ROADMAP FOR ENGAGING THE PUBLIC AS PARTNERS IN CLINICAL RESEARCH

At the National Institutes of Health (NIH), engendering trust and confidence in the research we support is one of our top priorities.  Three things guide these efforts: engaging in open, honest dialogue, acting in transparency, and delivering on our commitment to advancing science and improving health.  To help guide this work, the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC) recently undertook a multi-year effort to provide the NIH with a roadmap for incorporating public voices in clinical research (see NExTRAC report) https://osp.od.nih.gov/wp-content/uploads/2025/12/NExTRACs-ENGAGE-Report_FINAL.pdf.  Deliberations were informed by a team of multi-disciplinary experts https://partnersinresearch.nih.gov/members/ and community conversations across the country https://partnersinresearch.nih.gov/community-conversations/, specifically asked to think about strategies for incorporating public voices at every stage of the clinical research process.  I am pleased to endorse these recommendations, which focus on:

--providing a clear vision and framework for maximally involving patients and communities in clinical research;

--ensuring that people and communities have meaningful input into the agenda and direction of research that is relevant and impactful for them; and

--increasing transparency for how research participant data are utilized in moving the scientific enterprise forward.

NIH is eager to begin implementing this roadmap, starting in 2026.  First, NIH will work with the community to make the return of participant research results standard practice.  Initial efforts will focus on returning summary-level research results, with the intent of augmenting practices that result in returning individual-level research results to research participants.  Providing individuals with their research data so they can make their own healthcare decisions is one of my top priorities as NIH Director.  NIH is also working towards harnessing the widespread adoption of electronic health records and other large scale electronic clinical information systems to accelerate biomedical research in ways not previously possible.  In the spirit of transparency, NIH is establishing agency-wide principles https://osp.od.nih.gov/policies/healthcare-research/ to foster, promote, and guide the responsible conduct of research using clinical data.  These principles serve 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.  I want to thank the NExTRAC and the ENGAGE Working Group members for their keen insights and thoughtful deliberations.  Their efforts will serve as a valuable tool toward improving the health of all Americans.

Dr. Jay Bhattacharya

NIH Director