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Institutional Review Board Approaches to the Incidental Findings Problem

Published online by Cambridge University Press:  01 January 2021

Moira A. Keane
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Extract

With rapidly expanding technological capacity, research has outpaced the existing infrastructure of ethical and regulatory guidance. In the area of incidental findings (IFs), this is particularly true.

The regulations under which most Institutional Review Boards (IRBs) operate were established over 25 years ago and have not been substantially altered in the intervening years. The technology available today that creates the opportunity for IFs was not conceived of, or considered, in the crafting of those regulations. Therefore, little guidance can be derived directly from these regulations. Rather, aspects of existing ethical guidance and regulations can be adapted to assist IRBs and researchers in dealing with issues surrounding IFs.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 36 , Issue 2 , Summer 2008 , pp. 352 - 355
Copyright
Copyright © American Society of Law, Medicine and Ethics 2008

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References

Expectations that all drugs entering the U.S. marketplace be tested in humans were established in the mid-1960s. The federal regulations requiring that all federally funded research be reviewed by Institutional Review Boards (IRBs) followed slowly in 1974. The current set of regulations was established in 1983, with only minor revisions in content since that time. For a historical timeline of the evolution of the regulations, see “Historical Resources: Timeline of Laws Related to the Protection of Human Subjects,” compiled by Sparks, Joel, June 2002, available at <http://history.nih.gov/01docs/historical/2020b.htm> (last visited February 19, 2008).+(last+visited+February+19,+2008).>Google Scholar
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research was a product of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and was presented on April 18, 1979. Still widely quoted and applied, it is considered to be the cornerstone document for modern human subjects’ protections. It can be found at <http://ohsr.od.nih.gov/guidelines/belmont.html> (last visited February 19, 2008).+(last+visited+February+19,+2008).>Google Scholar
The federal regulations in Subpart D of 45 C.F.R. 46 state the requirements for direct benefit to children participating in research. The regulations outline specific requirements for IRB determinations and documentation, specific requirements for parental permission, minor assent, and waivers of consent. Regulations can be found at <http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm> (last visited February 19, 2008).+(last+visited+February+19,+2008).>Google Scholar
45 C.F.R. § 46.111 (a) (2), available at <http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.111> (last visited February 19, 2008).+(last+visited+February+19,+2008).>Google Scholar
45 C.F.R. § 46.116 (b) (5), available at <http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.111> (last visited February 19, 2008).+(last+visited+February+19,+2008).>Google Scholar
45 C.F.R. § 46.103 (b) (5), available at <http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.103> (last visited February 19, 2008).+(last+visited+February+19,+2008).>Google Scholar
As recently as January 2007, the Office for Human Research Protection (OHRP) has issued guidance and interpretation of the regulations pertaining to unanticipated problems. Entitled Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events, this document distinguishes the requirements for adverse event reporting from other problems requiring reporting in a research context. It can be found at <http://www.hhs.gov/ohrp/policy/AdvEvntGuid.htm> (last visited February 19, 2008). (Emphasis added.)+(last+visited+February+19,+2008).+(Emphasis+added.)>Google Scholar
See supra note 6.Google Scholar
See supra note 5. The IRB may require that information, in addition to that specifically mentioned in § 46.116, be given to the subjects when, in the IRB's judgment, the information would meaningfully add to the protection of the rights and welfare of subjects.Google Scholar