Bioethical discussion of sharing research findings with participants has proliferated over the last decade. To date, systematic research on returning individual research results has focused almost exclusively on situations where the sole purpose of returning results is to mitigate or prevent harm to participants, such as disclosure of an incidental finding of cancer or a genetic predisposition to a preventable disease. There is growing recognition in the participant and bioethical communities that considerations of autonomy—in addition to prevention of harm—form a sufficient basis for granting participants access to their data. Appropriate respect for participant autonomy may require acknowledging that participants, as the source of data, should have more access to and control over their personal data than current models afford. The University of Rochester and Kennedy Krieger Institute are conducting a study that seeks to ascertain stakeholder perspectives on the return of individual research results through qualitative interviews in order to inform decisions related to the return of individual results.
If you are interested in participating in this study, please see the invitation here.
Despite growing discussion and support for sharing individual results, there is little evidence to suggest widespread adoption in practice. This is likely due, in part, to the ethical and practical complexity of the issues involved. There are multiple considerations that bear on the advisability of returning individual results, including:
- the potential audiences for data sharing,
- intended or anticipated uses of shared data,
- appropriate and relevant data for sharing,
- ability to present the data in understandable and meaningful ways,
- investigator resources needed to prepare for data sharing, and
- the potential for unintended consequences or decision making based on shared individual data.
Initial discussions within the research community concerning return of individual results were focused on ethical and practical aspects of returning actionable unanticipated results, such as discovery through research imaging of a previously unknown tumor. Later, the debate expanded to include return of potentially clinically relevant individual genetic research results. Despite voluminous academic literature on return of genetic results, far less serious empirical or ethical work has been devoted to the return of other types of individual results that may be of interest to research participants.
Similarly, there is little work assessing how the particularities of different conditions and patient populations impact the relevant issues. In ultra-rare pediatric conditions, for example, disease-related information is scarce outside of the research setting and difficult to obtain, heightening interest in research data. Despite strong anecdotal evidence that caregivers of pediatric research participants desire individual results, guiding principles for clinical researchers faced with navigating the ethical and practical issues have not gained traction. The lack of a robust, empirically informed framework for returning individual results in this space has hindered efforts.
As a first step in developing such a framework, our research team is conducting a multi-stakeholder study of return of results in rare childhood-onset neurological conditions. Our overarching objective is to identify preferences, perceived risks and benefits, challenges, and obstacles related to returning individual results among multiple stakeholder groups, including patient and patient caregivers, researchers, physicians, IRB chairs and HRPP leads, and sponsor representatives in order to develop a comprehensive framework to guide processes related to returning individual research results. If you are interested in participating in this study, please see the invitation here.