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Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)

Funding Opportunity Title
NIA Expanding Research in AD/ADRD (ERA) Postbaccalaureate Research Education Program (R25 - Independent Clinical Trial Not Allowed)
Activity Code

R25 Education Projects

Announcement Type
New
Related Notices

NOT-AG-23-009 - Notice of Pre-Application Webinar for RFA-AG-24-012 and RFA-AG-24-013 on Postbaccalaureate and Summer Research Programs in AD/ADRD

NOT-OD-22-189 - Implementation Details for the NIH Data Management and Sharing Policy

NOT-OD-22-195 - New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023

NOT-OD-22-198 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023

NOT-OD-19-109 - Requirement for ORCID iDs for Individuals Supported by Research Training, Fellowship, Research Education, and Career Development Awards Beginning in FY 2020.

NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available

Funding Opportunity Announcement (FOA) Number
RFA-AG-24-012
Companion Funding Opportunity
RFA-AG-24-013 , R25 Education Projects
Assistance Listing Number(s)
93.866
Funding Opportunity Purpose

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this R25 program is to support educational activities that encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research.

To accomplish the stated over-arching goal, this FOA will support educational activities with a primary focus on:

  • Research Experiences

This Funding Opportunity Announcement (FOA) invites R25 applications to support the development and implementation of research education programs for recent baccalaureates from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences. It is essential to expand and diversify the skilled Alzheimer’s Disease (AD) and Alzheimer’s Disease and Related Dementias (ADRD) research workforce and provide exposure to AD/ADRD research to individuals early in their careers. The proposed research education programs will support intensive research experiences in the AD/ADRD field with the goal of preparing recent baccalaureates to transition into strong, research-focused advanced degree programs or competitive private sector research careers in AD-related disciplines.

This FOA does not allow participants to lead an independent clinical trial, but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor.

Key Dates

Posted Date
March 13, 2023
Open Date (Earliest Submission Date)
April 24, 2023
Letter of Intent Due Date(s)

April 24, 2023; April 24, 2024

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
May 24, 2023 May 24, 2023 Not Applicable October 2023 January 2024 April 2024
May 24, 2024 May 24, 2024 Not Applicable November 2024 January 2025 April 2025

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.

No late applications will be accepted for this Funding Opportunity Announcement.

Expiration Date
May 25, 2024
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 SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.


Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers.

The overarching goal of this R25 program is to support educational activities that encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research.

Background

A major goal of the National Plan to address Alzheimer’s Disease (AD) and Alzheimer’s Disease-related Dementias (ADRD) is to reduce the burden of AD/ADRD by accelerating research toward treatments, improving care and support for people facing these conditions now, and reducing the risk of AD/ADRD by promoting brain health. Despite this, there is a shortage of scientists conducting the wide variety of necessary innovative and interdisciplinary research projects, including basic biomedical, clinical, translational, prevention, and treatment research on AD/ADRD. This Funding Opportunity Annoucnment (FOA) aims to address goal G-4 of the National Institute on Aging's Strategic Directions for Research (2020-2025): "Attract and train more researchers from diverse scientific and cultural backgrounds." This will include supporting the recruitment of a variety of early-stage investigators from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to the NIH AD/ADRD portfolio. This FOA also aims to address the lack of early exposure to high-quality, hands-on research education experiences in the AD/ADRD field, another major barrier to increasing the AD/ADRD capable workforce.

To further expand the AD/ADRD training pipeline, NIA will support one-to-two-year intensive research experiences for recent baccalaureates, with a focus on receipt of mentorship for pursuing future research careers. The expectation is that such a program would help to transition the next generation of early-stage investigators into research careers representative of NIA mission critical areas, namely AD/ADRD research. Proposed programs should involve participants in independent research projects in AD/ADRD as it relates to aging. Participants will be required to work as research postbaccalaureates at nine person-months (75% full-time) effort, with the other three person-months (25% full-time effort) devoted to further academic and professional development. Academic development opportunities may include courses, seminars, or supplemental instruction that will enhance the technical, operational, and professional skills of the participants. Training in rigor and reproducibility is required. Professional development opportunities may include entrance exam preparation and conference and workshop participation. Program training objectives and mentoring activities should be grounded in literature and enable trainees to pursue advanced degrees and other research-related science career opportunities.

Focus on Postbaccalaureates: Postbaccalaureate programs consist of studies pursued after the completion of one's bachelor’s degree, but before entering an advanced degree program, such as a master s, doctoral, or clinical degree program. The Association of American Medical Colleges (AAMC) reports an increased number of prospective medical students taking time off between the completion of their undergraduate education and enrollment in medical school. While students may take these gap years for a variety of reasons and be involved in a range of activities, almost half of such students report being involved in research during this time. Moreover, the COVID-19 pandemic has impacted students decisions to take gap years in a way that has been leading to a rise in the number of students taking this path. Literature shows that postbaccalaureate programs enable recent graduates to pursue advanced degrees and other research-related science career opportunities.

For the purpose of this announcement, institutions should explain how this program will be developed in a way that will foster diversity and inclusion at their organization. As indicated below, applicants must include a Recruitment Plan to Enhance Diversity which describes the program’s proposed recruitment efforts and how the proposed plan reflects past experiences in recruiting individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences (see NOT-OD-20-031 for additional information on NIH's Notice of Interest in Diversity). All programs are expected to be inclusive, supportive, and safe, and to provide opportunities for participants to interact with investigators who could contribute to their growth. Applications from a variety of institutions, including those from minority serving institutions (MSIs), are encouraged.

Applicants should consider how the developed programs can optimize participation and potentially include additional participants from outside the applicant institution, especially those in local and/or affiliated institutions. Applicants must demonstrate how this program will add significant value over existing programs at the applicant institution.

Each institution must have a unique program structure that maximizes resources, departments, and faculty at the applicant institution. Applicants are encouraged to propose collaborations with affiliated and/or local institutions, as appropriate. Applicants are also encouraged to partner with existing NIH-funded or other federally funded resources and programs and leverage training activities from both federal and private-sector partners including, but not limited to, the following:

Non-Responsiveness Criteria

Applications that propose programs primarily outside of AD/ADRD research, or have a general STEM focus, will be considered non-responsive to this FOA and will be withdrawn prior to review.

Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. R25 programs may augment institutional research training programs (e.g., T32, T90), but cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New
Resubmission
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trial(s).

Note: Appointed participants are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor.

Funds Available and Anticipated Number of Awards

NIA intends to commit $2,000,000 in FY 2024 and FY 2025 to fund up to 5 awards each year.

Award Budget

Direct costs up to $400,000 per year may be requested.

Award Project Period

The scope of the proposed project period should determine the project period. The maximum period is five years.

Other Award Budget Information

Personnel Costs

Individuals designing, directing, and implementing the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with participants are not allowable costs from grant funds).

Participant Costs

Applications may request up to twelve postbaccalaureate positions for each year of the grant for individuals to engage in mentored research experiences. Remuneration for ERA Postbacc participants is through salary and wages. The total compensation package for participants can include fringe benefits, and tuition remission and fees (if applicable and necessary for the program). ERA Postbacc participants will be required to work as research postbaccalaureates devoting a minimum of 9 person-months (75% of full-time professional effort), and the remaining 3 person-months (25% effort) will be for further professional or academic development. In order for the participant to receive this compensation, the following conditions must be met:

  • The ERA participant must be performing necessary work relevant to the proposed research experience.
  • There must be an employee-employer relationship between the participant and the university.
  • The total compensation must be reasonable for the work performed.
  • It is the institution's practice to provide commensurate compensation for all individuals in similar circumstances, regardless of the source of support for the activity.
Other Program-Related Expenses

Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.

Limited program evaluation costs are allowed up to a maximum of $3,000 per year. This includes salaries for evaluation consultants, if any.

Reasonable expenses per participant may be requested to support participant travel to the research site or to a domestic scientific conference.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, expenditures for equipment and consortium costs in excess of $25,000), rather than on the basis of a negotiated rate agreement.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

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)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Governments

  • Local Governments
  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal
  • Governments (Other than Federally Recognized)

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving federal support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • 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 registration; 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.

NIA encourages multiple PD(s)/PI(s), particularly when each brings a unique perspective and skill set that will enhance the research education program. The PD(s)/PI(s) must be able to provide both administrative and scientific leadership to the development and implementation of the proposed program. At least one of the PD(s)/PI(s) should be an investigator with an active research program in an AD/ADRD-related discipline (e.g., as demonstrated by recent publications and current research support). Additional PD(s)/PI(s), including individuals with experience in the science of education, relevant social science disciplines, program evaluation, mentoring; diversity, equity, inclusion, and accessibility (DEIA) work; or university administration may be included to achieve the program goals. Any of the PD(s)/PI(s) may serve as the contact PD/PI.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

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 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.

Program Faculty

Researchers from a variety of backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, are encouraged to participate as preceptors/mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.

Participants

Unless strongly justified on the basis of exceptional relevance to NIH, research education programs should be used primarily for the education of U.S. citizens and permanent residents. Additionally, participants must have a baccalaureate degree.

The overarching goal of this program is to develop a diverse pool of well-trained postbaccalaureate participants who will transition into biomedical research careers or doctoral programs focused on AD/ADRD research. Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support, and maintain the quality of our scientific human capital. In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student, postdoctorate and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical and behavioral sciences (e.g., see the Notice of NIH's of Interest in Diversity). For the purpose of this announcement, institutions are strongly encouraged to identify candidates who will enhance diversity on a national basis. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in this program.

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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions will not be reviewed.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIA staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

NIA Training and Career Development
National Institute on Aging (NIA)
Email: NIATraining@mail.nih.gov

Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

Follow all instructions provided in the SF424 (R&R) Application Guide.

SF424(R&R) Project/Performance Site Locations

Follow all instructions provided in the SF424 (R&R) Application Guide.

SF424(R&R) Other Project Information Component

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

Facilities & Other Resources. Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.

Other Attachments.

Advisory Committee: An Advisory Committee is strongly encouraged as a component of the Research Education program. If an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the research education program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. New applications should not include the names of proposed Advisory Committee members, and proposed members should not be contacted prior to peer review. Please name your file Advisory_Committee.pdf .

Program Faculty Biosketches: Biosketches of Program Faculty must be included. The personal statement should describe a commitment to scientific rigor, training, mentoring, as well as promoting diverse, inclusive, safe, and supportive scientific environments. Please upload all of the biosketches as a single PDF and name your file Program Faculty Biosketches.pdf .

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

SF424(R&R) Senior/Key Person Profile Expanded

Follow all instructions provided in the SF424 (R&R) Application Guide.

R&R Budget

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

  • Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
  • Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.
PHS 398 Cover Page Supplement

Follow all instructions provided in the SF424 (R&R) Application Guide.

PHS 398 Research Plan

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

Research Strategy

Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components described below:

  • Proposed Research Education Program
  • Program Director/Principal Investigator
  • Program Faculty
  • Program Participants
  • Institutional Environment and Commitment
  • Recruitment Plan to Enhance Diversity
  • Plan for Instruction in Methods for Enhancing Reproducibility
  • Plan for Instruction in the Responsible Conduct of Research
  • Evaluation Plan
  • Dissemination Plan

Research Education Program Plan

Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program.

Program Rationale, Mission, Objectives, and Overall Research Education Plan: Applications must include the rationale for the proposed NIA ERA program as well as the feasibility of success in the context of the institutional setting. Describe and summarize institutional and externally sponsored programs to enhance diversity in the biomedical sciences at the participating institution within the last five years. Specifically, the application should describe the following:

  • The program mission (i.e., broad statement of purpose of the program), and objectives (i.e., specific measurable outcomes the program intends to achieve). Objectives should include, but not be limited to, program completion rates, the rate of transitioning into AD/ADRD-focused careers or advanced degree programs.
  • The application must describe how the activities will employ evidence to inform approaches to postbaccalaureate participant learning, critical thinking, mentorship, inclusion, and professional development.
  • The rationale and strategies used for selecting participants and a clear description of why the participants selected would benefit from additional preparation prior to applying to AD/ADRD-focused research positions or advanced degree programs.
  • The application must describe the activities that will build a strong cohort of research-oriented postbaccalaureate participants while enhancing the science identity, self-efficacy, and a sense of belonging among the cohort members.

Professional Development: The application should describe how the program participants will:

  • Be provided with adequate and appropriate information regarding the variety of careers in the biomedical research workforce for which their training would be useful; and
  • Learn the skills, knowledge, and steps needed to attain positions in the sectors of the AD research workforce that are of interest to them.

Program Oversight, Participating Faculty Selection, and Mentor Training: The application must include the planned strategy and administrative structure to select faculty, ensure faculty participate in training in mentorship, match participants to appropriate participating faculty, and oversee and monitor the program and to ensure appropriate participant progress. All programs must have a mechanism to monitor mentoring, including oversight of the effectiveness of the participant/faculty match, and a plan for removing faculty displaying unacceptable mentorship qualities from the research education program. If a program will utilize an Advisory Committee for oversight, provide details in the Advisory Committee attachment. If a program coordinator or administrator position is planned to enhance oversight, a description of the person's administrative capabilities that are essential to coordinate the program must be included in the application.

Program Director/Principal Investigator. Describe arrangements for administration of the program. Provide evidence that the Program Director/Principal Investigator is actively engaged in research and/or teaching in an area related to the mission of NIH, and can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple PDs/PIs, describe the complementary and integrated expertise of the PDs/PIs, their leadership approach, and governance appropriate for the planned project.

NIA encourages multiple PD(s)/PI(s) (MPI), particularly when each brings a unique perspective and skill set that will enhance the research education program as described in the Eligible Individuals section above. The application must expand on the information in the biosketch(es) to address how the PD/PI or PD/PI team has the following:

  • The administrative and training experience and skills to provide strong leadership, direction, management, and administration of the proposed research education program;
  • The time to commit sufficient effort to ensure the program’s success given other professional obligations (the application should indicate the program director’s effort in person months in the proposed program);
  • At least one member who has scientific expertise in AD/ADRD and who has a record of using rigorous and transparent methods in experimental design, data collection, analysis, and reporting;
  • A demonstrated commitment to the development of the next generation of AD/ADRD research workforce, leading recruitment efforts to enhance diversity, and fostering inclusive research environments. The PD(s)/PI(s) must receive training on how to effectively mentor participants from all backgrounds, including individuals from groups underrepresented in the biomedical sciences (Notice of NIH's Interest in Diversity).
  • The administrative structure and leadership succession plan for critical positions (e.g., PD(s)/PI(s)).

Program Faculty. Researchers from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, are encouraged to participate as program faculty. Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles. The application must address the following:

  • Whether the participating faculty have sufficient time to commit to the research education program given their other professional obligations;
  • Whether the participating faculty have a record of conducting ethically sound and responsible scientific research;
  • How the participating faculty receive training in the use of effective, evidence-informed mentoring and teaching practices that promote the development of participants from all backgrounds, including participants from underrepresented groups in the biomedical sciences;
  • How the participating faculty demonstrate a commitment to effective mentoring and to promoting inclusive, safe, and supportive scientific and training environments;
  • How the participating faculty are evaluated as mentors and teachers; and
  • Whether the applicant institution is engaged in recruitment efforts to diversify the pool of prospective program faculty.

Program Participants. The application must describe the steps to be taken to engage and retain students from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences. Describe how the program will identify eligible recent baccalaureates interested in AD/ADRD research. Program candidates must have the potential to strongly benefit from, and with proper support, succeed in the program and transition into rigorous research-oriented AD/ADRD-related careers or advanced degree programs. Applications should explain why participants will strongly benefit from participating in the NIA ERA program rather than going directly to research positions or advanced degree granting programs.

Institutional Environment and Commitment. Describe any additional aspects of the Institutional Environment and Commitment not addressed under Facilities & Other Resources or the required Institutional Commitment Letter of Support, described below. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. This section should not duplicate information provided elsewhere.

Each application must additionally describe the following:

  • An institutional commitment to advance the highest standards of safety, scientific rigor, reproducibility, and responsible conduct of research;
  • Policies and procedures in place to protect the participants from harassment and other prohibited practices;
  • How diversity, equity, inclusion, and accessibility (DEIA) will be promoted at each level of the research environment, including among program participants, staff, faculty, and leadership;
  • Accessibility of the research facilities to participants with disabilities;
  • Institutional support for any core facilities or technology resources necessary for the success of the program; and
  • Where applicable, how the proposed program will add significant value over existing programs at the applicant institution.

Recruitment Plan to Enhance Diversity. The applicant must provide a Recruitment Plan to Enhance Diversity. Include outreach strategies and activities designed to recruit prospective participants from diverse backgrounds (e.g. those from groups described in the Notice of NIH's Interest in Diversity). Describe the specific efforts to be undertaken by the training program and how these might coordinate with recruitment efforts of the institution and reflect past experiences in recruiting individuals from underrepresented groups. Centralized institutional efforts alone will not satisfy the requirement to recruit individuals from underrepresented groups. Participating faculty are expected to be actively involved in recruitment efforts.

Plan for Instruction in Methods for Enhancing Reproducibility. Applicants are required to provide a Plan for Instruction in Methods for Enhancing Reproducibility. The plan must describe how participants will be instructed in principles important for enhancing research reproducibility including, at a minimum, critical evaluation of foundational research underlying a project, rigorous experimental design and data interpretation, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, data and material sharing, record keeping, and transparency in reporting. Applicants are encouraged to consult the NIGMS Clearinghouse for Training Modules to Enhance Data Reproducibility and other resources when developing the plans.

Plan for Instruction in the Responsible Conduct of Research. All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019 and NOT-OD-22-055. The plan should be appropriate and reasonable for the nature and duration of the proposed program.

Evaluation Plan. Applications must include a plan for evaluating the activities supported by the award. The application must describe the following:

  • The evaluation or assessment process to determine whether the overall program is effective in meeting its mission and objectives, and whether the scientific research climate is inclusive, safe, and supportive of participant development. The application should additionally:
  • Detail the plans for being responsive to internal and external outcomes analyses, critiques, surveys and evaluations; and
  • Explain how the plan will effectively track participant career outcomes, provide information to prospective and current program participants about outcomes, and ensure the data collection and storage methods will be safeguarded and preserved.

Dissemination Plan. A specific plan must be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the research education program (e.g., sharing course curricula and related materials via web postings, presentations at scientific meetings, workshops).

Letters of Support

A letter of institutional commitment must be attached as part of Letters of Support (see section above: "Institutional Environment and Commitment."

Resource Sharing Plan
Note: Effective for due dates on or after January 25, 2023, a Data Management and Sharing Plan is not applicable for this FOA.

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

When relevant, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

  • Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.
  • The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
  • To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Appendix

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

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 Policy on Late Application Submission.

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

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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.

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.

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 and responsiveness by NIA, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIA Scientific Review Branch by email at ramesh.vemuri@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD(s)/PI(s) name(s), and title of the application.

Post Submission Materials

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

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, note the following:

The goal of this R25 program is to develop a diverse pool of well-trained postbaccalaureate participants who will transition into biomedical research careers or doctoral programs focused on AD/ADRD research.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to strongly advance research education by fulfilling the goal of this R25 Education Program, 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.

Significance

Does the proposed program address a key audience and an important aspect or important need in research education? Is there convincing evidence in the application that the proposed program will significantly advance the stated goal of the program?

For this particular FOA, note the following additional questions:

How well targeted is the program towards developing a diverse pool of well-trained postbaccalaureate participants who will transition into biomedical research careers or doctoral programs focused on AD/ADRD research? Is there convincing evidence that the proposed research education program will provide participants from diverse backgrounds with the experiences and skills that will allow them to transition into research-focused advanced degree programs or AD/ADRD-focused research careers?

Investigator(s)

Is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

For this particular FOA, note the following additional questions:

Do the PD(s)/PI(s) have a demonstrated commitment to training the next generation of AD/ADRD research workforce, leading recruitment efforts to enhance diversity, and fostering inclusive research environments?

Does the PD/PI team have the administrative and training experience and skills to provide strong leadership, direction, management, and administration of the proposed research education program?

Does at least one member of the PD/PI team have a demonstrated record of using rigorous and transparent methods in experimental design, data collection, analysis, and reporting in an AD/ADRD-related field?

Have the PD(s)/PI(s) and participating faculty received training on how to effectively mentor participants from various backgrounds, including those underrepresented in the biomedical and behavioral sciences, and promote inclusive, safe, and supportive research training environments?

Are the administrative structure and leadership succession plan for critical positions (e.g., PD(s)/PI(s)) well described?

Do the participating faculty have a record of conducting ethically sound and responsible scientific research?

Has the applicant institution made efforts to recruit prospective faculty from diverse backgrounds including individuals from groups underrepresented in the biomedical and behavioral sciences? If not, are there plans to recruit faculty to enhance the program faculty diversity?

Do the PD/PIs and participating faculty have the time to commit sufficient effort to ensure the program's success and participants' development and success, given their other professional obligations?

Innovation

Taking into consideration the nature of the proposed research education program, does the applicant make a strong case for this program effectively reaching an audience in need of the program’s offerings? Where appropriate, is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience?

For this particular FOA, note the following additional questions:

How innovative is the application in engaging recent baccalaureates from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, and sustaining their interest in Alzheimer’s disease research?

Approach

Does the proposed program clearly state its goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome? Is there evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? Is the plan for evaluation sound and likely to provide information on the effectiveness of the program? If the proposed program will recruit participants, are the planned recruitment, retention, and follow-up (if applicable) activities adequate to ensure a highly qualified participant pool?

For this particular FOA, note the following additional questions:

Are the rationale and strategies for recruiting and selecting participants who will strongly benefit from participating in the NIA ERA program rather than going directly to research-focused advanced degree programs or careers well-conceived?

Does the program employ modern, evidence-informed approaches to training, mentorship, inclusion, and professional development?

Are the activities likely to enhance the science identity, self-efficacy, and a sense of belonging among the cohort members?

Does the application describe an effective strategy and administrative structure to oversee and monitor the program to ensure appropriate and timely progress for the participants?

Is there a clear mechanism for matching the participants with appropriate participating faculty, and for monitoring mentoring, including oversight of the effectiveness of the participant/faculty match?

Is there a plan for removing participating faculty displaying unacceptable mentorship qualities from the training program?

If a program coordinator or administrator position is planned, is there a description of the person's administrative capabilities that are essential to coordinate the program?

Is the plan for dissemination of findings or materials developed under the auspices of the program to the broader training community well described?

Environment

Will the scientific and educational environment of the proposed program contribute to its intended goals? Is there a plan to take advantage of this environment to enhance the educational value of the program? Is there tangible evidence of institutional commitment? Is there evidence that the faculty have sufficient institutional support to create a sound educational environment for the participants? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, and institutions?

For this particular FOA, note the following additional questions:

Is there clear institutional commitment to develop and promote a culture in which the highest standards of safety, scientific rigor, reproducibility, and responsible conduct of research are advanced?

Are the core facilities and technology resources necessary for the success of the program well supported?

Is there evidence that the research facilities and laboratory practices ensure the safety of program participants (and trainees generally)?

Are diversity, equity, inclusion, and accessibility (DEIA) promoted at all levels of the research environment, including among participants/trainees, staff, faculty, and leadership?

Are appropriate policies and procedures in place to protect the participants from harassment and other prohibited practices?

Are the research facilities accessible to participants/trainees with disabilities?

If applicable, does the application demonstrate how this program will add significant value over existing programs at the applicant institution?

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.

Recruitment Plan to Enhance Diversity

Does the Recruitment Plan to Enhance Diversity describe a robust plan for outreach and recruitment of a diverse postbaccalaureate cohort, including individuals underrepresented in biomedical research? Will the program sufficiently leverage partnerships with other institutions to broaden their outreach and recruitment efforts?

Plan for Instruction in Methods for Enhancing Reproducibility

Does the Plan for Instruction in Methods for Enhancing Reproducibility describe a strong plan for instructing participants in principles important for enhacing research reproducibility? Does the curriculum cover, at a minimum, critical evaluation of foundational research underlying a project, rigorous experimental design and data interpretation, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, data and material sharing, record keeping, and transparency in reporting?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Revisions

Not Applicable

Renewals

Not Applicable

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.

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the proposed research education program, the level of participant experience, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also: NOT-OD-10-019 and NOT-OD-22-055. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Resource Sharing Plans

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. If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the proposed software dissemination plan.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute on Aging, 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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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 FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Aging (NACA). The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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 FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that 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.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.

Programs that involve participants should report on education in the responsible conduct of research and complete a Trainee Diversity Report, in accordance with the RPPR Instruction Guide.

NIH FOAs outline intended research goals

and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees 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.

Failure by the recipient institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

In accordance with the regulatory requirements 45 CFR Part 75 and 2 CFR Part 200 and Appendix XII to 45 CFR Part 75.113 and 2 CFR Part 200.113, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Other Reporting Requirements

  • The institution must submit a completed Statement of Appointment (PHS Form 2271) for each participant appointed full time for eight weeks or more or the equivalent. Recipients must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
  • Participant Termination Notice: Within 30 days of the end of the total support period for each participant, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each participant appointed full time for eight weeks or more, or the equivalent.

A final RPPR 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.

5. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH or its Institutes and Centers will periodically evaluate their R25 research education programs, employing the measures identified below. In assessing the effectiveness of its research education investments, NIH may request information from databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be contacted after the completion of a research education experience for periodic updates on participants subsequent educational or employment history and professional activities.

Upon the completion of a program evaluation, NIA will determine whether to (a) continue a program as currently configured, (b) continue a program with modifications, or (c) discontinue a program.

In evaluating this research education program NIA expects to use the following evaluation measures:

  • Aggregate number and demographic characteristics of participants
  • Subsequent educational/career progress, including the following:
    • Enrollment in an advanced degree program in an AD/ADRD-related field
    • Subsequent participation in a formal research training or career development program in an AD/ADRD-related field
    • Subsequent participation in research
    • Subsequent employment in a biomedical research or research-related field

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: 301-480-7075

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

SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg

Scientific/Research Contact(s)

NIA Training and Career Development
National Institute on Aging (NIA)
Email: NIATraining@mail.nih.gov

Peer Review Contact(s)

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9666
Email: ramesh.vemuri@nih.gov

Financial/Grants Management Contact(s)

Jessi Perez
National Institute on Aging (NIA)
Telephone: 301-402-7739
Email: perezj@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 45 CFR Part 75 and 2 CFR Part 200.

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