Return of aggregate results to study participants: Facilitators, barriers, and recommendations
Open accessAbstract
Background: Most researchers and study participants believe that the summary, or aggregate, results of health research should be returned to study participants. However, researchers often do not return aggregate results. A better understanding of the impediments to results return could support improvements in this practice. Methods: This qualitative study convened eight virtual focus groups, four with investigators and four with patient partners from research studies funded by the Patient-Centered Outcomes Research Institute (PCORI). In total, 23 investigators and 20 partners participated. We explored perspectives, experiences, influences, and recommendations related to aggregate results return. Results: Focus group participants described the ethical importance of returning aggregate results, as well as the benefits to study participants. They also noted important impediments to results return, emphasizing IRB and logistical challenges and describing a lack of support for the practice both on the part of institutions and the field at large. Participants highlighted the value of patients and caregivers' perspectives and contributions to results return, which focused on returning the most relevant findings through effective channels and formats. They further emphasized the importance of planning and identified resources that could support results return. Conclusion: Researchers, funders, and the field can better facilitate results return by promoting standardized processes in research, such as the earmarking of funds for results return and inclusion of results returns milestones in research plans. More intentional policies, infrastructures, and resources that support results return may lead to more widespread return of study results to those who make these studies possible.
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Communication of the trial results directly to the trial participants is widely considered an ethical responsibility supported by both researchers and participants.
“Communication of the trial results directly to the trial participants is widely considered an ethical responsibility supported by both researchers and participants.136”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [136]
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“Furthermore, researchers often lack formal or specific plans for results return, regardless of their intentions or support for the practice [3,13].”
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“, cost, timing) challenges, and the lack of incentives for aggregate results return [3,11].”
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- Authors
- Sgro, G. M., Maurer, M., Nguyen, B., & Siegel, J. E.
- Affiliations
- American Institutes for Research (US)
- Patient-Centered Outcomes Research Institute (US)
- Corresponding author
- Sgro, Gina M.
- Venue
- Contemporary Clinical Trials Communications
- Publisher
- Elsevier BV
- Published
- 2023-06
- Volume
- 33
- Pages
- 101136
- ISSN
- 2451-8654 (ISSN-L)
- PMC
- PMC10172747
- OpenAlex
- W4365518102
- Cited by
- 22
- References
- 15
- Citations by year
- 2026: 5 · 2025: 8 · 2024: 5 · 2023: 4
- FWCI
- 5.61
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Contemporary Clinical Trials Communications (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Patient-Centered Outcomes Research Institute
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Health Professions › General Health Professions › Mental Health and Patient Involvement
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Keywords
- research participant information, patient-centered outcomes research, patient and caregiver perspectives, research ethics, research planning, PCORI
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