Enforcement will be delayed until September 24, 2019, but issues remain.
The National Institutes of Health announced, in a notice in the NIH Guide, a series of “interim policy flexibilities” for some basic research studies that have recently been subsumed under the expanded reporting and registration requirements for clinical trials. From now until September 24, 2019, NIH will reassess its approach to registration and results reporting for prospective basic science studies involving human participants while delaying enforcement.
NIH will delay enforcement of its policy, published in the Federal Register on September 21, 2016, that defines a clinical trial as any research with human participants not excluded by separately listed cases, and establishes the expectation that investigators will register and report their studies in ClinicalTrials.gov. NIH will continue to expect registration and reporting for all human studies but allow reporting on existing basic science portals in addition to ClinicalTrials.gov.
NIH continues to expect Good Clinical Practice 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 during this interim period. There are free and short-duration training modules available, including one targeted towards behavioral research offered by the NIH Office of Behavioral and Social Sciences Research.
The American Psychological Association has worked closely with sister scientific organizations including the Federation of Associations in Behavioral and Brain Sciences to encourage NIH to reconsider its requirements that represent a significant burden to scientists who conduct basic research with human participants. As reported in Science, these organizations are continuing to push for basic science to be excluded from the definition of clinical trials.