The NIAID Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional), designated as PAR-22-241, is a funding opportunity issued by the NIH's National Institute of Allergy and Infectious Diseases (NIAID). The program targets New Investigators (NI) and At-Risk Investigators from underrepresented backgrounds in the biomedical, clinical, behavioral, and social sciences. New Investigators are those who have not previously secured substantial independent NIH funding, while At-Risk Investigators are those with previous funding but face a lack of funding in the following fiscal year unless a new grant is awarded. This initiative aligns with the goals of the 21st Century Cures Act to encourage new researchers, foster early independence, and support a more diverse scientific workforce.

This funding announcement supports research relevant to the NIAID mission, including the study and treatment of infectious, immunologic, and allergic diseases. Research areas of focus include microbiology, immunology, infectious diseases, AIDS, transplantation, and emerging diseases. Although clinical trials are optional, applicants proposing NIH-defined clinical trials must consult with NIAID before submission. The funding opportunity is open to projects that advance diversity in the R01 investigator pool and those promoting representation from underrepresented groups in line with NIH’s interest in enhancing diversity across all health-related fields.

To apply, investigators must be affiliated with U.S.-based higher education institutions or eligible nonprofits and for-profit organizations. This opportunity is also open to minority-serving institutions, such as Hispanic-serving Institutions, HBCUs, and Tribally Controlled Colleges and Universities. Non-domestic (non-U.S.) entities are not eligible, although foreign components of U.S. organizations are permitted. An essential part of the application process is an Eligibility Certification Letter from the applicant institution verifying the applicant’s eligibility and alignment with the program’s diversity objectives. Applications missing this letter will be considered incomplete.

Funding levels are based on the project’s actual needs and are not capped, with a project duration of up to five years. NIAID also expects applicants to allocate funding in their budgets for mandatory attendance at a workshop designed to foster networking, collaboration, and professional growth among awardees, to be held every three years starting in 2025. Additional support for necessary accommodations for researchers with disabilities may also be included in the budget.

The application process requires thorough adherence to NIH’s submission guidelines, which include registrations with SAM, Grants.gov, eRA Commons, and the acquisition of a UEI. Applications are accepted electronically through the NIH ASSIST system, Grants.gov Workspace, or a system-to-system solution. The next deadline cycle follows NIH’s standard due dates, with submissions due at 5:00 PM local time. Applicants are advised to submit early to address potential errors before the due date.

Applications will be evaluated on scientific merit and alignment with program priorities, using criteria focused on the significance of the research, investigator qualifications, project innovation, approach, and institutional environment. Specific review criteria for clinical trials include the adequacy of study design, data management, and statistical analysis plans. Following peer review, recommended applications will receive secondary review by the NIAID advisory council. Final award decisions consider both scientific merit and relevance to NIAID’s mission and diversity goals.