February 4, 2022
PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)
NOT-GM-19-054 - Notice of Information: NIGMS Priorities for Sepsis Research
National Institute of General Medical Sciences (NIGMS)
The purpose of this Notice is to define the types of investigator-initiated clinical trial applications that may be submitted to NIGMS in response to the "Research Project Grant (Parent R01 Clinical Trial Required)" Funding Opportunity Announcement (FOA).
NIGMS supports clinical trials in areas of high relevance to the NIGMS mission, which encompasses the clinical research areas of injury and critical illness, sepsis, wound healing, clinical pharmacology, innate immunity, anesthesiology, and perioperative pain. NIGMS priorities for sepsis research are described in NOT-GM-19-054.
NIGMS WILL accept applications in response to the "Research Project Grant (Parent R01 Clinical Trial Required)" FOA that propose:
- Studies that meet NIH’s definition of a clinical trial AND are mechanistic in nature. The primary objective of the trial should be to provide mechanistic understanding of the biology underlying one or more of the NIGMS clinical research areas. Studies focusing on mechanism of action of an intervention in these clinical areas are also potentially acceptable, subject to the limitations stated below. NIH provides examples of mechanistic clinical trials in NOT-OD-18-010. A strong evidence base of fundamental biological and clinical information supporting a robust, mechanistic hypothesis for the trial should already exist in peer-reviewed literature.
- Studies that meet the definition of Basic Experimental Studies Involving Humans (BESH). These clinical trials aim to understand fundamental aspects of phenomena without specific application towards processes or products in mind. Although NIGMS does not participate in R01 PA-20-184, the Institute will accept these applications under the Research Project Grant (Parent R01 Clinical Trial Required), consistent with its basic research mission.
- “Hybrid” applications, i.e., applications that propose non-interventional fundamental science aims along with the clinical trial(s) described above.
Applications proposing the following types of clinical trials WILL NOT be accepted by NIGMS under the "Research Project Grant (Parent R01 Clinical Trial Required)" FOA:
- Studies that do not meet the NIH definition of a clinical trial.
- Exploratory or pilot/feasibility clinical trials, that do not adhere to NIGMS’ published priorities for clinical research (e.g., NOT-GM-19-054, NOT-NS-20-005).
- Studies in which the primary objective is to test a clinical outcome such as: specific questions about safety, tolerability, clinical efficacy/effectiveness, clinical management, and/or implementation of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions, as well as preventive, therapeutic, and services interventions.
- Studies that propose clinical dissemination and implementation research, comparative effectiveness research, and/or pragmatic clinical trials.
- Studies specifically designed to support and seek regulatory approval of future clinical diagnostics or treatments, e.g., an IND is anticipated.
Any clinical trial must fall within an area of explicit programmatic interest to NIGMS; the institute does not intend to fund applications in areas that are most appropriate for the mission of other Institutes and Centers (ICs) at the NIH, or elsewhere in the Federal government. NIGMS is unlikely to support large-scale clinical trials unless other NIH ICs or federal agencies agree in advance to establish partnerships to optimize trial efficiency, recruitment, and oversight.
Applicants are strongly encouraged to consult with NIGMS staff at NIGMS-CT-Inquiries@nih.gov prior to submitting an application.
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