As you may have seen, NIH released a notice last week regarding “FORMS-E” and related human subjects policies. I expect this notice, "Delayed Enforcement and Short-Term Flexibilities for Some Requirements Affecting Prospective Basic Science Studies Involving Human Participants", will be the first of many responses to Congressional concerns about the NIH application requirements for clinical trials (see the Consolidated Appropriations Act, 2018, Public Law 115-141).
The notice highlights “interim policy flexibilities” in effect through 9/24/2019 for a subset of NIH-funded studies whose primary purpose is the pursuit of basic science. Affected studies must meet the NIH’s definition of a prospective basic science study: A systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind.
These interim flexibilities seem to pertain only to prospective basic science studies that also meet the NIH definition of a clinical trial (a distinction somewhat at odds with the less precise "studies involving human participants" language used throughout the notice). Highlights of the policy are as follows:
• Delayed enforcement of registration and reporting policy – NIH will continue to expect registration and reporting for prospective basic science studies involving human participants, with additional flexibility to allow reporting on existing basic science portals, with the expectation that data will eventually be transported to ClinicalTrials.gov.
• Leniency for applications submitted to an incorrect Funding Opportunity Announcement (FOA) – NIH will not administratively reject any application for submission to an incorrect FOA based on study-type designation. Applications will be reviewed based on the review criteria of the FOA to which they are submitted, and for FOAs that specify that clinical trials are optional, based on the designation specified by the applicant.
• Plans to issue new FOAs in November 2018 for due dates starting on January 25, 2019 specifically for prospective basic science studies involving human participants.
• No changes to Good Clinical Practice (GCP) requirements in accordance with NOT-OD-16-148; GCP is still required for all personnel involved in the conduct, oversight, or management of prospective basic science studies involving human participants.
• No changes to previously published review criteria.
• No change to Human Subjects and Clinical Trial Information Form – this form is still required for all applications for prospective basic science studies involving human participants.
I am interested to see how the last item will be enforced/evaluated given that the Human Subjects and Clinical Trial Information Form typically needs to be aligned with the FOA. I encourage researchers to check for the latest NIH rules and policies prior to submitting an NIH grant application, especially if your research meets the NIH definition of prospective basic science studies involving human participants.