Department of Health
and Human Services (HHS)
and Human Services (HHS)
National Institutes of Health (NIH)
National Institute on Aging (NIA)
R01 Research Project Grant
See Notices of Special Interest associated with this funding opportunity
This Funding Opportunity Announcement (FOA) solicits mechanism-focused dementia care and caregiver support intervention development research at Stages I through V of the NIH Stage Model to address the care needs and promote the health, function, and well-being of persons with Alzheimer’s disease (AD) and Alzheimer’s disease-related dementias (ADRD) and of those providing their care. The NIH Stage Model offers a framework to: (1) support development of efficacious interventions that are defined by their principles; and (2) ensure that these efficacious interventions can be administered in the community or in health systems with fidelity to the intervention’s principles. This includes the development, testing, and validation of scalable training materials and procedures so that these interventions can be delivered with fidelity in community settings or health systems. Settings can include the home, community, or formal care settings, such as nursing homes, assisted living facilities, nursing and rehabilitation centers, hospitals, adult day care, and specialized hospice settings. The overarching purpose of this FOA is to help to lay the groundwork for real-world implementation of AD/ADRD care and caregiving interventions.
The principle-based interventions under development may target behavioral, psychological, interpersonal, social, or institutional processes and may be designed for use at the individual, family, dyad, group, community, or health-systems level. Applications may propose mechanism-focused intervention research for individuals living with dementia or for individuals or systems providing care for people at any stage of AD/ADRD. Applications proposing the development of interventions that address the principles underlying the care needs and challenges for individuals from diverse racial, ethnic, and socioeconomic backgrounds are strongly encouraged. Applications that involve interdisciplinary expertise and translational expertise (e.g., basic behavioral, social, psychological, or neurobiological science expertise relevant to hypothesized intervention mechanisms; expertise in the AD/ADRD service delivery system; and clinical psychological science expertise in areas outside of aging or AD/ADRD, but potentially relevant to AD/ADRD caregiver research, etc.) are also strongly encouraged. Applications may propose to create, modify, and test AD/ADRD care and caregiver support interventions based upon hypothesized mechanisms of action and are encouraged to incorporate a test of essential components or mechanisms of change using an appropriate methodological approach.
30 days prior to the application due date
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| October 07, 2021 | October 07, 2021 | Not Applicable | March 2022 | May 2022 | July 2022 |
| February 10, 2022 | February 10, 2022 | Not Applicable | July 2022 | October 2022 | December 2022 |
| October 11, 2022 | October 11, 2022 | Not Applicable | March 2023 | May 2023 | July 2023 |
| February 10, 2023 | February 10, 2023 | Not Applicable | July 2023 | October 2023 | December 2023 |
| October 10, 2023 | October 10, 2023 | Not Applicable | March 2024 | May 2024 | July 2024 |
| February 13, 2024 | February 13, 2024 | Not Applicable | July 2024 | October 2024 | December 2024 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
Background
The NIA AD/ADRD Research Implementation Milestones highlight the need for novel and innovative dissemination and implementation methods to scale up promising practices in dementia care across settings and across disease severity spectrum (Milestone 13.H). A recent evidence review conducted by the Agency for Healthcare Research and Quality (AHRQ) on Care Interventions for People Living With Dementia and Their Caregivers underscored the need for rigorous, well-powered, replicable research addressing issues of intervention fidelity, efficacy, and potential intervention mechanisms, prior to dissemination and implementation on a wide scale. This Funding Opportunity Announcement (FOA) is intended to address challenges highlighted in this evidence review by calling for activities that can lay the groundwork for principle-based Alzheimer's disease (AD) and AD-related dementias (ADRD) care and caregiving interventions that can be delivered with fidelity in the real world. The activities called for in this FOA are designed to facilitate the success of these trials by providing additional stepping stones toward ultimate implementation.
Interventions are described by their essential components, the level of training required, and fidelity. Simple interventions are defined in this FOA as single-component interventions that can be administered easily with high fidelity, with minimal or no training required to ensure fidelity (e.g., nudge trials, default trials, pre-determined text messages etc.). Complex interventions are defined in this FOA as single- or multi-component interventions that require training to administer with high fidelity (e.g., interventions administered by clinical personnel, such as palliative care interventions, or interventions to cope with a dementia diagnosis).
Millions of people in the U.S. are afflicted with Alzheimer's disease (AD) and AD-related dementias (ADRD), and this number is increasing. The extensive care needs of individuals with AD/ADRD are variable, and care typically involves great demands on spouses and other family members. Because care also requires coordination with a wide range of community and healthcare providers, it is often associated with high out-of-pocket costs. While many studies have been developed to improve care or support care providers, many factors contribute to the creation of barriers between efficacy and implementation, and few interventions have been implemented at scale. Some of these are systematic barriers that impede implementation and dissemination generally. In addition, some impediments to implementation are specific to the intervention itself, such as deficiencies in (1) knowledge of the underlying mechanism(s) or critical components of the intervention or the implementation strategy for disseminating the intervention, and (2) methods to ensure fidelity of delivery of the intervention in the community, including scalable, tested and validated training materials, that are designed specifically for use by individuals in the community, to deliver complex interventions. This FOA solicits research to address these two major impediments to translation of AD/ADRD interventions into real world settings.
Intervention Principles: The first challenge relates to the lack of knowledge regarding how and why interventions work. An insufficient understanding of the underlying principles of interventions, or the mechanisms of action of the interventions, may impede implementation in several ways: 1) simplifying and streamlining an intervention while ensuring that it will retain its potency is not possible when the underlying principles of an intervention are unknown; 2) many interventions need to be modified for a specific population or setting, but modification may interfere with intervention potency if the active ingredients necessary for efficacy are inadvertently removed due to adaptation/modification; 3) flexible delivery of interventions is critical to implementation in the community, but interventions cannot be delivered with both flexibility and fidelity if the main underlying principles of an intervention cannot be explained to the person delivering the intervention.
Interventions that are defined by their principles could facilitate implementation by enabling simplification of the intervention and by promoting an understanding of how and when an intervention can or cannot be adapted while still retaining its positive effects. This understanding of principles is required for a scientifically informed understanding of the boundaries in which an intervention can be delivered with flexibility while retaining fidelity, a necessity for successful translation from research to practice.
Training and Fidelity: The second challenge concerns the training and expertise of those who administer intervention trials. Complex interventions conducted in efficacy trials are typically administered by interventionists who are experts or trained by experts, often accompanied by intensive supervision and/or monitoring. Pragmatic clinical trials and real-world implementation realistically cannot involve expert trainers, intensive training, supervision and/or monitoring, but instead may need to rely on training materials provided directly to participants or community representatives. Very few AD/ADRD care and caregiver support interventions, however, include user-friendly, relatively low-cost training materials, geared specifically to the person in the community who will be learning and administering the intervention, and that have been tested and validated for ensuring adequate and sustained fidelity.
This PAR utilizes the NIH Stage Model as its conceptual framework and encourages causal hypothesis testing as described in the Science of Behavior Change (SOBC) experimental medicine approach, wherever appropriate.
The NIH Stage Model for Behavioral Intervention Development: The NIH Stage Model has the goal of creating efficacious, ultimately implementable interventions defined by their principles. It offers a framework for describing where an intervention is in the developmental pipeline and specifies appropriate research activities within different Stages of intervention development. The model facilitates discussion of intervention development research by applicants, reviewers, and funders with a common language. An understanding of the mechanisms of action or the principles underlying an intervention is an inherent goal of the NIH Stage Model.
The NIH Common Fund's Science of Behavior Change (SOBC) Program/Experimental Medicine Approach: The SOBC mechanism-focused, experimental medicine approach is a methodology that is compatible with the NIH Stage Model . It encourages 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.
This approach, especially when timing is considered within the design (e.g., does the hypothesized mechanism change before the anticipated outcome, or after the anticipated outcome?) and the NIH Stage Model enable each intervention study to contribute to a cumulative science of behavior change, strengthening our understanding of the principles whereby efficacious care and caregiver interventions achieve their effects.
Research Designs
This FOA encourages applications that propose to modify, adapt, and conduct a preliminary test of efficacy and the principles of an existing AD/ADRD care and caregiver support intervention or an intervention originally developed in a non-caregiver population that might be adapted for use in the dementia care and caregiving context. Applicants are expected to articulate their research aims and define the Stage of intervention development proposed using the NIH Stage Model framework. Applicants are required to use an appropriate experimental design to test hypotheses that will identify the essential components of complex interventions, or that will elucidate the mechanism(s) by which an intervention exerts its effects. This FOA also encourages research to develop, test, and validate training materials to ensure fidelity to the principles of an intervention when it is delivered in the real world. The types of behavioral intervention development clinical trials of interest include, but are not limited to, the following:
(1) Mechanism-focused research seeking to develop dementia care and caregiver support interventions defined by their principles. This FOA solicits research to generate, modify, adapt and test interventions while simultaneously testing their hypothesized mechanism of action. Appropriate studies include the following:
Two of many possible examples of mechanistic hypotheses and the testing of these hypotheses are provided below for illustrative purposes. Applications proposing mechanisms-focused intervention development work would be designed to test such hypotheses:
(2) Research that seeks to enhance fidelity and/or develop, test, and validate training materials to ensure fidelity to the principles of the interventions for those in the community who deliver the interventions. Such projects may include, but are not limited to, the following:
Specific Areas of Research Interest
AD/ADRD care and caregiver support intervention research can be for ultimate implementation in the home, community, or formal care settings, such as primary care, nursing homes, assisted living facilities, nursing and rehabilitation centers, hospitals, adult day care, and specialized hospice settings. These interventions may target behavioral, psychological, interpersonal, social, or institutional processes and may be designed for use at the individual, family, dyad, group, community, or health systems level. AD/ADRD care and caregiver support interventions may be studied within Stages I, II, III, or IV. Implementation strategies for AD/ADRD care and caregiver support interventions may be studied within Stage V. Applications may propose intervention research for individuals or systems who are providing care for people at early-, mid-, or late-stage AD/ADRD. Applications that address the principles underlying the care needs and challenges for individuals from diverse racial, ethnic, geographic, and socioeconomic backgrounds are strongly encouraged. Applications that involve interdisciplinary and translational expertise, as relevant (e.g., basic science expertise regarding questions about mechanisms; healthcare system expertise when designing interventions to be used in assisted living or nursing home settings) are strongly encouraged. Applications are expected to propose principle-driven intervention development research with an eye toward real-world implementation, involving stakeholders and community participants wherever appropriate. Applications are required to use an appropriate methodology (e.g., the experimental medicine approach) to identify the essential components of interventions, to determine the mechanism(s) responsible for an intervention’s effects, or to demonstrate that intervention can be delivered with fidelity to the principles or mechanisms of action.
Dementia care and caregiver support interventions can focus on a variety of outcomes for the person living with dementia and/or their caregiver, including, but not limited to improvements in sleep, subjective well-being and quality of life, stress coping and stress management, decision-making, care planning, financial planning, adherence to health-promoting behaviors, memory, relationship quality, social engagement, management of behavioral symptoms of dementia, care coordination, care quality, and care delivery.
Intervention approaches may be derived from a variety of fields, including from psychology, neuroscience, behavioral economics, behavioral medicine, health services research, communication science, psychiatry, and geriatric medicine. Digital/mHealth or other technology approaches may be harnessed. Interventions may be at the individual, interpersonal, or systemic level and can include such things as environmental modification, electronic health record (EHR) modification, care coordination modification, etc.
Examples of individual, dyadic, or group level interventions for persons living with dementia and/or their care partners include, but are not limited to, the following:
Examples of interventions at the organizational or institutional level in Long Term Services and Supports (LTSS) settings, such as in-home health care, assisted living facilities, adult day cares, nursing homes, hospices, hospitals, include, but are not limited to, the following:
Applications Not Responsive to this FOA
The following types of applications will be considered nonresponsive and will not be reviewed. This includes applications that:
Design, Analysis, and Sample Size for Studies to Evaluate Group-Based Interventions: Investigators who wish to evaluate the effect of an intervention on a health-related biomedical or behavioral outcome may propose a study in which (1) groups or clusters are assigned to study arms and individual observations are analyzed to evaluate the effect of the intervention, or (2) participants are assigned individually to study arms but receive at least some of their intervention in a real or virtual group or through a shared facilitator. Such studies may propose a parallel group- or cluster-randomized trial, an individually randomized group-treatment trial, a stepped-wedge design, or a quasi-experimental version of one of these designs. In these studies, special methods may be warranted for analysis and sample size estimation. Applicants should show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. Additional information is available at https://researchmethodsresources.nih.gov/.
The National Institute on Aging (NIA) supports a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. This resource, the Clinical Research Operations Management System (CROMS), is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects. It is the expectation by NIA that all successful applicants will interface, integrate, or adapt their information system(s) and processes to interact with existing and future components of the CROMS as necessary.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Resubmissions from RFA-AG-18-030 "Dementia Care and Caregiver Support Interventions (R01 - Clinical Trial Required)" are not allowed.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Required: Only accepting applications that propose clinical trial(s).
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Application budgets are not limited but need to reflect the actual needs of the proposed project.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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. This means that the NIH will not accept:
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.
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:
The letter of intent should be sent to:
Lisa Onken, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: lisa.onken@nih.gov
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Interdisciplinary and translational expertise, as relevant, is strongly encouraged.
R&R or Modular Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Other Plan(s):
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
The research plan should provide the background and scientific justification for the trial and should address the following.
Significance: The significance of the proposed trial must be stated clearly. A compelling argument must be presented of how the proposed trial will shift caregiver intervention practice or inform health care policy.
Innovation: The application must challenge and seek to shift current behavioral intervention research or clinical dementia care practice paradigms by utilizing the NIH Stage Model.
Approach:The Approach must provide justification for the selected trial elements provided in the Protocol Synopsis, and should include the following:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
All applications, regardless of the amount of direct costs requested for any one year, should include a Data Sharing Plan.
The NIH announced a policy on allowable appendix materials (NOT-OD-17-098); however, this FOA allows specific materials to be included as appendices that are otherwise disallowed by the general policy. Applications may include as appendices the following materials: focus group guides, structured interview schedules, blank questionnaires or surveys with instructions, observational coding systems, fidelity monitoring checklists and rating tools, and draft or sample intervention manuals.
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.
The research strategy section of the application should justify the specifics of the trial, such as the proposed intervention and its target(s), stage of intervention research, and characteristics of the study population.
Section 3 - Protection And Monitoring Plans
3.3 Data and Safety Monitoring Plan
The Data and Safety Monitoring Plan (DSMP) should include a description of data monitoring activities, consistent with the NIA Guidance on Clinical Trials. This DSMP should include the following:
Do not name members of any oversight board in the application. The NIA will appoint members of any oversight committees after consultation with the clinical trial investigator team.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, 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 Referral Office by email at ramesh.vemuri@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Requests of $500,000 or more for direct costs in any year
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific to this FOA: Is significance of the proposed trial clearly stated? Is there a compelling argument for how the proposed trial will shift care or caregiver intervention practice or inform health care policy?
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Specific to this FOA: Does the application challenge and seek to shift current behavioral intervention research or clinical dementia care practice paradigms by utilizing NIH Stage Model?
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific to this FOA:
How well does the Approach provide justification for the selected trial elements provided in the Protocol Synopsis? To what extent the overview of the proposed study design include the Stage of Intervention Research (e.g., Stage I, II, III, IV or V of the NIH Stage Model)?
To what degree does the study design include the rationale for the selected Stage, including justification of the evidence from previous basic behavioral/social/affective/ cognitive research or previous relevant clinical trials?
How well does the study design include hypothesized principles or mechanism of action of the intervention, including the behavioral, cognitive, affective, or social targets it is hypothesized to engage?
To what extent does the study design include plans for addressing the fidelity of intervention delivery?
To what degree does the study design include rationale for the intervention study design (e.g., single case study, multiple baseline, adaptive/SMART design, factorial, partial factorial)?
How well does the study design include an explanation of the hypothesized relevance of process variables (i.e., hypothesized causal targets) and outcome variables (i.e., ultimate behavior to be modified) to the clinical and statistical hypothesis being tested (i.e., the hypothesized role each variable plays in the causal chain; specification of variables as hypothesized moderators, mediators, or outcomes)?
To what extent does the study design include discussion of potential biases or challenges to the integrity of the trial and how they will be addressed and mitigated?
To what degree does the application address potential threats to validity and present clear power calculations that reflect a range of effect sizes of clinical significance?
To what extent does the application incorporate trial design with rigorous controls for Stage of intervention proposed?
For Stage I, II, and III how well does the design maximize internal validity of the study?
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention appropriate for the Stage of intervention development being proposed (as defined by the NIH Stage Model) and is the Stage of the clinical trial proposed well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of behavioral, social, cognitive or biological mechanisms?
For Stage IV and Stage V trials, how well does the design maximize external validity? How well does this study test generalizability, and sustainability of findings across distinct health care settings and diverse staff, caregiver, and patient populations?
For Stage IV studies on interventions which require training, have real-world training materials been developed, tested, and validated to ensure the intervention can be delivered in the community with fidelity?
For Stage IV studies, how well did the application characterize the intervention? Does the intervention apply broadly to diverse AD/ADRD patient population or their caregivers? Is the intervention suitable for use in real-world settings? If successful, will the intervention be well poised to be adopted within a Stage V study (dissemination and implementation)?
For Stage IV pragmatic trials and Stage V studies, how strong are the partnerships with home health agencies, meal delivery services, adult day centers, respite care centers, assisted living facilities, memory units, nursing homes or other care providers, both nonresidential and residential, and did the application document commitment of the organization to the project? Will the PDs/PIs be able to access administrative data (e.g., Medicare or Medicaid claims or Electronic Health Records) and implement pilot interventions in various settings (e.g., is there a letter of support if the application proposed to access EHR in a nursing home)?
Is the complete Clinical Protocol appropriate for the proposed Stage?
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
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.
Specific to this FOA: If this proposed study is successful, does the application provide clear milestones which describe anticipated next steps? That is, what is the anticipated pathway (after the grant period ends) through the Stages of intervention development?
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
For Renewals, the committee will consider the progress made in the last funding period.
Revisions
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
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.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
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 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Not Applicable
Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
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 awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: 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
Melissa Riddle, Ph.D.
National Institute on Aging (NIA)
Telephone: 301.480.6761
Email: riddleme@mail.nih.gov
Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9666
Email: ramesh.vemuri@nih.gov
Ryan Blakeney
National Institute on Aging (NIA)
Telephone: 301-451-9802
Email: ryan.blakeney@nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
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