National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Eye Institute (NEI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
National Institute of Mental Health (NIMH)
National Center for Complementary and Integrative Health (NCCIH)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Office of Research on Women's Health (ORWH)
R01 Research Project Grant
See Notices of Special Interest associated with this funding opportunity
This Notice of Funding Opportunity (NOFO) solicits R01 grant applications that would support independent research projects within the scientific mission areas of the participating NIH Institutes or Centers from a diverse cohort of New Investigators and At-Risk Investigators.
Not applicable
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
February 05, 2025 * | March 05, 2025 * | Not Applicable | July 2025 | October 2025 | December 2025 |
June 05, 2025 * | July 05, 2025 * | Not Applicable | November 2025 | January 2026 | April 2026 |
October 05, 2025 * | November 05, 2025 * | Not Applicable | March 2026 | May 2026 | July 2026 |
February 05, 2026 * | March 05, 2026 * | Not Applicable | July 2026 | October 2026 | December 2026 |
June 05, 2026 * | July 05, 2026 * | Not Applicable | November 2026 | January 2027 | April 2027 |
October 05, 2026 * | November 05, 2026 * | Not Applicable | March 2027 | May 2027 | July 2027 |
February 05, 2027 * | March 05, 2027 * | Not Applicable | July 2027 | October 2027 | December 2027 |
June 05, 2027 * | July 05, 2027 * | Not Applicable | November 2027 | January 2028 | April 2028 |
October 05, 2027 * | November 05, 2027 * | Not Applicable | March 2028 | May 2028 | July 2028 |
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.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the NOFO) 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.
Background
The National Institutes of Health (NIH) recognizes the need to diversify the scientific workforce by fostering the recruitment of individuals from diverse backgrounds, including those from groups identified as underrepresented (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html) in the biomedical, clinical, behavioral and social sciences research workforce.
Need for the Program
The NIH and participating Institutes recognize a unique and compelling need to promote diversity in the biomedical, behavioral, clinical, and social sciences workforce. The 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 participants 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://grants.nih.gov/grants/guide/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. NIHs 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's mission.
Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous 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 populations and those that experience health disparities and inequities 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.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the report Women, Minorities, and Persons with Disabilities in Science and Engineering, http://www.nsf.gov/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 recipient institution should be encouraged to participate in this program. 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://www.govinfo.gov/content/pkg/FR-1997-10-30/html/97-28653.htm).
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.gov/pubs/adastatute08.htm). See NSF data at https://www.nsf.gov/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:
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.gov/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.gov/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.
Proposed Scope and Objectives:
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 PD(s)/PI(s).
Program Considerations:
Consistent with existing NIH practices and applicable law: (1) applicant organizations and awardees may not use the race, ethnicity, or sex (including gender identity, sexual orientation, or transgender status) of a researcher as an eligibility or selection criteria to participate in this program, and (2) NIH does not use the race, ethnicity or sex of a candidate researcher or participating researcher in the application review process or funding decisions. Applicant organizations are encouraged to consult with their General Counsel to ensure all applicable laws are being followed in program design and implementation.
For applications proposing a clinical trial, note the following definitions and restrictions for this funding announcement:
Specific Areas of Research Interest:
NINDS
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, sexual and gender minorities, and others who have been historically underserved, marginalized, and adversely affected by persistent inequality and socioeconomic disadvantage.
Please refer to https://www.ninds.nih.gov/Funding/Find-Funding-Opportunities to find the appropriate NIH or NINDS-specific NOFO for such clinical trials. In many cases, small interventional trials exploring an intervention are within scope of PAR-24-215: NINDS Exploratory Clinical Trials (U01 Clinical Trial Required). However, applicants are strongly encouraged to speak with the assigned Scientific/Research Contact prior to application.
Applicants are encouraged to leverage existing research resources for their studies, including but not limited to clinical biospecimen samples from the NINDS Human Biospecimen and Data Repository (BioSEND; https://biosend.org/) or cell lines from the NINDS Human Cell and Data Repository (NHCDR; https://stemcells.nindsgenetics.org/). Applications proposing to collect biospecimens from prospectively enrolled study participants are strongly advised to consult the BioSEND website for information about sample banking and budgeting (request a quote for biospecimen banking costs https://biosend.org/request_a_quote.html). Applicants are also encouraged to leverage the NINDS Human Cell and Data Repository (NHCDR) for banking of peripheral blood mononuclear cells (PBMC) and/or fibroblasts and induced pluripotent stem cell (iPSC) line derivation, when applicable (contact NHCDR for more information).
Per NOT-OD-16-011, the NIH expects applicants to apply rigor in designing and performing scientific research according to the NIH Principles and Guidelines for Reporting Preclinical Research.
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. Only applications that fall within the scientific mission of the NINDS will be considered for funding (see https://www.ninds.nih.gov/About-NINDS/Who-We-Are/Mission and the NINDS Strategic Plan, https://www.ninds.nih.gov/About-NINDS/Strategic-Plans-Evaluations/Strategic-Plans/NINDS-Strategic-Plan-and-Priorities/Neuroscience-Research).
Frequently asked questions about the mechanism and other resources can be found on Diversity R01 website.
NEI
The mission of the National Eye Institute (NEI) is to eliminate vision loss and improve quality of life through vision research. The NEI has framed its current strategic plan around this mission which addresses multiple opportunities as challenges in the vision field.
NEI will support applications that address or seek fundamental knowledge related to vision sciences, including, but not limited to: cellular and molecular neuroscience, imaging, genetics, development, basic/translational research on vision including how the visual system works from the eyes to the brain in health and disease. The overarching goal is to reduce visual impairment and blindness and thus resulting in an improvement in the quality of life for people of all ages. In all these areas and related areas of vision sciences research, NEI encourages an emphasis on understanding and addressing health disparities that are experienced by vulnerable populations.Please refer to https://www.nei.nih.gov/grants-and-training/funding-opportunities to find the appropriate NIH or NEI-specific NOFO for such clinical trials.
Applications considered for funding by the NEI must fall within the areas of emphasis detailed in the NEI Strategic Plan (NEI Strategic Plan: Vision for the Future).
NHGRI
NHGRI supports resources, approaches, and technologies that accelerate genomic research focused on the structure and biology of genomes; the genomics of disease; the implementation and effectiveness of genomic medicine; computational genomics and data science; the impact of genomic technology, advances, and implementation on health disparities and health equity; and ethical, legal, and social issues related to genomic advances. NHGRI recognizes the importance of diversity in the genomic workforce, without which the promise of genomics cannot be fully achieved.
In general, NHGRI supports studies that provide generalizable methods and knowledge. Approaches that are comprehensive across the genome or are generalizable across variants, tissues, diseases, or function may be in scope for NHGRI to the extent they address priority areas described in the NHGRI 2020 Strategic Vision and on the web pages for the research mission of NHGRIs Extramural Divisions and Offices:
Applications for studies relevant only to a particular disease or organ system should be directed to the appropriate Institute or Center. Applications whose primary scientific objective is to understand a single biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention, will not be in scope for NHGRI.
NIA
The mission of the National Institute on Aging (NIA) is to support and conduct biological, clinical, behavioral, social, and economic research on aging; foster the development of research and clinician scientists in aging; provide research resources to facilitate innovative aging research; and disseminate information about aging and related advances in research to the public, health care professionals, and the scientific community, among a variety of audiences. NIA will support meritorious applications that focus on aging research, as well as research on Alzheimers disease (AD) and AD-related dementia (ADRD). A strategic priority of NIA is understanding the environmental, sociocultural, behavioral, and biological drivers of health inequities and disparities related to aging as well as AD/ADRD. NIA also supports research to develop strategies for the improvement of health among midlife and older adults, including adults from racial and ethnic minority groups and other populations that experience health inequities/disparities. Studies that draw data from across the lifespan are especially encouraged and applicants are expected to factor sex as a biological variable into research designs, analyses, and reporting in vertebrate animal and human studies. These priorities are outlined in NIA Strategic Directions for Research 2020-2025, NIAs strategic directions for health disparities research and in the AD+ADRD Research Implementation Milestones related to health disparities, as well as reflected within NIAs Health Disparities framework.
NIAMS
NIAMS will support applications that address research into the causes, treatments, and prevention of arthritis and musculoskeletal and skin diseases. The NIAMS Strategic Plan Fiscal Years 2020-2024 provides a broad outline of opportunities and needs related to the understanding, diagnosis, treatment, and ultimately, prevention of diseases within the Institute's mission areas. The Institutes core mission areas are (1) Systemic Rheumatic and Autoimmune Diseases; (2) Skin Biology and Diseases; (3) Bone Biology and Diseases; (4) Muscle Biology and Diseases; and (5) Joint Biology, Diseases, and Orthopaedics. Within these mission areas, NIAMS supports research at multiple levels, ranging from basic studies of the molecular mechanisms underlying disease processes, to preclinical research in model systems, to translational studies, and finally to clinical and epidemiological research.
In keeping with the 2020-2024 strategic plan's priority area "Management, Scientific Stewardship, and Accountability" NIAMS seeks to continue its commitment to building and maintaining the scientific workforce. Attracting and maintaining a robust, diverse scientific workforce is critical to the NIAMS mission. Many forms of arthritis, musculoskeletal, and skin diseases disproportionately affect Americans from minority racial or ethnic backgrounds. NIAMS is committed to helping to improve health equity across NIAMS disease areas. In addition, NIAMS has a long history of supporting New Investigators (NI) and Early-Stage Investigators (ESI) and seek to support investigators in this critical early point in their careers.
NIAMS will only support applications that fall within one of NIAMS supported scientific programs. Supported areas can be found here: https://www.niams.nih.gov/grants-funding/funding-opportunities/supported-scientific-areas. Clinical trial applications will be considered low priority for funding through this NOFO.
It is recommended that investigators contact NIAMS Scientific/Research staff well in advance of submitting applications to discuss the match to NIAMS priorities.
NIBIB
NIBIB interests include the development and integration of advanced bioengineering, sensing, imaging, and computational technologies for the improvement of human health and medical care. An application is not within the NIBIB mission if its principal focus is the development of a technology with the goal of understanding basic biological function or pathological mechanisms. Additionally, NIBIB only supports projects developing platform technologies that are applicable to a broad spectrum of disorders and diseases. However, applicants may propose research that utilizes only a single tissue, organ, or physiological condition as a model system to facilitate the development of what is expected to be a more broadly applicable enabling technology. Potential applicants are encouraged to contact the appropriate Program Director in their scientific program area of interest (https://www.nibib.nih.gov/research-funding) to determine if their research fits within the NIBIB mission.
For applications proposing clinical trials, NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005 "NIBIB Guidance for Support of Clinical Trial Applications." Briefly, NIBIB will only support mission-focused early-stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early-stage technology development. NIBIB will not support applications proposing pivotal, Phase II, III, IV, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern. Also, mechanistic trials are not supported unless the primary focus of the project is on technology development.
Applicants are strongly encouraged to contact the NIBIB Scientific Contact listed in this Notice of Funding Opportunity for guidance in advance of submitting an application that includes human subjects research to ensure their proposed project is in compliance with new NIH human subjects research and clinical trials policies (https://grants.nih.gov/policy/clinical-trials.htm) and consistent with the types of clinical trial applications that NIBIB supports.
NIMH
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. For this NOFO, NIMH only accepts the following types of clinical trials: mechanistic trials using an intervention of known efficacy and Basic Experimental Studies Involving Humans (BESH). Mechanistic clinical trials 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.
See the Consolidated Notice on NIMH Clinical Trials Policies, NOT-MH-23-375, for a summary of NIMHs policies on support for mechanistic clinical trials, and https://www.nimh.nih.gov/funding/clinical-research for further information on support of clinical trials at the NIMH.
NCCIH
NCCIH supports research regarding the use of complementary and integrative health approaches including natural products, mind and body interventions, and multicomponent interventions focused on whole person health. NCCIH is also interested in research studying mind and body approaches to manage stress, mild anxiety, or depression, or pain, and to improve adherence to treatment and prevention regimens to promote health outcomes. Natural products include botanicals, pre/probiotics, and products marketed as dietary supplements. Mind and body approaches include various meditation approaches (e.g., mindfulness), hypnosis or guided imagery, meditative movement approaches (e.g., yoga, tai chi, qi-gong), body-based approaches (e.g., spinal manipulation, massage, mobilization, acupuncture), a combination of these approaches (e.g., meditation and yoga, such as in mindfulness-based stress reduction MBSR), or complex interventions including music and art therapy. Research on whole person health includes multicomponent interventions designed to improve health in multiple interconnected domains: biological (including multiple organs and systems), behavioral, social, and environmental. NCCIH will not accept single-site or multi-site efficacy or effectiveness research through this NOFO (please see NCCIH Clinical Trial Funding Opportunities instead). Applicants are strongly encouraged to discuss their plans with NCCIH Scientific/Research contact and to consult the NCCIH Strategic Plan to ensure their application addresses NCCIH scientific priorities prior to developing and submitting an application.
ORWH Specific Information:
The NIH Office of Research on Womens Health (ORWH) focuses on advancing research focused on the health of women, the science of sex and gender influences, and supporting a well-trained, diverse and robust scientific workforce. Applicants should ensure their proposed work intersects with the goals, objectives, and guiding principles of the trans-NIH Strategic Plan for Womens Health Research (https://orwh.od.nih.gov/about/strategic-plan). ORWH co-funds applications and research projects that have received an award from one of the participating NIH Institutes and Centers listed in the announcement. Visit the ORWH website (https://orwh.od.nih.gov/) or contact the appropriate ORWH staff to learn more.
See Section VIII. Other Information for award authorities and regulations.
Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.
Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
The following NIH components intend to commit the following amounts for the duration of this PAR:
NINDS intends to commit up to $9.5 million per fiscal year, approximately 15 awards, dependent on award amounts
NEI's number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
NHGRIs number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
NIA intends to commit funds for up to 4 awards, dependent on award amounts.
NIAMS's number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
NIBIB's number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
NIMH intends to commit up to $5 million per fiscal year, 12-15 awards, dependent on award amounts
NCCIH intends to commit up to $400,000 per fiscal year, 1 award, dependent on award amounts
Future year amounts will depend on annual appropriations.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the How to Apply-Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply- Application Guide.
Institutions must ensure that individuals identified as the PD(s)/PI(s) meet one of the eligibility criteria A or B below (i.e., status as either a New Investigator or At-Risk Investigator). For applications with multiple PDs/PIs, each individual serving as PD/PI is required to meet one of the eligibility criteria A or B, (i.e., must be either a New or At-Risk Investigator). New and At-Risk Investigator status will be verified by NIH at the time of application.
A. New Investigator (NI)
For the purpose of this NOFO, an investigator is considered a New Investigator (NI) if they have not competed successfully for substantial, independent funding from NIH. A "substantial" research award is defined as any research grant award, with the exception of smaller grants that maintain Early Stage Investigator (ESI)/NI status (see full list of smaller grant awards that maintain Early Stage Investigator (ESI)/NI status). PD(s)/PI(s) of NIH Training-Related and Mentored Career Awards are still considered New Investigators if the NIH awards are in any of the following categories: fellowships (F awards), individual or institutional career awards (K awards), loan repayment contracts (L30, L32, L40, L50, L60), and all training grants (T32, T34, T35, T90, D43).
OR
B. At-Risk Investigator
For the purpose of this NOFO, an investigator is considered an At-Risk Investigator (AR) if they have had prior support as a Principal Investigator (PD/PI) on a substantial independent research award from NIH and, unless successful in securing support from a substantial NIH research grant award in the current fiscal year, will have no substantial NIH research grant funding support in the following fiscal year. A "substantial" research award is defined as any NIH research grant award, with the exception of smaller grants that maintain ESI/NI status (see full list of smaller grant awards that maintain Early Stage Investigator (ESI)/NI status).
By the time of award, the PD/PI (or for a multiple PDs/PIs application, all PDs/PIs) must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.
All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply-Application Guide must be followed.
All instructions in the How to Apply-Application Guide must be followed.
Facilities & Other Resources: Although this NOFO seeks to support New Investigators and At-Risk Investigators at any independent career stage, please include the description of the institutional investments in the success of the investigator described in the SF424 (R&R) Application Guide for Early Stage Investigators.
Other Attachment (Institutional Letter(s)): Eligibility information must be submitted by the applicant institution in a letter certifying how PD(s)/PI(s) satisfy the eligibility criteria listed under Section III. "Eligible Individuals (Program Director/Principal Investigator)," i.e., 1) how the PD(s)/PI(s) qualify for New Investigator or At-Risk Investigator status at time of application and 2) confirm that by the time of award, the PD(s)/PI(s)will be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence. For applications with multiple PD(s)/PI(s), the institution must submit this information for each PD/PI.
The Institutional Letter(s) must be on institutional letterhead and the signatures (or digital signatures) from an Authorized Organization Representative (AOR) and the PD(s)/PI(s) must be clearly legible. Name the PDF formatted letter(s) InstitutionalCertification.pdf. Applications without Institutional Letter(s) that address the points above for each PD/PI will be deemed incomplete and withdrawn. Eligibility information provided in the Institutional Letter(s) will be evaluated at time of application.
In addition to the eligibility information above, the applicant institution must include in the letter(s) a statement explaining how participation of the identified PD(s)/PI(s) would further the goals of the Research Opportunities for New and At-Risk Investigators to Promote Workforce Diversity program. Refer to the Proposed Scope and Objectives and Program Considerations subsections in section I for additional information. Information provided in this Institutional Letter will be evaluated consistent with applicable law.
All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply-Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.
Other Plan(s):
All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions:
Appendix:
When involving human subjects research, clinical research, and/or NIH-definedclinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the How to Apply-Application Guide must be followed.
All instructions in the How to Apply-Application Guide must be followed.
See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIHs electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the How to Apply- Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.
Applications must be submitted electronically following the instructions described in the How to Apply-Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organizations profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply-Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or non-compliant will not be reviewed.
As part of this award, funds may be requested to make changes or adjustments in the research setting that will make it possible for a qualified individual with a disability to perform the essential functions associated with their role on the project. The accommodations requested under this program must be directly related to the performance of the proposed role on the research project and must be appropriate to the disabilities of the individual. Some types of accommodations that might be provided under this award include: specialized equipment, assistive devices, and personnel such as readers, interpreters, or assistants. In all cases, the total funds for accommodations requested must be reasonable and specific to the proposed project.
Requests of $500,000 or more for direct costs in any year
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact the Scientific/ Research Contact at the relevant institute or center at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].
Applicants are required to follow the instructions for post-submission materials, as described in the policy
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system. While any information in the application relevant to the program goals can be included as part of the review process, the race, ethnicity, or sex (including gender identity, sexual orientation, or transgender status) of candidate researchers or participating researchers may not, in and of themselves, be used as factors in the evaluation of applications.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.
Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score.
Significance
Innovation
Approach
Rigor:
Feasibility:
Investigator(s)
Environment
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Vertebrate Animals
When the proposed research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
Biohazards
When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
Not applicable
Revisions
Not applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, evaluate the brief plans proposed for identifying and ensuring the validity of those resources.
Evaluate whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions, consistent with applicable law:
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.
Prior to making an award, NIH reviews an applicants federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicants integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.
A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipients business official.
In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. NIH may terminate awards under certain circumstances. See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support.
Not Applicable
Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Lauren Ullrich, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-451-7966
Email: [email protected]
Beda Jean-Francois, Ph.D.
National Center for Complementary & Integrative Health (NCCIH)
Phone: 202-313-2144
Email: [email protected]
Isaah’s Vincent, PhD
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: (301) 402-2446
E-mail: [email protected]
Neeraj Agarwal
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8155
E-mail: [email protected]
Jyoti Dayal
NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Phone: 301.480.2307
E-mail: [email protected]
Brittany Haynes, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-496-2767
Email: [email protected]
Albert Avila
NIBIB - NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING
Phone: 301-496-8804
E-mail: [email protected]
Stacy Carrington-Lawrence, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-6402
Email: [email protected]
Carolyn Joy Bondar, PhD
ORWH - Office of Research on Women's Health
Phone: (301) 402-8770
E-mail: [email protected]
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]
Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: [email protected]
Erik Edgerton
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: 301-594-7760
E-mail: [email protected]
Karen Robinson Smith
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8178
E-mail: [email protected]
Deanna L Ingersoll
NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Phone: 301-435-7858
E-mail: [email protected]
Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: [email protected]
Mutema Nyankale
NIBIB - NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING
Phone: (301) 827-6317
E-mail: [email protected]
Jeni Smits
National Institute on Aging (NIA)
E-mail: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.