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Independent Ethics Committee

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Independent Ethics Committee for Clinical Research and
Bio availability and Bio equivalence for Clinical Research Sites

The Independent Ethics Committee (IEC) is constituted by the Head of Shubhdisha Business Solutions.

Purpose

The IEC shared to CDSCO (EC/NEW/IND/2022/13914) in the year 2022 to formalize and specify the Institution commitment to promotion of high ethical standards of patient care for Clinical Research and community interests. IEC Functions as per the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participant 2017

Applicable to all Clinical Trials from Phase 1 to Phase IV including Bioavailability/ Bioequivalence (BA/BE) studies, Non Therapeutic and Non Interventional Studies, Investigator, Initiated studies, Academic Studies applicable to Hospitals associated to IEC within 50 kms range.

All research involving human subjects should be conducted in accordance with three basic ethical principles, which include.

  • Respect for Persons
  • Beneficence
  • Justice

The IEC SOPs are formed to maintain effective functioning of the IEC and to ensure quality and technical excellence and consistent ethical review of all submitted biomedical research proposals and ongoing approved research studies involving human participants in accordance to ICMR national Ethical Guidelines and New Drugs and Clinical Trials Rules 2019.