Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2008 Summer;36(2):341-51, 213.
doi: 10.1111/j.1748-720X.2008.00278.x.

The future of incidental findings: should they be viewed as benefits?

Lisa S Parker  1
Affiliations

The future of incidental findings: should they be viewed as benefits?

Lisa S Parker. J Law Med Ethics. 2008 Summer.

Abstract

This paper argues against considering incidental findings (IFs) as potential benefits of research when assessing the social value of proposed research, determining the appropriateness of a study's risk/benefit ratio, and identifying and disclosing the risks and benefits of participation during informed consent. The possibility of generating IFs should be disclosed during informed consent as neither a risk nor benefit, but as a possible outcome collateral to participation. Whether specific IFs will be disclosed when identified is a separate question whose answer is material to determining whether IFs constitute a risk or a potential indirect benefit of participation. Finally, three types of IF should be distinguished and treated differently during informed consent: those that will be routinely generated (e.g., results of testing to determine study eligibility), those that can reasonably be characterized in terms of their nature and frequency of generation (e.g., misattributed parentage), and those of unpredictable nature and frequency that can be characterized only in general terms. Research protocols should provide a rationale for sharing or not sharing IFs of these three types with participants. Regulatory review of such plans should not, however, be confused with regarding IFs as potential benefits when assessing the study's risk/benefit ratio or merit.

PubMed Disclaimer

References

    1. Illes J, et al. Incidental Findings in Brain Imaging Research. Science. 2006;311(5762):783–784. - PMC - PubMed
    1. Davis D. The Changing Face of ‘Misattributed Paternity,’. Journal of Medicine and Philosophy. 2007;32(4):359–373. - PubMed
    2. Parker LS, Majeske RA. Incidental Findings: Patients' Knowledge, Rights, and Preferences. Journal of Clinical Ethics. 1995;6(2):176–179. - PubMed
    1. Freedman B. Equipoise and the Ethics of Clinical Research. New England Journal of Medicine. 1987;317(3):141–145. - PubMed

    1. Of course, sometimes IFs are managed according to a onesize-must-suit-all policy established at the institutional or clinic level. Nevertheless, such policies — like all clinical practice guidelines — should be developed with the welfare of the typical patient or majority of patients in mind.

    1. Wolf SM, et al. Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations. Journal of Law, Medicine & Ethics. 2008;36(2):219–248. In 1993, the Office of Protection from Research Risks (OPRR) came close to this definition in its IRB Guidebook section on human genetic research, which described IFs as “genetic information that is learned during the course of the study that does not directly relate to the research.” U.S. Department of Health and Human Services, Office of Protection from Research Risks . Protecting Human Research Subjects: IRB Guidebook. U.S. Government Printing Office; Washington, D.C.: 1993. pp. 5–54.

Publication types

LinkOut - more resources