Recommendations on managing incidental findings in human subject research

10 July 2008

The management of findings incidental to a research agenda involving human subjects is becoming an increasingly important issue, especially in the context of human genomic and genetics research. Studies involving human subjects result, in some instances, in unexpected findings unrelated to the original objectives of the research, such as the discovery of a tumour during a brain imaging study or misattributed paternity or parentage in a genetic family study. These discoveries, known as incidental findings, pose a dilemma for researchers, who must determine whether or not to disclose such information to the individual participant, whose health or well-being may be affected.

The usual practice in genomic research has been to inform participants prior to consent that there will be no disclosure of individual research results, including incidental findings. This procedure has, however, come under recent scrutiny, as genomic research produces a vast quantity of health-related data and information that may be beneficial to participants. The potential for disclosure of results raises new issues, such as, who might be responsible for dealing with any incidental findings, given the sharing of genomic data among researchers, the use of samples in multiple studies and the absence of defined time limits for their use.

Until recently, there had been a lack of guidance as to when it might be appropriate to disclose incidental findings to participants and how it is to be done. A set of recommendations has now been published, however, with regard to the management of incidental findings arising from genomic, genetics and other research involving human subjects [Wolf SM et al. (2008) J. Law Med Ethics 36(2): 219-48]. Included in the Summer 2008 issue of the Journal of Law, Medicine and Ethics dedicated to a symposium on incidental findings, the recommendations are the result of a two year project funded by the US National Human Genome Research Institute (NHGRI).

The authors recommend that researchers anticipate the discovery of incidental findings, and consider specifically the potential for incidental findings in future analyses of archived DNA.  They should plan to verify and evaluate a suspected incidental finding, with an expert consultant if necessary, and develop strategic criteria for reporting these findings, such as likely health or reproductive importance. It was recommended that the handling of incidental findings be addressed with participants during the consent process, and that an administrative pathway for dealing with incidental findings should be created and monitored by investigators and Institutional Review Boards (IRBs). Further recommendations addressed incidental findings involving paediatric and adolescent participants and adult participants without decisional capacity. The authors conclude that the responsible handling of incidental findings “requires clarity about the difference between research and clinical care” and suggest that more research is necessary to determine the prevalence of incidental findings and their impact on research participants.

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