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OBJECTIVE:


The objective of the Independent Ethics Committee (hereinafter referred to “IEC”) of Indian Medical Association (hereinafter referred to as “IMA”) is to ensure that all biomedical research in human subjects conducted in IMA and its affiliated wings are in accordance with the Ethical Guidelines for biomedical research on human subjects as prescribed by the Indian Council of Medical Research (hereinafter referred to as “ICMR”). For clinical trials, the IEC will follow the guidelines as prescribed by International Conference on Harmonization (hereinafter referred to as “ICH”), Good Clinical Practice (hereinafter referred to as “GCP”) as per Government of India and Schedule Y of the Drugs and Cosmetics Rules.

1.1 The IEC will abide by the following applicable regulatory guidelines:

  1. Good Clinical Practice (GCP), as prescribed by Government of India, Drugs and Cosmetics Act and Rules i.e. Rule 122-DAA and Schedule Y of the Drugs and Cosmetics Rules
  2. ICMR Guidelines for Biomedical Research on Human Subjects
  3. International Conference on Harmonization (ICH) guidelines for good clinical practice and Declaration of Helsinki
  4. ICMR , Guidelines for The Assisted Reproductive Technologies (Regulation)