In recent years, a greater consensus has developed that medical and health services researchers should share their study results openly with other researchers and the general public to foster trust and improve health care. Regulatory authorities including the US Food and Drug Administration and the European Union have stipulated that results of clinical trials be posted in free, open-access locations for public use.

The related idea of "return of results," the sharing of study findings directly with trial participants, is rooted in the ethical principles widely used to guide clinical research. The Belmont Principles, for example, highlight respect and acknowledgement of the important contributions study participants make to advance scientific knowledge, as well as the social obligation to maximize possible benefits to research participants. The most recent revision to the World Medical Association’s Declaration of Helsinki—which also provides ethical principles for medical research—explicitly states that “all medical research subjects should be given the option of being informed about the general outcome and results of the study.”  

In recent years, as patient-centeredness has become a greater priority in healthcare research, emphasis has been placed on making research results understandable and usable—as well as available—to lay audiences, including the study participants.

PCORI's Requirements Regarding Return of Research Results to Study Participants

Although no federal regulation requires the communication of study results to participants, and little guidance is available on results return, some research sponsors and other organizations have adopted results return policies and processes. PCORI, consistent with our mission to engage patients at all points during the research process, explicitly directs researchers to provide study results to participants and partners. This activity is described in our Process for Peer Review of Primary Research and Public Release of Research Findings, adopted by our Board of Governors in February 2015. 

As part of this process, PCORI asks Awardee Institutions to make “every reasonable effort” to ensure that the study participants receive an accessible summary of the results. PCORI prepares a 500-word summary of each project, written to be understandable to patients and the general public. Investigators receive a copy of this summary when it is completed and can distribute it to their study participants. Alternatively, they may choose to return results using other materials or a different approach. As of 2019, a substantial majority of active PCORI awardees stated they planned to return results, many indicating they plan to use presentations, website postings, and newsletter articles in addition to distributing the PCORI summary.

Beginning in 2020, new applicants for PCORI research funding are asked to budget up to $2500 to support results return activities. Awardees funded prior to 2020, with ongoing projects, may request the same amount to support return of their research findings to study participants upon study completion. More information can be found on PCORI’s Awardee Resources webpage.

Posted: August 17, 2016; Updated: December 1, 2020

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