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What is the value of having ethics review committees such as an institutional ethics committee (IEC),...

What is the value of having ethics review committees such as an institutional ethics committee (IEC), internal review board (IRB), or an infant care review committee (IREC)?

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Answer #1

The International Council on Harmonisation (ICH) defines an internal review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. IRBs can also be called independent ethics committees (IECs).

An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risks in relation to any benefits that might result from the research.

An IRB/IEC:

  • Reviews all study-related materials before and during the trial
  • Must operate in accordance with national and/or local regulations, as well as with ICH good clinical practices (GCPs) guidelines
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