The NIH requirements for the registration and reporting of results on ClinicalTrials.gov, for NIH-funded basic experimental studies with humans (BESH), have been delayed until September 24, 2021. This delayed enforcement only applies to BESH studies submitted to funding opportunities designated as “basic experimental studies with humans” in the title.

According to the Notice, “NIH continues to expect Good Clinical Practice (GCP) training in accordance with NOT-OD-16-148 for all personnel involved in the conduct, oversight, or management of prospective basic science studies involving human participants. Additionally, all such applications continue to require completion of the full PHS Human Subjects and Clinical Trials Information form, and will be evaluated using the clinical trial review criteria.”

OSU researchers can complete GCP training by logging into the CITI website and enrolling in Group 5 or 6 (FDA-Regulated Research) or Group 7 (NIH-funded clinical trials). Additionally, NIH offers GCP training through NIAID, NIDA, and NCATS.

Notice Number: NOT-OD-19-126