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Is returning aggregate results to study participants a PCORI requirement? (for all PCORI-Funded Researchers)

PCORI’s 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. This guidance states that “The Awardee Institution shall make every reasonable effort to ensure that the participants and partners receive this [lay language results] summary.”  As this language suggests, results return is not a formal requirement; however, it is equally clear that PCORI encourages and expects awardees to return results of their studies, consistent with PCORI’s mission in patient-centered outcomes research. 

While PCORI does not require awardees to return results, beginning in Fall 2020 awardees will be required to submit a brief ancillary form with their DFRR to report on their results return activities.  This form collects information about the awardee’s completed and/or planned efforts to return aggregate study results to research participants. Awardees will report on the material shared (e.g., lay language results summary) and how these materials are distributed.  If returning results is not applicable to a given project (see below), awardees will indicate this on the form.

For additional information, please email ResultsReturn@pcori.org with any questions.

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