NIH Requests Comments on Biomedical and Behavioral Research Real-World Data

The National Institutes of Health (NIH) released a request for comments on the collection, use, and sharing of biomedical and behavioral science research real-world data (RWD). RWD refers to observational data that is gathered from patients in real-world settings, including but not limited to patient surveys and electronic records. As the NIH develops guidelines for RWD, submitted comments are expected to aid the NIH in understanding public concerns of this type of data. The public is asked to comment on the following items:

• The value of RWD in NIH-funded research including opportunities, challenges, and barriers in biomedical and behavioral science research;
• The process of validation and verification of RWD including methods of reproducibility and open science practices;
• Methods of collection, use, and sharing of RWD for biomedical research; and
• Ethical implications of the use of RWD.

Comments are requested by December 14 and can be submitted here.