The future of incidental findings: should they be viewed as benefits?
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.
Parker
Lisa S
LS
Graduate School of Public Health, University of Pittsburgh, PA, USA.
D035843:Biomedical Research / Q000941:ethics* / Q000639:trends; D030881:Disclosure / Q000941:ethics* / Q000639:trends; D006801:Humans; D033162:Incidental Findings; D007258:Informed Consent; D018570:Risk Assessment; D012945:Social Values