In recent years, a consensus has developed that medical and health services researchers should share their study results openly with other researchers and the general public to "advance scientific discovery and improve clinical care." Regulatory authorities including the US Food and Drug Administration and the European Union have stipulated that results of all clinical trials must be posted in free, open-access databases for public use.
This "return of results" idea 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 are making to advance scientific knowledge, as well as the imperative that participants should receive the greatest possible benefit from their participation. 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, more emphasis has been placed on making research results understandable and usable by lay audiences—including the patient participants and partners who were essential to the study.
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 such activity, some research sponsors and other organizations have adopted policies and processes to this end. PCORI, consistent with our mission to engage patients at all points during the research process, directs researchers to provide their 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 will prepare a 500-word summary of each project, written to be accessible to patients and the general public, and post it on our website. We will supply each awardee institution with the summary. A section in our Process for Peer Review of Primary Research and Public Release of Research Findings states, “The Awardee Institution shall make every reasonable effort to ensure that the participants and partners receive this summary.”
A substantial majority of PCORI awardees surveyed to date are making plans to provide study results to patients and partners. Most intend to use various routes in addition to distributing the PCORI research abstract. These include presentations, website postings, and newsletter articles, as well as distributing summaries the awardees prepare for patients.
Posted: August 17, 2016