Washington Update

NIH Issues Request for Information on Reporting of Basic Science Studies Involving Human Participants

By: Elizabeth Barksdale
Thursday, August 16, 2018

On August 10, the National Institutes of Health (NIH) published a Request for Information (RFI): Registration and Results Reporting Standards for Prospective Basic Science Studies Involving Human Participants. NIH is requesting input from the scientific research community on issues related to the registration and reporting of results of studies involving human participants that seek new knowledge on fundamental aspects of basic biology.

This RFI culminates over a year of sometimes contentious discussions between basic research stakeholders and NIH around its definition of “clinical trial” and accompanying reporting, training, and funding policies, previously reported on by FASEB. Not hearing alternatives from NIH to these polices for human subjects research with no obvious clinical application, basic researchers lobbied Congress to include language in the 2018 appropriations bill directing the agency to “consult with the basic research community to determine the reporting standards best suited to this kind of research.”

Comments must be submitted electronically by November 12, 2018.