Part 1. Overview Information

Key Dates

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

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

This Funding Opportunity Announcement (FOA) invites NIH Research and Development Core Center Grant (P30) applications for Roybal Centers for Translational Research on Aging. The Roybal Center program was authorized by Congress in 1993 and named for the Chair of the former House Select Committee on Aging, Edward R. Roybal.

The overall goal of the Roybal Centers is to conduct foundational research to develop potent and scalable principle-defined behavioral interventions, programs, or practices that promote healthy aging at the individual, group, systems, institutional, or population level. Roybal Centers conduct clinical trials to create, modify, adapt, refine, optimize, and test behavioral interventions to improve the lives of mid-life and older people. Roybal Centers offer critical research infrastructure to advance progress on translational research priorities outlined in the recent National Advisory Council on Aging Review of NIA’s Division of Behavioral and Social Research. These priorities include: (1) careful testing of mechanism-driven interventions in preliminary studies before consideration is given to funding large-scale interventions; (2) support for large trials that incorporate a focus on causal drivers or mediators i.e., mechanisms of behavior change (MoBC) and moderators to help identify how an intervention works, for whom, and in which contexts, helping to identify heterogeneous subgroup effects; and (3) careful consideration of the settings in which interventions are tested, with an eye towards leveraging capabilities of organizations with access to minority health and health disparity populations, a communications infrastructure for reaching them, and the potential for scaled implementation.

By establishing an infrastructure organized in accordance with the NIH Stage Model, Roybal Centers will provide the necessary scientific expertise and resources to conduct clinical trials at Stages 0, I, II, III, IV and/or V of the translational behavioral intervention development pipeline. This reissuance of the NIA Roybal Centers program focuses specifically on the full range of translational behavioral intervention development research in the priority areas described below under "Thematic Areas of Focus." Characteristics of applications that will be considered non-responsive to this FOA are described below under "Non-Responsiveness Criteria." Specific required components of the application, including evaluation metrics, are described below in Section IV.

The Roybal infrastructure is also intended to lead to related research applications outside of individual Centers. To further advance intervention development, pursuit of research applications that can successfully leverage the expertise, resources, and findings of the clinical trials conducted and/or funded by Roybal Centers is strongly encouraged. NIA expects that successful Roybal Center clinical trials will lead to the submission of related translational behavioral intervention development applications for R01s or SBIRs to produce potent, implementable interventions that are defined by their governing principles (e.g., MoBC). Ideally, the Roybal program will result in the development of interventions defined by the principles that govern their effects, provide benefits to mid-life and older people, and advance our fundamental understanding of important basic scientific questions regarding mechanisms of individual or organizational behavior change. Such fundamental knowledge of the MoBC will contribute to a cumulative, progressive science of behavioral intervention development.

Individual Roybal Centers are expected to collaborate with and participate in meetings and calls facilitated by a Roybal Centers Coordinating Center funded under RFA-AG-24-008. Centers are also encouraged to collaborate with other Roybal Centers for Translational Research on Aging and Roybal Centers for Translational Research on Dementia Care and AD/ADRD Prevention funded under RFA-AG-24-007. In addition, collaboration is encouraged with other NIA-funded Centers and programs, including the NIA Research Centers Coordinating Network (RCCN), Resource Centers for Minority Aging Research (RCMAR), NIA IMPACT Collaboratory, Centers on the Demography and Economics of Aging, Claude D. Pepper Older Americans Independence Centers (OAICs), Behavioral and Social Research Networks, and Nathan Shock Centers of Excellence in the Basic Biology of Aging, in addition to relevant private sector partners. Centers are expected to make research resources available to the larger scientific community and to galvanize scientists at other academic institutions. Consortium arrangements are permissible, provided that the applicant institution meets the eligibility requirements.

Scope

Because Roybal Centers conduct research to develop principle-defined potent and scalable behavioral interventions, programs, or practices that promote healthy aging at the individual or population level, all Roybal Centers utilize a common conceptual framework: the NIH Stage Model.

The NIH Stage Model is a conceptual framework for behavioral intervention development with the goal of creating potent interventions, defined by their governing principles or MoBC, that can be successfully implemented in the real world. Through its focus on identifying the MoBC, or the how and why of intervention development, the model integrates basic behavioral and social science throughout the behavioral intervention development process to produce an understanding of the principles through which an intervention exerts its effects, enabling the intervention to be defined by those principles. The NIH Stage Model provides a common framework and language to facilitate discussion of intervention development research among applicants, reviewers, and funders.

Roybal clinical trials may be conducted in any of the following Stages of behavioral intervention research:

• Stage 0: Basic Behavioral Science: Questions related to MoBC, separate from but related to intervention development, are basic behavioral science questions that can be addressed in Stage 0 research. Stage 0 clinical trials (known as Basic Experimental Studies Involving Humans or BESH studies), may be needed to inform the creation, modification, adaptation, or refinement of interventions in Stage I intervention development studies. (Note: MoBC questions are considered basic behavioral science questions and are frequently integrated into Stage I through V clinical trials [without an additional Stage 0 label]).
• Stage I: Creation, Adaptation, Modification & Pilot-Testing (CAMP) of an Intervention: All studies that seek to adapt, modify, or refine an intervention are Stage I studies, by definition. This includes studies where the planned adaptation, modification, or refinement occurs before or after a Stage II, III, IV, or V clinical trial. Stage IA studies involve creation, adaptation, modification and feasibility/acceptability testing; when feasibility and acceptability have been demonstrated, Stage IA studies are typically followed by a Stage IB clinical trial for an initial test of efficacy. Like all other Stages of research within the NIH Stage Model, Stage I research typically seeks to utilize, gain information about, and ideally test hypotheses regarding the MoBC and/or the essential components of the intervention.
  • CAMP of a Training procedure: For interventions that ultimately will require delivery by an individual in the community, the development and pilot testing of provider-friendly training procedures (training being an intervention in its own right) and associated materials may be essential prior to progression to Stage III and later Stages. Scalable, real-world-friendly training procedures for community providers/interventionists that can ensure fidelity of intervention delivery, may be critical to the success of a Stage III, IV, or V study. (Please note: Within the framework of the NIH Stage Model, fidelity refers to the ability to deliver an intervention correctly, in accordance with the principles of the intervention).
  • Stage I clinical trials may be conducted by the research team in real-world or non-real-world contexts:
    • Non-real-world context: Examples include a research center or research clinic where the intervention is delivered by an individual from the research team.
    • Real-world context: The intervention is delivered within a real-world setting by an individual who works or functions within that setting, not by an individual from the research team.
  • Multiple Stage I studies may be necessary to optimize an intervention for maximal potency and scalability, and for developing and pilot testing real-world training procedures, making Stage I the most frequently visited Stage.
• Stage II: Traditional Efficacy Testing. Stage II studies test efficacy. Stage II research seeks to answer the question, Can this intervention work when administered under ideal conditions? Because Stage II research consists of tightly controlled experimental testing of interventions in highly controlled non-real-world research settings, with research-based interventionists/providers (highest internal validity), Stage II can be an ideal place to ask the question, What is/are the mechanism(s)/ principles(s) of behavior change causing the effect(s) of the intervention?
• 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 the real-world context. Stage III research seeks to answer the question, Can this intervention work when administered under the best possible conditions in the real world? That is, Can this intervention work under as highly controlled as possible real world conditions, when the intervention is delivered by someone in the community (not part of the research team)?
  • Stage III research 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 research strives for as high internal validity as possible within a real-world setting).
  • With relatively high internal validity, Stage III studies can provide critical information about the principles or MoBC responsible for any observed effects.
  • Stage III studies may include the testing of provider-friendly training materials, often necessary prior to progression to Stages IV and V.
• Stage IV: Effectiveness Testing & Pragmatic Trials: Stage IV research seeks to answer the question, Can this intervention work when administered under actual (non-ideal) conditions in the real world?
  • Stage IV involves effectiveness testing on interventions that have been shown to have efficacy in earlier Stages, and where it has been shown that the intervention can be delivered correctly (with fidelity) by the individual in the community responsible for delivering the intervention. Inherently lower in internal validity than Stage III, Stage IV research strives for maximal external validity. Despite typically low internal validity, Stage IV research can often provide valuable information relevant to the MoBC and/or essential ingredients of multi-component interventions.
• Stage V Research: Dissemination & Implementation: Stage V research 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.
  • 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.).

Behavioral intervention development is rarely a linear process, and there is often a need to take advantage of emerging knowledge from basic or clinical science and to revisit prior Stages before proceeding. Within the NIH Stage Model, although the stages are numbered for ease of reference, there is no prescribed path. An appropriate path is one that is scientifically well-justified, and includes rigorous, sufficiently powered, and reproducible clinical trials that are feasible and are geared toward achieving the goal of developing a potent, implementable intervention that can be defined by its governing principles.

Research Objectives

Roybal Centers are intended to create an infrastructure to support the nimble movement through the necessary Stages of intervention development research, so that where scientifically justified and appropriate, promising interventions may be efficiently readied for implementation and dissemination. Throughout the funding of the Center, all Roybal Centers must contain expertise on, and propose clinical trials that include a focus on, testing the hypothesized causal mechanisms that may explain how and why an intervention works. For interventions with multiple components, testing should seek to determine the essential components or ingredients of behavioral interventions. Roybals will facilitate the development of interventions through this infrastructure in the priority areas described below under "Thematic Areas of Focus.

A major goal of the Roybal Centers is to build a cumulative science of behavioral intervention development, and in doing so to build the intervention development pipeline to promote healthy aging. To achieve this goal, Roybal Centers will establish an infrastructure organized in accordance with the NIH Stage Model. Roybal Centers will provide the necessary scientific expertise and resources to conduct preliminary clinical trials at Stages 0, I, II, III, IV and V.

Roybal Centers will have two core components, 1) the Administrative Core and 2) the Behavioral Intervention Development Core. The Administrative Core will provide the overall vision for the Roybal Center, conduct national competitions to fund clinical trials in accordance with the Roybal theme, monitor progress of the Center, provide immediate feedback and ongoing evaluation, and serve as a national resource for the behavioral and social intervention research community. The Behavioral Intervention Development Core will conduct clinical trials to create, modify, adapt, refine, optimize, and test behavioral interventions to improve the lives of mid-life and older people. As noted, preliminary intervention development studies necessary for ultimate implementation do not cease with the initial Roybal clinical trial; subsequent clinical trials required to further develop interventions can be proposed within the Roybal Center over time, where necessary and appropriate, and/or can be planned in follow-up NIA grant applications (e.g., R01).

To maximize the chances of complete and successful intervention development, and to minimize the likelihood of prematurely halting the development of promising interventions, all Roybal clinical trials proposals must include an anticipated plan for navigation through the Stages, describing the intended pathway of next steps needed to produce a potent and implementable intervention. Clinical trials required to achieve this series of next steps may be accomplished through multiple venues: outside of the Roybal Center (e.g., R01s), within the Roybal Center, or through a collaboration with other Centers or organizations.

Thematic Areas of Focus

Each Roybal Center will have a core scientific theme, concentrating its resources and study investments on a set of principle-driven (MoBC-focused) intervention approaches designed to promote the health and well-being of individuals or groups of individuals as they age. In line with that scientific focus, Roybal Centers will support behavioral intervention clinical trials at Stages 0 through V. Centers should have appropriate expertise at all Stages. Interventions may target MoBC at the individual, interpersonal, organizational, or broader social level.

Interventions under development are expected to be designed for individuals or groups who share a common need or problem. Within this context, interventions being studied must have the goal of serving as inclusive a population as possible, and applicants are required to described how they will recruit participants from minority health and health disparity populations. This may involve creating, adapting, and/or testing interventions that are designed to be feasible and acceptable across multiple racial and ethnic groups; conducting studies that seek to determine the mechanisms through which an intervention may have efficacy for one group of individuals, but not for another; and/or using an understanding of the intervention’s principles to inform the development of precision interventions targeting the specific processes requiring modification.

With the goal of producing potent and implementable behavioral interventions, defined by their governing principles, to promote healthy aging, and within the context of mechanism-focused intervention development as described within the conceptual framework of NIH Stage Model, the following are provided as examples of possible themes. A Center theme may focus on a particular problem or challenge related to the health and well-being of midlife and older adults, or it may focus on a particular approach to designing and testing behavioral and social clinical trials. Examples include, but are not limited to, intervention development to:

• Address Causal Drivers of Health Disparities
• Enhance the Well-being of Midlife and Older Adults
• Manage the Stressors and Negative Affect Associated with Life Changes, Losses, and Diseases Associated with Aging
• Define the Structure, Mechanism, and Dosage of Arts-Based (e.g., music, painting, sculpting) Interventions
• Improve Pain Management
• Boost Cognitive and Functional Skills in Normal Aging
• Target MoBC Common to Multiple Health Behaviors
• Spur the Initiation and Maintenance of Personalized Physical Activity Regimens in Individuals or Groups of Individuals
• Promote Sleep Hygiene and Optimize Circadian Rhythms
• Promote Adherence and Maintenance of Long-term Behavior Change
• Maintain and Enhance Mobility and Independence
• Utilize Behavioral Economics Approaches to Improve Individual Behavior and/or Institutional Processes
• Leverage Technology to Ensure Fidelity and/or Scalability
• Use In Workplaces and Community Organizations to Promote Adaptive Aging
• Protect Older Adults from Physical, Sexual, Emotional, or Psychological Abuse; Neglect; Abandonment; Financial or Material Exploitation
• Redesign the Delivery of Community Services and Health Care to Promote Aging in Place

Resources for Applicants

• NIH Science of Behavior Change Common Fund Program (SOBC): Describes the experimental medicine approach, a method for identifying the MoBC of interventions.
• NIH Stage Model: A translational, multi-directional conceptual framework for the development of implementable behavioral interventions defined by their mechanisms or principles. The NIH Stage Model is the required structure for the Roybal Centers.
• Division of Behavioral and Social Research, National Institute on Aging: Provides information on behavioral and social research priorities, workshops, and publications from NIA-supported research.

Non-Responsiveness Criteria

Roybal Center applications submitted to this FOA should not focus primarily on interventions designed for prevention, treatment, or management of specific diseases. For behavioral intervention development related to Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD), please see RFA-AG-24-007.

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

• Applications that do not have a primary focus on behavioral and/or social intervention development.
• Applications without goals to improve the health and well-being of individuals as they age.
• Applications that do not specify, within their Specific Aims, the Stage of research, as defined by the NIH Stage Model for each of the two clinical trials proposed.
• Applications that do not state and propose to test, within their Specific Aims, hypotheses regarding the mechanism of behavior change of interventions for each of the clinical trials proposed.
• Applications that do not address issues of statistical power for proposed clinical trials.
• Applications that do not allocate a minimum of 2/3 of their direct cost budget to the Behavioral Intervention Development Core, in each year.

Frequently Asked Questions

Responses to frequently asked questions about this FOA will be posted here.

Clinical Research Operations Management System: 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, including the use of CROMS data templates as specified.

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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

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

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are 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.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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: 301-496-3136
Email: lisa.onken@nih.gov

Page Limitations

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

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.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

Overall Component

When preparing your application, use Component Type Overall .

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Locations (Overall)

Enter primary site only.

Applications must describe ongoing research activity at the applicant and collaborating institutions that is relevant to the theme of the proposed Center. Additionally, applications must describe how the environment facilitates the ability to conduct behavioral intervention research, informed by all relevant Stages of the NIH Stage Model, into significant practical outcomes for the benefit of mid-life and older people.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

Applications are required to include personnel or collaborators with relevant expertise in Stages 0 through V of the NIH Stage Model, as well as expertise in research designed to determine mechanisms of behavior change of behavioral interventions, such as the experimental medicine approach (see https://www.nia.nih.gov/research/dbsr/science-behavior-change-sobc). Applications for Roybals proposing studies of interventions with multiple components must also include personnel or collaborators with relevant expertise in research designed to determine the essential components of interventions.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

Applications must allocate a minimum of 2/3 of their direct cost budget to the Behavioral Intervention Development Core in each year.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Specific Aims: Describe the following:

• The goals to be achieved by the Center, including the Center's selected research theme(s) and the basis for their selection, and how the different Cores will contribute to these goals.
• Crucial problems or limitations that the Center will address with respect to the translational behavioral intervention development theme and activities proposed.
• The Stage of intervention development of proposed behavioral interventions, and the starting Stage and the subsequent anticipated Stage pathways for the interventions that the Centers will study over its entire award period.

Research Strategy: To achieve the FOA objectives, each Roybal Center application must:

• Identify a promising thematic area and justify the scientific evidence base in the behavioral or social sciences for the theme selected as well as its likelihood to promote health and well-being.
• Create a sustainable translational behavioral intervention development program, designed in accordance with the NIH Stage Model to address the chosen theme.
• Describe the potential for significant scientific and translation progress (including infusing basic science into the intervention development pipeline, increasing knowledge regarding the underlying principles or MoBC of the interventions being studied, readying an intervention for use in real-world non-research contexts by simplifying, developing training materials, developing methods to maximize fidelity, etc.) in the specific themes and clinical trials addressed by the application.
• Describe how the selected the theme is reflected in the design of the Roybal Cores.
• Describe the process through which the Roybal Center will ensure that the mechanism of action will be tested in the development of all interventions, such that any intervention developed within the Roybal Center may be defined by its governing principles.

Common Evaluation Metrics and Information Sharing:

The continued success and sustainability of NIA’s Roybal Centers program requires that Centers demonstrate their value and impact in line with program goals to develop principle-defined interventions that can be successfully implemented in the real world to have a positive effect on the health and well-being of individuals as they age by:

• Conducting foundational research to develop potent and scalable principle-defined behavioral interventions, programs, or practices that promote healthy aging at the individual, group, systems, institutional, or population level.
• Conducting clinical trials to create, modify, adapt, refine, optimize, and test behavioral interventions to improve the lives of mid-life and older people
• Advancing progress on translational research priorities outlined in the recent National Advisory Council on Aging Review of NIA’s Division of Behavioral and Social Research, including (1) careful testing of mechanism-driven interventions in preliminary studies before consideration is given to funding large-scale interventions, (2) support for large trials that incorporate a focus on causal drivers or mediators (mechanisms of behavior change), and moderators to help identify how an intervention works and for whom in which contexts, helping to identify heterogeneous subgroup effects, and (3) careful consideration of the settings in which interventions are tested, with an eye towards leveraging capabilities of organizations with access to minority health and health disparity populations, a communications infrastructure for reaching them, and the potential for scaled implementation.
• Establishing an infrastructure organized in accordance with the NIH Stage Model, Roybal Centers will provide the necessary scientific expertise and resources to conduct clinical trials at Stages 0, I, II, III, IV and/or V of the translational behavioral intervention development pipeline.
• Contributing to the development of related research proposals outside of individual Centers.

Roybal Centers must cooperate and collaborate with other Roybal Centers under the purview of the Roybal Coordinating Center in 1) promoting DEIA in the workforce supported by the Roybal, 2) sharing of Roybal information, and 3) identifying and using common metrics and processes to inform future Roybal program evaluations by the National Institute on Aging.

1) Ensuring appropriate expertise and promoting DEIA in the workforce supported by the Roybal: The Administrative Core plays a critical role in ensuring the appropriateness of expertise in the workforce, and in promoting diversity, equity, inclusion, and accessibility (DEIA) in the workforce of the Roybal Center. Specifically, it is expected that the Roybal Center will seek to recruit a diverse group of potential participants, including individuals from underrepresented groups as per NOT-OD-20-031 (Notice of NIH's Interest in Diversity) and NOT-OD-22-019 (Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities).

2) Sharing of Roybal information: This may include, but is not limited to, sharing information on:

• PDs/PIs of clinical trials
• Clinical trial study Stage
• Clinical trial study aims
• Proposed/intended pathways through the Stages of intervention development
• Hypotheses regarding mechanism of action, including measures of mechanistic targets
• Descriptions of interventions
• Descriptions of procedures for training research staff and community providers to deliver interventions with fidelity
• Measures used in Roybal clinical trials
• Publications and other products and accomplishments associated with each Roybal Center

Sharing of Roybal information also includes the regular and timely updating of each Roybal Center’s website, which should include information about ongoing research, seminars, webinars, publications, etc. Each Roybal website must include timely solicitations for clinical trial proposals from individuals outside their Roybal institution, and information on the schedule and the requirements to submit proposals to be reviewed for potential support by each Roybal Center.

3) Identifying and using of common metrics and processes: The routine collection and management of Roybal information for ongoing program evaluation by the Roybal Coordinating Center across the Roybal program requires the identification and use of common metrics and processes. Roybal Centers must cooperate and collaborate with the Roybal Coordinating Center and the other Roybal Centers in the development, utilization, and sharing of these metrics and processes. The Roybal Center Program and its constituent parts will be evaluated on the extent to which they meet the overall goals of the program. Possible Roybal potential metrics/measures include, but are not limited to:

• Number and characteristics of Roybal studies designed to test a hypothesized mechanism of action of an intervention.
• Number and characteristics of Roybal clinical trials designed to identify the essential components of an intervention.
• Number and characteristics of fully powered Roybal clinical trials.
• Number and characteristics of Stage I clinical trials creating and/or adapting and pilot testing the efficacy training procedures for community providers to deliver an intervention correctly (with sustained fidelity).
• Number and characteristics of Stage III clinical trials testing the efficacy of training procedures for community providers to deliver an intervention correctly (with sustained fidelity).
• Number and characteristics of Stage I clinical trials that have been followed by a study testing the efficacy (Stage II or III) of the intervention or the effectiveness (Stage IV) of the intervention.
• Number of funded (or to-be-funded; e.g., R01, SBIR, or non-federally funded) clinical trials based upon findings from a Roybal clinical trial.
• Number and characteristics of clinical trials that have produced data resulting in the successful the uptake of a behavioral intervention in the community.
• Number and scientific backgrounds of investigators supported to develop or conduct clinical trials through the Roybal Center.
• Number and nature of collaborations with other Roybal Centers; Products resulting from collaborations with other Roybal Centers.
• Number and nature of collaborations with other NIA or NIH funded projects; Products resulting from collaborations with other NIA or NIH funded projects.
• Number and nature of collaborations with organizations outside NIH; Products resulting from collaborations with organizations outside NIH.

Progress Report for Renewal Applications

Renewal applications must include descriptions of successful behavioral intervention development activities during the previous funding period since the last competitive review only and may not include activities during the years prior to the previous funding period, before the last competitive review, as part of the progress report. Progress reports must be fit into the Approach section of the Research Strategy within the prescribed page limits. Renewal applications must also justify continued funding of existing translation activities, in line with one or more of the focal priorities of this FOA.

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

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

? All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form (Overall)

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

Administrative Core

When preparing your application, use Component Type Admin Core.

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• For renewal applications, members of an External Advisory Committee (EAC) should be named. New applications should not select committee members prior to peer review of the Center application, to avoid creating conflicts of interest for review.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Funds must be set aside reflecting the costs for communicating with and convening an External Advisory Committee (EAC), which may meet virtually or in-person and should meet annually.

Applications must allocate a maximum of 1/3 of their Direct Cost budget to the Administrative Core, in each year. Funds should be set aside for annual travel to Center meetings. The meetings will be held at the NIH in Bethesda, MD, or at another site agreed to by the PD/PIs and the NIA.

PHS 398 Research Plan (Administrative Core)

Specific Aims: State concisely the goals of the proposed Core and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved. List succinctly the specific objectives of the research proposed.

Research Strategy: The Administrative Core manages the activities of the Center, providing coordination, research planning, logistical, centralized resources, and technical support.

The application must describe plans to complete the required activities of this Core.

• Develop a strategic vision for the Center, ensuring that all relevant Stages of expertise will be represented within the Center, and describe the ways in which experts across the range of the NIH Stage Model will interact, plan, coordinate, review and manage the Center's activities.
• Manage an EAC that oversees the functioning of the Center and assists the Director in making the scientific and administrative decisions relating to the Center, including the allocation of funds for clinical trials. The EAC will advise the Roybal and facilitate the ability to conduct clinical trials that further our understanding of the mechanisms of behavior change of the interventions under development and have significant scientific impact. Expertise in behavioral intervention development that focuses on determining the mechanisms of behavior change is required in the EAC. Statistical expertise is also required. For new applications, members of the EAC should NOT be named in the application; instead, areas of expertise should be listed. For renewal applications, members of the EAC should be named. Summary recommendations from the EAC must be included with the non-competing continuation (Type 5) application.
• Describe plans to convene a review panel to assist in selecting preliminary clinical trials. Criteria for selecting committee members, how they will be identified, the operating procedures of the groups, and the frequency of meetings should be described. The review panel should include a statistician, an expert in mechanism-focused research designs, as well as scientists from outside the Center. Members of the EAC may serve as reviewers for the proposed clinical trials, provided their expertise is appropriate for the submitted applications. New applications should not select committee members prior to peer review of the Center application, to avoid creating conflicts of interest for review. Describe a plan for the Center to develop, identify, review and monitor clinical trials in a manner consistent with the NIH Stage Model and consistent with the overall goals of the Center. This Core is responsible for submitting new clinical trials to NIA for approval, in accordance with Section VI.
• Monitor clinical trials. The description of all clinical trials, including the year the clinical trial was proposed, the PI of the clinical trial, the title, and the specific aims for each clinical trial approved, the progress for each specific aim, and any results must be reported in the Center's annual progress report (RPPR) to the NIA, in accordance with Section VI. Inclusion/Enrollment tables must also be included in the annual progress report. The Administrative Core is responsible for ensuring the accurate reporting of the progress of all clinical trials funded by the Roybal Center, and is responsible for ensuring that the written progress is consistent with the HSS Inclusion/Enrollment tables, with NIA’s Clinical Research Operations & Management System (CROMS), and with clinicaltrials.gov.
• Develop metrics that can be used for evaluation purposes, and code clinical trials on a variety of relevant characteristics, such as mechanistic targets, Stage of research, populations, outcomes, contexts, etc. of research, populations, outcomes, contexts, etc.
• Coordinate travel to Center meetings annually, held at the NIH in Bethesda, MD, or at another site agreed to by the PD/PIs and the NIA. The purpose of the meetings is to have Roybal investigators share information about the research they are conducting, including methods and findings, and to facilitate the successful progression through the NIH Stage Model, culminating in rigorous clinical trials leading to potent, implementable interventions that are defined by their principles. Collaboration among Roybal Centers is also a significant goal of these meetings. Applicants should include a statement in the application indicating a willingness to participate in such meetings and to cooperate with other researchers in the exchange of data, materials, processes, and ideas.
• Optionally, the Core may describe plans to:
  • Encourage and facilitate the development of networks among researchers, commercial interests, community interests, program design interests, and Governmental entities to support translation intervention development activities organized in accordance with the NIH Stage Model;
  • Expand the reach of the Center's activities through strategic collaborations with, for example, private sector/commercial interests, non-profit organizations, research institutions, government agencies, etc.

It is expected that NIA will fund one Coordinating Center (CC) for the Roybal (P30) Centers program. Applicants must commit to cooperate fully with the CC in its efforts to, for example,, establish a multi-center website, coordinate conferences/workshops, arrange annual meetings, prepare research briefs, and respond to NIA Program Officials on behalf of the Centers program, etc. It is expected that the CC will request that all awarded Centers follow a standardized reporting template when preparing the annual Non-Competing Continuation Grant Progress Report (PHS 2590); awarded P30s must commit to submitting their PHS 2590s following the standardized format developed by the CC.

Progress Report for Renewal Applications

Renewal applications must include descriptions of behavioral intervention development activities since the last competitive review. Progress reports must be fit into the Approach section of the Research Strategy within the prescribed page limits. Renewal applications must also justify continued funding of existing behavioral intervention development activities and must include a description of how the mechanism of behavior change was addressed for all behavioral intervention development activities, in line with one or more of the focal priorities of this FOA.

Appendix:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Behavioral Intervention Development Core

When preparing your application, use Component Type BID Core.

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

SF424 (R&R) Cover (Behavioral Intervention Development Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Behavioral Intervention Development Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Behavioral Intervention Development Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Behavioral Intervention Development Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Behavioral Intervention Development Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Behavioral Intervention Development Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Detailed Budget for Initial Budget Period

Each Roybal Center application must request funds to initiate clinical trials that are consistent with the theme of the Center grant. In order to ensure adequately powered clinical trials, to seed several lines of research in the thematic area of focus, and to support all necessary clinical trials, applications must allocate a minimum of 2/3 of their direct cost budget to the Behavioral Intervention Development Core in the initial budget period. Applicants must indicate in the Behavioral Intervention Development Core Budget the budgets of two clinical trials proposed to begin in Year 1 (see Section VI for information about prior approval of Clinical trials for awarded Centers); these should be included in the Behavioral Intervention Development Core Research Strategy as described below.

Budget for Entire Proposed Period of Support

In order to ensure adequately powered clinical trials, to seed several lines of research in the thematic area of focus, and to support all necessary clinical trials, applications must allocate a minimum of 2/3 of their Direct Cost budget to the Behavioral Intervention Development Core, in each year. Each Roybal Center application must request funds to initiate clinical trials research that is consistent with the theme of the Center. Applicants may propose as many clinical trials per year as are scientifically justifiable while staying within the budget limits for the overall Center. Individual Core budgets should be prepared for all years of the Roybal Center application.

PHS 398 Research Plan (Behavioral Intervention Development Core)

Specific Aims: State concisely the goals of the proposed Core and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved. List succinctly the specific objectives of the research proposed. Applications must state and propose to test, within their Specific Aims, hypotheses regarding the mechanism of behavior change of interventions for each of the clinical trials proposed.

Research Strategy: The objective of this Core is to support preliminary clinical trials that are consistent with the theme of the Center in Stages 0 V of the NIH Stage Model.

As appropriate, Roybal clinical trials are encouraged to: 1) leverage a Stage 0 basic research finding to create a potent implementable intervention, defined by its principles; 2) examine the principles, or mechanism of action underlying a behavioral intervention, in all Stages of research); 3) create and/or modify, and conduct preliminary testing of real-world-friendly training procedures (Stage I) and further test these procedures (Stage III), as appropriate, before progressing to Stage IV; and 4) create and/or modify and pilot test and test methods to maximize real-world fidelity (Stage I and III) to maximize successful later-Stage real-world clinical trials.

Please note: All clinical trials must have adequate statistical power to test mechanism of behavior change and/or efficacy of the intervention. This includes Stage I pilot testing studies that include a specific aim to test the efficacy of an intervention, or the mechanism of behavior change of an intervention.

Clinical trials proposed must include individuals that share a common problem or behavior for which the behavioral intervention is being developed. Within this context, interventions proposed must have the goal of serving as inclusive a population as possible, and applicants are required to described how they will recruit participants from minority health and healthy disparity populations. This may involve creating, adapting, and/or testing interventions that are designed to be feasible and acceptable across multiple races and ethnicities. It may also involve conducting studies that seek to determine the mechanisms through which an intervention may have efficacy for one group of individuals, but not for another, where the elucidation of mechanisms informs the development of precision interventions targeting the specific processes requiring modification.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PI(s) for Roybal clinical trials is invited to work with his/her organization to develop an application for support. The eligible PIs for Roybal clinical trials include, but are not limited to, junior investigators, investigators from diverse backgrounds including those from underrepresented groups, and established investigators at the Center institutions or at outside institutions, or in association with academic and/or corporate partners. Roybal Centers must conduct a national competition for clinical trials pilot and preliminary clinical trials. Each Center must include a combination of investigators from within the Roybal institution(s) and from outside the institution. While clinical trials may be proposed for any duration within the grant funding period, it is expected that most will be proposed for and completed within 1-3 years. Collaboration is encouraged, to improve the quality of the science and the rigor of the study, to maximize generalizability and power, and to complete trials more expeditiously.

Applications must:

• Address the pool of researchers from whom clinical trials would be solicited; describe the process by which clinical trials would be solicited and selected, via national competition, from within and from outside their institution; and describe how the process to select clinical trials relates to the NIH Stage Model and the overall Roybal Center theme.
• Describe two clinical trials with Stage of research defined, stating the hypothesized MoBC and fully powered to test the MoBC, proposed for Year 1.
  • Describe how the selected theme is reflected in the selection of these two clinical trials.
  • Identify and justify the scientific evidence base for the translational clinical trial project within the context of the appropriateness of the Stage of research proposed for the intervention, for each of the two clinical trials proposed.
  • Identify the hypothesized mechanism of action or principles underlying the intervention. Explain how mechanism of action or principles will be tested in the clinical trial.
  • Include detailed research strategies for the two proposed Year 1 clinical trials.
  • Include milestones for each of the two proposed Year 1 clinical trials.
• For Year 2 and thereafter of the Roybal (after Year 1), propose and justify an anticipated pathway, through the Stages of the NIH Stage Model, of the two interventions proposed to begin in Year 1. It is understood that depending upon the results of Year 1 clinical trials (and subsequent studies), anticipated pathways may or may not be appropriate to follow. Brief descriptions only are expected for the anticipated clinical trials in Year 2 and thereafter. Detailed research strategies are not requested and are not required for anticipated clinical trials in Years 2 through 5.
• Include an anticipated timeline for progression through the Stages for each of the two behavioral interventions proposed to be studied, (assuming there is scientific justification) over the course of the Roybal Center.
• Describe the internal institutional plans and procedures to ensure that all projects supported from this award will comply fully with all applicable Federal regulations, policies, and guidelines for research involving human subjects, including the evaluation of risks and protections in project proposals, appropriate ethical oversight and funded projects, and plans for data and safety monitoring for clinical trials. All plans must be consistent with all relevant NIH policies and the NIA policies for human intervention studies. A Data and Safety Monitoring Plan (DSMP) must be included for each Roybal proposed.

Appendix:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Behavioral Intervention Development Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the National Institute on Aging, 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.

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.

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

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.

Significance

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:

Does the center organization, approach, and topic/thematic area have potential to significantly advance behavioral intervention development that has potential to improve the health and well-being of midlife and older adults? What is the strength of evidence base for the translation theme and the goal and Stage of the clinical trials proposed? Is there potential for significant scientific and translation progress (including infusing basic science into the intervention development pipeline, increasing knowledge regarding the underlying principles or MoBC of the interventions being studied, readying an intervention for use in the real world by simplifying, developing training materials, developing methods to maximize fidelity, etc.) in the specific themes and clinical trials addressed by the application?

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?

Investigator(s)

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?

Specific to this FOA:

Does the application include personnel with expertise within Stages 0, I, II, III, IV, and V of behavioral intervention development?

Does the application include personnel with expertise in determining the mechanism(s) of behavior change of interventions (MoBCs) and, as appropriate, the necessary components of multi-component interventions?

Do the investigators demonstrate familiarity with the practical domain or environment being investigated as well as with aspects of aging and life-span developmental research, as relevant and appropriate? Do the key personnel listed contribute relevant expertise at all relevant Stages (0 through IV) and effort to the project? Do the key personnel have demonstrated expertise in research designed to determine causal mechanisms of behavior change of behavioral interventions, such as the experimental medicine approach? For Roybals proposing studies of interventions with multiple components, do the key personnel have demonstrated expertise in research designed to determine the essential components of interventions?

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?

Innovation

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:

To what degree will the Center stimulate new and important behavioral intervention development research, informed by basic behavioral and social science research that will improve the health, well-being, and productivity of mid-life and older people?

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?

Approach

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:

Will the Center's approach to translation likely lead to significant practical outcomes? Is the selected theme reflected in the design of the Roybal Cores? How well-described is the process through which the Roybal Center will ensure that hypotheses about casual mechanisms of action will be tested in the development of all interventions, such that any intervention developed within the Roybal Center may be defined by its governing principles? How sound is the Center’s approach to measuring its success in developing principle-defined interventions that can be successfully implemented in the real-world to have a positive effect on the health and well-being of individuals as they age? How well-described is the Center’s plan for cooperating and collaborating with other Centers under the purview of the Roybal Coordinating Center in 1) sharing of Roybal information, and 2) identifying and using common metrics and processes to inform future program evaluation by NIA? For renewal applications, how successful were the behavioral intervention development activities during the previous funding period since the last competitive review only and how-well justified is the plan for continued funding of existing translation activities?

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?

Environment

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?

Specific to this FOA:

Is there significant ongoing research activity at the applicant and collaborating institutions that is relevant to the theme of the proposed Center? Does the environment facilitate the ability to conduct behavioral intervention research, informed by all relevant Stages of the NIH Stage Model, into significant practical outcomes for the benefit of mid-life and older people?

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.

Study Timeline

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 Animals Section.

Biohazards

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

Resubmissions

Not Applicable.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable.

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

Not Applicable

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

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

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

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.

Scored Review Criteria - Administrative Core

Reviewers will consider each of the review criteria below in the determination of scientific merit but will not 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.

Significance

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?

Investigator(s)

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?

Innovation

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?

Approach

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-developed is the strategic vision for the Center, ensuring that all relevant Stages of expertise will be represented within the Center? How well-developed are the ways in which experts across the range of the NIH Stage Model will interact, plan, coordinate, review and manage the Center's activities? Is the plan to manage an External Advisory Committee (EAC) that oversees the functioning of the Center and assists the Director in making the scientific and administrative decisions relating to the Center, including the allocation of funds for clinical trials, logical and appropriate? How well-described are the plans to convene a review panel to assist in selecting projects? How well-described is the plan for the Center to develop, identify, review and monitor clinical trials in a manner consistent with the NIH Stage Model and consistent with the overall goals of the Center? Is there evidence that the Center will commit to cooperate fully with the Coordinating Center? For renewal applications, does the application adequately describe the behavioral intervention development activities since the last competitive review?

Environment

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?

Additional Review Criteria - Administrative Core

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.

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

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations - Administrative Core

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.

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 Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

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.

Scored Review Criteria - Behavioral Intervention Development Core

Reviewers will consider each of the review criteria below in the determination of scientific merit but will not 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.

Significance

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:

Do the proposed clinical trials test hypotheses regarding the MoBC of these interventions that can inform the development of potent, scalable interventions?

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 behavioral and social 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?

Investigator(s)

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?

Specific to this FOA:

Do the PD(s)/PI(s), collaborators and other researchers have expertise in the NIH Stage Model, and in research determining the MoBC of behavioral interventions?

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?

Innovation

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?

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?

Approach

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:

Do the clinical trials proposed include individuals that share a common problem or behavior that the behavioral intervention being studied is intended to alleviate or improve? Within this context, do the clinical trials proposed have the goal of serving as inclusive a population as possible, and has the applicant adequately described how they will recruit participants from minority health and healthy disparity populations? How well-described is the process by which clinical trials would be solicited and selected? Are two clinical trials with Stage of research defined, stating the hypothesized mechanism(s) of behavior change and fully powered to test the mechanism(s), proposed for Year 1? How well is the Center’s theme reflected in the selection of the two clinical trials? Is the scientific evidence base for the translational clinical trial project within the context of the appropriateness of the Stage of research proposed for the intervention identified and justified? Do the clinical trials adequately describe how the mechanism of action or principles will be tested? Do the clinical trials include detailed research strategies, including milestones? Are the pathways described to move from one Stage of behavioral intervention development to the next Stage (or a previous Stage) likely to help produce interventions with maximal efficacy as well as maximal potential for implementation? How well does the application describe the timeline for progression through the Stages for each of the two behavioral interventions proposed to be studied over the course of the Roybal Center? Are the internal institutional plans and procedures to ensure that all projects supported from this award will comply fully with all applicable Federal regulations, policies, and guidelines for research involving human subjects, including the evaluation of risks and protections in project proposals, appropriate ethical oversight and funded projects, and plans for data and safety monitoring for clinical trials well-described?

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?

Environment

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?

Additional Review Criteria - Behavioral Intervention Development Core

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.

Study Timeline

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

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations - Behavioral Intervention Development Core

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.

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 Resource Sharing Plan(s) (i.e.,Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIA, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Aging. The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

Prior Approval of Clinical Trials

Recipient-selected projects require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

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

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

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

Not Applicable

3. Data Management and Sharing

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

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

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

Section VII. Agency Contacts

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: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

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

Lisa Onken, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: lisa.onken@nih.gov

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

Jeff Ball
National Institute on Aging (NIA)
Telephone: 301-402-7732
Email: BallJ@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.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.