State Dementia Care Research Center (U54 Clinical Trial Not Allowed)

State Dementia Care Research Center (U54 Clinical Trial Not Allowed) is sponsored by National Institute on Aging (NIA). Establishes state-based research centers to improve care for persons living with dementia and their caregivers through evidence-based research on care coordination and integration.

Expired RFA-AG-24-033: State Dementia Care Research Center (U54 Clinical Trial Not Allowed) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations Funding Opportunity Title State Dementia Care Research Center (U54 Clinical Trial Not Allowed) U54 Specialized Center- Cooperative Agreements September 14, 2023 - Notice of Pre-Application Webinar for RFA-AG-24-033, State Dementia Care Research Center (U54 Clinical Trial Not Allowed).

See Notice NOT-AG-23-046 August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Notice of Funding Opportunity (NOFO) Number Companion Notice of Funding Opportunity See Section III. 3.

Additional Information on Eligibility .

Assistance Listing Number(s) Notice of Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) invites applications for a State Dementia Care Research Center (henceforth Center) which aims to ultimately improve care for persons living with dementia (PLWD) and their caregivers/care partners by building a research evidence base that can be used to improve dementia care coordination, integration, and care transitions in community settings, as well as inform policymaking.

With recognition of the differences in provision, coverage, and access to Alzheimer's disease (AD) and Alzheimer's disease-related dementias (ADRD) care across the nation, this infrastructure resource will support research on social services and health systems within states.

Specifically, the new resource will: (1) invite research on AD/ADRD care coordination, integration, and transitions within states; (2) foster the creation and integration of data on home and community-based services and health care data within states; and (3) support the dissemination of findings to stakeholders, the public, and policymakers.

The Center will directly address AD/ADRD research implementation milestones on care integration with emphasis on healthcare disparities and policy by creating a consortium of scholars who will study AD/ADRD care coordination across settings, accounting for state-level and sub-state-level heterogeneity in provision, coverage, and access to services.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO). Required Application Instructions It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts ).

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

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement Section I. Notice of Funding Opportunity Description There is an urgent need to better understand what works in terms of AD/ADRD care coordination, care integration, and care transitions in community settings across the United States.

Dementia care coordination refers to the deliberate organization of dementia care activities and the sharing of individual concerns to achieve more effective care; care integration refers to increasing the collaboration between professional and care organizations, thereby improving continuity of care; and care transitions refer to the movement of an individual from one care setting to another.

PLWD need care that maintains their safety; promotes human dignity, autonomy, and quality of life; limits medical error and unnecessary care transitions; and can be delivered in a fiscally responsible manner. All available evidence suggests that lack of care coordination and integration is frustrating, costly, and reduces safety and quality of care for PLWD.

Community-level care integration offers the promise of helping people with AD/ADRD access the services and supports they need in the setting of their choice. However, there is wide variation in state policies and payment that support care coordination and integration. Moreover, racial and ethnic minorities and rural PLWD are less likely to have access to well-integrated care.

Many states and sub-state entities work to improve dementia care coordination, integration, and transitions through the use of long-term services and supports (LTSS) in the community and/or institutional settings (e.g., nursing homes), but these efforts vary across and within states.

Examining this important topic in the context of states is critical to our increased understanding of how different states are meeting the challenges and opportunities in AD/ADRD care provision.

Existing efforts focused on the national level have left many research and research infrastructure gaps, in part because care coordination planning and programmatic decisions are often made at the state or local level; moreover, gaps in program data and analysis persist. A state or regional approach should include inputs from multiple stakeholders that can provide much-needed insights on what works and for whom in terms of AD/ADRD care.

The engagement of healthcare systems and social service systems and their providers at the state and sub-state level are critical to scientific advances in this area. To provide an example, Massachusetts is a state that offers many care integration options, with several programs allowing individuals with AD/ADRD to access services and supports in the community, while not all states provide this level of support.

The Massachusetts Program of All-inclusive Care for the Elderly (PACE) integrates Medicare and Medicaid benefits for the lowest-income individuals. For low-income individuals who exceed the poverty threshold, the state offers the Moving Forward Plan (MFP) in the form of MFP Residential Supports and MFP Community Living.

The residential supports program is for those who need around-the-clock assistance, similar to the level of care available in a nursing home. The community living waiver is for those seniors who can live in the community with the right combination of support services. Depending on the program, MFP may directly pay some of the costs of an assisted living community that provides support for activities of daily living.

While evidence from Massachusetts offers insights on structuring payment programs to pay for community-based services for PLWD, there is a lack of knowledge on state-level variation in payment for care integration services, and differential practices across state and local entities confounds a single national assessment.

Services that are known to enhance safety and positive outcomes for older adults as they transition across care settings include medication reconciliation and falls assessment and risk mitigation. Yet, little is known about state-to-state variation in community-based provision of care and payment for such services among PLWD. The context AD/ADRD care is provided in (access, coverage/payment, etc.) influences quality of outcomes.

Variation in rules and resources state-by-state influence that context. Analyses using a national lens will miss the variation that no doubt drives differences. Looking within states to examine outcomes allows researchers to consider which factors across states may drive better outcomes.

Research shows that most older adults prefer to remain in their home and receive care at home, instead of moving to an extended living facility. While many of the same custodial, hygiene, and nutrition services that are provided in long-term care settings can be delivered at home, the logistical hurdle of scheduling these services can be challenging for families.

Furthermore, because payment for home and community-based services comes from numerous sources that vary across states, it can be difficult for researchers to access the necessary data to determine whether home and community-based services truly can serve as substitutes for long-term care.

Thus, we lack knowledge on the care practices and state payment policies and programs that support safe, integrated, fiscally responsible care in home and community settings.

The aim of this initiative is to integrate data that are already available from in-patient and long-term care settings with data from home, community, and office-based settings, and data on state and local policies, so that an assessment of what works to support successful care coordination, care integration, and care transitions across settings can be made.

Given national variation in payment and services, incentivizing research at the state level to enable research on AD/ADRD care holds promise for providing a national evidence base about the most effective practices to key stakeholders who can improve care for PLWD.

Such an evidence base may be used to improve dementia care coordination, integration, and care transitions in community settings, as well as inform policymaking and program decisions. This NOFO invites applications for a State Dementia Care Research Center which will support research on social services and health systems within states.

The specific objectives of the Center are to: (1) facilitate state-based research on dementia care coordination, integration, and transitions; (2) create and integrate within-state data on home and community-based services and health care data; and (3) support the dissemination of findings.

The Center will build investigator capacity, support AD/ADRD care research on state-level and sub-state-level data, and maintain the resource and knowledge base for AD/ADRD state- and regional-level research through the four Center cores.

The Center will produce research that focuses on understanding structural, institutional, and resource-related factors that influence quality and access to care for those living with dementia and their care partners to build an evidence base for policymakers and other key stakeholders.

The Center's primary goals are to address data and measurement to support research exploiting state and regional differences and changes in policy and practice as they pertain to dementia care coordination, integration, and care transitions to develop an evidence base intended to improve care for PLWD and their families.

To inform research, the Center will build research-supporting partnerships and disseminate results and bring together scientists and community stakeholders from across settings (e.g., home, adult day care, social services, home health agencies, primary care, hospitals, health care systems, nursing homes, assisted living facilities (ALFs), and hospice providers).

This Center will overcome existing research and data limitations by integrating program data with Medicare/Medicaid data within states to identify approaches that improve dementia care access, cost of care, and quality of care as PLWD go through various transitions of care in the community. Applications should address forming research partnerships within institutions and across organizations at the state or sub-state level.

At least two different states should be proposed in an application, with the goal of including more states in the Center over time. Each state should have pre-established within-state partnerships (e.g., state and/or county governments, adult day care, social services, home health agencies, primary care, hospitals, health care systems, nursing homes, ALFs, and hospice providers).

The Center should advance research on good dementia care in order to promote the well-being of PLWD, care partners, and caregivers, supporting research that examines the extent to which dementia care programs meet any of the key components of dementia care, supports, and services put forward in a 2021 National Academies of Science, Engineering, and Medicine report, Meeting the Challenge of Caring for Persons Living with Dementia and Their Care Partners and Caregivers : Assessment of symptoms to inform planning and deliver care, including financial and legal planning Information and education Support in activities of daily living Support for care partners and caregivers Communication and collaboration Coordination of medical care, long-term services and supports, and community-based services and supports A supportive and safe environment Advance care planning and end-of-life care The Center will be comprised of four core components which will incorporate the features highlighted in the Objectives above: (A) Administrative and Dissemination Core; (B) Partnership and Engagement Core; (C) Data Core; (D) Research/Pilot Core.

Applicants should refer to Section IV for specific requirements for each Core. Applicants should propose a minimum of two states for inclusion in the Center. For each state, partners that represent the heterogeneity found in states should be included.

Applicants should be intentional in the coverage of proposed states in terms of not only regional diversity, but also in other areas where disparities exist, such as race/ethnicity, income, rurality, and other characteristics, as described in the NIA Health Disparities Research Framework .

It is not expected that the Center will involve all 50+ states and territories; applicants should propose a process to identify and establish partnerships for research and data access/sharing and build on successes to encourage other state entities to follow suit and become part of the Center.

An Administrative & Dissemination Core will oversee the operations of the Center and work to disseminate research findings to a wide range of stakeholders and promote use of Center-developed tools and infrastructure by the broader research and stakeholder communities.

The Partnership & Engagement Core has two goals: 1) establish state-based partnerships, and 2) encourage stakeholder engagement through a PLWD and care partner engagement panel.

Partnerships : The Core will build partnerships with institutions/programs (e.g., home health agencies, public health programs, ALFs, state-level data providers, social services providers, Area Agencies on Aging) within states to obtain access to program and other relevant data and expertise to facilitate research, aiming to support five to seven such state/sub-state partnerships over the proposed grant period.

Engagement : The Core will stand up a PLWD and care partner engagement panel. Applicants may propose that other individuals or organizations should be part of the panel (e.g., paid caregivers, payers, social service and health care providers). The Data Core will coordinate knowledge about data used by individual projects and may act as a data and/or code repository where applicable.

Based on provider data access and integration rules, the Center will either serve as a direct hub for data sharing or as a source of discovery/guidance for use of data from providers. In any case, the Data Core will facilitate research access and enhance usability/replicability via support tools for researchers (e.g., development of user-friendly files or supplemental documentation).

The Data Core includes data representing the context of care and resources within a state (e.g. health care systems interactions, social service data, and data on services paid for by Medicaid captured in state to county-based systems). The Research/Pilot Core will stimulate rigorous, reproducible research on topics that deepen our understanding of what works in terms of dementia care coordination, integration, and transitions.

Research/pilot projects must use data and/or resources associated with the Center, and research topics must focus on policy or contextual factors that influence successful or unsuccessful dementia care and caregiving coordination, transitions, and/or integration. Study design, data sharing, and research topic should be considered in the research/pilot application and review process.

Projects may focus on understanding drivers of successful approaches to managing dementia care coordination, integration and transitions. Care transitions is one research area of interest that can address the following research topics: Transitioning into palliative care for PLWD: what state-level policies and programs work and how? Care transitions for PLWD across community settings.

The economics/payment of care transitions and Medicare Advantage/plan variation. Non-Responsiveness Criteria The following types of applications will be considered non-responsive, and will be withdrawn prior to review: Applications that do not propose all required Cores: Administration and Dissemination, Partnership and Engagement, Data, and Research/Pilot Cores.

Applications that do not focus on AD/ADRD care populations, data, and research. Applications that do not address forming research partnerships within institutions and across organizations at the state or sub-state level, including at least two initial partnerships with entities from two different states.

Applications that do not include populations that experience AD/ADRD care disparities and inequities, as described in the NIA Health Disparities Research Framework .

AD/ADRD Research Implementation Milestone database 2021 NASEM report, Meeting the Challenge of Caring for Persons Living with Dementia and Their Care Partners and Caregivers NIA Health Disparities Framework NIA's webpage for information regarding the Decadal Survey of Behavioral and Social Science Research on AD/ADRD NIA's webpage for information regarding the 2020 National Research Summit on Care, Services, and Supports for Persons with Dementia and Their Caregivers NIA’s webpage for information regarding the 2023 National Research Summit on Care, Services, and Supports for Persons with Dementia and Their Caregivers NIA's Guidance on Sharing Data and other Resources Responses to frequently asked questions about this NOFO will be posted here .

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

Award Information Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.

2 for additional information about the substantial involvement for this NOFO. Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Not Allowed: Only accepting applications that do not propose clinical trials. Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NIA intends to commit $4,000,000 in fiscal year 2024 to fund 1 award.

Application budgets are limited to $2,500,000 in direct costs per year and need to reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period. The maximum project period is 5 years.

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

Eligibility Information 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) 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 not allowed. 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 Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registration; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with 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. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2. 3.

7. 4 Submission of Resubmission Application . This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2. 3.

9. 4 Similar, Essentially Identical, or Identical Applications ). 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 NOFO.

See the administrative office for instructions if planning 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 How to Apply - Application Guide , except where instructed in this notice of funding opportunity 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.

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: National Institute on Aging (NIA) All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Component Type for Submission Administrative and Dissemination Core Partnership and Engagement Core Instructions for the Submission of Multi-Component Applications The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing a multi-component application. When preparing the 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) 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) 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 NOFO) for the entire application. The application must describe how the PD/PIs expertise is relevant to the goals of the Center and provide examples of successfully working with social and governmental systems.

The application must describe the experience of the proposed team members with respect to working in research consortia or other collaborative efforts to achieve a shared goal. 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.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover. 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) Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component. Specific Aims: Describe the specific aims for the proposed Center.

The Center must create a dynamic infrastructure for developing an evidence base and supporting AD/ADRD state- or regional-level research with multiple social service systems, state government, care providers, and/or health systems that will facilitate translation into policies, strategies, or programs for improving care coordination, integration, and care transitions for PLWD and their caregivers/care partners.

The Center goals are to produce research that focuses on understanding structural, institutional, and resource-related factors that influence quality and access to care for patients with dementia to build an evidence base for policymakers and other key stakeholders. Over time, the states represented in the Center may produce cross-state comparisons. Address overall objectives and long-term goals of the Center.

Propose plans starting in Year 2 to establish future collaborations and maintain the Center. Include sustainability plans addressing post-award efforts. Sustainability may include letters of support from partnering institutions/social service systems/health systems as specified in the Letter of Support section below.

Describe how the Center will engage nationally with others working in similar areas to stay abreast of emerging experience, regulations, and technical advances that impact the ability for research to be conducted in social service and health care settings.

This could include other NIH-funded AD/ADRD projects (e.g., NIA's IMPACT Collaboratory , projects supported through RFA-AG-24-009 ), but also other federally and privately funded efforts, such as projects funded by the Center for Medicare and Medicaid Innovation (CMMI) and/or private foundations.

Letters of Support: At the time of application, the PD/PI must submit letters of support that demonstrate collaborations with at least 2 initial states to support within-state research on dementia care research. Over time, the number of states represented in the Center will likely grow. Comparison of research across states is a goal of the Center.

The state or sub-state entities that demonstrate within-state partnerships could come from places such as state government/program offices, academic institutions, third-party data providers, health systems, etc. The letters of support must indicate institutions that are willing to join the Center if funded by NIA in the first year.

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. 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. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

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. 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