Update: NIH Keeps Definition of Clinical Trials in New Announcement

Office for Research Protections     |     Institutional Review Board (IRB)

In March, Congress asked NIH to delay its enforcement of the new policy requiring registration and reporting of clinical trials on ClinicalTrials.gov, and the NIH has recently issued a response to Congress’s request. However, NIH is not narrowing its definition of a clinical trial, as many researchers had hoped. The NIH’s definition still includes basic science, or “fundamental research,” that involves prospective intervention to human subjects as part of the study.

However, the NIH is offering flexibility for the time-being. Most significantly, NIH is offering flexibility with its FOAs: there will be leniency through Sept. 24, 2019 for applications submitted to the incorrect FOA. The NIH is offering additional flexibility to basic science researchers, but it is fairly limited: NIH is allowing those researchers to initially register their studies on “existing basic science portals” with the expectation that the data will be transferred to ClinicalTrials.gov by September 2019. The Office for Research Protections recommends that investigators conducting basic science clinical trials still initially register on ClinicalTrials.gov to avoid duplicative work. Good Clinical Practice (GCP) training is still required for all NIH-funded clinical trials.

Not sure if your work is a clinical trial? See our 13-minute presentation on NIH’s definition of a clinical trial. See additional resources on our clinical trials page: https://www.research.psu.edu/qm/clinicaltrials.

 Read the full NIH announcement: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-212.html