Delayed Enforcement and Short-Term Flexibilities for Science Studies Involving Human Participants
Tuesday, July 24, 2018
Posted by: National Institutes of Health
Delayed Enforcement and Short-Term Flexibilities for Some Requirements Affecting Prospective Basic Science Studies Involving Human Participants
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.
Definition of Fundamental Research and Basic Science
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.”
Flexibility for Prospective Basic Science Studies Involving Human Participants
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.
- Registration and Reporting: NIH will delay enforcement of its policy, published in the Federal Register on September 21, 2016, that establishes the expectation that investigators will register and report their studies in ClinicalTrials.gov. Through September 24, 2019, 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. During this period of delayed enforcement, NIH will issue a Request for Information (RFI) to seek additional input from the research community, and in particular to collect feedback on registration and results reporting standards best suited for prospective basic science studies involving human participants.
- Study-Type Specific FOAs:
- NIH has instituted a temporary period of leniency for applications submitted to an incorrect FOA based on the study-type designation. In this initial implementation phase (for due dates through September 24, 2019), 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.
- NIH plans to issue FOAs specifically for prospective basic science studies involving human participants. A Notice of Intent to Publish these FOAs will be posted in October 2018. These announcements are scheduled to be published in November 2018 for due dates starting on January 25, 2019.
- Good Clinical Practice: 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. There are free and short-duration training modules available, including one targeted towards behavioral research offered by OBSSR. The topics covered in GCP training (e.g. recruitment, retention, consent, scientific misconduct) are relevant to researchers conducting prospective basic science studies involving human participants. As part of its obligations to assure maximal stewardship, NIH expects that scientists conducting prospective basic science studies involving human participants undergo this essential level of training.
- Review Criteria: There will be no change to previously published review criteria including the question: “For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?”
- Human Subjects and Clinical Trial Information form: All applications for prospective basic science studies involving human participants will require the Human Subjects and Clinical Trial Information form.
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