Notice Number: NOT-OD-18-212
Release Date: July 20, 2018
National Institutes of Health (NIH)
The purpose of this notice is to describe interim policy flexibilities for a subset of NIH-funded studies whose primary purpose is the pursuit of basic science. These are studies that meet the NIH definition of a “clinical trial” and that also meet the Federal definition of basic science. These studies will heretofore be referred to as “prospective basic science studies involving human participants.” These studies do not include those for which there are specific applications towards products or processes in mind, such as phase 0 or phase 1 studies of candidate interventions.
This initial implementation phase will last through September 24, 2019. During this time NIH will assess its approach to registration and results reporting for prospective basic science studies involving human participants, while delaying enforcement. In addition, it will provide leniency regarding submission to the correct funding opportunity announcement (FOA) based on the study type designation.
In 2016, NIH announced a series of initiatives aimed at assuring that NIH and NIH-funded scientists maximize stewardship and transparency. The NIH published a policy in the Federal Register noting that “In research involving human beings … scientists … have an ethical obligation to ensure that the burden and risk that volunteers assume by participating in research comes to something, at the very least by ensuring that others are aware of the study and that its findings contribute to the advancement of human health.” In order to accomplish these goals, NIH has rolled out several key changes including the use of study-type specific FOAs, study type-specific review criteria, requirements for Good Clinical Practice training, a new Human Subjects and Clinical Trial Information Form, and a policy on registration and reporting. The Consolidated Appropriations Act, 2018 (Public Law 115-141) directed NIH to delay enforcement of the policy published in the Federal Register on September 21, 2016 (also at NOT-OD-16-149) to provide additional time to consult with the basic science community about the best reporting standards for fundamental research.
NIH is defining “fundamental research” as stated in the 2018 appropriations bill as equivalent to “basic research” as defined in 32 CFR 272.3 as 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.”
Based on the 2018 appropriations bill and community feedback, NIH is delaying enforcement of registration and reporting policies for prospective basic science studies involving human participants under NOT-OD-16-149 through September 24, 2019. The delayed enforcement of registration and reporting is only applicable for prospective basic science studies that involve human participants. These studies do not include those for which there are specific applications towards products or processes in mind, such as phase 0 or phase 1 studies of candidate interventions.
In addition, NIH will provide leniency for applications submitted to the incorrect FOA based on the study type designation, as outlined below.
Please direct all inquiries to:
NIH Grants Information
Email: firstname.lastname@example.org (preferred method of contact)