NIH’s Roadmap to Engaging the Public as Partners in Clinical Research

Overview

The National Institutes of Health (NIH) has taken a decisive and unprecedented step toward transforming how clinical research is designed, conducted, and shared by uniquely placing the public at the center of the process. Unlike previous approaches, this initiative, through new leadership commitments and a multi-year effort led by the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC), introduces a singular roadmap for meaningful, bi-directional public engagement in clinical research not found in prior efforts.

At a time when trust in science is both essential and fragile, this initiative signals a shift from viewing individuals and communities solely as research participants to recognizing them as partners who help shape research agendas, methods, and outcomes.

A Leadership Commitment to Trust and Transparency

In his Director’s Statement, NIH Director Dr. Jay Bhattacharya reaffirmed that building trust and confidence in NIH-supported research is a top priority. He emphasized three guiding principles:

• Open, honest dialogue
• Transparency
• Delivering on commitments to improve health through science

To advance these goals, the NIH turned to NExTRAC and its Engaging the Public as Partners in Clinical Research (ENGAGE) Working Group, which brought together multidisciplinary experts and conducted community conversations nationwide. Their charge was to identify strategies for incorporating public voices at every stage of the clinical research lifecycle.

Dr. Bhattacharya formally endorsed the Working Group’s recommendations and announced that NIH will begin implementing this roadmap starting in 2026.

Why Public Partnership Matters in Clinical Research

The ENGAGE Working Group grounded its recommendations in a simple but powerful idea: clinical research is stronger, more relevant, and more equitable when people and communities help guide it.

Across its report, the Working Group identified that effective engagement:

• Improves the quality and relevance of research questions
• Expands how data are interpreted and applied
• Focuses outcomes on what truly matters to the people affected
• Helps restore and sustain trust between researchers and the public

Importantly, the ENGAGE framework stands out for its distinctive approach to engagement. Unlike prior models, it deliberately rejects symbolic or uniform participation, introducing tailored, substantive partnerships responsive to each community’s needs, values, and autonomy, including the right to opt out. Genuine collaboration is embedded at every research stage, uniquely making this initiative context-driven and fundamentally different from all past efforts.

A Framework for Engagement Across the Research Lifecycle

Central to the ENGAGE report is a Theory of Action—an aspirational but practical model that describes how sustained, bi-directional engagement can reshape clinical research. The goal is an environment in which people and communities can actively influence:

• Identification of health needs
• Development of research questions
• Study design and implementation
• Interpretation and sharing of findings

This framework is reinforced by ten guiding principles, including the obligation of researchers to ensure communities are equitably informed and included, and the need for long-term investment in engagement infrastructure that reduces barriers and supports cultural relevance.

Returning Research Results to Participants: A Major Shift

One of NIH’s most concrete near-term commitments is to make the return of research results to participants a standard practice.

Initial efforts will focus on returning summary-level research results, with the intention of expanding practices to provide individual-level results when appropriate. Dr. Bhattacharya highlighted this as a personal priority, noting that providing individuals with access to their research data empowers them to make informed decisions about their healthcare.

This step directly addresses long-standing public concerns about contributing data without ever seeing how it is used or what is learned from it.

Responsible Use of Clinical Data in the Digital Age

The NIH also recognizes that the growing use of electronic health records and large-scale clinical data systems presents both opportunities and responsibilities.

To ensure transparency and accountability, NIH is establishing agency-wide principles to guide the responsible conduct of research using clinical data. These principles are intended to clearly communicate how participant data are respected, protected, and shared in the service of improving health nationwide.

By explicitly addressing data governance, NIH aims to strengthen public trust as biomedical research becomes increasingly data-driven.

Building Practical Tools and Shared Infrastructure

The ENGAGE Working Group emphasized that meaningful engagement requires more than good intentions—it requires accessible tools and infrastructure.

Among its recommendations is the creation of a comprehensive, user-friendly repository of clinical research engagement resources, including templates, trainings, guidelines, and case studies. Feedback from community conversations made it clear that such resources must be easy to navigate, adaptable to local needs, and developed in collaboration with community and advocacy organizations.

The Working Group proposed a simplified tagging system to help users quickly find resources relevant to their role and stage of the research lifecycle, reinforcing the idea that engagement should be supported throughout, not added as an afterthought.

Looking Ahead

NIH’s endorsement of the ENGAGE recommendations represents a meaningful evolution in how clinical research is envisioned and conducted. By committing to transparency, shared decision-making, responsible data use, and the return of research results, NIH is laying the groundwork for a research enterprise that is scientifically rigorous, responsive, inclusive, and worthy of public trust.