National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Cancer Institute (NCI)
R15 Academic Research Enhancement Award (AREA)
See Notices of Special Interest associated with this funding opportunity
March 22, 2024 - Notice of Change to Budget Information Listed in PAR-21-357. See Notice NOT-AG-23-085.
May 4, 2023 - Notice of Informational Webinar for NIH Research Enhancement Award (R15) Programs. See Notice NOT-GM-23-042
NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022
NOT-OD-22-018 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available
NOT-OD-21-181 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients
NOT-OD-21-169 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022
NOT-OD-21-170 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements
NOT-OD-21-109 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel
The purpose of the Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools is to support small scale research grants at institutions that do not receive substantial funding from the NIH, with an emphasis on providing biomedical research experiences primarily for health professional, undergraduate and graduate students and enhancing the research environment at applicant institutions.
Eligible institutions must award baccalaureate or advanced science degrees and have received no more than $6 million dollars per year of NIH support (in both direct and F&A/indirect costs) in 4 of the last 7 fiscal years. For institutions composed of multiple schools and colleges, the $6 million funding limit is based on the amount of NIH funding received by all the schools and colleges within the institution as a whole.
Help determining the Organization Funding Level can be found here or https://grants.nih.gov/grants/funding/r15.htm.
This REAP funding opportunity announcement (FOA) supports investigator-initiated mechanistic and/or minimal risk clinical trials addressing the mission and research interests of the participating NIH institutes. For purposes of this FOA, minimal risk clinical trials are defined as those that do not require FDA oversight, do not intend to formally establish efficacy, and have low risks to potentially cause physical or psychological harm.
Not Applicable
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| February 25, 2022 * | February 25, 2022 * | May 07, 2022 * | July 2022 | October 2022 | December 2022 |
| June 25, 2022 * | June 25, 2022 * | September 07, 2022 * | November 2022 | January 2023 | April 2023 |
| October 25, 2022 * | October 25, 2022 * | January 07, 2023 * | March 2023 | May 2023 | July 2023 |
| February 25, 2023 * | February 25, 2023 * | May 07, 2023 * | July 2023 | October 2023 | December 2023 |
| June 25, 2023 * | June 25, 2023 * | September 07, 2023 * | November 2023 | January 2024 | April 2024 |
| October 25, 2023 * | October 25, 2023 * | January 07, 2024 * | March 2024 | May 2024 | July 2024 |
| February 25, 2024 * | February 25, 2024 * | May 07, 2024 * | July 2024 | October 2024 | December 2024 |
| June 25, 2024 * | June 25, 2024 * | September 07, 2024 * | November 2024 | January 2025 | April 2025 |
| October 25, 2024 * | October 25, 2024 * | January 07, 2025 * | March 2025 | May 2025 | July 2025 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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 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.
- Use the NIH ASSIST system to prepare, submit and track your application online.
- Use an institutional system-to-system (S2S) solution to prepare and submit your application
to Grants.gov and eRA Commons to track your
application. Check with your institutional officials regarding availability.
- Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
The National Institutes of Health (NIH) is continuing to make a special effort to stimulate research at educational institutions that provide baccalaureate and/or advanced degrees for a significant number of the Nation's research institutions that have not been major recipients of NIH support. Since Fiscal Year (FY) 1985 Congressional appropriations for the NIH have included funds for this initiative, known as the Academic Research Enhancement Award (AREA) program, that was intended to focus on undergraduate institutions (PAR-21-155). To complement the AREA program, this funding opportunity announcement (FOA) specifically supports eligible health professional schools and graduate schools to provide research experiences to health professional, undergraduate and/or graduate students pursuing biomedical or behavioral research.
The three objectives of this FOA are to: (1) provide support for meritorious research; (2) strengthen the research environment at these institutions; and (3) give health professional, undergraduate and/or graduate students an opportunity to gain significant biomedical research experience through active involvement in the research. For the purposes of this FOA, health professional schools and colleges are accredited institutions that provide education and training leading to a health professional degree, including but not limited to: BSN, MSN, DNP, MD, DDS, DO, PharmD, DVM, OD, DPT, DC, ND, DPM, MOT, OTD, DPT, MS-SLP, CScD, SLPD, AuD, MSPO, MSAT, and MPH. Eligible health professional schools/colleges may include schools or colleges of nursing, medicine, dentistry, osteopathy, pharmacy, veterinary medicine, public health, optometry, allied health, chiropractics, naturopathy, podiatry, rehabilitation medicine, physical therapy, orthotics & prosthetics, kinesiology, occupational therapy and psychology. Accreditation must be provided by a body approved for such purpose by the Secretary of Education.
The REAP program will enable qualified scientists to receive support for small-scale research projects. It is anticipated that investigators supported under the REAP program will benefit from the opportunity to conduct independent research; that the grantee institution will benefit from a research environment strengthened through REAP grants; and that students at recipient institutions will benefit from exposure to and participation in scientific research in the biomedical sciences so that they consider careers in biomedical research. The REAP FOA emphasizes the engagement and inclusion of health professional, undergraduates and/or graduate students in research. Since diversity strengthens the research environment, REAP projects are encouraged to include students from diverse backgrounds, including those from groups underrepresented in the biomedical research workforce (See NOT-OD-20-031 and NOT-OD-22-019).
The research project must involve health professional, undergraduate and/or graduate students and the research team must be composed primarily of health professional, undergraduate and/or graduate students. Student involvement in the research project may include participation in the design of experiments and controls, collection and analysis of data, execution and troubleshooting of experiments, participation in research meetings, and discussion of future directions. When applicable, it is highly desirable that student participation also include presentation at local and/or national meetings, publication of journal articles, and collaborative interactions. The REAP is a research grant program, not a training or fellowship program. As such, applications should not include training plans such as didactic training or non-research activities relating to professional development.
A REAP application submitted to this FOA may include other investigators, such as collaborators or consultants, or other individuals such as high school students, post baccalaureate participants, postdoctoral fellows, or clinical fellows. However, involvement of such individuals does not fulfill the goal to engage health professional, undergraduate and/or graduate students in eligible environments in research.
This FOA does not provide support for research at undergraduate-focused institutions, and investigators from those institutions should apply to PAR-21-155 Academic Research Enhancement Award for Undergraduate-Focused Institutions (R15 Clinical Trial Not Allowed). Additional information on R15 programs can be found at: NIH Research Enhancement Award (R15).
All applications submitted to this Clinical Trial Required REAP FOA must propose a clinical trial. It supports investigator-initiated clinical trials proposing mechanistic and/or low/minimal risk studies, with the goal of producing clinical findings that have significant public health impact. The NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions or experimental conditions (which may include placebo or other control) to evaluate the effects of those interventions/manipulations on health-related biomedical or behavioral outcomes (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html).
A low/minimal risk clinical trial meets the following criteria:
- Does not require FDA oversight such as those requiring Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications. For example, clinical trials involving utilization of a licensed product/device for an approved dose, population, and indication may not require an IND or IDE.
- Potential of the intervention to cause physical or psychological harm is low. For example, risks that are no greater than those encountered in routine medical care or procedures.
- Intends to gather scientific data/evidence to inform subsequent studies but is not aimed or sufficiently powered to directly change health policy or standard of care and is not an NIH defined Phase III Clinical Trial (https://humansubjects.nih.gov/glossary).
A mechanistic clinical trial meets the definition of a clinical trial and is designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention (i.e., a mechanistic trial is not a test of efficacy or effectiveness of an intervention). Research that is designed to understand a biological or behavioral process or the pathophysiology of a disease (but not the more applied goal of the mechanism of action of an intervention or therapeutic), is a subset of mechanistic clinical trials and is supported through this FOA. NIH defines this type of research as Basic Experimental Studies with Humans (BESH), as described in greater detail here: https://grants.nih.gov/policy/clinical-trials/besh.htm.
Proposed studies should be hypothesis-driven and produce research data/evidence that are necessary to inform core scientific design, implementation and issues essential to advance scientific knowledge.
Applicants are encouraged to consult the NIH guidance on clinical trials prior to submission: Does Your Human Subjects Research Study Meet the NIH Definition of a Clinical Trial? | grants.nih.gov
Investigators who are solely proposing non-clinical trial human subjects research (e.g., observational, epidemiological, secondary data analyses, device development), should apply to the Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools (R15 Clinical Trial Not Allowed) funding opportunity (PAR-22-060).
Applicants are encouraged to consult the Frequently Asked Questions website and the NIH Research Enhancement Award R15 website for more information about this program.
Pre-consultation
Participating NIH Institutes and Centers are listed on the first page of this announcement ("Components of Participating Organizations"). For additional scientific program information and for pre-application guidance, applicants are encouraged to contact the person listed for the participating NIH IC(s) with research interests relevant to the applicant's proposed topic. Consultation with relevant NIH staff prior to the application due date is strongly encouraged for new and resubmission applications. See Section VII for contact information.
Institute/Center Specific Interests
Eunice Kennedy Shriver National Institutes of Child Health and Human Development (NICHD)
The NICHD supports biological, behavioral, and clinical research related to conception and pregnancy, normal and abnormal development in childhood, reproductive health, population dynamics across the lifespan, and rehabilitation medicine: https://www.nichd.nih.gov/grants-funding/opportunities-mechanisms/areas-research/Pages/default.aspx.
Research projects considered for funding by NICHD must fall within the scientific missions of the twelve Scientific Branches of the NICHD Division of Extramural Research (DER) or the National Center for Medical Rehabilitation Research (NCMRR). Information about those scientific missions and program staff contacts may be found on the web pages for the DER scientific branches at: http://www.nichd.nih.gov/about/org/der/branches/Pages/index.aspx and the NCMRR at: http://www.nichd.nih.gov/about/org/ncmrr/Pages/overview.aspx. Potential applicants are strongly encouraged to read these webpages for any updates in response to recent scientific advances or emerging public health topics.
NICHD encourages applications that address its Extramural program priorities described in the 2020 NICHD Strategic Plan (see https://www.nichd.nih.gov/about/org/strategicplan) and will consider how well research projects align with one or more of those priorities when making award decisions. A detailed list of high priority research areas of NICHD Extramural Scientific Branches may be found at https://www.nichd.nih.gov/grants-funding/opportunities-mechanisms/areas-research/Pages/priorities.aspx.
National Institute on Deafness and Other Communication Disorders (NIDCD)
NIDCD supports applications that propose research projects in the normal and disordered processes of hearing, balance, taste, smell, voice, speech, and language. Applicants are strongly encouraged to learn more about NIDCD research areas at https://www.nidcd.nih.gov/research/extramural.
National Human Genome Research Institute (NHGRI)
NHGRI supports the development of resources, approaches, and technologies that will accelerate genomic research on the structure of genomes, the biology of genomes, and the biology of disease; that will use genomics to advance the science of medicine; and that will incorporate genomics to improve the effectiveness of healthcare. NHGRI also supports genomic research in several cross-cutting areas, including the ethical, legal and societal implications of genomics and genetics research, bioinformatics, technology development, and research training and career development. In general, NHGRI supports studies that provide generalizable methods and knowledge. Applications for studies relevant only to a particular disease or organ system should be directed to the appropriate Institute or Center. NHGRI strongly encourages potential applicants to reach out to the listed scientific contact in the early stages of developing an application.
National Institute of Drug Abuse (NIDA)
NIDA is the lead federal agency supporting scientific research on drug use and its consequences. Our mission is to advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual and public health. Applications considered for funding by the NIDA should address critical issues of neuroscience, genetics, behavior, prevention, treatment, epidemiology, etiology, health services, health disparities, data science, medications development, HIV/AIDS, and co-occurring opportunistic infections (e.g., hepatitis C) in substance using populations, or other research areas relevant to drug use and addiction. NIDA priorities are further described in the NIDA Strategic Plan (see https://www.drugabuse.gov/about-nida/strategic-plan/executive-summary) and on the NIDA Research Programs and Activities (see https://www.drugabuse.gov/research/nida-research-programs-activities). Applicants are encouraged to contact a program official to discuss the proposed application.
National Institute of Mental Health (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. Applications submitted for funding by the NIMH must fall within the areas of priority detailed in the NIMH Strategic Plan and the NIMH Strategic Research Priorities. Applicants are strongly encouraged to contact the person listed under Agency Contacts (Section VII) prior to submission.
For clinical trials (CTs), NIMH encourages an experimental therapeutics approach to the development and testing of interventions, in which they serve not only as potential treatments, but as probes to generate information about the mechanisms underlying a disorder or the therapeutic effect of the intervention. More information may be found on the NIMH clinical trials website and in the NIMH CT funding opportunity announcements for pilot/exploratory research (i.e., R61/R33, R33 and R34).
NIMH encourages mechanistic CTs. These studies are designed to provide information about physiological function, target engagement of novel therapeutics, and/or mechanisms of therapeutic responses, all examined in the context of a CT. Further examples of mechanistic clinical trial studies relevant to the NIMH mission are detailed in NOT-MH-19-006.
National Eye Institute (NEI)
NEI supports basic and clinical research aimed at increasing our understanding of the eye, the visual system, and visual function in normal health and disease as well as the special problems and requirements of the visually impaired. NEI will support Clinical Trial applications proposing mechanistic studies and/or those designated as minimal risk interventions as defined by 45 CFR 46. Applicants are strongly advised to contact the NEI R15 Program Contact person before submitting applications to this FOA for guidance about NEI’s mission and interests as related to the R15 program and more information regarding clinical trial designations.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIAAA supports basic, translational, and clinical research on the causes, consequences, prevention, diagnosis, progression, and treatment of alcohol-related problems across the lifespan. NIAAA encourages meritorious alcohol research projects in the broad areas of neuroscience and behavior, organ damage and other health effects, epidemiology and prevention, and treatment and recovery. Investigators who conduct original and innovative basic biomedical, social, behavioral, clinical, or population-based research directed toward eliminating health disparities are invited to apply to this FOA. Projects may include a focus on addressing disparities in disparity populations as a whole, a single health disparity population, or a subgroup within a health disparity population. Projects addressing the improvement of health in racial/ethnic minority populations (without a specific emphasis on disparities relative to other groups) are also accepted under this announcement. More information about NIAAA’s mission and research priorities is available in the NIAAA Strategic Plan at https://www.niaaa.nih.gov/strategic-plan. For clinical trials, the applicant should have an existing alcohol research clinical trial or a history of experience conducting clinical trials that examine alcohol-related outcomes. For specific programmatic questions, please contact the NIAAA point-of-contact listed in this FOA.
National Heart, Lung and Blood Institute (NHLBI)
The NHLBI supports basic and clinical research pertaining to the structure, function, and diseases of the cardiovascular system, lungs, blood and blood vessels, and sleep disorders. NHLBI supports clinical trial research that is mechanistic and/or efficacy focused, including behavioral, pharmacotherapeutic, device-based, and other intervention approaches. The NHLBI also supports research in stem cell biology and transplantation, transfusion medicine, and blood resources. The NHLBI carries out its mission through a number of research programs that provide support for projects ranging from studies at the molecular level to whole body studies in man and animals. Examples of research areas supported by the NHLBI include atherosclerosis, hypertension, cerebrovascular disease (directed at the dependent variable of blood, heart, or blood vessel), coronary heart disease, peripheral vascular diseases, arrhythmias, heart failure, and shock, congenital and rheumatic heart diseases, cardiomyopathies and infections of the heart, circulatory assistance, lung cell and molecular biology, chronic obstructive lung diseases, pediatric pulmonary diseases, cystic fibrosis, sleep-disordered breathing, asthma, fibrotic and immunologic lung diseases, acute respiratory failure, pulmonary vascular diseases, HIV-associated lung disorders and bone marrow suppression, bleeding and clotting disorders, disorders of the red blood cell such as sickle cell disease and Cooley's anemia, bone marrow failure syndromes, and blood resources.
National Institute on Minority Health and Health Disparities (NIMHD)
The mission of the NIMHD is to lead scientific research to improve minority health and reduce health disparities. NIMHD supports the study of many aspects of minority health and health disparities from biological and population sciences to clinical, behavioral, and translational research, as well as research on health care services, health systems and workforce development. NIMHD focuses on the full continuum of causes of health disparities and the interrelation of these causes. Projects must include a focus on one or more of the following NIH-designated populations that experience health disparities in the United States: African Americans, Latinos/Hispanics, American Indians and Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, less privileged socioeconomic groups, underserved rural populations, and sexual and gender minorities (lesbian, gay, bisexual, and transgender populations, as well as those whose sexual orientation, gender identity and expressions, or reproductive development varies from traditional, societal, cultural, or physiological norms. See, https://nimhd.nih.gov/about/directors-corner/message.html.). Comparison groups/populations may also be included as appropriate for the research questions posed.
Projects are also expected to focus on human and population-based studies in the biomedical, clinical, population, behavioral or social sciences. This can include research with human participants and/or secondary analyses of existing human data or specimens collected in research or clinical settings, in vitro studies that utilize human cells or tissues to investigate mechanisms underlying resilience or susceptibility to disease, observational studies, epidemiologic studies, patient outcomes research, intervention research, dissemination and implementation research, and health services research.
NIMHD encourages projects that use approaches encompassing multiple domains of influence (e.g., biological, behavioral, sociocultural, environmental, physical environment, health system) and multiple levels of influence (e.g., individual, interpersonal, family, peer group, community, societal) to understand and address health disparities (see the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html, for more information). NIMHD will not support animal studies under this FOA. Applicants are encouraged to contact the NIMHD program officers to discuss institute relevance/priorities before submission.
National Institute of Nursing Research (NINR)
The National Institute of Nursing Research (NINR) supports research that builds the scientific foundation for nursing practice and policy across clinical and community settings, and advances the prevention, detection, and management of disease and disability. Drawing on nursing’s holistic perspective, NINR funds research that integrates factors at multiple levels, including social determinants of health, to identify their role in health, health improvement, and health inequities. NINR promotes research that improves the health of individuals, families, and populations in a variety of settings, translating science in order to maximize the impact of findings on practice and policy. Advancing health equity is an area of high priority.
National Institute on Aging (NIA)
NIA will accept applications for research projects in areas within the Institute's mission that includes genetic, biological, behavioral, social, and economic research on aging. In addition, NIA encourages applications on Alzheimer’s Disease (AD) and AD Related Dementias (ADRD). The NIA website (https://www.nia.nih.gov/) provides additional information about the Institute mission and areas of research interest. For additional scientific program information and for pre-application guidance, a potential applicant is encouraged to contact the NIA Program Director (https://www.nia.nih.gov/research/research-divisions-contacts) whose portfolio covers the scientific topic of interest.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Renewal
Resubmission
Revision
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Required: Only accepting applications that propose clinical trial(s).
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Applicants may request up to $300,000 in direct costs for the entire project period of up to 3 years.
The scope of the proposed project should determine the project period. The maximum project period is 3 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Federal Government
- Eligible Agencies of the Federal Government
In addition, all organizations must meet the following criteria at the time of submission:
- The applicant organization must be an accredited public or non-profit private school that grants baccalaureate or advanced degrees in health professions (see section below for more details) or biomedical and behavioral sciences. The application must be submitted by the eligible organization with a unique entity identifier (such as UEI or DUNS) and a unique NIH eRA Institutional Profile File (IPF) number.
- At the time of application submission, all components of the institution combined must not have received support from the NIH totaling more than $6 million per year (in both direct and F&A/indirect costs) in 4 of the last 7 years. A year is defined as a federal fiscal year: from October 1 through September 30. For institutions composed of multiple schools and colleges, the $6 million funding limit is based on the amount of NIH funding received by all of the schools and colleges within the institution as a whole. Note that all activity codes are included in this calculation except the following: C06, S10, and all activity codes starting with a G.
- For this FOA: Only eligible Health Professional or Graduate Institutions may apply
- For this FOA: Non-health professional or non-graduate academic institutions are not eligible to apply
- For the purposes of this FOA, a graduate school offers advanced degrees, beyond the undergraduate level, in an academic discipline including M.A., M.S., and Ph.D. degrees.
- Health professional schools and colleges are accredited institutions that provide education and training leading to a health professional degree, including but not limited to: BSN, MSN, DNP, MD, DDS, DO, PharmD, DVM, OD, DPT, DC, ND, DPM, MOT, OTD, DPT, MS-SLP, CScD, SLPD, AuD, MSPO, MSAT, and MPH.
- Eligible health professional schools/colleges may include schools or colleges of nursing, medicine, dentistry, osteopathy, pharmacy, veterinary medicine, public health, optometry, allied health, chiropractic, naturopathy, podiatry, rehabilitation medicine, physical therapy, orthotics & prosthetics, kinesiology, occupational therapy and psychology. Accreditation must be provided by a body approved for such purpose by the Secretary of Education.
- For institutions with multiple campuses, eligibility can be considered for each individual campus (e.g., main, satellite, etc.) only if a unique identifier number and NIH IPF number are established for each campus. For institutions that use one identifier number or NIH IPF number for all campuses, eligibility is determined for all campuses (e.g., main, satellite, etc.) together.
Additional Eligibility Guidance
A signed letter is required from the Provost or similar official with institution-wide responsibility verifying the eligibility of the applicant institution at the time of application submission according to the eligibility criteria indicated above. See the application instructions for "Other Attachments" on the SF424(R&R) Other Project Information form in Section IV.2 Instructions for Application Submission. Final eligibility will be validated by NIH prior to award.
To assist in determining eligibility, organizations are encouraged to use the NIH RePORT website under NIH Awards by Location & Organization (http://projectreporter.nih.gov/reporter.cfm).
A REAP grant is permitted to have a subcontract to a non-REAP-eligible institution. However, applicants should keep the goals of the REAP program in mind when preparing the application, which include strengthening the research environment of eligible institutions and engaging students from eligible institutions to research. It is expected that the majority of the research will be directed by the PD(s)/PI(s) at the grantee institution.
Undergraduate-focused institutions with undergraduate enrollment greater than graduate enrollment should apply to PAR-21-155, Academic Research Enhancement Award for Undergraduate-Focused Institutions (R15-Clinical Trial Not Allowed) or to PAR-21-154, Academic Research Enhancement Award for Undergraduate-Focused Institutions (R15- Clinical Trial Required).
Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
- Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
- System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
- NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
- eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.
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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities 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).
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 SF424 (R&R) Application Guide.
To be eligible for an REAP grant, the PD(s)/PI(s) must meet the following additional criteria:
- Each PD(s)/PI(s) must have a primary appointment at a health professional or graduate school or college within the applicant institution, as defined in "Eligible Organizations," above. If proposing multiple PD(s)/PI(s), each PD/PI must be at a REAP-eligible institution.
- Each PD(s)/PI(s) may not be the PD(s)/PI(s) of an active NIH research grant, including another R15 grant, at the time of award of a REAP grant, although he or she may be one of the Key Personnel for an active NIH grant held by another PD/PI.
- Each PD(s)/PI(s) may not be awarded more than one R15 grant at a time, although he or she may hold successive New or Renewal grants.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
- A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
- A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
- An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications)
1. Requesting an Application Package
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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement 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 SF424 Application Guide and the Table of Page Limits must be followed.
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Facilities & Other Resources: The following information must be included.
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- A profile of the students of the applicant institution and any information or estimate of the number who have obtained a health prefessional, baccalaureate or advanced degree and gone on to obtain an academic or professional doctoral or other other advanced degree in the health-related sciences during the last five years.
- Description of plans to encourage participation of individuals from diverse backgrounds, including those from underrepresented racial and ethnic groups and individuals with disabilities to participate in the research project (See NOT-OD-22-019 and NOT-OD-20-031).
- Description of the special characteristics of the applicant institution that make it appropriate for a REAP grant awarded through this FOA, where the goals of this FOA are to: (1) provide support for meritorious research at health professional or graduate institution or institutional components; (2) strengthen the research environment at these institutions/components; and (3) give health professional, undergraduate and/or graduate students an opportunity to gain significant biomedical research experience through active involvement in the research.
- Description of the likely impact of a REAP grant on the PD(s)/PI(s).
- Description of the likely impact of a REAP grant on the research environment of the applicant institution.
- Description of the likely impact of the REAP grant on the ability of health professional, undergraduate and/or graduate students at the institution to gain experience conducting biomedical research.
- Provide a description of the resources of the grantee institution available for the proposed research (e.g., equipment, supplies, laboratory space, release time, matching funds, etc.).
- Although the majority of the research must be directed by the PD(s)/PI(s) and conducted at the applicant institution, limited use of special facilities or equipment at another institution is permitted. For any proposed research sites other than the applicant institution, provide a brief description of the resources and access students will need and have to these resources.
Other Attachments:The application must include a PDF-formatted letter named "ProvostLetter.pdf" (without quotation marks). For MPI applications a signed Provost letter is required from each involved institution. The letter must be signed by the Provost or similar official with institution-wide responsibility attesting to the following information:
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- The eligible academic component(s) (i.e., the college/school level) must be a health professional or graduate school that awards health professional, baccalaureate or advanced degrees in biomedical and/or biobehavioral sciences.
- All the health professional components of the institution together have received support from the NIH totaling no more than $6 million per year (in both direct and F&A/indirect costs) in 4 of the last 7 years, as described in Section III, "Eligible Organization .
- Validation that the PD(s)/PI(s) has (or in the case of a multiple PD/PI application that all PD(s)/PI(s) have) a primary appointment at the qualifying component (i.e., the college/school level).
Applications that do not contain this signed letter will be withdrawn without review.
All instructions in the SF424 (R&R) Application Guide must be followed.
Biographical Sketch: The PD(s)/PI(s) should include a summary of his or her previous and/or current experience supervising health professional, undergraduate and/or graduate students in research in the Personal Statement. The PD(s)/PI(s) should indicate which peer-reviewed publications or other research products involved undergraduate and/or graduate students under his or her supervision.
R&R or Modular Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
Modular Budget (direct costs of $250,000 or less):
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Budget Period 1: Direct Costs
Direct Costs less Consortium F&A: Select the appropriate dollar amount from the drop-down list. This number must not exceed $250,000.
Budget Justification:
Personnel Justification: Since a primary objective of the REAP is to engage students in meritorious research, the research team must be composed primarily of health professional, undergraduate and/or graduate students from the applicant institution/REAP-eligible component. Indicate aspects of the proposed research in which students will participate. If participating students have not yet been individually identified, the number and academic level of those to be involved should be provided. If there are any Collaborators or Consultants for the project, provide their names, organizational affiliations, and the services they will perform.
R&R Budget (direct costs of $250,001 to $300,000):
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Budget Period 1: Direct Costs
Total Direct Costs less Consortium F&A: This number must not exceed $300,000.
Budget Justification:
Personnel Justification: Since a primary objective of the REAP is to engage students in meritorious research, the research team must be composed primarily of health professional, undergraduate and/or graduate students from the applicant institution/REAP-eligible component. Indicate aspects of the proposed research in which students will participate. If participating students have not yet been individually identified, the number and academic level of those to be involved should be provided. If there are any Collaborators or Consultants for the project, provide their names, organizational affiliations, and the services they will perform.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Other Plan(s):
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: Describe how the proposed plan can achieve the specific aims using a research team composed primarily of health professional, undergraduate and/or graduate students. Describe how students will be engaged in and supervised in conducting hands-on, rigorous research. Describe how students will participate in research activities such as planning, execution, and/or analysis of the research. Describe any other plans for student involvement, such as presentation at local or national meetings, participation in publication of research findings and development of, or participation in, collaborative activities. Formal training plans (e.g., non-research activities, didactic training, seminars) should not be provided, although a brief description of activities related to enhancing students' research capabilities and progress (e.g., the use of individual development plans, etc.) is permitted.
Progress Report Publication List: For renewals, when listing publications, manuscripts accepted for publication, patents, and other printed materials that have resulted from the project, note which of these products have included the work of students conducting research supported by the REAP grant.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) 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 SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. 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, NIH’s 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 Policy on Late Application Submission.
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 SF424 (R&R) Application Guide.
5. Intergovernmental Review (E.O. 12372)
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.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) 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 Component of the SF424(R&R) Application Package. 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 FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
1. Criteria
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
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.
For this particular announcement, note the following:
This FOA has three objectives: (1) provide support for meritorious research at health professional or graduate institutions or institutional components; (2) strengthen the research environment at these institutions/components; and (3) give health professional, undergraduate and/or graduate students an opportunity to gain significant biomedical research experience through active involvement in the research.
The scientific foundation for the proposed research should be established using preliminary data (if available) and/or published data. Although preliminary data are not required for an R15 application, they may be included if available.
Health professional, graduate, and/or undergraduate students in health professional schools as well as graduate and/or undergraduate students in graduate schools, pursuing biomedical or behavioral research, must be included in the research team. Any combination of health professional, graduate and/or graduate students from PIs institutions is allowed on the research team.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to make important scientific contributions to the research field(s) involved; to provide research opportunities to health professional, undergraduate and/or graduate students by engaging them in primary research activities; and to strengthen the research environment of the institution, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in determination of scientific merit, in relation to the REAP program objectives, and give a separate score for each. An application does not need to be strong in all categories to be judged as a high impact REAP application. For example, a solid and interesting scientific research project that is not by its nature innovative or paradigm-shifting, and includes a good plan to engage health professional, graduate, and/or undergraduate students in primary research, may be considered a strong REAP application.
Significance
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
If the aims of the project are achieved, will the data be publishable, disseminated, and important to the field? If funded, will the REAP grant have a substantial effect on the applicant institution in terms of strengthening the research environment and exposing students to research?
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Do the PD(s)/PI(s) have suitable experience in supervising and engaging health professional, undergraduate and/or graduate students in research?
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Does the application take advantage of, challenge or build on current research concepts and models or research techniques? Are innovative approaches to engaging health professional, undergraduate and/or graduate students in research proposed?
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Does the application provide sufficient evidence that the project can stimulate the interests of students so that they consider a career in biomedical or behavioral sciences?
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Does the application demonstrate the likely availability of students to participate in the research project? Does the application demonstrate appropriate plans to recruit health professional, undergraduate and/or graduate students from diverse backgrounds, including those from groups underrepresented in the biomedical research workforce (See NOT-OD-20-031) to participate in the research project? Does the application provide sufficient evidence that students at the REAP-eligible institution/academic component have in the past and/or are likely in the future to pursue careers in the biomedical sciences? Does the PD/PI(s) have sufficient time and institutional support to conduct the proposed project?
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Additional Review Criteria
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.
Study Timeline
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will 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, the committee will 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.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment 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. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine 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
For Renewals, the committee will consider the progress made in the last funding period, as well as whether the application provides sufficient evidence that health professional, undergraduate and/or graduate students have been included in publications in the past.
Revisions
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
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.
Applications from Foreign Organizations
Not Applicable.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
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.
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates
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.
1. Award Notices
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.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
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).
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
- Federalwide Research Terms and Conditions
- Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
- Acknowledgment of Federal Funding
If a recipient is successful and receives a Notice of Award, 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 of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
- Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
- Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
- HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 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.
Not Applicable
Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the 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.
3. Reporting
Progress reports for multi-year funded awards are due annually on or before the anniversary of the budget/project period start date of award. The reporting period for multi-year funded award progress report is the calendar year preceding the anniversary date of the award. Information on the content of the progress report and instructions on how to submit the report using the RPPR are posted at http://grants.nih.gov/grants/policy/myf.htm
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. NIH FOAs 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 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
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: http://grants.nih.gov/support/ (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]
Mahua Mukhopadhyay, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phone: 301-435-6886
Email: [email protected]
National Cancer Institute (NCI)
Telephone (cell): 202-731-8506
Email: [email protected]
Cheri Wiggs
National Eye Institute (NEI)
Phone: (301) 402-0276
E-mail: [email protected]
Aaron D Laposky
National Heart, Lung, And Blood Institute (NHLBI)
Phone: 301-435-0193
E-mail: [email protected]
National Institute on Aging (NIA)
Phone: 301-451-9798
Email: [email protected]
Lisa Chadwick
National Human Genome Research Institute (NHGRI)
Phone: 301-435-7275
E-mail: [email protected]
Li Lin, Ph.D.
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: 301-827-7749
E-mail: [email protected]
Yuki Lama, Ph.D.
National Institute On Drug Abuse (NIDA)
Phone : 301-443-4577
E-mail: [email protected]
Susan L Sullivan, Ph.D.
National Institute On Deafness And Other Communication Disorders (NIDCD)
Phone: 301-496-8683
E-mail: [email protected]
National Institute of Mental Health
Telephone: 667-900-1640
Email: [email protected]
Olga Herren, PhD
National Institute On Minority Health And Health Disparities (NIMHD)
Phone: 301-402-4492
E-mail: [email protected]
Liz Perruccio, MS, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-402-8084
Email: [email protected]
Delany Torres, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-402-9286
Email: [email protected]
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phone: 301-642-4552
Email: [email protected]
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]
Karen Robinsonsmith
National Eye Institute (NEI)
Phone: (301) 451-2020
E-mail: [email protected]
Ryan Lombardi
National Heart, Lung, And Blood Institute (NHLBI)
Phone: (301) 435-0141
E-mail: [email protected]
Ryan Blakeney
National Institute on Aging (NIA)
Phone: 301-451-9802
Email: [email protected]
Deanna L Ingersoll
National Human Genome Research Institute (NHGRI)
Phone: 301-435-7858
E-mail: [email protected]
Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4707
Email: [email protected]
Pamela G Fleming
National Institute On Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: [email protected]
Samantha Tempchin
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-1404
Email: [email protected]
National Institute of Mental Health (NIMH))
Telephone: 301-443-8811
Email: [email protected]
Priscilla Grant
National Institute On Minority Health And Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: [email protected]
Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807
Email: [email protected]
Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [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 45 CFR Part 75.
and Human Services (HHS)
