Increasing Our Support for Sharing Research Results with Study Participants

At PCORI, our mission is to fund research that can help patients and those who care for them make better-informed decisions about their health care. When people contribute to this research, it’s important that they hear about the results they’ve helped make possible.

Sharing the overall results of studies with participants fulfills an important ethical responsibility to those who take part in research. We have always encouraged PCORI-funded researchers to return results to their study participants and have recently made improvements to our process to emphasize the importance of this practice and support awardees in their efforts. Now, we are providing a clearer, more consistent message to our awardees about results return and will reinforce this message throughout the award and research process.

Changes Encourage Early Planning

Beginning with our Cycle 2 2020 PCORI Funding Announcements, awardees may ask for up to $2,500 to support results return activities. This change will allow us to review researchers’ plans for results return early and help us better track return activities. We will also ask investigators to provide details of these activities in their Draft Final Research Report. Returning results could be as simple as sharing the results summary, which is tailored to a lay audience.

Interest in promoting the return of results to study participants has been growing around the world. The European Union is laying the groundwork for a policy requiring clinical research sponsors to produce plain-language summaries of trial results, which would be posted to a public website, and to let participants know the results are available.

Sharing the overall results of studies with participants fulfills an important ethical responsibility to those who take part in research.

Removing Barriers to Sharing Results

Several journal articles show that despite viewing the practice as an important part of conducting research, investigators often don’t follow through, citing cost, logistics, and review policies as barriers. And not all funders encourage their supported researchers to undertake return activities. A study published in the September 2019 issue of The BMJ Open, which surveyed clinical trial authors indexed in PubMed from 2014 to 2015 who had enrolled individual patients, found that only 17 percent of their funders had suggested returning results to study participants.

Through PCORI’s heightened support for and prioritization of this important work, we aim to be part of the solution. We know that most PCORI-funded researchers intend to return results to individuals who take part in their studies, and we hope that by allowing awardees to budget for these activities and asking them to plan them earlier in their projects, we can help all our supported investigators complete this step in their research.

Sharing results with research participants fulfills an important ethical responsibility to those who take part in research. PCORI is now doing more to help its awardees return overall study results to participants. Find out how: https://bit.ly/3ebUHYY