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. Respondents are free to address any or all topics listed below, as well as other relevant topics, for NIH’s consideration.
- Scientific value and quality considerations for collection, use, and sharing of RWD in biomedical and behavioral research.’
- Using RWD as part of the scientific paradigm, including open science, scientific rigor and reproducibility, and team science.
- Administrative and logistical considerations for collecting, using, and sharing RWD for biomedical research.
- Ethical considerations for using RWD for biomedical and behavioral research.
Please see the recently published Request for Information (RFI) to solicit public comments on the use of Real-World Data (RWD), including Electronic Health Records, for Biomedical and Behavioral Research.
https://datascience.nih.gov/rfi-rwd
Note: Responses must be received by 11:59:59 pm (ET) on December 14, 2023.

