Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

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 Nursing Research (NINR)

National Cancer Institute (NCI)

Funding Opportunity Title
Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutions (R15 Clinical Trial Required)
Activity Code

R15 Academic Research Enhancement Award (AREA)

Announcement Type
Reissue of PAR-24-214
Related Notices

    See Notices of Special Interest associated with this funding opportunity

  • April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084.
  • August 31, 2022- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 5, 2022- Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
Funding Opportunity Number (FON)
PAR-25-148
Companion Funding Opportunity
None
Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.865, 93.173, 93.273, 93.172, 93.361, 93.867, 93.838, 93.233, 93.837, 93.839, 93.840, 93.279, 93.866, 93.394, 93.395, 93.396, 93.399, 93.393, 93.242
Funding Opportunity Purpose

The purpose of this Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutions 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 undergraduate students and enhancing the research environment at applicant institutions.

Eligible institutions must award baccalaureate 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 non-health professional schools and colleges within the institution as a whole. Consult Part 2. Section III.1 Eligible Organizations for more information.

This Notice of Funding Opportunity (NOFO) supports investigator-initiated mechanistic and/or minimal risk clinical trials such 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, and which address the mission and research interests of the participating NIH institutes.

AREA (Academic Research Enhancement Awards)

Key Dates

Posted Date
November 21, 2024
Open Date (Earliest Submission Date)
January 25, 2025
Letter of Intent Due Date(s)

Not Applicable 

The following table includes NIH standard due dates marked with an asterisk.
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 25, 2025 * February 25, 2025 * May 07, 2025 * July 2025 October 2025 December 2025
June 25, 2025 * June 25, 2025 * September 07, 2025 * November 2025 January 2026 April 2026
October 25, 2025 * October 25, 2025 * January 07, 2026 * March 2026 May 2026 July 2026
February 25, 2026 * February 25, 2026 * May 07, 2026 * July 2026 October 2026 December 2026
June 25, 2026 * June 25, 2026 * September 07, 2026 * November 2026 January 2027 April 2027
October 25, 2026 * October 25, 2026 * January 07, 2027 * March 2027 May 2027 July 2027
February 25, 2027 * February 25, 2027 * May 07, 2027 * July 2027 October 2027 December 2027
June 25, 2027 * June 25, 2027 * September 07, 2027 * November 2027 January 2028 April 2028
October 25, 2027 * October 25, 2027 * January 07, 2028 * 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.

Expiration Date
January 08, 2028
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. 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.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

The National Institutes of Health (NIH) is continuing to make a special effort to stimulate research at educational institutions that graduate baccalaureate students who go on to become the Nation's research scientists, but that have not been major recipients of NIH support.  This Notice of Funding Opportunity (NOFO) aims to support biomedical research projects proposed by faculty members at undergraduate-focused institutions that do not receive substantial funding from the NIH. 

The three objectives of this NOFO are to:

  1. Provide support for meritorious research at undergraduate-focused institutions or institutional components
  2. Strengthen the research environment at these institutions/components
  3. Give undergraduate students an opportunity to gain significant biomedical research experience through active involvement in the research 

For the purpose of this announcement, an undergraduate-focused institution/component is one in which the undergraduate enrollment is greater than the graduate enrollment.

The AREA program will enable eligible organizations to receive support for small-scale research projects led by faculty members. It is anticipated that investigators supported under the AREA program will benefit from the opportunity to conduct independent research; that the grantee institution will benefit from a research environment strengthened through AREA grants; and that students at recipient institutions will benefit from exposure to and participation in scientific research in the biomedical sciences to encourage them to consider careers in biomedical research. This AREA NOFO emphasizes the engagement and inclusion of undergraduates in research.

The research project must involve undergraduate students, and the research team must be composed primarily of undergraduate students. Student involvement in research may include participation in the design of experiments and controls, collection and analysis of data, execution and troubleshooting of experiments, presenting at meetings, drafting journal articles, participation in lab meetings to discuss results and future experiments, etc. The AREA program is a research grant program, not a training or fellowship program, and, as such, applications should not include training plans such as didactic training or non-research activities relating to professional development.

NIH recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse 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 participate in, and benefit from research, and enhancing public trust (see NOT-OD-20-031). To support the best science, NIH encourages inclusivity in research and AREA projects are encouraged to make students from diverse backgrounds aware of potential research opportunities.

This NOFO does not provide support for research at Health Professional Schools as defined in Part 2, Section III.1 Eligible Organizations regardless of student composition.

An AREA application submitted to this NOFO may include other investigators, such as technicians, collaborators, consultants, or other individuals such as high school students, post baccalaureate participants, graduate students, or postdoctoral fellows. However, involvement of such individuals does not fulfill the goal of engaging undergraduate students at eligible institutions in research. In all cases, majority of students conducting research through the award must be undergraduates.

Pre-consultation with IC staff

Participating NIH Institutes and Centers are indicated in Part 1. Overview Components of Participating Organizations. For additional scientific program information and for pre-application guidance, applicants are encouraged to contact the Scientific/Research Contact(s) in Part 2. Section VII 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. 

Institute/Center-Specific Interests

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/about/org/der). 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 and will consider how well research projects align with one or more of those priorities when making award decisions. A detailed list of NICHD high priority research areas may be found at https://www.nichd.nih.gov/grants-funding/opportunities-mechanisms/areas-research/Pages/priorities.aspx.

NCI considers meritorious R15 applications requesting support for cancer research-focused projects across the full spectrum of its mission, including projects focused on studies of cancer biology, etiology, prevention, detection, diagnosis, treatment, control, survivorship, and population sciences. The NCI R15 Program Contact person (listed in the NOFO) can be contacted for more information and guidance about NCI’s mission, priorities, and interests as related to the R15 Program, this R15 funding opportunity announcement, and R15 applications.

NEI’s mission is to eliminate vision loss and improve quality of life through vision research. Integral to achieving this mission is to inspire and train a talented and diverse future research workforce.  The NEI invites applications for research that aligns with our strategic plan.  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 efforts to enhance accessibility for individuals with visual impairment.  NEI will support Clinical Trial applications proposing minimal risk interventions as defined by 45 CFR 46 (i.e., the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests).  NEI will also support clinical trials defined as basic experimental studies involving humans (i.e., a systematic study directed toward understanding the fundamental aspect of phenomena).  Applicants are strongly advised to reach out to the NEI Scientific/Research Contact (listed under Section VII. Agency Contacts) before submitting applications for guidance about NEI’s interests as related to the R15 program and more information regarding clinical trial designations.  Applicants are also encouraged to discuss their research plans with NEI program staff with portfolios in relevant areas.

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. 

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. 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.

NIDA supports innovative research addressing critical issues related to substance use, substance use disorders, and addiction. This includes: neuroscience, genetics, behavior, prevention, treatment, epidemiology, etiology, health services, medication and other therapeutics development, co-occurring infections, such as HIV/AIDS, hepatitis C, tuberculosis, sexually transmitted infections, and other associated consequences of substance use/misuse and use disorders. NIDA priorities are further described in the NIDA Strategic Plan and on the NIDA Notice of Special Interest webpage.. Applicants are encouraged to contact a program official to discuss the proposed application.

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.

NIA will accept applications for research projects in areas within the Institute's mission that includes genetic, biological, behavior, social and economic research on aging.  In addition, NIA encourages applications on Alzheimer's Disease (AD) and AD Related Dementias (ADRD).  The NIA website 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 whose portfolio covers the scientific topic of interest.

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. NIAAA also encourages meritorious research projects on alcohol-related topics of relevance to understanding and addressing minority health and health disparities and that train a diverse research workforce. 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 PD/PI 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.

NIMH has a mission to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. Applications supported 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.

NINDS seeks fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease. NINDS supports basic, translational, and clinical research within specifically defined areas of neuroscience. Research projects considered for funding by NINDS must fall within the scientific research mission of the Institute. A key component of research projects submitted to NINDS in response to this NOFO is to provide an outstanding research experience for undergraduate students, which will enable them to gain a solid understanding of rigorous scientific methodology, experimental design, statistical methodology, and quantitative literacy, within the particular field of study. NINDS also expects the application to contain evidence that the PD/PI fosters an inclusive environment where all voices and perspectives are equally encouraged, as well as a strong commitment to providing effective, supportive mentorship. For this NOFO, projects are limited to prospective basic science studies involving human participants that fall within the broad NIH definition of a clinical trial and meet the definition of basic research as described in NOT-OD-24-118. It is critical that applicants with research interests relevant to the NINDS mission contact the person listed under Agency Contacts (Section VII) to confirm that the proposed research fits the NINDS’ scientific research mission.

NINR supports research aligned with our mission and strategic priorities, conducted by scientists from any discipline. NINR discovers solutions to health challenges through the lenses of health equity, social determinants of health, population and community health, prevention and health promotion, and systems and models of care. Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectoral research that examines the factors that impact health across the many settings in which nurses practice, including homes, schools, workplaces, clinics, justice settings, and the community.

In addition, applicants are encouraged to consult the Frequently Asked Questions website and the NIH Research Enhancement Award R15 website for more information about this program.

See Section VIII. Other Information for award authorities and regulations.

All applications submitted to this Clinical Trial Required AREA NOFO must propose a clinical trial. This NOFO supports investigator-initiated clinical trials proposing mechanistic and/or studies involving low or no more than minimal risk, 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 (NIHGPS 1.2 Definition of Terms).

Clinical trials considered responsive to this NOFO must meet 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://grants.nih.gov/policy/clinical-trials/glossary-ct.htm#NIHDefinedPhaseIIIClinicalTrial).

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 supported through this NOFO.

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 Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutions - clinical trial not allowed NOFO (PAR-24-152). 

Section II. Award Information

Funding Instrument

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New
Renewal
Resubmission
Revision

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.

Clinical Trial?

Required: Only accepting applications that propose clinical trial(s).

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the number of meritorious applications submitted.

Award Budget

Applicants may request up to $375,000 in direct costs, excluding consortium F&A for the entire project period of up to 3 years. 

Award Project Period

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 NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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)

In addition, all organizations must meet the following criteria at the time of application submission:

1. The applicant institution must be an accredited public or non-profit private school that grants baccalaureate degrees in biomedical sciences. This NOFO does not provide support for research from Health Professional Schools and Colleges and 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, MS-SLP, CScD, SLPD, AuD, MSPO, MSAT, and MPH. Health Professional Colleges may include but are not limited to schools of medicine, dentistry, osteopathy, pharmacy, nursing, veterinary medicine, public health, optometry, allied health, chiropractic, naturopathy and podiatry.

The application must be submitted by the eligible undergraduate-focused organization with a Unique Entity Identifier (UEI) and a unique NIH eRA Institutional Profile File (IPF) number.

2. At the time of application submission, all the non-health professional 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 the non-health professional 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. Help determining the Organization Funding Level can be found at https://grants.nih.gov/grants/funding/Determing-Organization-Funding-Levels-R15-Eligibility.pdf  

  • For this NOFO: 
    • An academic component is any school/college that is not a Health Professional School or College.
    • A qualifying academic component (i.e., school/college) within an institution (e.g., School of Arts and Sciences) has greater undergraduate student enrollment than graduate student enrollment.
    • All types of Health Professional Schools and Colleges are not eligible to apply and are not considered in this calculation. 

3. For institutions with multiple campuses, eligibility can be considered for each individual campus (e.g., main, satellite, etc.) only if separate UEIs and NIH IPF numbers are established for each campus. For institutions that use one UEI or NIH IPF number for all campuses, eligibility is determined for all campuses (e.g., main, satellite, etc.) combined.

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. Check 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 and Organization and to consult the NIH Research Enhancement Award R15 website

An AREA grant is permitted to have a subcontract to a non-AREA-eligible institution. However, applicants should keep the goals of the AREA program in mind when preparing the application, including strengthening the research environment of eligible institutions and engaging undergraduate students from eligible institutions in research. The majority of the research must be directed by the PD(s)/PI(s) at the grantee institution.

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.

Required Registrations

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 Late Applicationsfor additional information.

  • 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.
    • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; 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 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.

Eligible Individuals (Program Director/Principal Investigator)

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 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.

To be eligible for an AREA grant, the PD(s)/PI(s) must meet the following additional criteria:

  • Each PD/PI must have a primary appointment at a non-health professional school or college within the applicant institution, as defined in "Eligible Institutions," above. If proposing multiple PD/PI, each PD/PI must be at an AREA-eligible institution.
  • Each PD/PI may not be the PD/PI of an active NIH research grant, including another R15 grant, at the time of award of an AREA grant, although they may be one of the Key Personnel for an active NIH grant held by another PD/PI.
  • Each PD/PI may not be awarded more than one R15 grant at a time, although they may hold successive New or Renewal grants.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

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 Resubmission of an Unfunded 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

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 NOFO. 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 How to Apply - Application Guide except where instructed in this Notice of Funding Opportunity (NOFO) 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.

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

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.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply- Application Guide must be followed.

Facilities & Other Resources: This attachment should include the following information:

  • A profile of the students of the applicant institution and any information or estimate of the number who have obtained a baccalaureate degree and gone on to obtain an academic or professional doctoral degree in the health-related sciences or to pursue careers in biomedical sciences during the last five years. Please note that the race, ethnicity, or sex of students of the applicant institution will not be considered in the application review process or when making funding decisions.
  • Description of plans to inform undergraduate students from diverse backgrounds of potential opportunities to participate in the research project. 
  • Description of the special characteristics of the applicant institution that make it appropriate for an AREA grant to be awarded through this NOFO, where the goals of this NOFO are to: 
    1. Provide support for meritorious research at undergraduate-focused institutions or institutional components
    2. Strengthen the research environment at these institutions/components
    3. Give undergraduate students an opportunity to gain significant biomedical research experience through active involvement in the research
  • Description of the likely impact of an AREA grant on the research environment of the applicant institution.
  • Description of the resources of the applicant 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, the access PD(s)/PI(s) and students will have to these resources and justification for their need.

Other Attachments: The application must include a PDF-formatted letter named "ProvostLetter.pdf" (without quotation marks) signed by the Provost or similar official with institution-wide responsibility attesting to the following information:

  • The eligible academic component(s) (i.e., the college/school level) has more undergraduates than graduate students as of the date of submission.
  • All the non-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/PI has (or in the case of a MPI application that all PD(s)/PI(s) have) a primary appointment at the qualifying component (i.e., the college/school level).

For Multiple Principal Investigators (MPI) applications where the MPIs are from different institutions, a signed Provost letter is required from each involved institution. MPI applications where the MPIs are from the same institution, only require one letter.

Applications that do not contain this signed letter will be withdrawn without review.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply- Application Guide must be followed.

Biographical Sketch:  Each PD/PI should include a summary of their experience supervising and engaging undergraduate students in research in the Personal Statement. The PD(s)/PI(s) should indicate how undergraduate student researchers helped disseminate research results. Products for dissemination may include, among others,  presentations, posters, publications, and datasets.

R&R or Modular Budget

All instructions in the How to Apply- Application Guide must be followed.

  • The total budget for all years of the proposed project must be requested in Budget Period 1.  Do not complete Budget Periods 2 or 3. They are not required and will not be accepted with the application.
  • Applicants submitting an application with direct costs of $250,000 or less (total for all years, excluding consortium Facilities and Administrative [F&A] costs) must use the Modular Budget.
  • Applicants submitting an application with direct costs of $250,001 - $375,000 (total for all years, excluding consortium Facilities and Administrative [F&A] costs) must use the R&R Budget.
  • Students must be compensated for their participation in the lab's research and in accord with institutional policies. Salaries can be requested for students in the R15 budget or other resources at the university can be used to pay them for their participation. Undergraduate students who are compensated from the R15 grant or other institutional funds should receive at least the national minimum wage. Compensation through course credit hours towards graduation is allowable, but must be justified. If universities/colleges provide room and board for summer research students, details must be provided in the application.
  • NIH does not fund stipends for undergraduates on R15 awards.

 

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 AREA program is to engage undergraduate students in meritorious research, the research team must be composed primarily of undergraduate students from the applicant institution/AREA-eligible component. Indicate aspects of the proposed research in which undergraduate 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 $375,000)

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 $375,000.

Budget Justification:

Personnel Justification: Since a primary objective of the AREA program is to engage undergraduate students to meritorious research, the research team must be composed primarily of undergraduate students from the applicant institution/AREA-eligible component. Indicate aspects of the proposed research in which undergraduate 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 Subaward Budget

All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply- Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

Research Strategy: The proposed project should address an important problem in the field. Preliminary data are not required for an R15 application, but they may be included if available. The scientific foundation for the proposed research should be established using preliminary data or published data.  Describe how the proposed plan can achieve the specific aims yielding rigorous data that can be disseminated, with a research team composed primarily of undergraduate students within the timeframes proposed. Describe how undergraduate students will be supervised while conducting research. Describe how undergraduate students will participate in research activities such as planning, execution, and/or analysis of the research. 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. Describe plans to ensure a safe laboratory environment and that all research personnel follow laboratory safety best-practices. 

Progress Report Research Product List: For renewals, when listing research products that have resulted from the project, note which of these products have included the work of undergraduate students conducting research supported by the AREA grant. Research products may include, for example, publications, posters, presentations, patents, and datasets. Distinguish between undergraduate and graduate students.

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:

  • 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.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

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 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 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 How to Apply- Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply- Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

Part I. 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 Grants Policy Statement Section 2.3.9.2 Late 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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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.

7. Other Submission Requirements and Information

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 organization’s 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Mandatory Disclosure

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].

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Provost letters may be solicited at the sole initiative and discretion of NIH. 

Section V. Application Review Information

1. Criteria

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.

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.

For this particular announcement, note the following:

The NOFO has three objectives:

  1. Provide support for meritorious research at undergraduate-focused institutions or institutional components
  2. Strengthen the research environment at these institutions/components
  3. Give students opportunities to gain significant biomedical research experience through active involvement in the research

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.

Overall Impact

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, while providing research opportunities to undergraduate and strengthening 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 evaluate 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 criterion score.

 

Significance

  • Evaluate the importance of the proposed research in the context of current scientific challenges and opportunities, either for advancing knowledge within the field, or more broadly. Assess whether the project will yield rigorous data that can be disseminated and will be important to the field.
  • Evaluate the rationale for undertaking the study, the rigor of the scientific background for the work (e.g., prior literature and/or preliminary data) and whether the scientific background justifies the proposed study.
  • Evaluate the effect of this award on strengthening the institutional research environment and involving [undergraduate or graduate or health professional students] in research.

Innovation

  • Evaluate the extent to which innovation influences the importance of undertaking the proposed research. Note that while technical or conceptual innovation can influence the importance of the proposed research, a project that is not applying novel concepts or approaches may be important for the field.
  • Evaluate whether the proposed work applies novel concepts, methods or technologies or uses existing concepts, methods, technologies in novel ways, to enhance the overall impact of the project.
 

Approach

  • Evaluate the scientific quality of the proposed work. Evaluate the likelihood that compelling, reproducible findings will result (rigor) and assess whether the proposed studies can be done well and within the timeframes proposed (feasibility).
  • Evaluate the proposed plans for engaging undergraduate in meaningful aspects of the research.

Rigor:

  • Evaluate the potential to produce unbiased, reproducible, robust data.
  • Evaluate the rigor of experimental design and whether appropriate controls are in place.
  • Evaluate whether the sample size is sufficient and well-justified.
  • Assess the quality of the plans for analysis, interpretation, and reporting of results.
  • Evaluate whether the investigators presented adequate plans to address relevant biological variables, such as sex or age, in the design, analysis, and reporting.
  • For applications involving human subjects or vertebrate animals, also evaluate:
    • the rigor of the intervention or study manipulation (if applicable to the study design).
    • whether outcome variables are justified.
    • whether the results will be generalizable or, in the case of a rare disease/special group, relevant to the particular subgroup.
    • whether the sample is appropriate and sufficiently diverse to address the proposed question(s).
  • For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research. Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science.

Feasibility:

  • Evaluate whether the proposed approach is sound and achievable, including plans to address problems or new challenges that emerge in the work. For proposed studies in which feasibility may be less certain, evaluate whether the uncertainty is balanced by the potential for major advances.
  • For applications involving human subjects, including clinical trials, evaluate the adequacy and feasibility of the plan to recruit and retain an appropriately diverse population of participants. Additionally, evaluate the likelihood of successfully achieving the proposed enrollment based on age, racial, ethnic, and sex/gender categories.
  • For clinical trial applications, evaluate whether the study timeline and milestones are feasible.
 

Investigator(s)

  • Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work and in supervising and engaging undergraduate students] in research, including dissemination of research results. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.

Environment

  • Evaluate whether the institutional resources, both applicant and other leveraged organization(s) are appropriate to ensure the successful execution of the proposed work.
  • Assess the likely availability of [undergraduate or graduate or health professional students] to participate in the research project. Evaluate plans for informing undergraduate students of opportunities to participate in the research project.
Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.

 

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.

 

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.

 

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.

 

As applicable, evaluate the full application as now presented.

 

As applicable, evaluate the progress made in the last funding period as well as whether the application provides sufficient evidence that undergraduate students have been included in products resulting from past research. Research products may include, for example, publications, posters, presentations, patents, and datasets.

.

 

As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.

Additional Review Considerations

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.

 

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.

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.

Applications will be assigned on the basis of established PHS referral guidelines 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:

  • 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.
  • Portfolio breadth.

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 applicant’s 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 applicant’s 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.

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 Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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 recipient’s 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).

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Data Management and Sharing

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.

4. 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

The three objectives of the AREA R15 program are to: 

1. Provide support for meritorious research at undergraduate-focused institutions or institutional components 

2. Strengthen the research environment at these institutions/components 

3. Give undergraduate students an opportunity to gain significant biomedical research experience through active involvement in the research 

Therefore, progress reports should include information on how the R15 award has strengthened the research environment and specifically in Section B.4 of the RPPR, information on how undergraduates have been actively involved in research and information on outcomes for undergraduates including but not limited to how many students have: 

  • Gone on to and/or graduated from graduate or health professional schools or
  • Found employment in the biomedical workforce. 

Section D.1 of the RPPR should list all researchers, including undergraduate researchers, whether or not they were compensated by the R15 award.

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.

5. Evaluation

In carrying out stewardship of grant programs, NIH will periodically evaluate the AREA R15 program, employing the representative measures identified below. In assessing the effectiveness of research project grant investments, NIH may use information from progress reports and public databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be appropriately contacted after the completion of the grant period for updates on participants’ subsequent outcomes.

The overall evaluation of the program will be based on metrics that may include, but are not limited to, the following:

Characteristics of the applicant and awardee pool for the program, such as:

  • Geographic distribution
  • Investigator demographics
  • Undergraduate student researcher demographics
  • Institution types
  • Scientific topics of supported research

Indicators of scientific accomplishments/productivity, such as:

  • Outcomes for undergraduate student researchers
  • Effects on the institution’s research environment
  • Peer-reviewed research publications and citations
  • Presentations at scientific conferences (talks, posters, etc.)
  • Patent activity among grantees

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

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]

Scientific/Research Contact(s)

Mahua Mukhopadhyay, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6886
Email: [email protected]

Susan L Sullivan
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: 301-496-8683
E-mail: [email protected]

René Etcheberrigaray
National Institute on Aging (NIA)
Telephone: 301-451-9798
Email: [email protected]
 

Cheri Wiggs
NEI - NATIONAL EYE INSTITUTE
Phone: (301) 402-0276
E-mail: [email protected]

Aaron Laposky, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-827-7837
Email: [email protected]

Lisa Chadwick
NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Phone: 301-435-7275
E-mail: [email protected]

Jasenka Borzan, PhD
National Institute of Mental Health (NIMH)
Phone: 667-900-1640
Email: [email protected]

Biman C. Paria, Ph.D., MS (Reg. Sc)
National Cancer Institute (NCI)
Phone: 202-731-8506
Email: [email protected]

Yuki Lama, PhD
NATIONAL INSTITUTE ON DRUG ABUSE (NIDA)
Phone : 301-443-4577
E-mail: [email protected]

Li Lin, Ph.D.
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: 301-827-7749
E-mail:[email protected]

Karen Marie McNamara, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-337-1372
Email: [email protected]
 

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

General R15-Related Review Questions:

Rebecca Burgess, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-480-8034
Email: [email protected]

Financial/Grants Management Contact(s)

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

Samantha J Tempchin
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: (301) 435-1404
E-mail: [email protected]

E.C. Melvin
National Institute on Aging (NIA)
Phone: (301) 594-3912
E-mail: [email protected]

Karen Robinson Smith
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8178
E-mail: [email protected]

Leslye Fulwider
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-480-9544
Email: [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]

Crystal Wolfrey
Phone: 240-276-6277
Email: [email protected]

Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807
Email: [email protected]
 

Section VIII. Other Information

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.

Authority and Regulations

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.

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