Return of aggregate results to study participants: Facilitators, barriers, and recommendations.

BACKGROUND

Most researchers and study participants believe that the summary, or aggregate, results of health research should be returned to study participants. However, researchers often do not return aggregate results. A better understanding of the impediments to results return could support improvements in this practice.

METHODS

This qualitative study convened eight virtual focus groups, four with investigators and four with patient partners from research studies funded by the Patient-Centered Outcomes Research Institute (PCORI). In total, 23 investigators and 20 partners participated. We explored perspectives, experiences, influences, and recommendations related to aggregate results return.

RESULTS

Focus group participants described the ethical importance of returning aggregate results, as well as the benefits to study participants. They also noted important impediments to results return, emphasizing IRB and logistical challenges and describing a lack of support for the practice both on the part of institutions and the field at large. Participants highlighted the value of patients and caregivers' perspectives and contributions to results return, which focused on returning the most relevant findings through effective channels and formats. They further emphasized the importance of planning and identified resources that could support results return.

CONCLUSION

Researchers, funders, and the field can better facilitate results return by promoting standardized processes in research, such as the earmarking of funds for results return and inclusion of results returns milestones in research plans. More intentional policies, infrastructures, and resources that support results return may lead to more widespread return of study results to those who make these studies possible.