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 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 Cancer Institute (NCI)

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

R15 Research Enhancement Award (REA)

Announcement Type
Reissue of PAR-21-154
Related Notices

    See Notices of Special Interest associated with this funding opportunity

  • 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-24-214
Companion Funding Opportunity
PAR-24-152 , R15 Research Enhancement Awards (REA)
Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.865, 93.273, 93.242, 93.393, 93.173, 93.394, 93.395, 93.396, 93.399, 93.867, 93.837, 93.233, 93.838, 93.839, 93.840, 93.853, 93.866, 93.279, 93.361
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. See Part II. Section 3.1 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.

Key Dates

Posted Date
May 08, 2024
Open Date (Earliest Submission Date)
May 25, 2024
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
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
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

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
May 08, 2027
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; and
  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 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.

All applications submitted to this Clinical Trial Required AREA NOFO must propose a clinical trial. It 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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html).

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://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 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).

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.

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 (see https://www.drugabuse.gov/about-nida/strategic-plan/directors-message) and on the NIDA Notice of Special Interest webpage (see https://www.drugabuse.gov/research/nida-research-programs-activities/nida-notice-special-interest-nosi). 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 focus on the training of 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 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.

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 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-22-205 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-205.html). 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.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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 SF424 (R&R) 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.

Foreign Organizations

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 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for 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.

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 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 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 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 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 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 SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) 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; and 
    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 PD(s)/PI(s).
  • Description of the likely impact of an AREA grant on the research environment of the applicant institution.
  • Description of the likely impact of the AREA grant on the ability of undergraduate 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, the access 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 SF424 (R&R) Application Guide must be followed.

Biographical Sketch:  Each PD/PI should include a summary of their experience supervising 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 SF424 (R&R) 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. Student salaries can be requested 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.

Budget Justification:

Personnel Justification: Since a primary objective of the AREA program is to engage undergraduate students in meritorious biomedical 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 SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy: 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. 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. 

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.

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 application forms packages.

All instructions in the SF424 (R&R) 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 SF424 (R&R) 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 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.

PHS Assignment Request Form

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

4. Submission Dates and Times

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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide.

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 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 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 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.

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.

For this particular announcement, an undergraduate institution/component is one in which the undergraduate enrollment is greater than the graduate enrollment. 

This NOFO has three objectives: 

  1. Provide support for meritorious research at undergraduate-focused institution 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.

Preliminary data are not required for an R15 application, but they may be included if available. Scientific foundation for the proposed research can be established with either preliminary data or published data.

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.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

 

Does the project address an important problem or a 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, will the project yield rigorous data than can be disseminated and is likely to be important to the field? If funded, will the AREA grant have a substantial effect on the applicant institution in terms of strengthening the research environment and engaging undergraduate students in a meaningful research experience?

 

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If investigators are in the early stages of their careers, do they have appropriate scientific experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their scientific field(s)? Do the PD(s)/PI(s) have suitable experience supervising and engaging undergraduate students in research? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

 

Does the application take advantage of, challenge or build on current research concepts and models or research techniques? Although not required, are the approaches to engaging undergraduate students in research particularly innovative? 

 

Are plans for engaging undergraduate students in meaningful aspects of the research clearly outlined in the experimental plan?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? Are plans for engaging undergraduate students in meaningful aspects of the research clearly outlined in the experimental plans? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? Are the plans to ensure safe laboratory environments and the use of safety best practices by research personnel adequate?

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 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?

 

Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Does the application demonstrate the likely availability of undergraduate students to participate in the research project? Does the application demonstrate appropriate plans to recruit undergraduate students from diverse backgrounds including those from groups underrepresented in the biomedical research workforce (See NOT-OD-22-019) to participate in the research project? Does the application demonstrate appropriate plans for informing undergraduate students from groups underrepresented in the biomedical research workforce (See NOT-OD-20-031) of opportunities to participate in the research project? Does the application provide sufficient evidence that students at the AREA-eligible institution/academic component have in the past and/or are likely in the future to pursue careers in the biomedical sciences? Do the PD(s)/PI(s) have sufficient time and institutional support to conduct the proposed project?

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.

 

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)?

 

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.

 

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.

 

The committee will will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

 

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.

 

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.

 

For Renewals, the committee will consider the progress made in the last funding period and whether the application provides sufficient evidence that undergraduate students have been included in products resulting from past research. Research products may include, among others, publications, posters, presentations, patents, and datasets.

 

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.

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.

 

Not Applicable

 

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).

 

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

 

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.

 

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.

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. 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. 

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

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.6. 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 NOFO 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: Generaland 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:

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.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website.

HHS recognizes that NIH 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 NOFO.

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 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.

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; and 

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. 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.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), 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 the threshold.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, 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 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Mahua Mukhopadhyay, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301- 435-6886
Email: mukhopam@mail.nih.gov

Yuki Lama, PhD
NATIONAL INSTITUTE ON DRUG ABUSE (NIDA)
Phone : 301-443-4577
E-mail: NIDAreferral@mail.nih.gov

Liz Perruccio, MS, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-402-8084
Email: liz.perruccio@nih.gov

Delany Torres, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301- 402-9286
Email:delany.torressalazar@nih.gov


René Etcheberrigaray
National Institute on Aging (NIA)
Telephone: 301-451-9798
Email: rene.etcheberrigaray@nih.gov


Biman C. Paria, Ph.D., MS (Reg. Sc)
National Cancer Institute (NCI)
Email:  ncirefof@dea.nci.nih.gov


Cheri Wiggs
NEI - NATIONAL EYE INSTITUTE
Phone: (301) 402-0276
E-mail: cheri.wiggs@nih.gov


Susan L Sullivan
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: 301-496-8683
E-mail: sullivas@nidcd.nih.gov


Aaron Laposky, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-827-7837
Email: laposkya@nhlbi.nih.gov

Li Lin, Ph.D.
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: 301-827-7749
E-mail:li.lin@nih.gov


Aileen Schulte, Ph.D.
National Institute of Mental Health (NIMH)
Phone: 301-443-1225
Email:aschulte@mail.nih.gov


Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov

Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov


Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807
Email: wertzr@mail.nih.gov

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov  


E.C. Melvin
National Institute on Aging (NIA)
Phone: (301) 594-3912
E-mail: e.melvin@nih.gov


Crystal Wolfrey
240-276-6277
wolfreyc@mail.nih.gov


Karen Robinson Smith
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8178
E-mail: kyr@nei.nih.gov


Christopher Myers
NIDCD - NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
Phone: (301) 435-0713
E-mail: cm143g@nih.gov


Leslye Fulwider
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-480-9544
Email: leslye.fulwider@nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: judy.fox@nih.gov


Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
Email: tjarosik@mail.nih.gov


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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