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Stage
Disseminate and Close Out
Topic

Return results to participants

Need assistance with returning results to participants?

The focus of most investigators at this point in their project is to publish results of their research in academic journals; however, these results are often not communicated to the public or to the participants who contributed to the success of the research study. Developing and disseminating lay-friendly research results to participants demonstrates respect and appreciation for their contribution to advancing science at a relatively low cost. At a minimum, Duke research teams are expected to share summary/aggregate results with study participants around the time of publication of the primary outcome manuscript.

To facilitate returning results to participants, DOCR will track CT.gov results reporting for Duke-sponsored studies and will provide return of results template documents to study teams, starting in July 2026. Studies with a publication identified will be included in a new School of Medicine CRU metric, which will track the posting of aggregate results on the My Duke Research website. The metric will be expanded to include additional Duke studies in the future.

Summaries should be written with the study participant in mind while also adhering to regulations and policies. Observing principles of readability, including tone, style, language, reading level and ease, layout, cognitive load, and health literacy all facilitate clear communication, which benefits all, regardless of education, literacy level, or familiarity with the clinical research process.

Access return of results template and instructions in Box

Public release of study data

Duke is committed to a culture of open science and open scholarship to ensure transparency and accountability in research. This commitment involves making scientific processes, data, analyses, and publications as accessible as possible. The "engage in open science and open scholarship" page contains information about data sharing requirements and best practices.  

ClinicalTrials.gov is utilized to not only alert the public to studies currently enrolling participants, it also serves as means to disseminate study findings to the general public. If an investigator is required to register and share project results through ClinicalTrials.gov, results should be entered and accepted by ClinicalTrials.gov prior to closing the study with the IRB. For questions or need assistance, contact DOCR-ctgov@dm.duke.edu.

Engage in open science and open scholarship

Return of aggregated study results to participants

At a minimum, each study team is expected to share study level/aggregate results with study participants. This shows respect and appreciation for the contribution of the participants and is a fairly low-cost effort.

Every study should plan to share the study level/aggregate results to each individual participant in a manner that is easy to access and easy to interpret. With proper planning and budgeting, there is no reason not to return aggregate results back to participants. In fact, a recent study showed:

  • 90% of study volunteers want to know the results of their study
  • 77% never hear back about the results
  • 68% of participants would not participate again if not informed of the results

The DOCR operations team is available to assist study teams with planning, development and distribution of summary/aggregate results to participants with processes, templates, editing, graphic design, and dissemination strategies.

Return of incidental findings

Incidental findings are unexpected, and usually surprising news for the participant. Routine study procedures may detect some previously unknown medical condition ranging from a tumor, to a pregnancy, or genetic disorder. Under these circumstances, in most cases, the study team is ethically required to notify the participant. It is best practice to have the action plan of returning incidental findings written into the study protocol.

Return of individual participant results

Some studies may deliberately give individual test results back. This could be a study benefit or a form of compensation of the study where a participant gets an expensive test done for free, or it may be part of the intervention, or just for the sake of doing it. While potentially more difficult, costly, and not appropriate for every study, the return of individual results to participants should always be a considered option in the design of a study protocol.