Institutional Review Board (IRB)

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An Institutional Review Board (IRB) is an oversight body focused on research involving human subjects [1,2,3]. The purpose of IRBs is to protect the rights and welfare of human subjects involved in research [1,2,3]. IRBs protect human subjects through initial review and approval, ongoing monitoring, and periodic re-review of research protocols that enroll human subjects [1,3]. IRBs focus on assuring that research is done: ethically; under conditions whereby subjects participate in the research voluntarily and with informed consent; with regard for the safety of and minimization of risks to subjects; and, with attention to protecting the privacy of subjects and confidentiality of research data [1,3]. Most IRBs are based in academic or research institutions while others are commercial entities offering IRB services to organizations that function independently of an academic or research institution [3].

The authority of and requirements for IRBs are defined under Title 45 of the Code of Federal Regulations Part 46 (45CFR46) of the U. S. Department of Health and Human Services (DHHS) [1]. The rule consists of 5 subparts [1]. Subpart A specifies the basic policy [1,2]. As stated on the DHHS website, 45CFR46, Subpart A, Section 46.101(a), the rule “… applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research” [1]. Subpart A also provides guidance on IRB membership, functions, operations and procedures, and requirements for informed consent [1]. Subpart A is the “Common Rule” [1,2]. The “Common Rule” has been adopted by or is complied with by more than a dozen additional federal agencies and departments [2]. Subparts B, C and D provide additional protections for vulnerable populations including pregnant women, human fetuses and neonates, children, and prisoners [1]. Subpart E provides guidance on registering IRBs with DHHS [1].

Additional Resources

Office for Human Research Protections. U. S. Department of Health and Human Services. http://www.hhs.gov/ohrp/index.html

References

1. U. S. Department of Health and Human Services. Code of Federal Regulations: Title 45 Part 46. Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html. Accessed 10/24/2013.

2. U. S. Department of Health and Human Services. Federal Policy for the Protection of Human Subjects (‘Common Rule’). Available at: http://www.hhs.gov/ohrp/humansubjects/commonrule/index.html. Accessed 10/24/2013.

3. Wikipedia: IRBs. http://en.wikipedia.org/wiki/Institutional_review_board. Accessed 10/25/2013.