Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)

Funding Opportunity Title
Short Courses on Utilizing the NIH Stage Model to Develop Behavioral Interventions to Promote Healthy Aging (R25 - Independent Clinical Trial Not Allowed)
Activity Code

R25 Education Projects

Announcement Type
New
Related Notices
  • 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.
  • July 22, 2019- Requirement for ORCID iDs for Individuals Supported by Research Training, Fellowship, Research Education, and Career Development Awards Beginning in FY 2020. See Notice NOT-OD-19-109.
Funding Opportunity Number (FON)
RFA-AG-25-029
Companion Funding Opportunity
None
Number of Applications

See Section III. 3. Additional Information on Eligibility.

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 foster a better understanding of biomedical, behavioral and clinical research and its implications.

To accomplish the stated over-arching goal, this Notice of Funding Opportunity (NOFO)  will support educational activities with a primary focus on:

  • Courses for Skills Development

The purpose of this NOFO is to invite applications that propose the creation of short courses on utilizing the NIH Stage Model to develop behavioral interventions to promote healthy aging and prevent illness, improve care, foster disease management, assist with end of life decision-making and care, and support the needs of the growing older adult population. 

The term behavioral intervention is used broadly here, to include a variety of non-pharmacological interventions for individuals, dyads, families, groups, communities, organizations, and systems. 

The NIH Stage Model is a conceptual framework of behavioral intervention development composed of the following six stages: 

  1.  Stage 0 - Basic science
  2. Stage I - Intervention generation, refinement, modification, and adaptation and pilot testing 
  3. Stage II - Traditional efficacy testing (Stage II) 
  4. Stage III - Efficacy testing with real-world providers (Stage III); 
  5. Stage IV - Effectiveness research 
  6. Stage V - Dissemination and implementation research

The goal of the NIH Stage Model is to produce potent, scalable, and culturally competent behavioral interventions that are defined by their mechanism(s) of behavior change (MoBC(s); therefore, examination of MoBC is encouraged in every stage of intervention development. The Model can be used for the development of single or multi-component interventions and for interventions meant for individuals, dyads, groups, communities, organizations, or systems. This NOFO supports the development, delivery, and evaluation of a short-course curriculum to equip investigators to apply the NIH Stage Model to intervention development research.

Key Dates

Posted Date
August 2, 2024
Open Date (Earliest Submission Date)
September 06, 2024
Letter of Intent Due Date(s)

September 06, 2024

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
October 08, 2024 Not Applicable Not Applicable March 2025 May 2025 July 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 Notice of Funding Opportunity (NOFO).

Expiration Date
October 09, 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 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 How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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. 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 foster a better understanding of biomedical, behavioral and clinical research and its implications.

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

  • Courses for Skills Development: For example, advanced courses in a specific discipline or research area, clinical procedures for research, or specialized research techniques.

The R25 program supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers. The purpose of this NOFO is to invite applications that propose the creation of short courses on utilizing the NIH Stage Model to develop behavioral interventions to promote healthy aging.

Background

A major goal of the National Institute on Aging (NIA) is to promote the health and well-being of older adults to “extend the healthy, active years of life.” To realize this goal, NIA supports research on behavioral interventions to promote healthy aging and prevent illness (e.g., improve memory, increase physical activity, improve mood, support stress management, encourage good sleep hygiene), improve care, foster disease management (e.g., promote adherence to medical regimens, support caregivers, improve healthcare system practices), assist with end of life decision-making and care, and support the needs of the growing older adult population. The term behavioral intervention is used broadly here, to include a variety of non-pharmacological interventions for individuals, dyads, families, groups, communities, organizations, and societies. NIA’s behavioral intervention development research program is guided by the NIH Stage Model, which is a six-stage intervention development framework that encourages a focus on understanding “how and why” interventions exert their effects. An understanding of how and why interventions work, sometimes called the principle(s) or mechanisms of behavior change (MoBCs) of an intervention, is often helpful, and may be critical to the creation of potent interventions that can be implemented efficiently in the settings where they are needed. Of course, interventions must be culturally competent to work, and understanding how and why an intervention will --or will not—work for particular groups of individuals is crucial to developing culturally competent interventions. So, ascertaining MoBCs to facilitate the development of culturally competent interventions is viewed as essential and is an inherent part of the NIH Stage Model.

NIH Stage Model 

The following are the six Stages of the NIH Stage Model:

  1. Stage 0: Basic Behavioral Science: Questions separate from but related to the MOBC(s) of the intervention being developed are basic behavioral science questions that can be addressed in Stage 0 research. Basic science research questions—research on mechanisms of change—is an integral part of all other stages of intervention development. Such research involves asking basic science questions about behavior change within the context of intervention development studies. Questions of mechanisms of behavior change are relevant to every Stage of behavioral intervention development.
  2. Stage I: Creation, Adaptation, Modification & Pilot-Testing (CAMP) of the full interventions, including procedures for teaching providers to deliver the intervention correctly:
    • CAMP of the InterventionAll studies that seek to create or change (adapt, modify, tailor or refine) and pilot test the feasibility and acceptability of an intervention are Stage I studies.  Stage I studies can be conducted in controlled research settings or in community settings.
    • CAMP of a Training ProcedureTraining procedures may be needed to ensure an interventionist (e.g., a, nurse, peer counselor, psychotherapist, social worker, physician, etc.) can deliver the intervention correctly (with “fidelity”), and the testing of training procedures can be considered interventions in their own right. The development and pilot feasibility and acceptability testing of provider-friendly training procedures (and associated materials) are included in Stage I studies.
  3. Stage II: Traditional Efficacy Testing. Stage II studies test efficacy under highly controlled ideal conditions (e.g., in a research setting), where internal validity is maximized.
  4. Stage III: Efficacy in the “Real World:” Like Stage II, Stage III studies test efficacy. However, Stage III studies involve the delivery of the intervention by an individual, or a group of individuals, in a real-world context, and are conducted with as high internal validity as possible within this real-world setting:
    • Stage III efficacy testing of an intervention consists of the experimental testing of an intervention while maintaining as high a level of control as possible in a real-world setting, with community-based interventionists/providers.
    • Stage III studies testing the efficacy of training materials for real-world providers are often necessary to ensure an intervention can be delivered with fidelity prior to progression to Stages IV and V.
  5. Stage IV: Effectiveness Testing: Stage IV research tests the effectiveness of an intervention. Stage IV tests intervention effectiveness, where the intervention is delivered in community settings by community interventionists (e.g., under actual conditions in the “real world”). Stage IV research strives for maximal external validity.
  6. Stage V ResearchDissemination & Implementation: Stage V research is focused on strategies to disseminate and implement interventions, rather than modifying or testing the intervention itself. Specifically, Stage V seeks to create, modify, and test implementation and dissemination strategies, to achieve an understanding of the principles (or mechanisms) that govern effective dissemination and implementation strategies. Stage V research testing an implementation strategy is sometimes combined with Stage IV effectiveness testing. This is sometimes referred to as a “Type 2 Hybrid.”

Because dissemination and implementation strategies and approaches are behavioral interventions in and of themselves, the intervention development process for implementation strategies can also be conceptualized using the relevant Stages of intervention development (e.g., Stage I [within Stage V], Stage III [within Stage V], etc.).

Henceforth, the six Stages of the NIH Stage Model will be referred to as “the Stages” or the “six Stages.”

The NIH Stage Model goal is to develop maximally potent and implementable interventions defined by the principles through which they work. However, the NIH Stage Model is nonprescriptive. It accommodates intervention research wherever it is in its development. It integrates basic and applied science by encouraging research designs that seek to understand the principles or MoBCs of an intervention, wherever possible in all Stages of intervention development. Consideration of ease of implementation is encouraged as early as possible and as often as necessary, but the Model does not prescribe how this should be accomplished. The Model also does not dictate the use of any particular theory, research design, measure, or statistical analytic approach. It can be used for the development of single or multi-component interventions, and for interventions designed to target mechanisms of change at any level --or multiple levels--of a socioecological model (e.g., the Health Disparities FrameworkThe Social-Ecological Model: A Framework for Prevention, etc.).  The pathway taken through the Stages is also non-prescriptive, except that any pathway proposed requires a scientifically justifiable rationale and a rigorous approach.

The NIH Science of Behavior Change (SOBC) Program shares with the NIH Stage Model a goal of understanding of mechanisms of behavior change. The SOBC mechanism-focused, experimental medicine approach is a methodology that is compatible with the NIH Stage Model. It encourages a clear a priori specification of the intended mechanistic target(s) of an intervention and methods that test causal hypotheses about the degree to which an experimental manipulation or intervention engages those targets. Within the experimental medicine approach to behavior change, intervention targets may include mechanisms or processes at any level of analysis (e.g., environmental, social, contextual, interpersonal, behavioral, psychological, and/or neurobiological). The SOBC program established the expectation that behavior change interventions are designed to explicitly test hypotheses about mechanisms of action, and that they incorporate appropriate measures to enable such tests. This includes testing hypotheses about which components of an intervention are responsible for change in a target mechanism or process, as well as hypotheses about whether changes in that mechanism result in a change in the relevant outcome. The SOBC website provides valuable resources to researchers, including information on the experimental medicine approach, as well as a measures repository, to help achieve this goal.

The National Advisory Council on Aging (NACA) Review  of NIA’s Division of Behavioral and Social Research advised that intervention research be conducted using the NIH Stage Model, with a focus on careful testing of mechanisms of behavior change and for mechanism-based intervention research that aims to reduce health disparities. This NOFO is intended to provide resources for short courses on the NIH Stage Model to help researchers acquire expertise in this Model to achieve these goals, and to foster the creation of potent, scalable interventions that promote healthy aging among all people and support the needs of the growing older adult population.  

Short Course Curriculum

This NOFO will support development of a curriculum that must include instruction in the following 6 broad topics. The sub-bullets are recommended sub-topics for each broad topic.

  1. NIH Stage Model Goals - Understanding the overarching goals of the NIH Stage Model:
    • Developing interventions that are defined by their principles (MoBCs).
    • Identifying principles that allow for an intervention to be maximally potent, scalable and culturally competent.
    • Contributing to behavioral intervention development as a cumulative science.
  2. Stages - Understanding each of the six Stages of intervention development:
    • The goals of each of the six Stages.
    • Examples of relevant research activities in each Stage.
    • Matching research questions to the Stage of intervention development.
    • Navigation through and between the six Stages, emphasizing the iterative nature of the Model.
  3. Mechanisms - Understanding mechanisms, moderators, and mediators of behavior change across the Stages of intervention development:
    • Distinctions between mechanisms, moderators, and mediators of behavior change.
    • The links between behavior change theory and hypothesized MoBCs, moderators, and mediators.
    • Developing and testing hypotheses of the MoBCs of an intervention, based upon testable theories about behavioral, interpersonal, organizational, or systemic change.
    • Measurement of hypothesized MoBCs, moderators, and mediators.
    • Differentiating between adaptations/modifications/tailoring of intervention that are believed to change the hypothesized MoBCs of interventions vs. those that are not believed to change the hypothesized MoBCs.
  4. Fidelity - Understanding the role of intervention fidelity across the Stages of intervention development:
    • Definition of fidelity in accordance with the NIH Stage Model: Fidelity is the degree of consistency with the (hypothesized or known) principles of the intervention.
    • Understanding how to deliver an intervention with fidelity to its principles, while allowing flexibility (e.g., to respect participant’s language and values).
    • Intervention fidelity activities in each Stage, including those related to training, calibrating, supervising/tracking, and re-training interventionists.
    • Developing and testing fidelity methods (e.g., training and tracking procedures) appropriate for different types of interventionists, settings, and interventions. Developing guidance on fidelity methods for community interventionists is of particular interest.
    • Ensuring that hypothesized MoBCs are reflected in intervention training and fidelity procedures.
    • Clarifying the relationship of fidelity to the determination of MoBC: Implications of different intervention fidelity methods for testing MoBCs at each Stage.
  5. Methodology - Understanding research methods and designs appropriate for each Stage that clarify or test MoBCs:
    • Methodologies and study designs appropriate for each Stage that contribute to understanding MoBCs (e.g., multi-component interventions, multi-site designs, adaptive interventions, N=1 interventions, etc.).
    • Statistical considerations of research methodologies and designs at each Stage, and implications for conclusions about MoBCs.
  6. Scalability - Understanding how determining mechanism contributes to the creation of potent, scalable, culturally competent interventions:
    • Differentiating between meaningful adaptations that affect the intervention’s hypothesized principles vs. flexible delivery methods devised to retain consistency with the hypothesized principles governing the intervention.
    • Creating inherently personalized interventions that work across widely disparate groups of individuals who share a common characteristic or problem, amenable to remediation by an intervention that targets this specific characteristic or problem, minimizing the need for later adaptation.
    • Simplifying interventions and their delivery, based upon knowledge of MoBCs.

As long as the curriculum addresses the required topics, short courses may be in any of a variety of formats, delivery modalities, length, and expected time to complete. Curricula should include at least some case studies or examples from aging-related behavioral intervention research, but others may be included too.

Evaluation Plan. Applications must include a plan for evaluating the activities supported by the award.  The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. Wherever appropriate, investigators are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements. Further, applications must:

  • Describe 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.
  • Detail the plans for being responsive to internal and external outcomes analyses, critiques, surveys and evaluations.

Dissemination Plan. Candidates must provide a description of the strategy for dissemination of the short courses as it is critical that these courses reach a broad audience. 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).

Non-Responsiveness Criteria

The following types of applications will be considered non-responsive to this NOFO and will not be reviewed:

  1. Applications that do not develop an NIH Stage Model training curriculum that explicitly addresses the six required topics as described above, and as defined by the NIH Stage Model.
  2. Applications that do not include an evaluation plan for evaluating the activities supported by the award.
  3. Applications that do not include a dissemination plan describing how course materials will be made available nationally.

Additional Considerations

Candidates are 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:

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.

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 recruit participants who will enhance diversity on a national basis.  

Consistent with existing NIH practices and applicable law: (1) Funded programs may not use the race, ethnicity, or sex (including gender identity, sexual orientation, or transgender status) of a participant or faculty candidate as an eligibility or selection criteria, and (2) NIH does not use the race, ethnicity, or sex of prospective participants, participants, or faculty in the application review process or funding decisions.   Applicants and award recipients are encouraged to consult with their General Counsel to ensure all applicable laws and regulations are being followed in program design and implementation.

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

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

The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

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

Funds Available and Anticipated Number of Awards

NIA intends to commit $756,000 in FY 2025 to fund up to 2 awards.

Award Budget

Direct costs up to $350,000 per year may be requested.

Award Project Period

A project period of up to 5 years may be requested. Funds may be requested for a minimum of 8 weeks and a maximum of 14 weeks of research education experience each year.

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

Participants may be compensated for participation in activities specifically required by the proposed research education program, if sufficiently justified. Participant costs must be itemized in the proposed budget.

Allowable participant costs depend on the educational level/career status of the individuals to be selected to participate in the program.

While generally not an allowable cost, with strong justification, participants in the research education program may receive per diem unless such costs are furnished as part of the registration fee. Participants may also receive funds to defray partial tuition and other education-related expenses.

Expenses for foreign travel must be exceptionally well justified.

Individuals supported by NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by an R25 program, as participants, but may not receive salary or stipend supplementation from a research education program.

Because the R25 program is not intended as a substitute for an NRSA institutional training program (e.g.,T32), costs to support full-time participants (supported for 40 hours/week for a continuous, 12-month period) are not allowable.

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.

Funds may be utilized to secure approvals for continuing education credits, as appropriate.

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 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)

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)

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

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

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 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 not allowed. 

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference 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 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 &ndashndash; 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 individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

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. In addition to relevant clinical psychological science expertise in behavioral intervention development, PD(s)/PI(s) may have broader expertise in clinical and/or basic psychological science relevant to intervention development. To achieve the program goals, PD(s)/PI(s) and/or key personnel also may include individuals with experience in mentoring, program evaluation, or university administration. Any of the PD(s)/PI(s) may serve as the contact PD/PI.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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)

No more than two applications are allowed per institution. If two applications are submitted then the 2 awards must address the NIH Stage Model as it relates to behavioral interventions to address a different aspect of healthy aging.

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.

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 How to Apply - 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 IC 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:

Lisa Onken, Ph.D. 
National Institute on Aging (NIA) 
Telephone: 301-402-4447 
Email: Lisa.Onken@nih.gov 

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

Follow all instructions provided in the How to Apply - Application Guide.

SF424(R&R) Project/Performance Site Locations

Follow all instructions provided in the How to Apply - Application Guide.

SF424(R&R) Other Project Information Component

Follow all instructions provided in the How to Apply - 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. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

Other Attachments.

While not required, an Advisory Committee may be useful in structuring and evaluating the program. Please include a plan for the appointment of an Advisory Committee to monitor progress of the research education program, if applicable. 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, and mentoring. 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 How to Apply - Application Guide.

R&R Budget

Follow all instructions provided in the How to Apply - 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 How to Apply - Application Guide.

PHS 398 Research Plan

All instructions in the How to Apply - 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 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. As a reminder, applicants may choose to address one or more of the activities listed in Section I. Funding Opportunity Description.

Program Rationale, Mission, Objectives, and Overall Research Education Plan: Applications must include the rationale for the proposed NIH Stage Model Short Course as well as the feasibility of success in the context of the institutional setting. Specifically, the application should clearly describe the following:

  • The goals and objectives of the proposed research experience program and how they address the NIA mission with respect to using the NIH Stage Model to develop principle-based behavioral interventions.
  • Overall didactic philosophy, strategy, and concepts.
  • The activities that support the participants' scientific development, such as the design and conduct of behavioral intervention research consistent with the NIH Stage Model.
  • The feasibility of the proposed activities and how they relate to the strengths of the institution and describe the benchmarks to be used to assess the success of the research experiences program.
  • Potential problems that may be encountered and describe alternative strategies that could be employed.
  • The timeline for development of the overall NIH Stage Model Course.

Required Components:

Curriculum Content: Applications must propose curricula that instruct on all of the following broad topics:

  1. NIH Stage Model Goals: Understanding the overarching goals of the NIH Stage Model.
  2. Stages: Understanding each of the six Stages of intervention development.
  3. Mechanisms: Understanding mechanisms, moderators, and mediators of behavior change across the Stages of intervention development.
  4. Fidelity: Understanding the role of intervention fidelity across the Stages of intervention development.
  5. Methodology: Understanding research methods and designs appropriate for each Stage that clarify or test MoBCs.
  6. Scalability: Understanding how determining mechanism contributes to the creation of potent, scalable, culturally competent interventions.

Program Oversight, Participating Faculty Selection, and Mentor Training: The application must include the planned strategy and administrative structure to oversee and monitor the program and to ensure appropriate participant progress. The application must describe how the participating faculty are trained to ensure the use of evidence-informed approaches to teaching, training, and mentoring practices that promote the development of participants from all backgrounds, including participants from underrepresented groups in the biomedical sciences (e.g., Notice of NIH's Interest in Diversity). All programs must describe a mechanism to monitor mentoring, including oversight of the effectiveness of the participant/faculty match. 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 behavioral intervention development methodologies that are aimed at the identification of mechanisms of behavior change (e.g., the experimental medicine approach), and the same or another team member with expertise in the identification of essential ingredients/components of behavioral interventions (e.g., factorial designs).
  • A demonstrated commitment to the development of future behavioral intervention researchers to promote healthy aging research workforce, leading recruitment efforts to encourage students from diverse backgrounds to apply for the research education program, and fostering inclusive research environments. 
  • 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 basic or clinical psychological science.
  • 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.
  • Whether the applicant institution is engaged in recruitment efforts to diversify the pool of prospective program faculty.

Program Participants. Applications must identify the career level for which the proposed program is planned. Describe how steps are being taken to tailor coursework and overall content to the target population needs, interests, and career stage. Applications should explain why participants will strongly benefit from participating in this NIH Stage Model short courses program.

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 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 DEIA will be promoted through legally permissible means 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. For purposes of this requirement, “recruitment” refers to outreach efforts intended to encourage individuals to apply for the program. “Recruitment” does not mean the appointment or hiring of an individual into the program. Include outreach strategies and activities designed to recruit prospective participants from groups described in the Notice of NIH's Interest in Diversity. Describe the specific efforts to be undertaken by the training program 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. 

Applications lacking a Recruitment Plan to Enhance Diversity will not be reviewed.

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.

Applications lacking a plan for instruction in responsible conduct of research will not be reviewed.

Evaluation Plan. Applications must include a plan for evaluating the activities supported by the award.  The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. Wherever appropriate,  PI/PDs are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements. Further, applications must:

  • Describe 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.
  • Detail the plans for being responsive to internal and external outcomes analyses, critiques, surveys and evaluations.

Dissemination Plan. Candidates must provide a description of the strategy for dissemination of the short courses as it is critical that these courses reach a broad audience. 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 NOFO.

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - 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 How to Apply - 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 How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed.

PHS Assignment Request Form

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

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

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 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 How to Apply - Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIA, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, candidates 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 NOFO 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 NOFO, note the following:

The goal of this R25 program is to create short courses on utilizing the NIH Stage Model to develop behavioral interventions to promote healthy aging.

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 research 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.

 

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

Specific to this NOFO:

  • How convincing is the evidence that the proposed research education program will provide participants from all backgrounds, including those from underrepresented groups, with the experiences and skills needed to engage in research and innovation on utilizing the NIH Stage Model to develop effective and scalable behavioral interventions that are defined by their mechanisms?
 

How capable is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? To what extent 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? To what extent  is there evidence that the participating faculty have experience in mentoring students and teaching science? To what extent  are the faculty good role models for the participants by nature of their scientific accomplishments? If the project is collaborative or multi-PD/PI, to what extent do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

Specific to this NOFO:

  • To what extent do the PD(s)/PI(s) have a demonstrated commitment to training future behavioral intervention researchers, leading recruitment efforts to encourage students from diverse backgrounds to apply for the research education program, and fostering inclusive research environments?
  • To what extent 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?
  •  To what extent does the team have scientific expertise in behavioral intervention development methodologies that are aimed at the identification of mechanisms of behavior change (e.g., the experimental medicine approach), and the same or another team member with expertise in the identification of essential ingredients/components of behavioral interventions (e.g., factorial designs)?
  • How well described are the administrative structure and leadership succession plan for critical positions (e.g., PD(s)/PI(s))?
  • To what extent do the participating faculty have a record of conducting ethically sound and responsible scientific research?
  • To what extent has the PD(s)/PI(s) engaged in recruitment efforts to diversify the pool of prospective program faculty? For purposes of this review, “recruitment” refers to outreach efforts intended to encourage individuals to apply for the program. “Recruitment” does not mean the appointment or hiring of an individual into the program.
  • To what extent do the PD(s)/PI(s) 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? 
 

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? To what extent is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience?

 

To what extent 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? To what extent is there strong evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? To what extent is the plan for evaluation sound and likely to provide information on the effectiveness of the program? If the proposed program will recruit participants, to what extent are the planned recruitment, retention, and follow-up (if applicable) activities adequate to ensure a relevant and qualified participant pool?

Specific to this NOFO:

  • To what extent does the proposed study provide accurate and appropriate interventions relying on  the principles of the NIH Stage Model?
  • How likely it is that the proposed curriculum will efficiently prepare learners to correctly use the NIH Stage Model to build principle-based behavioral interventions?
 

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

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.

 

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 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.

 

Does the Instruction in Methods for Enhancing Reproducibility plan describe how trainees will be instructed in principles important for enhancing research reproducibility including, at a minimum, evaluation of foundational research underlying a project (i.e., scientific premise), rigorous experimental design, 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? Are the rigor and transparency components sufficiently well integrated into the overall curriculum? Are they taught at multiple stages of trainee development and in a variety of formats and contexts? Does the teaching synergize with elements of the curriculum designed to enhance trainees' abilities to conduct responsible research? Is there evidence that all program faculty reiterate and augment key elements of methods for enhancing reproducibility when trainees are performing mentored research in their laboratories?

 

Not Applicable.

 

Not Applicable.

 

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.

 

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. For purposes of this review, “recruitment” refers to outreach efforts intended to encourage individuals to apply for the program. “Recruitment” does not mean the appointment or hiring of an individual into the program. Reviewers will examine the strategies to be used in the recruitment of prospective participants from underrepresented groups. 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.

 

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.

 

Not Applicable.

 

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

 

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.

 

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), in accordance with NIH peer review policies and practices, 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 NOFO.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the 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 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. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding. 

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.

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.

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 Laws and Regulations Enforced by 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 System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, 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.

The 2023 NIH Policy for Data Management and Sharing policy is not applicable for R25 research education program awards.

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 Training Diversity Report, in accordance with the RPPR Instruction Guide.

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 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.

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 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 (Responsibility /Qualification in SAM.gov, formerly 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.

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, 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, NIH and its ICs 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:

For Courses for Skills Development:

  • Aggregate number and demographic characteristics of participants
  • Educational level of participants
  • Content
  • Participants’ feedback on the program
  • New knowledge or skills acquired
  • Efforts to disseminate the course and course materials beyond the original department, school, institution, etc.
  • Uptake and delivery of the course
  • Evidence that the course is serving its purpose(s)

Section VII. Agency Contacts

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

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

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)

Lisa Onken, Ph.D.
National Institute on Aging (NIA)
Email: lisa.onken@nih.gov

Melissa Riddle, Ph.D.
National Institute on Aging (NIA)
Email: melissa.riddle@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 2 CFR Part 200.

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®