Appendix: Institutional Regulatory Oversight

Consent, Disclosure, and Non-Disclosure

Section 8

Appendix: Institutional Regulatory Oversight


Kevin Weinfurt, PhD

Jeremy Sugarman, MD, MPH


Contributing Editor

Karen Staman, MS

Institutional Review Boards (IRBs)

The Common Rule and FDA require that all research involving human subjects be reviewed by an institutional review board (IRB) (also known as a research ethics committee). IRBs can be local (with oversight of a single hospital or health system) or may involve multiple health systems or institutions. In order for an IRB to approve research, the following criteria must be met:

  • Risks to subjects are minimized
  • Risks to subjects are reasonable in relation to anticipated benefits
  • Selection of subjects is equitable
  • Informed consent is sought and appropriately documented from each prospective subject or the subject’s legally authorized representative
  • The research plan makes adequate provision for monitoring of data
  • There are adequate provisions to protect the privacy of subjects and to maintain the quality of data.
  • Additional safeguards have been taken for vulnerable populations

More information regarding IRB study approval criteria can be found in 45 CFR 46.111.

An IRB is “any board committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of biomedical research involving human subjects (21 CFR 56.102g).”

IRBs and Informed Consent

In accord with regulations and guidance established by DHHS/FDA, the IRB decides how and what information should be furnished to potential research participants as a part of the informed consent process, and requires documentation of informed consent unless documentation can be waived. A detailed summary of informed consent and its related regulatory issues is described in Consent, Disclosure, and non-Disclosure.

Accrediting Bodies

The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) is an independent, nonprofit accrediting body that uses a voluntary, peer driven education model to accredit human research protection programs. Accreditation by AAHRPP is considered a global gold standard, and recent articles detail issues involved in the expansion AAHRPP accreditation to research sites in India (Bairy and Pereira 2012) and China (Zi et al. 2012).





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Bairy KL, Pereira P. 2012. Accreditation of human research protection program: An Indian perspective. Perspect Clin Res. 3:80–84. doi:10.4103/2229-3485.96455. PMID: 22701825.

Welch MJ, Lally R, Miller JE, et al. 2015. The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials. Clinical Trials. 12:503–510. doi:10.1177/1740774515597701. PMID: 26374681.

Zi M, Tang X, Gao R. 2012. [The difference in acknowledging the AAHRPP between China and America]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 32:1117–1120. PMID: 23173265.

Version History

Published August 25, 2017


Weinfurt K, Sugarman J. Consent, Disclosure, and Non-Disclosure: Appendix: Institutional Regulatory Oversight. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: Updated November 13, 2018. DOI: 10.28929/028.