SPECT-ERB

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SPECT-ERB is an independent body constituted of medical professionals and non-medical members, whose responsibility is to ensure the protection of the rights, safety and well being of human subjects involved in a clinical trial or BA/BE study and to provide public assurance of that protection, by, among other things, reviewing and approving / providing favorable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

Registered with the U.S. Department of Health and Human Services (DHHS # IRB00005032) and Drugs Controller General of India (ECR/8/Indt/DL/2013) it has a ‘quorum’ to provide collective expertise ensuring a comprehensive review of the projects submitted to it. The composition is in compliance with ICH-GCP guidelines as well as Schedule Y of Drugs and Cosmetics Act and includes:

  1. 1. Basic Medical Scientists (Pharmacologist)
  2. 2. Clinicians
  3. 3. Legal Expert
  4. 4. Social Scientists
  5. 5. Lay Person from the Community
  6. 6. Clinical Research Experts

SPECT-ERB operates as per the charter that is in compliance with the guidelines laid down for ERBs by Schedule Y of Drugs and Cosmetics Act, ICH-GCP, WHO, ICMR and Indian GCP Guidelines.

Since August 2005, 222 study proposals have been reviewed and evaluated by SPECT-ERB.

        

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