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Institutional Review Boards and Ethics Committees

In: Principles and Practice of Clinical Trials

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  • Keren R. Dunn

    (Office of Research Compliance and Quality Improvement, Cedars-Sinai Medical Center)

Abstract

Institutional review boards (IRBs) are committees established in accordance with US federal regulations to review and monitor clinical trials and other research with human subjects. IRBs evolved from a history of egregious ethical violations in research with human subjects and the ethics codes and declarations that ensued, and were first mandated by US law in 1974, with the passing of the National Research Act. IRBs help to ensure the protection of the rights and welfare of human subjects by applying the ethical principles of the Belmont Report, respect for persons, beneficence, and justice, in their review of research projects. They have the authority to approve, require modifications to, or disapprove proposed research. IRBs review plans to obtain and document informed consent from research participants and can waive the requirements for informed consent in certain circumstances. IRBs may exist within the institution where research is being conducted or institutions can rely on an external IRB with a written agreement. While the term IRB is unique to the USA, clinical trials internationally adhere to the ethical principles of the Declaration of Helsinki, which requires independent review by an ethics committee.

Suggested Citation

  • Keren R. Dunn, 2022. "Institutional Review Boards and Ethics Committees," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 36, pages 657-678, Springer.
    • Handle: RePEc:spr:sprchp:978-3-319-52636-2_65
    DOI: 10.1007/978-3-319-52636-2_65
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