https://orcid.org/0000-0002-5460-274X
Figures
Abstract
Background
Disseminating research findings to study participants is a critical component of clinical research. There is evidence that dissemination strengthens social relations and understanding between researchers and participants and their communities, and it is increasingly required by funding bodies. However, there is limited funding support for and guidance on the implementation of dissemination of research results to study participants.
Methods and findings
We conducted a systematic review to describe the current global practice of dissemination of aggregate research results to study participants. The databases Medline (OVID), Embase, and CINAHL were searched to identify publications published from January 1, 2008, to June 17, 2025. Primary quantitative studies including randomized control trials, retrospective or prospective cohorts, cross-sectional, case-control or case series studies or studies within a trial or nested cohort studies as well as qualitative and mixed-methods studies reporting on the predefined outcomes in English language were included. A total of 96 studies met the inclusion criteria: 38 were qualitative, 30 were quantitative, and 28 were mixed-methods studies. Most studies concentrated on dissemination of broad health-related research (n = 28; 29%), followed by cancer research (n = 18; 19%) and genetics (n = 17; 18%). Data were extracted and analyzed based on an a priori developed thematic framework. Most participants expected researchers to share results regardless of study outcomes. Many participants viewed receiving results as essential for fostering trust with researchers, feeling valued for their contributions, and fulfilling ethical obligations. Many researchers saw sharing results as a moral duty, especially when participants had limited access to scientific knowledge. The most common method for disseminating results was mailing lay summaries or result letters to participants. Group presentations and workshops were predominantly used in lower income countries. Identified barriers and enablers to result dissemination included researcher attitudes and communication skills, logistics and resources, institutional guidance, and ethical and cultural considerations. Impact of dissemination on research findings included improving health literacy, increased understanding of research, and trust in research. Synthesis of the literature is challenging given the heterogeneity of the studies included.
Conclusions
Result dissemination is an integral component of modern clinical research practice and appears to translate into a broad range of benefits in most circumstances. The current lack of agreement on what constitutes best practice will need to be addressed. The design of frameworks to guide the conduct of dissemination, which are now in early development, require validation in a range of settings, populations and clinical domains. Further work on approaches to dissemination of research findings in lower-middle income countries is required.
Author summary
Why was this study done?
- Disseminating research findings is key to research integrity, but there is limited guidance on the implementation of dissemination of research results to study participants.
What did the researchers do and find?
- We found that most research participants wanted study results to be shared with them, no matter the outcome.
- Receiving results made participants feel respected and valued and built trust and was seen as the right thing to do.
- Researchers also felt a moral responsibility to share results.
- The most common way to share results was by sending a written summary or letter. In lower-income countries, group talks and workshops were more common.
- Factors that helped with or got in the way of dissemination included researchers’ attitudes, how well they communicated, available resources, and cultural or ethical issues.
What do these findings mean?
- The synthesis of available literature is challenging given the large differences in study types, methodology, and outcomes that were assessed in relation to results dissemination. This makes conclusion across different populations and disciplines challenging.
- Sharing summary findings of clinical research with participants appears to have many benefits. However, it remains unclear how to best approach dissemination, highlighting the need to develop best practice guidance.
- More work is especially needed on how to share results in lower-middle-income countries.
Citation: Bagita-Vangana M, Unger HW, Thriemer K (2025) Current global practice and implications for future research on disseminating health research results to study participants: A systematic review. PLoS Med 22(8): e1004569. https://doi.org/10.1371/journal.pmed.1004569
Academic Editor: Margaret E. Kruk, Washington University In St Louis: Washington University in St Louis, UNITED STATES OF AMERICA
Received: February 23, 2025; Accepted: July 16, 2025; Published: August 14, 2025
Copyright: © 2025 Bagita-Vangana et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: All relevant data are available within the manuscript and Supporting Information files.
Funding: The author(s) received no specific funding for this work.
Competing interests: The authors have declared that no competing interests exist.
Abbreviations: CBPR, community-based participatory research; DVD, digital video disk; ENTREQ, Enhancing Transparency in Reporting the Synthesis of Qualitative Research; LMIC, low- and middle-income countries; NHI, National Health Institute; PIL, patient information leaflets; PLS, plain language summaries; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses; WMA, World Medical Association
Introduction
Disseminating research findings to the research community, which includes study participants, is part of community engagement. Community engagement, a process that involves strengthening social relations and understanding between researchers and participants and their communities [1–3], is recognized as a critical component of medical research [4].
Disseminating research findings is key to research integrity, specifically promoting transparency and discussion of new knowledge, and having the potential to change practice at all levels [5]. Indeed, the World Medical Association (WMA) Declaration of Helsinki, General Principle 26, states that “all medical research subjects should be given the option of being informed about the general outcome and results of the study” [6]. It further specifies (General Principle 36) the ethical obligations of researchers, sponsors, and editors to make results available and accessible in the public domain, irrespective of study outcomes [6]. While not mandatory, dissemination of research results is now recommended by many research ethics committees and funding agencies and included in research regulations in Australia, Canada, and the United Kingdom [7–9]. This underlines the imperative that study participants receive aggregate research results.
In 2008, a narrative review summarized the available literature on disseminating research results to study participants [10]. It highlighted that research participants want results made available to them but reported uncertainty about best practice [10]. Since then, the number of articles reporting on methods and experiences with results dissemination has increased. Additional work focusing on specific participant populations, geographical locations, fields of research, and methodologies are now also available. For example, a systematic review focused on results dissemination in community-based participatory research (CBPR) [11], and a scoping review summarized the experiences with results sharing among Indigenous populations in the Circumpolar North [12]. A further scoping review focused on dissemination of study results to participants of phase 3 randomized controlled trials and identified a largely ad hoc approach to dissemination by investigators, suggesting a guiding framework is needed [13].
This systematic review aimed to summarize the current global practice of disseminating information on the general outcome and results of clinical research studies (aggregate research findings) to participants involved in health-related research, with specific focus on the following research questions: i) what are the expectations of participants regarding results sharing; ii) what are the reasons for results dissemination; iii) to what extent are results shared with participants; iv) what are the methods used for sharing results; v) what are participant and researcher preferences for how results should be shared; vi) what are potential barriers and enablers to disseminating results; vii) what is the best timing for dissemination activities; and viii) what are the impacts of results sharing.
Methods
Search strategy and study selection
The databases Medline (OVID), Embase, and CINAHL were searched separately to retrieve publications on dissemination of research results to study participants published from January 1, 2008, to June 17, 2025. The search commenced at the cut-off date of a previous review by Shalowitz in 2008 [10]. The search strategy included the main keywords “results dissemination,” “research findings,” and “study participants” combined with “OR” and “AND” operators using different keyword variations in line with the previous review [10]. The final search string and the search strategies for each database are presented in S1 Table. Retrieved articles were exported to Covidence (Melbourne, Australia) for screening and data extraction.
Inclusion and exclusion criteria
Primary quantitative studies including randomized control trials, retrospective or prospective cohorts, cross-sectional, case-control or case series studies, or studies within a trial or nested cohort studies that reported on reasons, extent, methods of result sharing, preferences by participants and researchers, barriers and enablers, timing of dissemination, and impact were included. Primary qualitative studies were included when they reported on researcher or participant attitudes, knowledge, experiences and perspectives on sharing research results, barriers and enablers, and methods of dissemination. Mixed-methods studies that reported any of the predefined outcomes were also included. Inclusion was restricted to articles in the English language. Review articles, study protocols, conference presentations and proceedings, guidelines and policy documents, editorials, letters, viewpoints, and commentaries were excluded (S2 Table).
Eligibility of studies
Two reviewers separately screened the articles by title, abstract, and full text. Any disagreement between abstract screeners on the eligibility of included papers was resolved through discussion among all three authors.
Data extraction
The thematic framework for data extraction was informed by findings of prior reviews on the subject matter and our own work [11–14] and developed prior to extraction. This included location and year of study and whether quantitative or qualitative methods were used. The remaining extractions fields corresponded with the research questions (reasons, extent, methods of result sharing, preferences by participants and researchers, barriers and enablers, timing of dissemination, and impact).
At the beginning of the data extraction process, data were extracted by at least two authors (MBV, KT, HWU) to ensure common understanding of the data categories. Data extraction for the remaining articles was then conducted by one reviewer (MBV) and confirmed by a second reviewer (KT or HWU). Authors of included studies were not contacted for further information or verification.
Quality assessment
Given the large heterogeneity of study methodologies included in this review, no standard tools to assess quality were deemed suitable. Particularly for qualitative and mixed methodologies, the value of critical appraisal is contested [15]. We, therefore, only included study design and sample size as a measure of quality (S3 Table). No studies were excluded based on quality.
Data synthesis
Results were grouped thematically for descriptive analysis based on a priori identified themes. These themes included expectations of participants, reasons for results dissemination, extent of result sharing, methods used, participant and researcher preferences for how results should be shared, barriers and enablers, timing for dissemination activities, and impact (Fig 1). Subthemes were identified through thematic analysis using an inductive approach with most themes being separated by researchers and participants views (Fig 1). Subthemes were developed in an iterative process (MBV, HWU, and KT), subsequent studies were coded into pre-existing concepts, and new subthemes were created when necessary.
Quantitative data were not pooled due to significant heterogeneity among study settings, types of research, data collection instruments, and sampling.
This study is reported as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline (S1 Checklist) and per Enhancing Transparency in Reporting the Synthesis of Qualitative Research (ENTREQ) guidelines (S2 Checklist).
Results
After removing duplicates, a total of 1,422 studies were screened for inclusion. After excluding 1,188 studies based on title or abstract, full texts were retrieved for 231 studies. A total of 96 studies met the predefined inclusion criteria (Fig 2, S3 Table).
Of the 96 studies, 38 (40%) were qualitative [3,16–52], 30 (31%) were quantitative [53–82], and 28 (29%) were mixed-methods studies [5,14,83–108]. Most studies concentrated on dissemination of health-related research more broadly (n = 28; 29%), followed by studies reporting from cancer research (n = 18; 19%), genetics (n = 17; 18%), and adult medicine (n = 13; 14%). Other research areas included infectious diseases (n = 10; 10%), obstetrics (n = 4; 4%), pediatric/adolescent medicine (n = 4; 4%), geriatrics (n = 3; 3%) and gynecology (n = 1; 1%). Half of included studies (n = 47; 49%) were conducted in the Americas including the United States and/or Canada and one in Brazil. A total of 28 (29%) studies came from Europe and 8 (8%) from Africa. Four studies (4%) were conducted in the Western Pacific region (Australia, New Zealand, and Japan), and 9 (9%) studies involved multinational populations.
What are participants’ expectations?
Thirty-seven studies reported on expectations of study participants about results sharing, a third of them using qualitative methods (n = 12, 32%), nearly half using quantitative methods (n = 18, 49%) and 7 studies (19%) using mixed-methods research. The expectations were described as general expectations [3,16,26,30,34,35,37,41,42,46,48,54–58,60,62,64,65,67,69,71,73,74,77,79,83,98,100,101,104,106], and expectations on aggregate versus individual study results dissemination [29,35,56,60–62,78,91].
General expectations. Across all included studies the majority of participants’ felt that researchers should share results with study participants irrespective of study outcomes [16,26,35,46,48,54–58,60,62,64,65,71,73,74,79,83,98,101]. The expectation to receive results was associated with a higher level of education among research participants [55,67,77]. Participants felt results should be presented neutrally, sensitive results should be shared in an appropriate manner and those results should also be shared even if there was some initial lack of understanding of what the results meant for clinical practice [30,41,69].
Returning individual versus aggregated results. Among UK cancer trial participants, 70% (57/81) requested summary results and 69% (56/81) individual results. When cross-tabulated, 43% (35/81) wanted both overall and individual results, and about one-quarter requested only overall (27%; 22/81) or individual (26%; 21/81) results [56]. Similar findings were shown in a Dutch genetics study of 1,678 respondents; 59% of participants were interested in receiving individual results, even if they had no health consequence [78]. In a diabetic self-management study, almost all participants (99%; 110/111) desired both individual and aggregate results to influence future health behavior [35]. While there is growing evidence on the strong interest among participants to receive individual results, especially in cancer and genetics research, some studies indicate that this will have significant resource implications [29,60–62].
What are the reasons for disseminating results to study participants?
Participants’ perspectives.
A total of 21 (22%) articles were identified for this theme. Two-thirds of the studies (n = 14; 67%) used qualitative research methodologies. Participant reasons for wanting to receive results fell into five main categories: i) to foster trust and transparency [20,29,41,44,51,84,106], ii) to be recognized for contributions to research [29,30,40,41,44,80,84,101], iii) as an ethical and moral obligation [3,44,51,60,61,101], iv) to increase knowledge and awareness [17,21,29,48,60,80], and v) to improve health decision-making [21,29,31,34,35,41,44,60,106]. Two studies reported reasons for not wanting to receive study results [61,62].
Fostering trust and transparency. Participants felt that receiving research results would improve relations with researchers and motivate participation in future research [29,41,44]. In a cross-sectional survey of 502 study participants in the United States, transparency and accountability from researchers were reasons for wanting research results [106] and was identified as a logical conclusion to the research process [20]. Respondents in a qualitative study in the United States explained that providing samples and information for research gave them ownership of research findings and, therefore, sharing final results with them honored their “contract” with researchers [41].
Recognizing contributions. Participants also wished to be acknowledged for their time and individual contributions to research [29,80,101]. Being acknowledged made participants feel valued and showed that their participation mattered to the research community [41,44]. The act of “giving back” results was also seen as a mark of respect for the community from which participants originated [30,40].
Ethical and moral obligation. In a Malawian bioethics study, many participants felt it was their ethical right to receive research results [3]. In a survey of adult participants in a cancer study in Canada, 91.5% (173/189) expressed that they had a “strong/very strong” right to receive information on final study outcomes [60]. Similarly, a large survey of parents of children or adolescents with cancer in the United States and Canada found that parents felt it was their right to receive research results [61]. Community members also viewed receiving results as a moral and ethical obligation for researchers, thereby acknowledging participants’ time and involvement for little or no compensation [44,101].
Increased knowledge and awareness. Receiving results for their own education, interest, and scientific curiosity were reasons identified in two qualitative studies [21,48]. Other participants wished to know future directions of research and how conclusions and recommendations were derived from research data [21]. A majority of Canadian cancer research participants (116/189; 61.4%) indicated receiving results to increase public awareness around cancer research [60], while in a genetics study from the United States patients wished to receive results to increase their awareness of scientific progress [29].
Improve health decision-making. Returning research results provides information to help personal health decision-making, behavior modification and health management [21,34,44,106]. For example, in genomics studies in Kenya, returning results to the community was perceived as being enabling and motivating for individuals to know their health status and seek care if necessary [29]. For cancer patients, respondents in a Canadian study felt the information could help improve their quality of life or reduce risks of harm later in life [60]. Similarly, in a qualitative US study of diabetic trial participants, understanding how the research was affecting their community was important to 99% (110/111) of participants [35]. Overall, many study participants recognized an individual as well as collective health benefit [21,31,41] in results sharing.
Not wanting to receive study results. Two studies included data on why results should not be shared [61,62]. The main reasons cited in a cancer study were distress due to harm as a result of research participation, loss of a family member, and insurance or employment concerns [62]. However, many parents of children and adolescents with cancer thought, there were no good reasons to not want results [61].
Researchers’ perspectives.
Reasons for sharing results with participants by researchers were described in 17 (18%) articles. Reasons were categorized as follows: i) ethical and moral obligations [3,14,32,39,44,51,68,85,92,94], ii) recognizing participant contributions [44,54,76,85,92,94], iii) fostering transparency and trust [32,44,85,92], iv) improving participant health and research literacy [14,44,68,94], and v) improving individual and community health [36,38,39,92]. Four articles described various reasons for not sharing results [14,32,47,92].
Ethical and moral obligations. Many researchers considered sharing results a moral and ethical obligation [3,14,32,39,44,51,92,94]. Genetics researchers indicated that failing to communicate results of potential benefit was in violation of ethical principles [39]. Others felt an obligation to disseminate results to study participants because they recognized that participants often have limited access to scientific events and journals [92].
Recognizing participant contributions. Recognizing participants’ contributions to research was identified as an important rationale for results sharing [85,92,102]. Acknowledging participants’ contributions to scientific evidence was important even when interventional studies ultimately did not report benefits [44]. For example, living older participants were informed of the non-benefit of a dietary supplement on cataract prevention after a trial that lasted 13 years [76]. In this study investigators recognized that giving back results acknowledged the important role of participants’ contribution to research and although disappointed, participants felt that their contribution mattered enough for investigators to return results to them [76].
Fostering transparency and trust. In a mixed-methods study among US researchers, returning research results was found to build relationships and trust between researchers and participants [92]. Returning aggregate results was a way of reciprocating participants’ engagement with research [92] and accounting for public funds used for research [32,92,94]. The dialogue and exchange of information created a sense of shared ownership and value among participants which encouraged research participation and new ideas for research [32,44,92].
Improving health and research literacy. In a survey of genetic researchers, 87% (298/343) of respondents felt it their duty to ensure participants were aware of the latest developments [68], while in HIV and malaria research in low- and middle-income countries (LMICs), returning results helped researchers to correct errors, misinformation, and myths about infectious diseases of public health importance [14,94]. Furthermore, returning results was thought not only to satisfy scientific curiosity but also to improve health and research knowledge of individuals and communities [14].
Improvement of individual and community health. In a community engagement study in Brazil, returning results to participants and their communities appeared to strengthen HIV-related care processes, thereby overcoming some challenges participants experienced in a fragile healthcare system [36].
Reasons for not sharing results. Some researchers argued that aggregate study results should not be shared with participants [14,32,47,92]. For example, 15.7% (65/414) of health researchers in the United States surveyed disagreed with dissemination and a further 19.8% (82/414) were unsure [92]. Principal reasons given were that the health literacy of participants could limit their understanding of research findings; participants did not explicitly ask for results; there were challenges with explaining inconclusive/incomplete results; and concerns about potential harms to participants may be triggered by sharing results [32,92]. The reason that participants did not always ask for results appears to underscore the power inequality between researcher and participant as it assumes that participants may not be interested [14]. Other reasons to not disseminate aggregate results included concerns that this could cause harm to research; foster misconceptions about clinical trials which may ultimately not always report benefits for participants; and violation of privacy in small communities where participants may be easily identifiable [32,47,92]. Some researchers thought publication in peer-reviewed journals was sufficient and where participant involvement was minimal, there was no need to disseminate results [92].
To what extent are results disseminated to study participants?
A total of 47 articles focused on extent of results dissemination to participants. There were slightly more mixed-methods (n = 20, 43%) studies than quantitative (n = 14, 31%) and qualitative (n = 13, 29%) studies. Of these studies, 32 (68%) disseminated results directly to participants—26 (55%) from a parent trial [17,20,22,23,33,35,38,40,46,54,57–59,62,66,67,69,76,84,86,89,90,94,98,102,104] and 6 (13%) from general surveys of researchers and participants [27,64,65,83,85,92]. Fifteen (32%) studies were not related to direct dissemination of study results to participants but included results relevant to the theme [5,14,29,32,34,56,60,70,85,87,93,97,103,105,108].
Many health researchers considered but did not widely practise disseminating results to participants after study completion [34,60,93], the process itself being described as suboptimal by one author [87]. In a survey of 414 researchers in the United States, two-thirds thought research results should always be shared; however, only 8.1% (12/148) had specific plans for sharing [92]. Among malaria researchers, 83% (35/42) thought results sharing was extremely or mostly important, but only 24% (10/42) conducted such activities after trial conclusion [14]. In another survey of 79 trial participants, the majority (86%; 68/79) had not been asked if they wanted to receive research results [56]. Further evidence of the inertia to share results with participants was seen in a large UK audit of phase 3 registered clinical trials in which 12% (173/1,404) of registered trials did not have explicit plans to share results with participants. While 88% (1,231/1,404) did intend to disseminate results to participants, only 19% (231/1,231) actively planned sharing results, and 81% (991/1,231) depended on passive means requiring participants to seek aggregate study results on their own initiative [105]. These and other examples show a clear gap between intention and behavior regarding result sharing [29,32,34].
A systematic review investigating CBPR in the United States in 2010 found that contrary to poor dissemination to participants in clinical trials [105], dissemination to participants and the general public in CBPR was largely occurring, with 98% (63/65) of authors reporting dissemination to community participants and 84% (55/65) to the general public [11]. However, among National Health Institute (NHI)–funded studies in the United States, only about one-fifth (26/122; 21%) of researchers shared results with community representatives [27].
In a review of patient information leaflets (PILs) in Europe [103], 73% (174/238) described plans to share results with participants; however, the majority (123/176, 70%) relied on participants’ own initiative to find results. In addition, 90% (157/174) of the planned dissemination exercises were largely suitable for health professionals rather than participants [103]. Another European study of plain language summaries (PLSs) found that only 14 of 99 (14%) trials had PLSs available in the public domain and that these were not easy to find on internet search engines [70]. In a survey of PubMed authors, 27% (498/1818) shared results with participants, with half using lay summaries sent to patient groups/communities, patient-friendly conferences, mainstream media or online [5]. Furthermore, an assessment of trial protocols in LMICs identified that 44% (21/48) contained communication language but none included communication plans [97].
What are the methods used for disseminating results?
Fifty-five studies described methods used to disseminate research results to participants. Most (n = 20, 36%) were qualitative studies, followed by 33% (n = 18) quantitative and 31% (n = 17) mixed-methods studies.
The most common format reported was the posting of lay summaries or result letters to participants [54,57,58,67,69,71,76,81,84,89,90,98,105,108]. To illustrate, in a British randomized controlled trial among survivors of acute myocardial infarction, 80% (115/143) of those who requested results received lay summaries via post [57] and in a breast cancer trial in the United States, 304 Spanish-speaking Latino participants received summary results via standard mail [54]. Other studies that utilized mail to send lay summaries, leaflets, or result letters were to parents of children with advanced cancer [40,84], women in a prenatal antibiotic trial [17,46,89], and older participants in a cataract prevention trial [90]. Some of the posted summaries included a telephone number for questions [58,90] and a website link [90].
Another common mode of dissemination was group presentations. This was done in a number of ways, including slide presentations [49,62,102], roundtable meetings with community members in an Ugandan village [32] and among Hmong participants [26], dissemination workshops in Malawi, Brazil, and Kenya [3,36,40,70], using pictorial aids in local languages for Ethiopian malaria trial participants [23] and pediatric participants and their parents [75], and classroom discussions among year 11 students in South Africa [94]. A photo essay workshop for Huntington disease participants and their families was organized to engage with them on sensitive issues [18].
Other modes utilized were email notifications [22,63,65,83,85], websites [43,53,66,86], telephone calls [59], and individual face-to-face meetings [20,33,35,78,83,87]. Several studies reported multiple strategies to address various needs of community members [5,14,34,38,44,60,101,103]. Other creative methods employed were a comic [63], a short film [45], or visual storytelling [52].
What are the preferences for how dissemination of results is conducted?
Participants’ perspectives.
Thirty-nine articles evaluated participants’ preferences for dissemination. The majority were quantitative (n = 17, 44%) followed by qualitative (n = 14, 36%) and mixed-methods studies (n = 8, 21%). A third of these studies (n = 11, 28%) focused on dissemination preferences among cancer patients.
The preferred format in many reports was text media including, but not limited to, lay summaries, leaflets, results letters, brochures, and posters [16,21,32,41,48,54,57,58,60,61,67,71,73,74,78,79,81,83,84,90,100,101,106]. For example, in a cardiac rehabilitation study, 80% (115/143) of participants wished to receive results by letter [57] and among adolescent participants with idiopathic scoliosis, 98% (84/86) wished to receive results in the written form [58]. Many participants preferred to receive these text media via standard mail. Among French participants in breast cancer genetic studies [67] and older participants in a qualitative preferences survey [41], postal delivery allowed participants to have a “hard copy” on hand to refer to or share [83,100].
Other studies reported preference for electronic versions of lay summaries. For example, receiving online summaries via email was preferred by 47% (52/111) of integrative medicine participants in a US survey [83] and 65% (17/26) of French patients with a rare disease [16]. However, participants in some studies did not favor websites to access online material [33,43,78].
Fewer publications indicated group meetings, workshops, or other interactive methods as preferences for receiving study results [29,34,40,43,56,62,80,100].
Less commonly reported formats were dissemination of study results through mainstream media [32,58,78] or social media [50] and pictorial representation in the written or electronic form [26,54]. Preference for a comic over lay summaries and scientific abstracts was described in a randomized controlled trial [63], a film was preferred for communicating HIV research to young people [45], visual story telling in genetics research [52], and results in the form of poetry in a study among cancer patients and their partners [107].
Other formats reported were via telephone calls [16,65], meeting with other parents [16], digital video disk (DVD) [100], social media and text messages [65], and scientific publications [41,63].
Many participants preferred a combination of formats and modes to receive results, for example, a telephone number in their results letter [58,101], a link to an online webpage in their letters or emails [58], a meeting after receipt of results [21], or dissemination tailored to the needs of the study population [87].
Researchers’ perspectives.
Nine articles described researcher preferences for results dissemination to participants. Of these, 11% (n = 1) were quantitative studies, 33% (n = 3) were qualitative, and 55% (n = 5) were mixed-methods studies.
A survey among research investigators indicated that 44% (10/23) preferred lay summaries followed by info-graphs (39%; 9/23) and newsletters (39%; 9/23) to share results of their studies [44]. Other preferred methods were via online platforms [44,105] and group presentations [102]. While the use of social media was a potential avenue for malaria researchers [14], others preferred to use multiple strategies including social media, lay summaries, a letter with a number to call, and online platforms depending on context [14,34,44,56].
Tailoring communication plans to participant preferences and population characteristics, for example, employing print material and standard mail for older participants and online and social media for younger participants, were reported [44]. Five studies reported that researchers considered community and participant engagement important in planning for dissemination [34,39,44,94,101].
What are the barriers and enablers to dissemination?
Participants’ perspectives.
Nineteen articles described participant barriers and enablers to dissemination of study results. Fourteen (40%) were qualitative studies, 3 (15%) were quantitative studies, and 2 (10%) were mixed-methods studies.
Barriers and enablers suggested by participants were grouped as follows: i) researcher attitudes and communication skills [19,21,24,28,34,37,56,61], ii) logistics and resources [21,33,34,37,41,42,55,56,61], iii) personal circumstances [61,102], and iv) participant engagement [3,24,29,34,40,41,44,45,48,55,101].
Researcher attitudes and communication skills. A condescending attitude was perceived as a significant barrier by participants in patient-centered outcomes research [21], often leading to ineffective communication [19,28,37] and poor understanding of information by participants [61]. This included the non-prioritization of communication with participants by researchers and a lack of awareness and insensitivity to participants’ needs [21,37]. At the same time, staff being able to understand context was considered enabling, for example, understanding why participants in cancer research want feedback [56] or understanding cultural contexts and being culturally appropriate in studies with Indigenous Alaskans [24] and Afro-American and Latina participants [34].
Logistics and resources. Researchers’ time constraints [21], participants’ lack of time [61], and the burden of committing to a trial [37] were noted as barriers to dissemination. Cost was of less concern to Canadian parents of pediatric cancer patients [61]. Providing extra funding for research and staff [42] to cope with the workload, and appropriate training for research staff, were identified as enabling factors among African American and cancer participants [34,53].
Personal circumstances. Emotional challenges grounded in personal circumstances were identified as barriers to dissemination in pediatric cancer research. The death of a child would make it more difficult to desire results, as it evoked memories of the illness [61].
Participant engagement. Participants criticized a lack of community engagement by researchers and suggested involving participants in the dissemination process [29,44,48,55,101]. In Malawi, study participants complained that only village chiefs were consulted before study commencement [3]. Participants in a Kenyan HIV study dissemination workshop desired consideration as active partners. This was reflected by suggestions to train community members in relaying research findings to the wider community, thus helping to change behaviors and reduce spread of the infection [40]. Similarly, collaborating with trusted community leaders would enable researchers to disseminate study findings in appropriate ways [41]. Co-development of a film and leaflet by teenage participants with perinatal HIV for other affected young people [45] and collaborative efforts with indigenous and ethnic minorities enabled more effective dissemination of results [24,34].
Researchers’ perspectives.
Thirty-one studies described researcher barriers and enablers to research dissemination. Half the studies were qualitative (n = 15; 48%), one-third were mixed-methods studies (n = 12; 39%), and the rest were quantitative studies (n = 4; 13%). Barriers and enablers for researchers included i) reaching/contacting participants [3,14,18,32,34,39,76,85], ii) limited preparedness [14,34,44,92,93], iii) logistics and finances [23,32,34,38,42,48,56,62,71,85,90,92–94,97,99,102], iv) continuous communication [5,29,32,34,39,40,43,44,56,85,87,93], v) institutional guidance [5,14,32,34,39,40,85,92,93,97], and vi) ethical and cultural considerations [5,36,38,44,47,92,93,96].
Difficulty reaching participants. In a survey among genetic cousellors in the United states and Canada, 31% (33/105) of respondents reported that after trial involvement was complete, it was difficult contacting participants [85]. Similarly, research staff involved in bioethics research in Malawi noted that many participants were not contactable and may have relocated during the long interval between end of study and availability of results [3]. In Italy, older participants often appeared to change addresses and phone numbers [76]. Many researchers reported low literacy levels among participants in LMICs as being a barrier to reach participants. This was perceived as contributing to inabilities to comprehend research results [14,39] even if translated to local languages [39]. Time constraints, lack of interest, mistrust, and being too academic also made dissemination more difficult [14,18,32,34].
Limited preparedness. Lack of early planning at study inception, together with long intervals between trial completion and completion of the final report, was reported as the main barriers among malaria researchers [14]. As a result, not planning ahead could lead to poor or no dissemination or an expensive exercise [44]. In addition, lack of awareness about returning results was reported as the main barrier among US health researchers [92,93]. Additionally, researchers often felt they lacked time or communication skills [34,93] to effectively impart results to a lay audience.
Logistics and finances. Logistic barriers were reported by a majority (68.9%; 246/357) of health researchers in one study [92]. These included inability to contact participants as contact details were either not collected, or rural/remote location precluded internet or phone contact [38,92,93]. Lack of electricity and poor road conditions were additional challenges in Uganda [32]. Furthermore, the lack of communication methods that are cost-effective and time-efficient [90] such as challenges with organizing group events [23] or time spent disseminating printed materials were identified as barriers [42,71,99]. The lack of specific funding for dissemination activities was identified as a major obstacle [34,48,92,94]. Among malaria researchers in LMICs, 52% (13/25) identified inadequate funding as a barrier to dissemination [14] and among researchers in the United States, 54% (204/378) reported financial constraints that had impacted on their ability to disseminate findings to participants in previous studies [93]. Allocating extra resources, such as data-tracking systems to allow long-term follow-up, were reported as facilitators by 12.8% (16/125) of cancer researchers [56]. Similarly, finding an inexpensive but appropriate venue and keeping group presentations simple, worked for a Canadian dissemination exercise [62].
Continuous communication. The initial consent process was thought crucial by researchers to discuss the concept of dissemination to participants. For example, in a survey of UK cancer researchers, 32% (41/125) of respondents indicated the importance of early communication about end of trial result dissemination to better understand participants’ preferences [56]. Furthermore, 18% (23/125) of participants in this same study suggested that transforming dissemination activities into a routine task would improve dissemination [56]. Researchers thought community members play an important role in dissemination and should be engaged effectively as partners in developing and implementing dissemination plans [32,34,39,40,87]. Understanding terminology surrounding return of results has also been identified as important. For example, Kisiangani suggested using terminology like “sharing knowledge” rather than “returning results” when referring to the return of aggregate results [29]. In a French qualitative study of breast cancer patients, the term “results” was generally misunderstood with difficulties distinguishing between results related to medical research and those of usual clinical care [43]. Differentiating between “aggregate results return” and “dissemination of findings” was suggested [44]. Overall, agreement on definition of terms would enhance participant and researcher understanding.
Institutional guidance. Some researchers reported a lack of guidance at national and institutional level as an additional barrier [5,14,34,39,40,85,93,97]. Only 22.5% (9/40) of malaria researchers received institutional support, and 8% (2/25) thought institutions lacked interest in disseminating to participants [14]. Moreover, there was a lack of dissemination requirement from funding bodies to the extent that sharing results with participants was perhaps not seen as an essential component of the research process and funding [93]. Other institutional barriers included lack of communication and training [34,39] and lack of incentives [5,32,34,92].
Ethical and cultural considerations. Among 355 health researchers from the United States, ethical concerns were reported as barriers for 38.5% of their studies [96]. Three main concerns were that of harm caused by either emotional distress or stigma arising from learning about research results [96], misunderstanding or misinterpretation of results [5,92,96], and concerns about maintaining privacy and confidentiality of participants [47,96]. Concerns about patient confidentiality were highlighted in Burkina Faso where hierarchical structures and power differences existed within small research communities [47]. However, understanding cultural context, using vernacular knowledge and critical pedagogy were strong enablers for dissemination of HIV-related activities in a poor Brazilian community [36]. Regulatory barriers included the perception that sharing results required approval by institutional review boards [5,44,92,93].
What is the best timing of dissemination to participants?
Participants’ preferences for timing of dissemination.
Nineteen articles described participant preferences for timing of dissemination of research findings. Eight (42%) of these studies were quantitative, 7 (37%) were qualitative, and 4 (21%) were mixed-methods studies. Participant preferences for timing of results dissemination commonly described the following time periods: i) during the course of the study [3,21,29,40,41,43,53,56,66,74,90], ii) at the end of study before publication of results, with or without peer review [3,21,34,40,41,53,56,59–61,65,74,87], iii) upon publication [53,61,74], and iv) after publication [61,65].
Timing played a key role in understanding participant’s experiences of results dissemination [107,109]. Studies that described participant preferences for receiving results during the course of the study placed emphasis on long-term studies [3,21]. The disclosure of results many years after the end of an obstetric study (UK) brought unpleasant feelings of guilt and uncertainty to those who perceived results as being ‘bad’ [89]. In other studies, participants involved in cancer and genetics research felt that the time interval to learning results was too long [29,66] and others participating in diabetes and urology studies felt that regular updates helped them overcome feelings of disappointment at receiving results later than expected [90].
Almost three-quarters of studies (n = 13, 68%) described participants preferred timing for receiving results to be at the end of the study and before publication, either before or after peer review. Preferences for end of study results ranged from 24% of parents (98/409) and 33% (28/86) of adolescents with cancer [61] to 78% (124/158) of genetics research participants [53]. While 64% (121/189) of adult oncology patients preferred results disclosure prior to peer review, 27% (110/409) of parents and 15% (13/86) of adolescents with cancer preferred receiving results after peer review [60,61]. In general, participants preferred to be the first, and not the last, to know of study results [53,61].
Preference for receiving results as soon as the study was accepted for publication ranged from 26% (22/86) of adolescents and 33% (136/409) of parents of children with cancer [61] to 44% (70/158) of genetics research participants [53]. Post-publication dissemination of results to participants was preferred by 12.8% (11/86) of adolescents with cancer and 45.6% (1,543/3,381) of past research participants [61,65]. Other timing preferences described were receiving results soon after preventive measures were available, upon contacting the research team, or within a year of study completion [29,53].
Overall, participants expectations on when to receive results are not well documented. Representing 178 UK trials in Ireland and the United Kingdom, only 8% (14/173) of PILs included a time period for when to expect results while the majority of PILs did not specify a time period after end of study (47%; 82/173) or did not include any information (45%; 77/173) on when to expect results [103].
Researchers’ preferences for timing of dissemination.
Studies describing researcher preferences for timing of disseminating study findings to participants were limited. Three studies described preferred timing by researchers for sharing results with participants [3,5,56]. In a Malawian dissemination workshop, research staff felt participants should receive results after study completion [3]. Meanwhile, in a survey of UK cancer researchers, 89.4% (127/142) endorsed sharing results after a trial had ended and at the time of publication [56]. In comparison, among clinical trial researchers across 71 countries, two-fifths had either disseminated or planned to disseminate study findings within 2 years after publication [5].
What are the impacts of dissemination?
Fifty-nine studies described impacts of dissemination on study participants. Almost half the studies were qualitative (n = 26, 44%), and a quarter each were quantitative (n = 15, 25%) and mixed-methods (n = 18, 31%) studies. The impacts of dissemination described included the following: i) evoking emotional responses [17,23,26,29,32,34,36,37,40–42,44,46,52,54,58,61,62,69,71,76,81,84,86,89,91,98,99,102,107], ii) improving health literacy and decision-making [5,22,29,33–36,45,75,78,82,90,94], iii) understanding research in which they participated [14,58,60,62,76,83,88–90,102], iv) likely participation in future studies [5,16,34,35,46,58,88,95,102], v) trust in medical research [5,40,46,47,66,67,88,93], and vi) impact on the broader community [5,38–40,62,97,101]. A lack of post-study dissemination also impacts participants [3,19,20,28,34,44,47,54,72,88,106].
Evoking emotional responses. Receiving results evoked mostly positive but also negative emotions. Most common feelings among participants who received aggregated study results were those of satisfaction [41,58,62,69,71,76,84,107], gratefulness [84,102], and appreciation [23,40,52]. Other positive emotions included being relieved [58], pleased [32,69,98], feeling valued [40,44], respected [34,40] recognized [84], and accomplished [42,44] as well as knowing their contribution was important and valuable [36,42,44,54]. As an example, 71% (10/14) of parents of children with advanced cancer felt ‘a lot or extremely satisfied’ about receiving results [84]. In a Canadian study of men with prostate cancer, all respondents (n = 39) were satisfied with the manner in which they received results [62], and 60% (368/610) of older participants in a cataract trial were satisfied receiving results [76].
While most participants responded favorably, a smaller proportion of participants experienced negative emotions. These included feelings of regret [46,98] and guilt [58,71,89], anxiety [26,58,69,71,84,89], confusion [37,84,91], sadness [58,71,84], and anger [58]. For some women involved in a prenatal antibiotic trial, regret and guilt were strongly felt after participating in a trial that resulted in poorer outcomes for their babies [46]. In an ovarian cancer trial, 16% (23/140) of participants found the results upsetting, and 3% (4/138) regretted learning about the results [98]. These findings indicate that while most participants were satisfied receiving results, some experienced negative emotions, especially those receiving unexpected or unwelcome findings, mostly in cancer research. Help and support for participants may be required in these instances [17,29,36,99].
Improving health literacy and decision-making. Participants in a diabetes trial indicated that their general knowledge about diabetes improved [22]. Similarly, patients in an HIV study also saw an improvement in their knowledge about the infection [36]. Others felt that receiving results improved their understanding of their specific medical condition and motivated them to make better health decisions for themselves [29,34,35,75], or for their children [75].
Understanding research better. In a range of studies respondents indicated that results dissemination improved their understanding of research when results received were clear, concise, and easily understood [58,82,83,89] and dissemination was described as being informative [14,58,62,83]. In a qualitative study, comprehension of research results was better after a presentation compared to reading the scientific publication of a urology trial [102]. Among African-American participants, receiving results increased overall understanding of the research process [88].
Participation in future research. Result dissemination can impact on willingness to participate in future research. For example, 41% (11/27) of participants with a rare childhood disease were willing to participate in future trials [16]. Similarly, participants in adult medicine [35,102], minority ethnic groups [34,88], and adolescent health [58] expressed higher willingness to participate after receiving research results. However, some participants expressed that they would never participate in a trial again, and this was mainly attributed to what they perceived as a negative experience [46].
Increase trust in medical research. Among African-American participants, trust in researchers significantly improved [88], and 28% (66/235) of participants involved in breast cancer genetic studies reported increased trust in medical research after dissemination of results [67]. Similarly, a lack of confidentiality and poor consent processes undermined trust in medical research in an obstetric trial [46,47]. In a breast cancer trial, less than half (47%; 24/51) of participants were able to access research summaries via a website link and while this was intended to increase trust in research, the opposite was achieved [66].
Impact on the broader community. Finally, disseminating results to study participants can impact the wider non-academic community. For example, key findings from the dissemination process in an HIV study were adopted to other health research in Kenya [40]. In addition, 91% (54/59) of Canadian prostate cancer participants, spouses and guests [62] and those in an Irish hypothyroidism trial suggested that the results would be of benefit to the broader community [101].
Discussion
Despite increasing awareness of the need and potential benefits of returning research results to participants, further progress with embedding result dissemination into clinical research is needed. While many researchers intended to share results and most participants desired learning about research results, multiple barriers to dissemination persist. Poor planning, funding constraints, lack of institutional support, and lack of guidance on best practice were found to be key challenges. Unless these barriers are addressed, efforts to close the dissemination gap will remain challenging. There is a need for researchers to better engage with the communities they work in and tailor communication strategies to participant preferences through co-design. While processes to avoid unethical research practices are well established in relation to consenting and study conduct, there is less guidance or monitoring of post-trial processes including result dissemination. Frameworks to guide results dissemination are limited and focus predominantly on planning [110]. Shifting from perceiving dissemination as an optional add-on to an expected component of ethical research likely requires stronger accountability mechanisms. Ethics committees and institutional review boards could play a more proactive role by routinely requesting detailed dissemination plans at the protocol review stage, thereby reinforcing the expectation that communication of results is a core responsibility [111]. Similarly, funders could create enabling environments by making dissemination activities a required component in the final reporting [112]. Beyond these structural “push” mechanisms, positive incentives such as recognition in academic promotion criteria and authorship opportunities for community-engaged dissemination activities could support dissemination not only being an ethical imperative but also a valued academic output.
Dissemination practices are reported mostly from middle-to-high-income countries in the Americas and Europe. This reflects findings from previous reviews [10–13] suggesting limited progress in relation to the dissemination of aggregate research results in lower-resource settings, where a significant amount of clinical research is now being conducted [113]. While there has been an increase in dissemination studies from LMICs, these have mainly come from the African continent. This missed opportunity of engaging with communities to enable high-quality research centered on community needs must be mitigated through the development of guidelines, funding support, and training.
Furthermore, dissemination is currently mostly performed in cancer and genetics research but seems to translate into positive benefits for both participants and researchers across other medical domains. Co-design of clinical research that integrates dissemination of results also appears to substantially improve community acceptance in underserviced patient populations, for whom access to research is limited because of language, systemic racism, gender, and poverty [114]. Dissemination may be a key element to restore trust in medical research and is critical to overcome imbalances in health outcomes.
Participant and researcher preferences for methods of dissemination may not always align, and multiple modalities of dissemination may be required [80]. Dissonance largely appears to arise from financial and logistical constraints to enable researchers to match participant expectations. Furthermore, preferences for how participants wish to learn about study results are invariably diverse as they depend on socio-cultural, economic and disease context. Failure to determine these context-specific requirements at the outset may, therefore, undermine the impact of any subsequent dissemination efforts. Furthermore, enabling better tracking of participants to permit researchers to reach former study participants in a safe and appropriate manner is essential. This may be facilitated by early planning and funding dissemination of interim results or study progress that keeps participants engaged, including canvassing feedback from participants on their study experience to date.
The present review focused on summarizing the current state of activities relating to the dissemination of aggregate study results. However, our review indicates that study participants may also be interested in receiving individual test results arising from their participation in, for example, a clinical trial. While at least some individual results generated during trials might be shared with patients in the context of their clinical care, findings from downstream sample analyses are often not shared. It remains to be explored how much individual result sharing is feasible within the context of trials and how much it can potentially foster future engagement in research. Most of the literature on individual result sharing derives from genomic research where interpretation of clinical significance of results remains challenging and complicates the process compared to standard clinical data [115].
Our literature review has several limitations. Firstly, while there is an increase in literature on result sharing, its synthesis is challenging given the substantial heterogeneity in study types, methodology, and outcomes that were assessed in relation to results dissemination. This makes conclusion across different populations and disciplines challenging. Secondly, reporting bias is likely to influence this review towards more reports of successful or generally positive experiences with result sharing. Lastly, our review was limited to English language publications and did not consider grey literature, thereby potentially missing relevant reports and was not registered in any databases prior to study selection, data extraction or analysis.
Result dissemination is an integral component of modern clinical research practice and appears to translate into a broad range of benefits in most circumstances. The current lack of agreement on what constitutes best practice will need to be overcome through the design of frameworks to guide the conduct of dissemination, which are now in early development and require validation in a range of settings, populations and clinical domains. Early planning and co-design appear to lead to more effective dissemination and positive returns as they are more likely to meet community preferences but require adequate funding support. Further work on approaches to dissemination of research findings in LMICs is required. Lastly, defining outcomes, such as measures of participant satisfaction, engagement in clinical research, and translation of research findings into personal health practices will enhance assessment of the overall impact of dissemination itself, and clinical research overall.
Supporting information
S3 Table. Characteristics of included studies.
https://doi.org/10.1371/journal.pmed.1004569.s003
(XLSX)
S1 Checklist. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist.
https://doi.org/10.1371/journal.pmed.1004569.s004
(DOCX)
S2 Checklist. Enhancing Transparency in Reporting the Synthesis of Qualitative Research (ENTREQ) checklist.
https://doi.org/10.1371/journal.pmed.1004569.s005
(DOCX)
References
- 1. Ahmed SM, Palermo A-GS. Community engagement in research: frameworks for education and peer review. Am J Public Health. 2010;100(8):1380–7. pmid:20558798
- 2. Klingberg S, Adhikari B, Draper CE, Bosire E, Nyirenda D, Tiigah P, et al. Enhanced or hindered research benefits? A realist review of community engagement and participatory research practices for non-communicable disease prevention in low- and middle-income countries. BMJ Glob Health. 2024;9(2):e013712. pmid:38341191
- 3. Mfutso-Bengo J, Ndebele P, Masiye F. Disseminating research results to research participants and their communities. Malawi Med J. 2008;20(2):64–6. pmid:19537435
- 4. Adhikari B, Pell C, Cheah PY. Community engagement and ethical global health research. Glob Bioeth. 2019;31(1):1–12. pmid:32002019
- 5. Schroter S, Price A, Malički M, Richards T, Clarke M. Frequency and format of clinical trial results dissemination to patients: a survey of authors of trials indexed in PubMed. BMJ Open. 2019;9(10):e032701. pmid:31636111
- 6.
WMA - The World Medical Association-WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects [Internet]. [cited 2023 Nov 29]. Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
- 7.
National Statement on Ethical Conduct in Human Research (2007) - Updated 2018 | NHMRC [Internet]. [cited 2023 Jul 30]. Available from: https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018
- 8.
Canada H. Public release of clinical information: guidance document. 2021. [cited 2024 April 24. Available from: https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/profile-public-release-clinical-information-guidance/document.html
- 9.
Health Research Authority [Internet]. [cited 2024 Apr 24]. Planning and improving research. Available from: https://www.hra.nhs.uk/planning-and-improving-research/.
- 10. Shalowitz DI, Miller FG. Communicating the results of clinical research to participants: attitudes, practices, and future directions. PLoS Med. 2008;5(5):e91. pmid:18479180
- 11. Chen PG, Diaz N, Lucas G, Rosenthal MS. Dissemination of results in community-based participatory research. Am J Prev Med. 2010;39(4):372–8.
- 12. McDonald ME, Papadopoulos A, Edge VL, Ford J, IHACC Research Team, Sumner A, et al. What do we know about health-related knowledge translation in the Circumpolar North? Results from a scoping review. Int J Circumpolar Health. 2016;75:31223. pmid:27105134
- 13. Bruhn H, Cowan E-J, Campbell MK, Constable L, Cotton S, Entwistle V, et al. Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review. Trials. 2021;22(1):361. pmid:34030707
- 14. Weston S, Adhkari B, Thriemer K. Sharing results with participants (and community) in malaria related research: perspectives and experience from researchers. PLOS Glob Public Health. 2023;3(9):e0002062. pmid:37669255
- 15. Hong QN, Pluye P. A conceptual framework for critical appraisal in systematic mixed studies reviews. J Mixed Method Res. 2019;13(4):446–60.
- 16. Amelot V, Bungener C, Guilmin-Crepon S, Schroedt J, Alberti C, Husson I. Preferences for receiving results from a rare disease clinical trial: a survey of subjects with Friedreich’s ataxia and their parents. Pharm Med. 2017;31(5):329–37.
- 17. Armstrong N, Jackson CJ, McNicol S, Dixon-Woods M, Kenyon S, Tarrant C. Unblinding following trial participation: qualitative study of participants’ perspectives. Clin Trials. 2013;10(1):97–103. pmid:23231970
- 18. Bombard Y, Cox SM, Semaka A. When they hear what we say: ethical challenges in presenting research findings to the Huntington disease community. J Empir Res Hum Res Ethics. 2011;6(3):47–54. pmid:21931237
- 19. Boyd P, Sternke EA, Tite DJ, Morgan K. “There was no opportunity to express good or bad”: perspectives from patient focus groups on patient experience in clinical trials. J Pat Exp. 2024;1–6.
- 20. Bureau E, Pellegrini I, Noguès C, Lasset C, Julian-Reynier C. “Maybe they have found something new” participants’ views on returning cohort psychosocial survey results. Health Expect. 2015;18(6):2425–36. pmid:24889689
- 21. Cook S, Mayers S, Goggins K, Schlundt D, Bonnet K, Williams N, et al. Assessing research participant preferences for receiving study results. J Clin Transl Sci. 2019;4(3):243–9. pmid:32695496
- 22. Darbyshire JL, Price HC. Disseminating results to clinical trial participants: a qualitative review of patient understanding in a post-trial population. BMJ Open. 2012;2(5):e001252. pmid:23012330
- 23. Degaga TS, Weston S, Tego TT, Abate DT, Aseffa A, Wayessa A, et al. Disseminating clinical study results to trial participants in Ethiopia: insights and lessons learned. Malar J. 2020;19(1):205. pmid:32513176
- 24. Dirks LG, Wanda P. Technology to support collaborative dissemination of research with Alaska Native communities. AMIA Annu Symp Proc. 2021;2021(101209213):398–407.
- 25. Halverson CME, Ross LF. Incidental findings of therapeutic misconception in biobank-based research. Genet Med. 2012;14(6):611–5. pmid:22261760
- 26. Holzer K, Culhane-Pera KA, Straka RJ, Wen YF, Lo M, Lee K, et al. Hmong participants’ reactions to return of individual and community pharmacogenetic research results: “A positive light for our community”. J Community Genet. 2021;12(1):53–65. pmid:32761465
- 27. Hood NE, Brewer T, Jackson R, Wewers ME. Survey of community engagement in NIH-funded research. Clin Transl Sci. 2010;3(1):19–22. pmid:20443949
- 28. Keusch F, Rao R, Chang L, Lepkowski J, Reddy P, Choi SW. Participation in clinical research: perspectives of adult patients and parents of pediatric patients undergoing hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2014;20(10):1604–11. pmid:24972252
- 29. Kisiangani I, Mohamed SF, Kyobutungi C, Tindana P, Ghansah A, Ramsay M, et al. Perspectives on returning individual and aggregate genomic research results to study participants and communities in Kenya: a qualitative study. BMC Med Ethics. 2022;23(1):27. pmid:35300680
- 30. Kraft SA, Rothwell E, Shah SK, Duenas DM, Lewis H, Muessig K. Demonstrating “respect for persons” in clinical research: findings from qualitative interviews with diverse genomics research participants. J Med Ethics. 2020;j1d:7513619.
- 31. Lindquist LA, Seltzer A, Forcucci C, Wong N, Ramirez-Zohfeld V. Leveraging patient/community partnerships to disseminate patient centered outcomes research in geriatrics. Geriatr. 2019;4(2).
- 32. MacKenzie CA, Christensen J, Turner S. Advocating beyond the academy: dilemmas of communicating relevant research results. Qualitat Res. 2013;15(1):105–21.
- 33. Madadi P, Joly Y, Avard D, Chitayat DC, Smith MA, Ross CJD. The communication of pharmacogenetic research results: participants weigh in on their informational needs in a pilot study. J Popul Ther Clin Pharmacol. 2011;18(101530023):e152–5.
- 34. Mayo-Gamble TL, Cunningham-Erves J, Kas-Osoka C, Johnson GW, Frazier N, Joosten Y. A multiperspective on the broad dissemination of research findings to past research participants and the community-at-large. Transl Behav Med. 2022;12(1):ibab095. pmid:34244808
- 35. McElfish PA, Purvis RS, Scott AJ, Haggard-Duff LK, Riklon S, Long CR. “The results are encouragements to make positive changes to be healthier:” qualitative evaluation of Marshallese participants’ perceptions when receiving study results in a randomized control trial. Contemp Clin Trials Commun. 2020;17:100543. pmid:32140610
- 36. Milnor JR, Santana CS, Martos AJ, Pilotto JH, Souza CTV de. Utilizing an HIV community advisory board as an agent of community action and health promotion in a low-resource setting: a case-study from Nova Iguaçu, Rio de Janeiro, Brazil. Glob Health Promot. 2020;27(3):56–64. pmid:31347439
- 37. Natale P, Gutman T, Howell M, Dansie K, Hawley CM, Cho Y, et al. Recruitment and retention in clinical trials in chronic kidney disease: report from national workshops with patients, caregivers and health professionals. Nephrol Dial Transplant. 2020;35(5):755–64. pmid:32240311
- 38. Ndase P, Celum C, Campbell J, Bukusi E, Kiarie J, Katabira E, et al. Successful discontinuation of the placebo arm and provision of an effective HIV prevention product after a positive interim efficacy result: the partners PrEP study experience. J Acquir Immune Defic Syndr. 2014;66(2):206–12. pmid:24828268
- 39. Ochieng J, Kwagala B, Barugahare J, Mwaka E, Ekusai-Sebatta D, Ali J, et al. Perspectives and ethical considerations for return of genetics and genomics research results: a qualitative study of genomics researchers in Uganda. BMC Med Ethics. 2021;22(1):154. pmid:34798900
- 40. Ondenge K, McLellan-Lemal E, Awuonda E, Angira F, Mills LA, Thomas T. Disseminating results: community response and input on Kisumu breastfeeding study. Transl Behav Med. 2015;5(2):207–15.
- 41. Purvis RS, Abraham TH, Long CR, Stewart MK, Warmack TS, McElfish PA. Qualitative study of participants’ perceptions and preferences regarding research dissemination. AJOB Empir Bioeth. 2017;8(2):69–74. pmid:28949841
- 42. Richards JE, Bane E, Fullerton SM, Ludman EJ, Jarvik G. Allocation of resources to communication of research result summaries. J Empir Res Hum Res Ethics. 2016;11(4):364–9. pmid:27613778
- 43. Sarradon-Eck A, Sakoyan J, Desclaux A, Mancini J, Genre D, Julian-Reynier C. They should take time: disclosure of clinical trial results as part of a social relationship. Soc Sci Med. 2012;75(5):873–82.
- 44. Sgro GM, Maurer M, Nguyen B, Siegel JE. Return of aggregate results to study participants: facilitators, barriers, and recommendations. Contemp Clin Trials Commun. 2023;33:101136. pmid:37180845
- 45. Sturgeon K, Judd A, Burke T, Foster C, Gibb DM, Le Prevost M, et al. Disseminating the research findings from the adolescents and adults living with perinatal HIV (AALPHI) study: an approach from young people living with HIV. Res Involv Engagem. 2024;10(1):9. pmid:38238837
- 46. Tarrant C, Jackson C, Dixon-Woods M, McNicol S, Kenyon S, Armstrong N. Consent revisited: the impact of return of results on participants’ views and expectations about trial participation. Health Expect. 2015;18(6):2042–53. pmid:25929296
- 47. Turcotte-Tremblay A-M, Mc Sween-Cadieux E. A reflection on the challenge of protecting confidentiality of participants while disseminating research results locally. BMC Med Ethics. 2018;19(Suppl 1):45. pmid:29945598
- 48. van Overbeeke E, Vanbinst I, Jimenez-Moreno AC, Huys I. Patient centricity in patient preference studies: the patient perspective. Front Med. 2020;7:93.
- 49. Jaarsma T, Strömberg A. Sharing research results with research participants: experiences from the TeleYoga study. Eur J Cardiovasc Nurs. 2025;24(1):176–7. pmid:39811945
- 50. Jackson JE, Moreton J, Barnett N, Hurst M. Understanding how nurses can effectively utilise social media for increasing public involvement, recruitment and impact dissemination of clinical research trials. J Res Nurs. 2024;29(4–5):321–31. pmid:39291220
- 51. Simpson PL, Guthrie J, Jones J, Haire B, Butler T. Ethical issues in conducting health research with people in prison: results of a deliberative research project conducted with people in Australian prisons. Soc Sci Med. 2025;367:117751. pmid:39874839
- 52. Zamora AN, Brown JEH, Outram S, Ackerman SL. Using visual storytelling to share aggregate findings with families participating in clinical genomics research. Genet Med Open. 2024;2:101844. pmid:39764519
- 53. Baret L, Godard B. Opinions and intentions of parents of an autistic child toward genetic research results: two typical profiles. Eur J Hum Genet. 2011;19(11):1127–32. pmid:21673746
- 54. Bonilla J, Alhomsi A, Santoyo-Olsson J, Stewart AL, Ortiz C, Samayoa C, et al. Sharing research results with Latina breast cancer survivors who participated in a community-engaged behavioral RCT study: a descriptive cross-sectional survey study. Trials. 2022;23(1):25. pmid:34998436
- 55. Canedo JR, Villalta-Gil V, Grijalva CG, Schlundt D, Jerome RN, Wilkins CH. How do Hispanics/Latinos perceive and value the return of research results? Hisp Health Care Int. 2022;20(4):238–47. pmid:35018873
- 56. Cox K, Moghaddam N, Bird L, Elkan R. Feedback of trial results to participants: a survey of clinicians’ and patients’ attitudes and experiences. Eur J Oncol Nurs. 2011;15(2):124–9.
- 57. Dalal H, Wingham J, Pritchard C, Northey S, Evans P, Taylor RS, et al. Communicating the results of research: how do participants of a cardiac rehabilitation RCT prefer to be informed?. Health Expect. 2010;13(3):323–30. pmid:19906214
- 58. Donaldson S, Khetani N, Maniatis G, Stephens D, Wright JG. Sharing clinical trial results with adolescent idiopathic scoliosis patients. J Pediatr Orthop. 2009;29(5):467–75. pmid:19568019
- 59. Dorsey ER, Adams M, Chadwick G, Briner L, Deuel L, Clarke A, et al. Communicating clinical trial results to research participants. Arch Neurol. 2008;65(12):1590–5.
- 60. Elzinga KE, Khan OF, Tang AR, Fernandez CV, Elzinga CL, Heng DY, et al. Adult patient perspectives on clinical trial result reporting: a survey of cancer patients. Clin Trials. 2016;13(6):574–81. pmid:27559022
- 61. Fernandez CV, Gao J, Strahlendorf C, Moghrabi A, Pentz RD, Barfield RC, et al. Providing research results to participants: attitudes and needs of adolescents and parents of children with cancer. J Clin Oncol. 2009;27(6):878–83. pmid:19164211
- 62. Hussain S, Breunis H, Timilshina N, Alibhai SMH. Effective communication of study results to older participants with prostate cancer: Results of a survey. J Geriatr Oncol. 2012;3(3):205–11.
- 63. Kearns C, Eathorne A, Kearns N, Anderson A, Hatter L, Semprini A, et al. How best to share research with study participants? A randomised crossover trial comparing a comic, lay summary, and scientific abstract. J Vis Commun Med. 2022;45(3):172–81. pmid:35382694
- 64. Kost RG, Lee LN, Yessis JL, Wesley R, Alfano S, Alexander SR, et al. Research participant-centered outcomes at NIH-supported clinical research centers. Clin Transl Sci. 2014;7(6):430–40. pmid:24842076
- 65. Long CR, Stewart MK, Cunningham TV, Warmack TS, McElfish PA. Health research participants’ preferences for receiving research results. Clin Trials. 2016;13(6):582–91. pmid:27562368
- 66. Mancini J, Genre D, Dalenc F, Maylevin F, Martin A-L, Viens P, et al. Transparency in the presentation of trial results may not increase patients’ trust in medical researchers. Clin Trials. 2012;9(1):90–3. pmid:22049088
- 67. Mancini J, Le Cozannet E, Bouhnik A-D, Resseguier N, Lasset C, Mouret-Fourme E, et al. Disclosure of research results: a randomized study on GENEPSO-PS cohort participants. Health Expect. 2016;19(5):1023–35. pmid:26205609
- 68. Miller FA, Hayeems RZ, Li L, Bytautas JP. What does “respect for persons” require? Attitudes and reported practices of genetics researchers in informing research participants about research. J Med Ethics. 2012;38(1):48–52. pmid:21685149
- 69. Partridge AH, Wolff AC, Marcom PK, Kaufman PA, Zhang L, Gelman R, et al. The impact of sharing results of a randomized breast cancer clinical trial with study participants. Breast Cancer Res Treat. 2009;115(1):123–9. pmid:18543100
- 70. Penlington M, Silverman H, Vasudevan A, Pavithran P. Plain language summaries of clinical trial results: a preliminary study to assess availability of easy-to-understand summaries and approaches to improving public engagement. Pharmaceut Med. 2020;34(6):401–6. pmid:33113147
- 71. Scott SM, Ashford JM, Clark KN, Martin-Elbahesh K, Conklin HM. Returning research results: caregivers’ reactions following computerized cognitive training among childhood cancer survivors. Neurooncol Pract. 2018;5(3):194–200.
- 72. Sood A, Prasad K, Chhatwani L, Shinozaki E, Cha SS, Loehrer LL, et al. Patients’ attitudes and preferences about participation and recruitment strategies in clinical trials. Mayo Clin Proc. 2009;84(3):243–7. pmid:19252111
- 73. Tajima S, Akaishi A, Miyamoto T, Katashima R, Nakai K, Mitsui T, et al. Participant preferences for the provision of registration trials results. J Clin Med Res. 2013;5(5):401–6. pmid:23976914
- 74. Taylor CO, Manov NF, Crew KD, Weng C, Connolly JJ, Chute CG. Preferences for updates on general research results: a survey of participants in genomic research from two institutions. J Pers Med. 2021;11(5):399.
- 75. Weitzman ER, Magane KM, Wisk LE. How Returning aggregate research results impacts interest in research engagement and planned actions relevant to health care decision making: cohort study. J Med Internet Res. 2018;20(12):e10647. pmid:30578228
- 76. Williams SL, Ferrigno L, Maraini G, Rosmini F, Sperduto RD. A post-trial survey to assess the impact of dissemination of results and unmasking on participants in a 13-year randomised controlled trial on age-related cataract. Trials. 2011;12:148. pmid:21672204
- 77. Ziegenfuss JY, Shah ND, Deming JR, Van Houten HK, Smith SA, Beebe TJ. Offering results to participants in a diabetes survey: effects on survey response rates. Patient. 2011;4(4):241–5. pmid:21995829
- 78. Meulenkamp TM, Gevers SK, Bovenberg JA, Koppelman GH, van Hylckama Vlieg A, Smets EMA. Communication of biobanks’ research results: what do (potential) participants want?. Am J Med Genet A. 2010;152A(10):2482–92.
- 79. Moorcraft SY, Marriott C, Peckitt C, Cunningham D, Chau I, Starling N, et al. Patients’ willingness to participate in clinical trials and their views on aspects of cancer research: results of a prospective patient survey. Trials. 2016;17:17. pmid:26745891
- 80. Bamboro SA, Jabbar FA, Bagita-Vangana M, Hasibuan N, Degaga TS, Ghanchi N. How do study participants want to be informed about study results: findings from a malaria trial in Cambodia, Ethiopia, Pakistan, and Indonesia. J Clin Transl Sci. 2023;9(1):e83.
- 81. Hoffman E, Gaglianone S, Ketema R, Tu W, Peay H, Clemens P, et al. Return of participant-level clinical trial results to participants: pilot of a simplified centralised approach. BMJ Open. 2024;14(3):e080097. pmid:38521535
- 82. Holst C, Woloshin S, Oxman AD, Rose C, Rosenbaum S, Munthe-Kaas HM. Alternative presentations of overall and statistical uncertainty for adults’ understanding of the results of a randomized trial of a public health intervention: parallel web-based randomized trials. JMIR Public Health Surveill. 2025;11((Holst, Oxman, Rose, Rosenbaum, Munthe-Kaas) Centre for Epidemic Interventions Research, Norwegian Institute of Public Health, Oslo, Norway):e62828.
- 83. Aldinger CE, Ligibel J, Shin IH, Denninger JW, Bierer BE. Returning aggregate results of clinical trials: Empirical data of patient preferences. J Clin Transl Sci. 2018;2(6):356–62. pmid:31404276
- 84. Bilodeau M, Dussel V, Wolfe J. Experience of parents receiving results from a quality-of-life study in pediatric advanced cancer: a report from the PediQUEST study. Pediatr Blood Cancer. 2019;66(9):e27880. pmid:31207083
- 85. Blanche E, Wainstein T, Dey A, Elliott AM. Genetic counselors’ research dissemination practices and attitudes. J Genet Couns. 2023;2023.
- 86. Brody JG, Cirillo PM, Boronow KE, Havas L, Plumb M, Susmann HP, et al. Outcomes from returning individual versus only study-wide biomonitoring results in an environmental exposure study using the digital exposure report-back interface (DERBI). Environ Health Perspect. 2021;129(11):117005. pmid:34766835
- 87. Bruhn H, Campbell M, Entwistle V, Humphreys R, Jayacodi S, Knapp P, et al. What, how, when and who of trial results summaries for trial participants: stakeholder-informed guidance from the RECAP project. BMJ Open. 2022;12(3):e057019. pmid:35338065
- 88. Cunningham-Erves J, Stewart EC, Duke J, Alexander L, Davis J, Wilus D, et al. Use of community listening sessions to disseminate research findings to past participants and communities. J Community Health. 2022;47(2):201–10. pmid:34625863
- 89. Dixon-Woods M, Tarrant C, Jackson CJ, Jones DR, Kenyon S. Providing the results of research to participants: a mixed-method study of the benefits and challenges of a consultative approach. Clin Trials. 2011;8(3):330–41. pmid:21730081
- 90. Getz K, Hallinan Z, Simmons D, Brickman MJ, Jumadilova Z, Pauer L, et al. Meeting the obligation to communicate clinical trial results to study volunteers. Expert Rev Clin Pharmacol. 2012;5(2):149–56. pmid:22390557
- 91. Lemke AA, Halverson C, Ross LF. Biobank participation and returning research results: perspectives from a deliberative engagement in South Side Chicago. Am J Med Genet Part A. 2012;158(5):1029–37.
- 92. Long CR, Purvis RS, Flood-Grady E, Kimminau KS, Rhyne RL, Burge MR, et al. Health researchers’ experiences, perceptions and barriers related to sharing study results with participants. Health Res Policy Syst. 2019;17(1):25. pmid:30832733
- 93. McElfish PA, Long CR, James LP, Scott AJ, Flood-Grady E, Kimminau KS, et al. Characterizing health researcher barriers to sharing results with study participants. J Clin Transl Sci. 2019;3(6):295–301. pmid:31827902
- 94. Nixon SA, Casale M, Flicker S, Rogan M. Applying the principles of knowledge translation and exchange to inform dissemination of HIV survey results to adolescent participants in South Africa. Health Promot Int. 2013;28(2):233–43. pmid:22237939
- 95. Ottenhoff L, Vijverberg EGB, Visser LNC, Verijp M, Prins ND, Van der Flier WM, et al. Experiences of and recommendations on clinical trial design in Alzheimer’s disease from the participant’s point of view: a mixed-methods study in two clinical trial centers in the Netherlands. Alzheimers Res Ther. 2023;15(1):72. pmid:37016435
- 96. Purvis RS, Long CR, Eisenberg LR, Hester DM, Cunningham TV, Holland A, et al. First Do No Harm: Ethical Concerns of Health Researchers That Discourage the Sharing of Results With Research Participants. AJOB Empir Bioeth. 2020;11(2):104–13. pmid:32163009
- 97. Shelly CE, Logan C, Skorochod B, Wiyeh A, Ndwandwe D, Choko A, et al. Creating a best practice template for participant communication plans in global health clinical studies. Trials. 2023;24(1):158. pmid:36864516
- 98. South A, Joharatnam-Hogan N, Purvis C, James EC, Diaz-Montana C, Cragg WJ, et al. Testing approaches to sharing trial results with participants: The Show RESPECT cluster randomised, factorial, mixed methods trial. PLoS Med. 2021;18(10):e1003798. pmid:34606495
- 99. South A, Bailey J, Bierer BE, Burnett E, Cragg WJ, Diaz-Montana C, et al. Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomised, factorial, mixed-methods trial. Clin Trials. 2023;20(6):649–60. pmid:37515519
- 100. Wood J, Cotton SC, Gillies K. The relative importance of information items and preferred mode of delivery when disseminating results from trials to participants: A mixed-methods study. Health Expect. 2022;25(1):419–29. pmid:34878212
- 101.
Racine E, Hurley C, Cheung A, Sinnott C, Matvienko-Sikar K, Baumgartner C, et al. Participants’ perspectives and preferences on clinical trial result dissemination: The TRUST Thyroid Trial experience [Internet]. HRB Open Research; 2019 [cited 2024 Mar 4. ]. Available from: https://hrbopenresearch.org/articles/1-14
- 102. Avins AL, Bent S, Padula A, Staccone S, Badua E, Goldberg H. Initial experience with a group presentation of study results to research participants. Trials. 2008;9((Avins, Goldberg) Division of Research, Northern California Kaiser Permanente, Oakland, CA, United States):16.
- 103. Bjorklund M, Shiely F, Gillies K. Information about dissemination of trial results in patient information leaflets for clinicals trials in the UK and Ireland: The what and the when. PLoS One. 2022;17(5):e0268898. pmid:35609047
- 104. Smyth RMD, Duley L, Jacoby A, Elbourne D. Women’s experiences of participating in the Magpie Trial: a postal survey in the United Kingdom. Birth. 2009;36(3):220–9. pmid:19747269
- 105. Raza MZ, Bruhn H, Gillies K. Dissemination of trial results to participants in phase III pragmatic clinical trials: an audit of trial investigators intentions. BMJ Open. 2020;10(1):e035730. pmid:32014881
- 106. Mangal S, Niño de Rivera S, Choi J, Reading Turchioe M, Benda N, Sharko M, et al. Returning study results to research participants: Data access, format, and sharing preferences. Int J Med Inform. 2023;170:104955. pmid:36565546
- 107. Bybee SG, Eaton J, Wong B. Dissemination innovation: Using found poetry to return study results to patients and partners facing cancer. PEC Innov. 2024;4:100286. pmid:38770044
- 108. Dal-Ré R, Caplan AL, Holm S, Sofat R, Stephens R. What participants are told about receiving trial results when they consent to participate in a trial. Basic Clin Pharmacol Toxicol. 2025;136(1):e14115. pmid:39702885
- 109. Dixon-Woods M, Jackson C, Windridge KC, Kenyon S. Receiving a summary of the results of a trial: qualitative study of participants’ views. BMJ. 2006;332(7535):206–10. pmid:16401631
- 110. South A, Snowdon C, Burnett E, Bierer BE, Gillies K, Isaacs T. The show respect adaptable framework of considerations for planning how to share trial results with participants, based on qualitative findings from trial participants and site staff. Trials. 2024;25(1):467.
- 111.
Schichter B, Januwalla A, Nicol K, Aistov N, Flann S. A tool for Research Ethics Boards.
- 112. Shih T. The role of research funders in providing directions for managing responsible internationalization and research security. Technological Forecasting and Social Change. 2024;201:123253.
- 113. Strüver V, Ali S, Fneish F, Fortwengel G. Patient benefit of clinical research in diversely advanced African developing countries. Current Therapeutic Research. 2022;96:100656.
- 114. Urquhart L, Roberts Dunghutti K, Gibbs Muruwari C, Fisher K, Brown LJ, Duncanson K. Experiences of co-designing research about a rural Aboriginal well-being program: Informing practice and policy. Aust J Rural Health. 2022;30(6):747–59. pmid:36250967
- 115. Wolf SM, Lawrenz FP, Nelson CA, Kahn JP, Cho MK, Clayton EW, et al. Managing incidental findings in human subjects research: analysis and recommendations. J Law Med Ethics. 2008;36(2):219–48, 211. pmid:18547191