April 17, 2023
NOT-AR-21-009, NIAMS Policy for Acceptance of Clinical Trial Applications and Participation in Parent R01 and R21(Clinical Trial Required)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
The purpose of this announcement is to notify the research community that the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is interested in receiving Exploratory/Developmental grant applications focused on NIAMS core mission areas. Awards will provide support for innovative projects that introduce novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential for significant impact, and to substantially advance research within the NIAMS mission. These studies often assess the feasibility of a novel avenue of investigation and involve considerable risk, but have the potential to bring about breakthroughs of high value to the NIAMS research community.
This Notice of Special Interest (NOSI) uses the R21 mechanism, ending NIAMSs participation in the NIH-wide parent R21 notice of funding opportunity (NOFOs). NIAMS will not accept applications to the Parent R21 Exploratory/Developmental Grant, Clinical Trial Not Allowed or the Parent R21 Exploratory/Developmental Grant, Clinical Trial Required Notices of Funding Opportunities (NOFOs) after May 7, 2023 without referencing this NOSI.
Only applications that focus on the core scientific mission areas of the NIAMS, as outlined in the NIAMS Strategic Plan (https://www.niams.nih.gov/sites/default/files/pdf/NIAMS-StrategicPlan-2020-2024-v1.pdf), will be accepted under this NOSI.
To assess the relevance of an application topic, applicants are strongly encouraged to contact NIAMS program staff before submitting. A listing of NIAMS program staff can be found at: https://www.niams.nih.gov/grants-funding/funding-opportunities/supported-scientific-areas. Applications that are not within the NIAMS core mission areas, as determined by NIAMS staff, will be deemed as non-responsive and withdrawn without review.
Under this NOSI, NIAMS will only accept mechanistic clinical trial studies that meet NIHs definition of a clinical trial AND that are mechanistic in nature, such as those that are designed to understand a behavioral or biological process, the pathophysiology of a disease, or the mechanism of action of an intervention (see NOT-AR-21-009). Applicants who wish to submit clinical trial applications that are not mechanistic in nature for consideration by NIAMS must use one of the NOFOs listed at https://www.niams.nih.gov/grants-funding/conducting-clinical-research/grants. Applicants are strongly advised to consult with NIAMS program staff prior to submitting an application with human subjects to determine the appropriate funding opportunity.
NIAMS is committed to enhancing diversity and promoting inclusion and accessibility in all areas of research. NIAMS encourages applications from investigators from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women (see NOT-OD-22-019). NIAMS also encourages applications from all institution types and organizations (e.g., research-intensive and research active, undergraduate-focused, minority-serving, community-based), applications with partnerships that can enhance geographic and regional representation in the NIAMS portfolio, and applications with training and mentoring opportunities encouraging participation of students, postdoctoral researchers, and co-investigators from diverse backgrounds. Likewise, projects that involve human subject research should include activities and measures to enhance recruitment of a broad variety of research participants , including those from understudied backgrounds.
Application and Submission Information
This notice applies to due dates on or after June 16, 2023 and subsequent receipt dates through January 8, 2027.
Submit applications for this initiative using one of the following (NOFOs) or any reissues of these announcements through the expiration date of this notice.
All instructions in the SF424 (R&R) Application Guide and the NOFO used for submission must be followed, with the following additions:
Although NIAMS is not listed as a Participating Organization in all the NOFOs listed above, applications for this initiative will be accepted.
Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.
Please direct all inquiries to the contacts in Section VII of the listed notice of funding opportunity with the following additions/substitutions:
Peer Review Contact(s)
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Financial/Grants Management Contact(s)