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.
References
Beecher HK (1966) Ethics and clinical research. N Engl J Med 274(24):1354–1360. https://doi.org/10.1056/NEJM196606162742405
Cobb N, Witte E, Cervone M, Kirby A, MacFadden D, Nadler L, Bierer BE (2019) The SMART IRB platform: a national resource for IRB review for multisite studies. J Clin Transl Sci 3(4):129–139. https://doi.org/10.1017/cts.2019.394
Department of Health and Human Services (2011) Human subjects research protections: enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators. Fed Register 76(143):44512–44531. https://www.federalregister.gov/documents/2011/07/26/2011-18792/human-subjects-research-protections-enhancing-protections-for-research-subjects-and-reducing-burden. Accessed 26 Jun 2021
Department of Health and Human Services, FDA (2017) IRB Waiver or alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects guidance for sponsors, investigators, and institutional review boards. https://www.fda.gov/media/106587/download. Accessed 26 Jun 2021
Department of Health and Human Services, NIH (1998) Protection of human subjects: categories of research that may be reviewed by the Institutional Review Board (IRB) through an expedited review procedure. Fed Register 63(216):60364–60367. https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html. Accessed 4 Jun 2021
Department of Health and Human Services OHRP and FDA (2017) Minutes of Institutional Review Board (IRB) meetings guidance for institutions and IRBs. https://www.hhs.gov/ohrp/minutes-institutional-review-board-irb-meetings-guidance-institutions-and-irbs.html-0. Accessed 26 Jun 2021
Emanuel EJ, Wood A, Fleischman A, Bowen A, Getz KA, Grady C, Levine C, Hammerschmidt DE, Faden R, Eckenwiler L, Muse CT, Sugarman J (2004) Oversight of human participants research: identifying problems to evaluate reform proposals. Ann Intern Med 141(4):282–291. https://doi.org/10.7326/0003-4819-141-4-200408170-00008
Harkness J, Lederer SE, Wikler D (2001) Laying ethical foundations for clinical research. Bull World Health Organ 79(4):365–366
International Committee of Medical Journal Editors (2019) Recommendations for the conduct, reporting, editing, and Publication of scholarly work in Medical Journals. http://www.icmje.org/icmje-recommendations.pdf. Accessed 1 Jul 2021
Menikoff J, Kaneshiro J, Pritchard I (2017) The common rule, updated. N Engl J Med 375:613–615. https://doi.org/10.1056/NEJMp1700736
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978) Reports and recommendations institutional review boards. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/access-other-reports-by-the-national-commission/index.html. Accessed 30 Jun 2021
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) The Belmont report. https://www.hhs.gov/ohrp/sites/default/files/the-belmont-report-508c_FINAL.pdf. Accessed 4 Jun 2021
National Institutes of Health (2016) Final NIH policy on the use of a single institutional review board for multi-site research. NOT-OD-16-094. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html. Accessed 1 Jul 2021
Office for Human Research Protections (OHRP) (2021) Assurance process frequently asked questions. https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/assurance-process-faq/index.html. Accessed 1 Jul 2021
Rice TW (2008) The historical, ethical, and legal background of human-subjects research. Respir Care 53(10):1325–1329
Shalala D (2000) Protecting research subjects – what must be done. N Engl J Med 343(11):808–810. https://doi.org/10.1056/NEJM200009143431112
Steinbrook R (2002) Improving protection for research subjects. N Engl J Med 346(18):1425–1430. https://doi.org/10.1056/NEJM200205023461828
US Congress Senate (1974) (Reprint of) National Research Act. https://www.govinfo.gov/content/pkg/STATUTE-88/pdf/STATUTE-88-Pg342.pdf. Accessed 4 Jun 2021
U.S. Government Printing Office (1949) The Nuremberg Code: Trials of war criminals before the Nuremberg military tribunals under control council law No. 10, vol 2. pp. 181–182. https://history.nih.gov/display/history/Nuremberg+Code. Accessed 4 Jun 2021
White MG (2020) Why human subjects research protection is important. Ochsner J 20(1):16–33. https://doi.org/10.31486/toj.20.5012
World Medical Association (2013) WMA Declaration of Helsinki – ethical principles for medical research involving human subjects as amended by the 64th WMA General Assembly, Fortaleza, Brazil. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/. Accessed 4 Jun 2021
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Dunn, K.R. (2021). Institutional Review Boards and Ethics Committees. In: Piantadosi, S., Meinert, C.L. (eds) Principles and Practice of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-52677-5_65-1
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DOI: https://doi.org/10.1007/978-3-319-52677-5_65-1
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