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