Currently the focus of most investigators 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.
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.
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. Access the Engage in open science and open scholarship page for more 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 your study is required to register and share results through ClinicalTrials.gov, results should be entered and accepted by ClinicalTrials.gov prior to closing the study with the IRB. If you have questions or need assistance, contact DOCRfirstname.lastname@example.org.
Return of incidental findings
Incidental findings are usually bad news for the participant. Routine study procedures may detect some previously unknown medical condition ranging from a tumor, to a surprise bundle of joy, or genetic disorder. These Results in most cases the study team is ethically required to notify the participant. It is best practice to have the action plan of returning foreseeable 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 considered in the design of a study protocol.
Return of aggregated study results to participants
At a minimum, each study team should be 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. 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 Duke CTSI Recruitment Innovation Center is available to facilitate the planning, development and distribution of summary/aggregate results to participants with processes, templates, editing, graphic design, and dissemination strategies.