Decision-Making About Biospecimens

This digital drawing of a long, spiraling document suggests a confusing and lengthy consent process. Prospective risks and benefits of a clinical intervention can be too numerous to cover in a single clinical encounter, and risks of participating in clinical trials can be unknown. In both standard care and research settings, genomic and genetic biospecimen sampling adds to a list of social, psychological, and physical risks that can permanently alter the lives of participants and, at times, their biological relatives or descendants.¹ Psychological risks of participating in research, especially, can be “subtle and poorly defined” despite their importance.¹

In 2019, the US Department of Health and Human Services revised the Common Rule to “provide key information and promote [the] autonomy” of subjects.² Revisions to informed consent regulations, in particular, also included an updated definition of the term human subject and updated informed consent exceptions.^2,3 Improvements in regulations or consent forms, “including simplified language, illustrations, shorter length, and teach-back approaches, have led to only modest improvements” in subjects’ clearer understandings of research protocols and goals.¹ Consent processes that prioritize personal interactions between clinician-investigators and patient-subjects tend to hold more promise for promoting patient-subjects’ understandings of their roles in research⁴ and of how their biospecimens might be used.