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Department of Health and Human Services

Components of Participating Organizations

NIDA, NIMH, NINR, and NINDS Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional)

August 4, 2022 - Notice of NINR Participation in PAR-22-181, "NIDA, NIMH, and NINDS Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional)". See Notice NOT-NR-22-016

August 4, 2022 - Notice of Change to the title of PAR-22-181, "NIDA, NIMH, and NINDS Research Opportunities for New and "At-Risk" Investigators to Promote Workforce Diversity (R01 Clinical Trial Optional)". See Notice NOT-NS-22-111

Funding Opportunity Announcement (FOA) Number

Open Date (Earliest Submission Date)

Section I. Funding Opportunity Description

Funds Available and Anticipated Number of Awards

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Section III. Eligibility Information

Eligible Individuals (Program Director/Principal Investigator)

Section IV. Application and Submission Information

Instructions for Application Submission

SF424(R&R) Project/Performance Site Locations

SF424(R&R) Other Project Information

SF424(R&R) Senior/Key Person Profile

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information

7. Other Submission Requirements and Information

Section V. Application Review Information

For this particular announcement, note the following:

Section VI. Award Administration Information

Cooperative Agreement Terms and Conditions of Award

Financial/Grants Management Contact(s)

Department of Health
and Human Services (HHS)
NIH... Turning Discovery Into Health ®
National Institutes of Health ( NIH )
National Institute of Neurological Disorders and
Stroke ( NINDS )

National Institute on Drug Abuse ( NIDA )

National Institute of Mental Health ( NIMH )

National Institute of Nursing Research ( NINR )

This Funding Opportunity Announcement (FOA) solicits R01 grant applications that propose independent research projects that are within the scientific mission areas of the participating NIH Institutes or Centers. This program is intended to support New Investigators and At-Risk Investigators from diverse backgrounds, including those from groups underrepresented in the health-related sciences. Investigators from diverse backgrounds, including those from underrepresented groups (e.g., see NOT-OD-20-031 , Notice of NIH’s Interest in Diversity), are encouraged to work with their institutions to apply for support under this program. Investigators from categories A and B are particularly encouraged to work with their institutions to apply.
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and
Department of Health and Human Services partners. You must use one of these submission
options to access the application forms for this opportunity.
The National Institutes of Health (NIH) recognizes the need to diversify the scientific workforce by enhancing the participation of individuals from diverse backgrounds, including those from groups identified as underrepresented (https:// g rants.nih. g ov/ g rants/ g uide/notice-files/NOT-OD-20-031.html) in the biomedical, clinical, behavioral and social sciences research workforce.
Diversity at all levels — from the kinds of science to the regions in which it is conducted to the backgrounds of the people conducting it — contributes to excellence in research training environments and strengthens the research enterprise.
NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences workforce. NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from minority and other health disparity populations into clinical research protocols; and to improve the Nation's capacity to address and eliminate health disparities. For more information, see Notice of NIH's Interest in Diversity, NOT-OD- 20-031 (https:// g rants.nih. g ov/ g rants/ g uide/notice-files/NOT-OD-20-031.html) .
Notice of NIH's Interest in Diversity
Every facet of the United States scientific research enterprise—from basic laboratory research to clinical and translational research to policy formation–requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further the NIH mission.
Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.
Underrepresented Populations in the U.S. Biomedical, Clinical, Behavioral and Social Sciences Research Enterprise
In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences, such as:
A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis
(see data at http://www.nsf. g ov/statistics/showpub.cfm?TopID=2&SubID=27 ) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering (http://www.nsf. g ov/statistics/women/) . The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in this opportunity. For more information on racial and ethnic categories and definitions, see the OMB Revisions to the Standards for Classification of Federal Data on Race and Ethnicity ( https://obamawhitehouse.archives.gov/omb/fedreg_1997standards ).
B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended (http://www.ada. g ov/pubs/adastatute08.htm) . See NSF data at, https://www.nsf. g ov/statistics/2017/nsf17310/static/data/tab7-5.pdf .
C. Individuals from disadvantaged backgrounds, defined as those who meet two or more of the following criteria:
1. Were or currently are homeless, as defined by the McKinney-Vento Homeless Assistance Act (Definition: https://nche.ed. g ov/mckinne y -vento/) ;
2. Were or currently are in the foster care system, as defined by the Administration for Children and Families (Definition: https://www.acf.hhs. g ov/cb/focus-areas/fostercare ;
3. Were eligible for the Federal Free and Reduced Lunch Program for two or more years (Definition: https://www.fns.usda. g ov/school-meals/income-eli g ibility- g uidelines );
4. Have/had no parents or legal guardians who completed a bachelor’s degree (see https://nces.ed. g ov/pubs2018/2018009.pdf ) ;
5. Were or currently are eligible for Federal Pell grants (Definition: https://www2.ed. g ov/pro g rams/fp g /eli g ibilit y .html ) ;
6. Received support from the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) as a parent or child (Definition: https://www.fns.usda. g ov/wic/wic-eli g ibilit y -requirements ) .
7. Grew up in one of the following areas: a) a U.S. rural area, as designated by the Health Resources and Services Administration (HRSA) Rural Health Grants Eligibility Analyzer ( https://data.hrsa. g ov/tools/rural-health ) , or b) a Centers for Medicare and Medicaid Services-designated Low-Income and Health Professional Shortage Areas (https://www.qhpcertification.cms. g ov/s/LowIncomeandHPSAZipCodeListin g PY2020.xlsx?v=1) (qualifying zip codes are included in the file). Only one of the two possibilities in #7 can be used as a criterion for the disadvantaged background definition.
D. Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See
e.g., From the NIH: A Systems Approach to Increasing the Diversity of Biomedical Research Workforce ( https://www.ncbi.nlm.nih. g ov/pmc/articles/PMC5008902/) . Women have been shown to be underrepresented in doctorate-granting research institutions at senior faculty levels in most biomedical-relevant disciplines, and may also be underrepresented at other faculty levels in some scientific disciplines (See data from the National Science Foundation National Center for Science and Engineering
Statistics: Women, Minorities, and Persons with Disabilities in Science and Engineering, special report available at https://www.nsf. g ov/statistics/2017/nsf17310/ , especially Table 9-23, describing science, engineering, and health doctorate holders employed in universities and 4-year colleges, by broad occupation, sex, years since doctorate, and faculty rank).
Upon review of NSF data, and scientific discipline or field related data, NIH encourages institutions to consider women for faculty-level, diversity-targeted programs to address faculty recruitment, appointment, retention or advancement.
Section 404M of the Public Health Service Act (added by Section 2021 in Title II, Subtitle C, of the 21st Century Cures Act, P.L. 114-255, enacted December 13, 2016), entitled, “Investing in the Next Generation of Researchers,” established the Next Generation Researchers Initiative within the Office of the NIH Director. This initiative is intended to promote and provide opportunities for new researchers and earlier research independence, and to maintain the careers of at-risk investigators. In particular, subsection (b) requires the Director to “Develop, modify, or prioritize policies, as needed, within the National Institutes of Health to promote opportunities for new researchers and earlier research independence, such as policies to increase opportunities for new researchers to receive funding, enhance training and mentorship programs for researchers, and enhance workforce diversity; and subsection (c) requires the Director to “Carry out other activities…as appropriate, to promote the development of the next generation of researchers and earlier research independence.” See, The NIH Policy Supporting the Next Generation Researchers Initiative ( NOT-OD-17-101 ). The NIH Advisory Committee to the Director (ACD) offered a number of recommendations to NIH on the “ Next Generation Researchers Initiative" . Among those: the Committee recommended “special funding consideration for “at-risk” investigators. These are researchers who developed meritorious applications who would not have significant NIH research funding if the application under consideration is not awarded.
The objective of this program is consistent with the provisions of the 21st Century Cures Act and the recommendations from the NIH ACD and will support research from New Investigators and At-Risk Investigators from diverse backgrounds, including investigators from underrepresented racial and ethnic groups, in order to enhance the diversity of R01-funded investigators. Investigators from diverse backgrounds, including those from underrepresented groups (e.g., see NOT-OD-20-031 , Notice of NIH’s Interest in Diversity), are encouraged to work with their institutions to apply for support under this program. Investigators from categories A and B are particularly encouraged to work with their institutions to apply.
Specific Areas of Research Interest:
NIDA will support applications that address or seek fundamental knowledge related to addiction sciences, including, but not limited to: cellular and molecular neuroscience, neuroimaging, genetics, medication and treatment development, development of new and improved strategies to prevent substance use and its consequences, neuroimmune signaling, neuropathology in brain systems, cognitive processes, population neuroscience, HIV and drugs of abuse (including basic discovery science research as well as applied research on delivery of HIV and substance use prevention and treatment services to persons who use drugs), medication development, epidemiology, identifying the biological, environmental, behavioral, and social causes and consequences of substance use and addiction across the lifespan, and implementation science, including secondary data analysis. In all these and related areas of addiction sciences research, NIDA encourages an emphasis on understanding and addressing health disparities which are experienced by vulnerable populations. Only applications that fall within the scientific mission of NIDA will be considered for funding ( https://nida.nih.gov/about-nida/strategic-plan/directors-message ).
The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. NIMH supports research on topics that include basic neuroscience and behavioral science, and translational application of brain and behavior relationships in healthy and diseased states. Mental disorders may be defined according to existing diagnostic criteria or along dimensions of neurobehavioral functioning according to the NIMH Research Domain Criteria (RDoC ) framework. If existing diagnostic criteria are to be used, investigators should include plans for addressing heterogeneity within the diagnostic category or categories. Applications considered for funding by the NIMH must fall within the areas of priority detailed in the NIMH Strategic Plan and the NIMH Strategic Research Priorities . It is recommended that investigators contact NIMH Scientific/Research staff well in advance of submitting applications to discuss the match to NIMH priorities. NIMH supports mechanistic clinical trials that focus on biomarker studies that may provide information about physiological function, target engagement of therapeutics, and/or the impact of therapeutic responses. These types of studies do not have as a primary aim to establish the efficacy or effectiveness of the intervention.
NIMH considers two major categories of mechanistic trials (though there may be others):
See the “Consolidated Notice on NIMH Clinical Trials Policies,” NOT-MH-20-105 , for a summary of NIMH’s polices on support for mechanistic clinical trials.
NINDS will support applications that address or seek fundamental knowledge about the brain and nervous system by supporting and conducting research on the healthy and diseased brain, spinal cord, and peripheral nerves and to use that knowledge to reduce the burden of neurological disease. NINDS supports basic, translational, and clinical research. NINDS also encourages activities focused on understanding and addressing disparities in neurologic health, healthcare, and health outcomes in disparate populations, including racial and ethnic minorities, the geographically disadvantaged, sex and gender minorities, and others who have been historically underserved, marginalized, and adversely affected by persistent inequality and socioeconomic disadvantage.
The National Institute of Nursing Research (NINR) supports research to solve pressing health challenges and inform practice and policy - optimizing health and advancing health equity into the future. NINR discovers solutions to health challenges through the lenses of health equity, social determinants of health, population and community health, prevention and health promotion, and systems and models of care. Only applications that fall within these areas as detailed in the NINR 2022–2026 Strategic Plan will be considered. Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectoral research that examines the factors that impact health across the many settings in which nurses work, including homes, schools, workplaces, clinics, justice settings, and the community. Observational, intervention, and implementation research are of interest.
For applications proposing a clinical trial, note the following definitions and restrictions for this funding announcement:
Applicants are strongly advised to consult with the appropriate IC Scientific/Research staff prior to submitting an application with human subjects to determine the appropriate funding opportunity.
Per NOT-OD-16-011 , the
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