or translational research projects (Intra and Extra mural) for scientific and ethical content
  3. Improve ethical standards and issue guidelines on ethical dilemmas related to patient care services
  4. To function as a forum to advise the administration in case of any ethical issues that may arise from patients, families or public
  5. To maintain our leadership as a national standard of reference in all fields
  6. To issue and periodically, update  and revise SOP s and guidelines for effective functioning of IEC as and when necessary
  7. 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
  8. 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 10.00a.m (unless otherwise notified) in the Board Room, Paymaster Shodhika, 3rd Floor, ACTREC, Kharghar, Navi Mumbai. The Member Secretary of IEC will be  Members of TRAC.

Data Safety Monitoring Committee (DSMC):

The Data Safety Monitoring committee (DSMC) is a subcommittee of the IEC, supported by well staffed DSMC whose primary responsibility is to review annual reports and safety issues (SAES, PSUR etc) related to projects approved by the IEC. The DSMC comprises of a Physician, an intensivist, basic scientists and medical, surgical and radiation oncologists. The Members of DSMC are trained in causality assessment as per WHO criteria and routinely implement them in assessing the relatedness of adverse events.

The mandate of the TMC-ACTREC Data Safety Monitoring Committee (TMC-ACTREC DSMC) is to:

  1. Monitor the overall progress of institutional clinical trials and for ensuring adherence to clinical trial and procedural requirements.
  2. Ensure the safety of participants, validity of data, projected accrual goals is maintained.
  3. Ensure that eligibility and evaluation criteria that are followed and risks are not excessive.
  4. Adverse events are appropriately monitored and reported to the appropriate agencies.
  5. Enhance the quality of the research by providing the investigator with constructive criticism.
  6. Provide regular reports to the Institutional | Ethics Committee

List of Members:

Sr No.

Names

Affiliation

Gender

Expertise

1

Dr.  Prafulla Parikh

Secretary

Assistant Professor, General Medicine, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

Female

Clinician

2

Dr.  Jayant Goda

Joint Secretary

Associate Professor, Radiation Oncology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

Male

Clinician Scientist

3

Dr. Kakoli Bose

Member

Scientific officer ‘F’, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

Female

Basic Scientist

4

Dr. Vikram Gota

Member

Associate Professor, Dept of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

Male

Clinical Pharmacologist

5

Dr. Sudhir Nair

Member

Associate Professor, Dept of Surgical Oncology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

Male

Clinician Scientist

6

Dr. Deepa Philip

Member

Assistant Professor, Medical Oncology, Tata Memorial Hospital

Female

Clinician

7

Dr. Reshma Ambulkar

Member

Associate Professor & Anesthesia 'F', Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

Female

Clinician

8

Dr. Abhishek Mahajan

Member

Assistant Professor Radiology 'E', Dept of Radio-diagnosis, Tata Memorial Hospital

Male

Clinician

9

Dr. Rajani Nagrani

Member

Scientific Officer ‘D’, Epidemiologist, Tata Memorial Hospital

Female

Epidermiologist

10

Dr. Rukmini Govekar

Member

Scientific Officer ‘F’, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

Female

Basic Scientist

 

List of Forms for Principal Investigators / Research staffs
Effective from 01.04.2016 for human study

1a Project submission form for human involvement study 6 Amendment reporting form
1b Revised submission form 7a ASR form A for Clinical trial
1c Project classification form-ACTREC 7b ASR form B for Basic study
2 Checklist of documents 8 Protocol deviation-violation form
3a ICF template 9 SAE submission form
3b Child assent form 10a Offsite Safety report classification form
3c Parent consent form 10b Off site safety log
3d Short ICF for patients prospective study 11 Document request form
3e Short ICF for parents prospective study 12 Study completion Form
3f Short assent for Child prospective study 13 Premature termination form
4 Review exemption form 14 Waiver of consent request form
5 Expedited Review Application form 15 Monitoring form
16 General instructions to PI- project submission    

 

 

Link for IEC SOPs effective from 1.4.2016

 

Last updated on 11.04.2016