Expanded NIH Clinical Trials Definition Will Impact Federal Funding and Reporting of Social Science Research

In an effort to improve its transparency and stewardship over the clinical trials it funds, the National Institutes of Health (NIH) released a definition and set of case studies that make a clear distinction between clinical trials and basic research.

However, further policies authored by the NIH indicate that many basic research activities will now also be considered clinical trials. Although the new definition was developed for traditional biomedical research, social and behavioral sciences will be impacted as well.

The NIH announced in late July 2018 that it will delay the enforcement of its recent clinical trial guidelines until Sept. 24, 2019, in response to advocacy from social science organizations, including the Consortium of Social Science Associations (COSSA), of which NCFR is a member.

In August, the NIH released a Request for Information (RFI) seeking input on the standards NIH should use in registration and results reporting for prospective basic science studies involving human participants. Responses must be received by November 12, 2018.

COSSA and other organizations have raised concerns over the agency redefining areas of basic science and have especially noted that the reporting requirements designed for traditional clinical trials are not a good fit for basic research studies.

Read COSSA’s full analysis below on how the clinical trials guidelines will impact social science research.

COSSA's Analysis on Clinical Trials (PDF)