Conducting research with human participants depends on a collaborative, productive relationship: Volunteers give their time and biospecimens, and investigators and their teams conduct research to make scientific discoveries that improve the health of patients, communities, and society. While the sharing of individual research results with participants has not traditionally been a part of the research process, the last several decades have begun to emphasize greater transparency and engagement with participants throughout the research enterprise. The return of individual research results is one way to engage and show respect for research participants; however, the risks—such as returning unvalidated or poor-quality results—and associated burdens on the research enterprise are competing considerations that need to be balanced.
An ad hoc committee reviewed the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. The resulting report offers a process-oriented approach to returning individual research results that considers the value to the participant, the risks and feasibility of return, and the quality of the research laboratory.