October 26, 2026
Dr. Lyric Jorgenson
Associate Director for Science Policy
Director, Office of Science Policy
National Institutes of Health
Bethesda, MD 20892
Re: Request for Information: Draft NIH Policy on Sharing Summary Level Study Results with Clinical Research Participants—Notice no. NOT-OD-26-113
Dear Dr. Jorgenson,
The FasterCures team at the Milken Institute appreciates the opportunity to provide comments in response to the draft NIH Policy on Sharing Summary Level Study Results with Clinical Research Participants. NIH has made significant progress in engaging patients as partners with its new policy proposal on sharing summary-level study results, and we welcome NIH’s interest in feedback on the proposed policy and recommendations for additional guidance and tools to improve compliance with the policy and health outcomes for patients.
As a nonprofit, nonpartisan think tank, the Milken Institute believes in the power of capital markets to address urgent social and economic challenges, thereby improving lives. Its guiding belief is that societies thrive when they cultivate an educated, healthy workforce, foster transparent and efficient capital markets, and sustain effective social institutions.
FasterCures at the Milken Institute is driven by a singular goal: to save lives by speeding scientific advancements to all patients. With an independent voice, FasterCures is working to build a system that is effective, efficient, and driven by a clear vision: working with our partners to build a patient-centric system where science is accelerated, unnecessary barriers are overcome, and lifesaving and life-enhancing treatments get to those who need them as rapidly and as safely as possible. For more than 15 years, FasterCures has worked to advance patient engagement (PE) in biomedical research and development by convening stakeholders, identifying barriers and opportunities to drive progress, and developing practical resources to support the implementation of PE activities.
Sharing results with patients is a critical component of patient engagement and is one of the priorities set forth in FasterCures’ recently released report, Enabling Access to Clinical Research: An Action Plan for Policy and Practice Change.[1] We developed the report with a 19-member working group of patient groups, health systems, drug developers, and policy experts, all a subset of the Enabling Networks of Research Infrastructure for Community Health through Clinical Trials (ENRICH-CT) coalition.[2] FasterCures launched ENRICH-CT in 2023 to serve as a precompetitive forum to share best practices, support collective action on common challenges, and build an ecosystem of excellence that sustains the workforce, partnerships, resourcing, and technology needed to effectively conduct research closer to communities.
As noted in the Enabling Access to Clinical Research report, despite growing recognition of its importance, the systematic return of results in participant-friendly forms is the exception rather than the rule. Three interconnected problems sustain this gap: the absence of a requirement to return plain-language summaries, uncertainty about what individual information can lawfully be shared, and the lack of systematic planning for the return of results across funders and oversight bodies. FasterCures applauds NIH for its leadership in setting forth a clear requirement for all grantees and intramural studies to share summary results. Below, we provide feedback on the elements of the plan, followed by responses to the questions posed in the Request for Information.
- Purpose
The purpose of NIH’s policy clearly sets forth the agency’s intent to further its commitment to engaging research participants as partners. FasterCures fully supports beginning the policy with this commitment to patient engagement and partnership.
Returning research results to participants is important for building a partnership with patients. Sharing lay summaries of study results demonstrates respect for participants’ contributions, helps build trust, potentially informs health decisions, and encourages future study participation.
Establishing a clear requirement for returning results is critical because sharing aggregated trial results in understandable, participant-friendly ways is still rare in the United States, even though the European Union has required lay summaries since 2022,[3] and practical tools and templates to support this practice are readily available. NIH’s new policy and subsequent guidance and tools have the potential to substantially increase results sharing with participants in the United States.
- Scope
NIH clarifies that this requirement will apply to all trials fully or partially supported by NIH, as well as intramural studies. FasterCures urges NIH to work with the US Food and Drug Administration (FDA) to ensure that FDA-regulated trials have similar requirements to align across the federal government.
- Compliance and Enforcement
It will be important for NIH to consistently enforce the new requirement and verify compliance. The Patient-Centered Outcomes Research Institute (PCORI) adopted a policy requiring return of results in 2015 and has extensive experience with these requirements that may be helpful to NIH. PCORI requires that all applicants include in their application a description of how they plan to communicate summary findings from their research to enrolled participants and to budget for these activities.[4] PCORI notes the benefit of planning early. In addition, PCORI has a specific form that awardees must complete that describes how they have reported study results to participants.
It will be helpful to provide technical assistance tools to assist clinical trials with compliance. PCORI has developed resources to help researchers plan for returning summaries, and examples of 500-word summaries are readily available. PCORI has also published lessons learned from its grantees’ work providing patient summaries.[5] The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) has developed resources[6] to lower barriers for returning aggregated results, created useful tools, and published guidance for the clinical trials community.
- General Definitions
FasterCures recommends the use of plain language in all patient communications, including return of results. As NIH works to define this term, it may want to consider lessons learned from PCORI’s experience:[7] “Investigators reported tailoring communication channels based on participants’ ages, race, cultures, and languages; this included mailing results to older participants and using email and social media platforms (e.g., YouTube, Facebook) to return results to younger participants.” It is particularly important that the plain-language definition includes returning results in the participant’s primary language for health communications. The investigators also noted that socioeconomics were relevant to communication methods and access to electronic devices.
- Requirements
NIH requires return of results and encourages researchers to consult with research participants, among others, in developing the plain-language summaries. FasterCures recommends strengthening this recommendation to require consultation with research participants prior to developing the summary. Engagement with participants will ensure that the information conveyed is relevant to patients and is appropriately tailored to the participants in the study. As NIH noted in its purpose section, conveying summaries to patients is one part of an overall effort to partner with patients. It should evolve to continual patient engagement from the early planning stages of the study.
Future Guidance
NIH asks several questions to inform future guidance and seeks information on patient preferences and experiences, as well as best practices for researchers and implementation challenges.
- Participant Preferences and Experiences
What participants find valuable when receiving summary level study results and what, in addition to the final result(s), they find relevant to be shared.
The value of returning results to participants is fundamental. It is a driving interest and one of the most frequent reasons for participating. It also affects whether or not some patients choose to participate at all.
The key motivators for participating in clinical trials are well established in the literature.[8] Altruism, advancing science, and personal benefit are the overwhelming reasons people choose to participate in research. Most participants are driven by altruism: between 25 percent and 62 percent cite the potential to benefit others as their primary reason for enrolling.[9] Advancing science (55 percent) and helping others with their condition (53 percent) top the list in large surveys, but personal benefit is also a genuine and common motivator; more than a third of respondents (39 percent) cite the possibility that participation will improve their own health.[10]
A survey[11] of 449 people with 12 different health conditions from 45 US states asked people about their preferred sources and methods of receiving health information and interest in learning about clinical trials as it relates to their condition. The vast majority (85 percent) of participants were somewhat to very interested in learning about the results of clinical trials, with the most interest in clinical trial safety (78 percent) and efficacy (74 percent) results presented in short summaries. Virtually all were interested in learning about trials available in their condition.
Participants’ preferred method(s) for receiving summary level study results and expectations for what information should be communicated.
Understanding participant motivators and study benefits only creates value if that knowledge reaches people in actionable formats. The value proposition is either realized or lost through communication, and the research enterprise has historically been better at simple, compliant disclosure than at meaningful engagement. Technology advances offer opportunities to more easily personalize communications, both in content and in delivery.
People’s preferences for receiving health information vary considerably by source of information, format, and type of results. A survey of preferences for health-care communication found that online reading materials are the most preferred format (33 percent), followed by videos (28 percent) and infographics (27 percent). Printed materials and audio podcasts were the least preferred. These preferences are not uniform across populations. Younger participants and those with lower education levels prefer videos, graphics, and audio; participants with lower health literacy and older participants tend to prefer printed materials.[12]
An analysis of research studies of returned results found that “In studies involving vulnerable populations, such as persons living with HIV/AIDS, mailed results or live discussions were seen as more respectful and trustworthy. Digital formats, while scalable, were often perceived as impersonal or inaccessible, especially among older participants or those with limited internet access.”[13]
Combining culturally relevant communication with plain, accessible language produces measurable benefits, including stronger participant relationships, better protocol adherence, and reduced racial and ethnic disparities in both recruitment and retention.[14] PCORI provided examples of accessible return of results, including one in Spanish.[15]
For future guidance, NIH may want to further explore the under-realized opportunity in health AI to directly connect data to the value proposition for patients and leverage trial-generated data to return genuinely useful insights to participants. In FasterCures’ work with patient organizations, they report using AI to revise scientific data, treatment guidelines, and disease information to different reading levels and adapting them to culturally specific formats and language. In this way, health AI can be used as a tool to share relevant information in an accessible manner. It would be helpful for NIH to fund studies, gather information, and highlight best practices for using health AI to ensure results shared are useful to participants.
Participant/family/community concerns about receiving summary level study results, and how they could be addressed.
Participants have raised concerns[16] that information will not be relevant, will include terms that they do not understand, and will be condescending. These concerns can best be addressed by a requirement to involve study participants in the development of the plan for sharing information, including asking them about what is relevant, testing messaging, and learning about culture, context, and formats used by participants.
An analysis[17] of dissemination studies highlighted that some studies established that materials codeveloped with participants—through participatory workshops or advisory panels—were more likely to be understood in the context of the participants’ experiences. A study of PCORI investigators[18] noted “investigators credited patient partners with proposing ideas for results return that resonated with study participants, offering guidance on which results to return, influencing the format and channels for returning results, and providing insight into language acceptable to study participants.”
- Best Practices for Researchers
Effective, low burden approaches for developing summary level study results that are in plain language and culturally and contextually appropriate.
As previously noted, PCORI requires[19] its grantees to “make every reasonable effort to provide summary results to study participants.” It has developed resources to help researchers plan for returning summaries and examples for creating 500-word summaries[20] of their research to help facilitate public understanding. The MRCT Center has developed resources to lower barriers for returning aggregated results,[21] created useful tools, and published guidance for the clinical trials community. Its recommendations have been incorporated into European Medicines Agency regulation, draft guidance for FDA, and Clinical Data Interchange Standards Consortium (CDISC) standards.
- Implementation Needs
Types of activities required to share summary level study results to participants and the anticipated costs associated with those activities for different kinds of studies.
FasterCures has recommended that the NIH Grants Policy Statement and application instructions explicitly recognize results return as a direct cost in clinical trial grant budgets and include results return planning as a scored element within the “Approach” criterion in peer review. The NIH Institutes and Centers (ICs) should incorporate results return as a scored review criterion and allowable budget item in their IC-specific funding opportunity announcements.
Funding should include the cost of planning, engaging participants early in what and how to communicate summaries, and producing and sharing the information. PCORI currently has a fixed amount for return of results, but investigators can fill out a form to request more for large-scale studies. FasterCures recommends that NIH provide a mechanism for investigators to request additional resources when needed for large studies, as well as complex populations or those with diverse needs requiring multiple formats.
Information on resources, infrastructure and other non-monetary supports that would help prospectively plan for and implement the requirement to share summary level study results in a way that is understandable and meaningful to all clinical research participants in a study.
When PCORI was in the early stages of requiring summaries, investigators requested[22] support, including “training in or assistance with plain language translation and data visualization, best practice guidelines for effective results return strategies and channels, and examples of successful results return products.”
In conclusion, patient engagement should be a critical part of the summary report development process from the beginning of the clinical trial planning to ensure those summaries are addressing what patients find valuable and that the information shared is understandable and accessible. In addition to the policy and guidance for shared summaries, FasterCures also recommends that NIH consider future guidance and policy on patient engagement and require patient engagement throughout the study process with specific scored criteria and milestones, including return of results.
FasterCures is grateful for the opportunity to share our perspective and experience and looks forward to continuing to discuss policy, guidance, and additional actions NIH can take to improve patient engagement and increase value and recognition for research participants.
Sincerely,
Esther Krofah
Executive Vice President, Health
Milken Institute
[5] M. Maurer et al., “Lessons Learned from Developing Plain Language Summaries of Research Studies,” Health Literacy Research and Practice 5, no. 2 (April 2021): e155–e161, https://doi.org/10.3928/24748307-20210524-01.
[7] G. M. Sgro et al., “Return of Aggregate Results to Study Participants: Facilitators, Barriers, and Recommendations,” Contemporary Clinical Trials Communications 33 (June 2023): 101136, https://doi.org/10.1016/j.conctc.2023.101136.
[8] R. Sheridan et al., “Why Do Patients Take Part in Research? An Overview of Systematic Reviews of Psychosocial Barriers and Facilitators,” Trials 21, no. 1 (March 2020): 259, https://doi.org/10.1186/s13063-020-4197-3.
[9] S. Y. Moorcraft et al., “Patients’ Willingness to Participate in Clinical Trials and Their Views on Aspects of Cancer Research: Results of a Prospective Patient Survey,” Trials 17, no. 1 (January 2016): 17, https://doi.org/10.1186/s13063-015-1105-3; E. Rodríguez-Torres, M. González-Pérez, C. Díaz-Pérez,
“Barriers and facilitators to the participation of subjects in clinical trials: An overview of reviews,”
[11] D. Majumdar et al., “Understanding Preferences for Receiving Health Communications and Information About Clinical Trials: A Cross-Sectional Study Among US Adults,” Current Medical Research and Opinion 40, no. 6 (June 2024): 999–1006, https://doi.org/10.1080/03007995.2024.2340720.
[12] Majumdar et al., “Understanding Preferences for Receiving Health Communications.”
[13] B. Idnay et al., “Returning Aggregate Research Results to Participants: A Scoping Review of Current Practices, Preferences and Challenges,” BMJ Open 15, no. 11 (November 2025): e107270, https://doi.org/10.1136/bmjopen-2025-107270.
[14] J. Cunningham-Erves et al., “Development and Pilot Implementation of Guidelines for Culturally Tailored Research Recruitment Materials for African Americans and Latinos,” BMC Medical Research Methodology 22, no. 1 (September 2022): 248, https://doi.org/10.1186/s12874-022-01724-4; L. T. Clark et al., “Increasing Diversity in Clinical Trials: Overcoming Critical Barriers,” Current Problems in Cardiology 44, no. 5 (May 2019): 148–172, https://doi.org/10.1016/j.cpcardiol.2018.11.002; D. Boatman et al., “Designing Communication Strategies to Increase Rural Participation in Clinical Trials Using the Health Belief Model and Strategic Communication,” Contemporary Clinical Trials Communications 50 (April 2026): 101610, https://doi.org/10.1016/j.conctc.2026.101610.
[16] Sgro et al., “Return of Aggregate Results to Study Participants.”
[17] Idnay et al., “Returning Aggregate Research Results to Participants.”
[18] Sgro et al., “Return of Aggregate Results to Study Participants.”
[19] Patient-Centered Outcomes Research Institute, “Returning Study Results to Participants.”
[20] Maurer et al., “Lessons Learned from Developing Plain Language Summaries.”
[21] MRCT Center, “Return of Aggregate Results.”
[22] Sgro et al., “Return of Aggregate Results to Study Participants.”
