September 14, 2023
Office of Data Science Strategy (ODSS)
The purpose of this Request for Information (RFI) is to solicit public comments on the use of Real-World Data (RWD), including Electronic Health Records, for Biomedical and Behavioral Research.
Researchers are increasingly using data collected in real-world settings to augment traditional research studies as well as develop more effective treatments and interventions for patients. These real-world data (RWD), defined by the U.S. Food and Drug Administration, are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status. While these data hold tremendous promise for biomedical and behavioral research, they can be collected from a variety of sources through multiple mechanisms, creating challenges for researchers and questions for those whose data are being shared.
Importantly, the National Institutes of Health (NIH) is committed to ensuring participant privacy and autonomy are protected in all NIH supported research. As NIH establishes health-related research data platforms that include access to RWD, NIH continues to prioritize maximizing data access while upholding participant preferences regarding the collection and use of their data. Most recently, through an NIH Director Advisory Committee, NIH met with stakeholders to understand their perspectives on benefits and risks of combining and using human datasets, particularly from disparate sources (e.g., research and non-research settings) and how their data should be used in biomedical research. NIH will continue working to incorporate these perspectives in its research studies to build trust and honor participant preferences. Input requested on this RFI will be used to inform NIHs continuing development of guidance on the use of RWD for research and assist in the planning for appropriate mechanisms and programs for research with RWD.
Comments must be received no later than December 14, 2023
NIH is requesting public comment on the use of RWD for NIH supported biomedical and behavioral research, including opportunities for leveraging the benefits of RWD and strategies for responsible use. NIH also seeks to understand community perspectives on the potential value and constraints – including scientific, administrative, legal, business, and ethical – for the greater use of RWD in biomedical and behavioral research.
Response to this RFI is voluntary and may be submitted anonymously. Respondents are free to address any or all topics listed below, as well as other relevant topics, for NIHs consideration.
All comments must be submitted electronically on the submission website: datascience.nih.gov/rfi-rwd
Responses to this RFI are voluntary and may be submitted anonymously. You may voluntarily include your name and contact information with your response. If you choose to provide NIH with this information, NIH will not share your name and contact information outside of NIH unless required by law.
Other than your name and contact information, please do not include any personally identifiable information or any information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Government will use the information submitted in response to this RFI at its discretion. Other than your name and contact information, the Government reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements. This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for use of that information.
We look forward to your input and hope that you will share this RFI opportunity with your colleagues.
NIH Office of Data Science Strategy