August 29, 2023

Recommendations on responsible stewardship of personal health data in clinical research

Today, the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC) delivered recommendations on how NIH can strengthen safeguards of personal health data captured and analyzed through current and emerging technologies and used in research. Digital health devices, high throughput “-omics”, neural recordings, and artificial intelligence are just some of the technologies being used to collect and analyze personal health data with increasing granularity. While the use of such data is catalyzing scientific discovery in human health, there may be individual, familial, and societal implications as these technologies continue to gain power. The NExTRAC recommendations emphasize the importance of engaging research participants and communities early and often throughout the research lifecycle on the use of personal health data, improving how researchers inform and gain consent from participants on the use and sharing of their health data, and ensuring that bioethics is integrated into research to inform the return of the value from these studies, including the research results, to participants and their communities.

I want to thank the members of the NExTRAC for their insights and consideration. I also want to express my sincere appreciation to the hundreds of people in communities across the United States who volunteered to share their thoughts on this important issue with us. For decades, NIH has been guiding researchers through policy and best practices on how to integrate bioethics throughout the research process and engage communities. The recommendations from the NExTRAC and input from communities have energized NIH’s commitment to engagement. Therefore, I have asked the NExTRAC to help NIH develop a harmonized and implementable vision and framework for including public voices in the design and planning of NIH-funded clinical research and to define pathways for widespread dissemination of study findings. This endeavor aims to build a model of engagement with patients, communities, researchers, and other members of the public that is based on trust, transparency, accountability, and respect.      

Lawrence A. Tabak, D.D.S., Ph.D.
Acting Director, NIH