Returning Study Results to Participants: An Important Responsibility
Putting Evidence to Work
- PCORI Dissemination and Implementation Funding Initiatives
- Health Systems Implementation Initiative
- Returning Study Results to Participants: An Important Responsibility
- PCORI Public Access to Journal Articles Presenting Findings from PCORI-Funded Research
- Dissemination and Implementation Framework and Toolkit
Sharing the overall results of studies with participants fulfills an important ethical responsibility to those who take part in health research. We have always encouraged PCORI-funded researchers to return results to their study participants, and our current process provides support for our awardees’ results return activities.
PCORI's Policy on Communicating Study Results to Participants
PCORI asks investigators to make every reasonable effort to provide summary results to study participants. Our commitment to having awardees return the aggregate results of their studies to those who participated in the research is described in PCORI’s Process for Peer Review of Primary Research and Public Release of Research Findings, adopted by the Board of Governors in February 2015.
Just seeing the results lets me know that I've accomplished something.Patient Partner, PCORI-Funded Study
How Awardees Plan for and Share Study Results
PCORI asks applicants and awardees to plan for and report on their sharing of aggregate results both at the application stage and at the completion of their research:
- Application Process. Applicants are asked to describe how they plan to communicate summary findings from their research to participants who were enrolled in the study and to budget for these activities. By thinking about this early on, applicants are laying the groundwork to make these activities a reality later in their project.
- Draft Final Research Report. Awardees are asked to complete a form—Return of Aggregate Research Results to Study Participants—that describes how they have reported on study findings to participants, or on activities they have in progress.
PCORI encourages researchers to use the 500-word public facing summary of their study, which PCORI creates for all funded research, to support their sharing of results. This summary is written in lay language, with a reading level at or below the 8th grade level.
Researchers have shared results in a variety of ways, including creating and distributing an infographic, tailored report, fact sheet or video; posting a summary on their website; adding summary details to their newsletter; and more.
PCORI's Support for the Return of Study Results
Beginning with applications submitted in Spring 2020, PCORI has asked applicants to describe their plans for results return as part of their overall research plan and to budget up to $2,500 for results return activities. By building return of results into funded project activities from the beginning, we hope to address barriers that may hinder the success of these activities if they are initiated later, such as constraints related to the IRB approval process or a shortage of funds at the end of a project. Read more
To support results return for projects funded earlier, PCORI offers awardees the opportunity to request up to $2,500, using a simple request form. Large studies with more than 5,000 participants may request additional funds to cover added costs. Read more
Awardee Perspectives and Experiences on Communicating Aggregate Results
To support continued progress among PCORI awardees and inform the field, we undertook a qualitative study to better understand awardees' perspectives and experiences with communicating aggregate results, factors that influence the return of results to study participants, and the supports that may further facilitate such results return.
We held focus groups with PCORI investigators who intended to or had already returned aggregate results, as well as with patient and caregiver partners who contributed to the design and conduct of PCORI-funded studies.
Findings from this study, new insights into facilitators and challenges to results return, and recommendations for successful results return from the perspectives of investigators and patient partners engaged in patient-centered research, are published in Contemporary Clinical Trials Communications.
What Awardees Are Doing
We know that most PCORI awardees intend to return results to individuals who take part in their studies. In the initial reports PCORI received over the past two years, more than three-quarters of investigators indicated that they planned to return or had already returned results to study participants. This response compares favorably with the findings of a large recent survey of clinical trials investigators, published in The BMJ Open, which found that only 40 percent of respondents had either distributed results to participants or planned to.
You have an ethical obligation to share with your participants and the rest of the world … what you found through their participation.Principal Investigator, PCORI-Funded Study
Through PCORI’s heightened support for and prioritization of this important work, we aim to help researchers overcome the common barriers to returning results to study participants.
If you have questions or comments regarding PCORI’s results return activities, please contact us at [email protected].
Posted: May 23, 2023
What's Happening at PCORI?
The Patient-Centered Outcomes Research Institute sends weekly emails about opportunities to apply for funding, newly funded research studies and engagement projects, results of our funded research, webinars, and other new information posted on our site.