Tagore Medical College & Hospital

Research Ethics / Promotion Policy

IEC

Institutional Ethics Committee

Tagore Medical College and hospital Institutional Ethics Committee (IEC) was constituted for discussion and approval of institutional/ collaborative research projects with a view to safeguard the dignity, rights, safety and well being of all research participants and to ensure that the research is carried under prescribed guidelines.

Institutional Ethics Committee operates as per the ICMR guidelines and has been registered (Ethics Committee Registration No.ECR/634/Inst/TN2014 issued under Rule 122DD of the drugs & cosmetics Rule 1945).

Responsibilities of IEC

To ensure the competent review and evaluation of all ethical aspects of research projects received in an objective manner.
To protect the safety, rights and well being of the potential research participants.
To conduct scientific evaluation and ensure technical appropriateness of the proposed study.
To ensure that universal ethical values and international scientific standards are expressed in terms of local community values and customs.
To assist in the development and the education of a research community responsive to local health care requirements.
Creation, developing, revising and implementing ethical guidelines (SOPs)

DCGI approval number - ECR/1122/Tagore/Inst/TN/2014/RR20

NABH accreditation number - EC-CT-2021-0174

List of Institutional Ethics Committee Members

Name of member	Designation in EC
Dr. S. Seethalakshmi	Chairperson
Dr. R. Geetha	Member Secretary
Dr. Jaishree Vasudevan	Clinician
Dr. TKV Sharavanan	Clinician
Dr. A. Balaji	Clinician
Dr. E. Premalatha	Medical Scientist
Dr. I. Kannan	Scientific Member
Dr. M. G. Rajanandh	Scientific Member
Mr. K. Sethuraman	Lay Person
Mr. J. Raja Samuel	Legal Expert
Mrs. Sudha Ganapathy	Social Scientist
Mr. K. Karuthapandi	Social Scientist

Manuals

New Drugs and Clinical Trial Rules, 2019 – CDSCO - https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/NewDrugs_CTRules_2019.pdf
ICMR ethical guidelines - https://main.icmr.nic.in/sites/default/files/guidelines/ICMR_Ethical_Guidelines_2017.pdf

Institutional Ethics Committee Standard Operating Procedures

SOP No.	Standard Operating Procedure
1	Composition, procedures for new induction and resignation of members
2	Agenda Preparation, Meeting Procedures and Recording of Minutes
3	Receipt, review and decision making of proposals
4	Continuing Review of Study Protocols
5	Expedited Review
6	Exemption from the Ethics Review for Research Projects
7	Reviewing proposals involving vulnerable Populations
8	Conduct of Emergency Meeting
9	Review of Resubmitted Protocols
10	Review of protocol amendments
11	Review of Study Completion Reports
12	Review of Serious Adverse Events (SAE) Reports and Unexpected Adverse Events (UAE)
13	Confidentiality / Conflict of Interest Agreements
14	Audio Visual (AV) Recording of Informed Consent Process
15	Constituting SAE Subcommittee
16	Protocol Deviation/Violation
17	Selection and Responsibilities of Subject expert
18	Maintenance of Active Project Files
19	Management of Premature Termination /Suspension / Discontinuation of the study /Withdrawal of study before site initiation
20	Site Monitoring Visit
21	Procedure for Research Participant’s Request or Complaint
22	Archiving and Retrieving Documents
23	Preparation of Standard Operating Procedures (SOPs) for Institutional Ethics Committee (IEC)
24	Annexure, templates and forms