NIH sets out framework to embed public partnership across clinical research

A new roadmap from the US National Institutes of Health (NIH) sets out a standardized framework for engaging patients and communities as partners in clinical research, with implementation expected to begin in 2026 and an early focus on returning research results to participants. 

The initiative was developed through a multi-year process led by the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC) and its Engaging the Public as Partners in Clinical Research (ENGAGE) Working Group, drawing on multidisciplinary expertise and community consultations across the US. In endorsing the recommendations, NIH Director Dr Jay Bhattacharya said that building trust and confidence in NIH-supported research is a priority, guided by: 

“Engaging in open, honest dialogue, acting in transparency, and delivering on our commitment to advancing science and improving health.” 

Why NIH is introducing a unified approach 

The ENGAGE Working Group reports that NIH “does not have a unified vision and framework for including patient and community voices in the design and conduct of its clinical research.” While some NIH programs have developed engagement models, the roadmap aims to create a consistent approach across “Institutes, Centers, and Offices,” and across study designs. 

The report defines clinical research engagement as occurring when: 

“People, groups of individuals, communities, and/or organizations partner with researchers to plan, design, and conduct research so that the research and its outcomes are meaningful, actionable, or support understanding of disease for those who could benefit from the research.”  

It argues that engagement can improve study feasibility and efficiency, increase relevance of outcomes, strengthen dissemination, and support trust-building between researchers and communities. 

To inform both the framework and its accompanying recommendations, NIH gathered public input through a Request for Information (RFI), a virtual listening session, and six in-person Community Conversations held between October 2024 and January 2025. According to the report, insights from these activities converged around five themes: centering communities early in the research process; relying on trusted local voices; implementing engagement with purpose rather than “tokenism;” investing in sustainable capacity and training; and offering fair compensation and practical incentives to reduce burdens associated with engagement. 

Embedding community perspectives across all stages of clinical research 

The roadmap introduces a Framework for Clinical Research Engagement, described as “a roadmap of concrete steps” that can be applied across different research questions, study designs, and partnership models. The framework is grounded in three core values: trust, accountability, and equity. Trust is described as being built when researchers “consistently show up, communicate transparently, and follow through on commitments.” Accountability is linked to clearly defined roles and responsibilities, co-developed timelines and deliverables, and ongoing monitoring of commitments. Equity is framed around shared decision-making and credit, fair compensation for community partners, and access to training and capacity-building.  

Building on these values, the framework places communities at the center of clinical research and identifies four key partners: community members, researchers, organizations, and funders. It sets out engagement objectives and practical action steps across five stages of the research lifecycle: identifying health needs, setting the research question, planning the research, carrying out the research, and sharing the findings. 

The framework begins with identifying community health needs through ongoing, bi-directional engagement. It calls for regular assessment of needs and for researchers to understand why particular priorities matter to communities, ensuring that research questions reflect lived experience as well as scientific evidence gaps. 

This is followed by a shared priority-setting process to focus research topics and align community priorities with evidence gaps. This process involves jointly identifying what is already known, where key uncertainties remain, which research approaches could address those gaps, and which funding opportunities are realistic. 

The planning stage then centers on co-design, with clear agreement on roles, responsibilities, and decision-making processes, supported by appropriate training. Community input on recruitment approaches, data collection methods, and outcome selection is highlighted as essential for improving both feasibility and relevance. 

During study conduct, the framework emphasizes ongoing monitoring to ensure research remains community centered, alongside community-informed adjustments to address barriers as they arise. It also encourages community partners to contribute to the interpretation of results, combining scientific analysis with contextual insight. 

Sharing findings is presented as a final collaborative phase that requires early planning and tailoring for different audiences. The report recommends co-designing plans for returning results to participants, communities, scientific audiences, and the public; co-creating dissemination materials; and using multiple formats and channels. It states that dissemination products should be: 

“Scientifically accurate, health literate, culturally congruent, and provide meaningful information.” 

Preparing for engagement and sustaining partnerships 

The report emphasizes that effective engagement depends on practical preparation at the study level before the research lifecycle formally begins. This includes establishing working relationships between researchers and communities, clarifying roles and decision-making processes, agreeing compensation and resource allocation, and ensuring both community partners and research teams have the training needed to collaborate effectively. 

It also makes clear that engagement is an ongoing process rather than a single, time-limited activity. The framework presents research as a continuous cycle, linking the sharing of findings back to the identification of new health needs, with the aim of sustaining partnerships across multiple studies where appropriate. When collaborations do conclude, the report recommends a structured “close-out” meeting following dissemination to support transparency, accountability, and mutual learning. 

Recommendations and planned implementation from 2026 

To translate the framework into standard practice, the ENGAGE Working Group proposes four recommendations for NIH, each with associated strategies. These focus on NIH-level policy and infrastructure changes, including: 

1. Setting funding and application requirements for engagement 
2. Embedding expectations into peer review and strategic planning 
3. Creating mechanisms for community input into NIH initiatives 
4. Investing in evaluation, metrics, and accountability to assess engagement quality and impact 

NIH has indicated it is “eager to begin implementing this roadmap, starting in 2026.” Early efforts are expected to focus on making return of participant research results standard practice, initially returning summary-level results, alongside an intention to augment practices for returning individual-level results. Bhattacharya stated:  

“Providing individuals with their research data so they can make their own healthcare decisions is one of my top priorities as NIH Director.” 

In parallel, NIH said it is working to use electronic health records (EHRs) and other large-scale clinical information systems to accelerate research, and to establish agency-wide principles to guide responsible research using clinical data. The agency described these principles as: 

“An initial transparent foundation for building trust with the public in how their data are respected and shared to drive improvements in health across the country.”