Return of results and data to study participants

12 October 2018  Vol 362, Issue 6411
Special Issue – Brain Development

Policy Forum
Return of results and data to study participants
By Susan M. Wolf, Barbara J. Evans
Science12 Oct 2018 : 159-160 Restricted Access
A recent report urges progress but builds barriers to research participants’ access
Researchers conducting imaging, environmental health, and genetics studies have offered participants their research findings for years, publishing data on this experience and producing consensus guidelines (1–5). Research participants have articulated the value in the return of results and data (6). The National Academies recently issued a report at the request of the National Institutes of Health (NIH), the Centers for Medicare and Medicaid Services (CMS), and the Food and Drug Administration (7) that focuses on the return of results in studies with human biospecimens. It proclaims support for the interests of research participants, endorses the importance of offering participants their individual-specific results, and advocates assessing the value of results from the standpoint of participants. Unfortunately, in our view, the report’s announced commitment to participant-centered progress is undercut by its actual recommendations. We believe the report creates major roadblocks to the return of data and results and would constrict participants’ existing rights of access.