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Institutional Ethics Committee

Institutional Ethics Committee (IEC)

At SIU, these principles are put into practice through the formation and operation of Independent / Institutional Ethics Committee (IEC). This committee focuses on the rights, safety, and wellbeing of the research participants if the research involves human subjects or if there is a possibility of involvement of ethical issues. IEC is expected to review and approve such research proposals.

As per the New Drugs and Clinical Trial Rules (NDCTR), 2019 by Drugs Controller General of India (DCGI), MoHFW, GoI, three IECs are functional at SIU currently: 1) Independent Ethics Committee for Biomedical and Health Research (BHR) studies, 2) Institutional Ethics Committee for Biomedical and Health Research (BHR) studies, & 3) IEC for Clinical Trials (CT), Bioavailability (BA) and Bioequivalence (BE) Studies.

The composition of these IECs can be found with the hyperlink given below:

Constitution of Independent Ethics Committee for BHR studies

Link

Constitution of Institutional Ethics Committee for BHR studies

Link

Constitution of IEC for CT, BA & BE studies

Link

The three committees work independently as per the Standard Operating Procedures (SOPs). No violation of SOPs is entertained. The researchers who are willing to seek ethical approval from the IECs should go through the SOPs which are attached with the hyperlink below:

SOP for IEC for Biomedical and Health Research (BHR) studies

Link

SOP for IEC for Clinical Trials (CT), Bioavailability (BA) and Bioequivalence (BE) Studies

Link

The Application form (Annexure IV) should be accompanied with necessary relevant documents such as Research proposal, Informed Consent Form, Participant Information Sheet, Case Record Form (Questionnaire), Investigator’s Brochure, Details of funding agency/sponsor, Curriculum Vitae of Investigators, Regulatory permissions, Relevant administrative approvals/agreements, etc.

To submit a research proposal for review by Ethics Committee, the Principal Investigators should follow the procedures, and submit the related documents as mentioned in the Circular 6 of 2023, SIU.

Institute Research Committee (IRC) and its functions Agencies

Link

Flow chart of research process

Link

Application Form for submission of proposal for IEC review

Link

The researchers should refer to the latest guidelines (2017) published by the Indian Council of Medical Research (ICMR) for Biomedical and Health Research involving human participants which is attached with the hyperlink below:

  • pdf icon
    ICMR National Ethical Guidelines

For more details, please contact:

Secretariat Independent / Institutional Ethics Committee of Symbiosis International (Deemed University)

Address: 4th Floor, Building no. 1, Symbiosis University Hospital and Research Centre (SUHRC)

At Post: Lavale, Block: Mulshi, Dist. Pune - 412115

Contact Number: 020-61930000 (Ext: 1825) / 8237425116 / 8888161710

Email ID: iec@siu.edu.in