Broad Consent for Research With Biological Samples: Workshop Conclusions

TLDR

Human biospecimen research relies on varied consent models, leading to confusion, unintended constraints, and unconsented use, and recent Common Rule updates make this issue particularly timely. The NIH Clinical Center workshop sought to assess the ethical acceptability of broad consent for future research on stored biospecimens and to outline areas of agreement and needed further dialogue. Bioethics scholars reviewed consent reasons, strategies, and knowledge gaps, proposing broad initial consent with oversight and, when feasible, ongoing donor information.

Abstract

Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health (NIH) Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and timely topic.