Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

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

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from 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 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

Nursing homes, certified skilled nursing facilities that provide post-acute and long-term care (LTC), provide care for the most vulnerable older adults who live with multiple chronic conditions (MCCs) and experience a very high prevalence of cognitive impairment and Alzheimer’s disease (AD) and Alzheimer’s disease-related dementias (ADRD). Of the 1.3 million current residents of U.S. nursing homes, only a few hundred participated in randomized clinical trials (RCTs) related to the ongoing COVID-19 pandemic, and few regularly participate in RCTs related to the testing, prevention, diagnosis, or treatment of other prevalent conditions. The context of MCCs is crucial for such trials since those older adults living with MCCs are more likely to come from socioeconomically deprived backgrounds and are frequently excluded from, or not enrolled sufficiently in, the RCTs that generate evidence of efficacy/effectiveness. An increasing proportion of nursing home residents require more medicalized, post-acute care, and patients often have different goals, needs, and payment sources depending on whether they require rehabilitation following a hospitalization or long-term, custodial care. Some challenges for conducting clinical research and RCTs in the setting include an under-resourced and unstable nursing home industry, complex federal and state regulations relating to oversight of nursing homes, the need for special protections of the vulnerable nursing home population when conducting research, and the absence of clinical research experience and infrastructure in long-term care settings.

The National Academies of Science, Engineering, and Medicine have advocated for high-quality research to advance the quality of care in nursing homes. In 2021, an NIA conference examined special considerations of pragmatic trials in long-term care, and contrasted the recommendations to explanatory trials. Explanatory trials are designed to maximize the likelihood of finding efficacy of an intervention by testing in an ideal setting, whereas pragmatic trials aim to test effectiveness of an intervention in a more generalizable setting. Therefore, pragmatic trials require interventions with evidence of efficacy generated from explanatory trials, and some interventions are best tested in explanatory trials in the long-term care setting. Previously, the American College of Cardiology, in collaboration with the American Geriatrics Society (AGS) and NIA, held a U13 satellite symposium addressing pharmacotherapy in nursing homes to identify information gaps and research priorities. They outlined broad research priorities in nursing facilities which center on how to best measure quality, optimize prescribing, and evaluate best practices for improving care for short- and long-stay residents. In short, person-centered, goal-directed quality interventions that address multimorbidity and geriatric syndromes are needed.

The data management infrastructure known as the Long-Term Care Data Cooperative (part of the NIA IMPACT Collaboratory), includes electronic health records (EHRs) and other information about residents of geographically diverse set of home chains and linked Medicare data. One of its purposes is to be available for use to awardees of NIH funding opportunities.

Purpose and Research Objectives

This Notice of Funding Opportunity (NOFO) invites U24 applications to establish a national consortium of transdisciplinary aging researchers that will develop the infrastructure to conduct explanatory randomized clinical trials in nursing homes to test the efficacy of preventive interventions, treatments and treatment strategies, and complex services for single and multiple chronic conditions, including AD/ADRD. The trials should address critical knowledge gaps and generate high-quality evidence to inform medical decision-making for the prevention and treatment of MCCs and AD/ADRD. The investigators will create a centralized research infrastructure that will address essential core functions, including (1) overall coordination, (2) recruitment, (3) training, (4) data management and resources, (5) methods and measures, and (6) communication and dissemination. These are merely examples and are not intended to prescribe a specific organizational structure. Investigators may propose the components and functions that best suit the aims of the network.

There is a wide range of clinical and health care delivery research questions in this setting. Examples of interventions that could be studied for efficacy and safety in the nursing home setting include the following:

• Prevention strategies for care of nursing home residents (e.g., infection transmission, vaccines)
• Investigational pharmacological therapeutics and non-pharmacological interventions for conditions common among nursing home residents, including AD/ADRD (e.g., related neuropsychiatric symptoms, including agitation, aggression, depression, apathy, etc.)
• Complex services given in the nursing home setting (e.g., intensive rehabilitation, deprescribing with substitution of behavioral interventions)

Beyond intervention type, efficacy trials may incorporate laboratory tests, imaging, or other procedures that have special requirements (e.g., exercise, injection, or ingestion of active agents). Infrastructure development is needed in the nursing home setting because of the long-standing lack of both resources and personnel. Research projects can demonstrate innovative methods for patient recruitment and measurement of key variables, including outcome measures that may advance the clinical trial enterprise. Potentially, the research proposed can incorporate noninvasive and innovative measures that can be done at the bedside or in the facility. Pilot studies could foster the development of larger explanatory trials by demonstrating feasibility.

Investigators

Investigators must display sufficient expertise, commitment of effort, organizational structure, and operational effectiveness to successfully implement a plan for this undertaking. It is expected that investigators from a variety of professional backgrounds and research expertise across multiple institutions will form an interdisciplinary consortium. Some investigators who are experienced research staff that have worked or previously done research in these types of facilities are desirable. Examples of the kinds of investigators who could be included in this network include, but are not limited to, neuroscientists, epidemiologists, biostatisticians, clinical trialists, neurologists, geriatricians, pharmacists, and social workers. Where appropriate, involvement of collaborators or consultants from industry or other private sector organizations is permissible. A multiple Program Director/Principal Investigator (PD/PI) model of leadership may be proposed, if warranted.

Specific Areas of Research Interest

Potential areas of research may include, but are not limited to, the following:

• Developing infrastructure to enable explanatory randomized clinical trials in nursing homes, including recruitment, patient assessment, treatment delivery, and obtaining investigational samples and/or imaging.
• Integrate and build on available research infrastructure where appropriate.
• Addressing data interoperability, common data elements, and data harmonization; and measurement of patient outcomes.
• Developing diverse stakeholder engagement, including underrepresented communities, to engage priorities of nursing home residents, care partners, and providers. Consider including ways to recruit and retain persons from underrepresented backgrounds within the context of LTC.
• Develop ways to approach precision recruitment, streamline screening criteria, and overcome known barriers to trial participation.
• Developing approaches to encourage involvement and coordination with the NIA-funded Older Americans Independence Centers (OAIC, or Pepper Centers) experienced in conducting research in the long-term care setting.
• Developing and focusing on key priorities for prevention and treatment in the nursing home, with attention to emerging priorities.
• Developing and testing ways of bringing clinical research to skilled nursing facilities.
• Holding periodic competitions for research projects and/or pilot studies that might evaluate feasibility for a larger explanatory RCT.
• Fostering the development of the next generation of nursing-home researchers who can conduct explanatory randomized clinical trials.

Support of research projects and/or pilot studies within the network would provide a means to jumpstart new areas, or develop and extend existing areas, that need more clinical trials research. Pilot study designs may include, but are not limited to, clinical trials. Research projects may test and develop subject recruitment, evaluate patient assessment methods, or other appropriate topics.

This network may plan one or more definitive multicenter randomized clinical trials to be conducted in nursing home settings, but the funds for this network are intended only for the planning (e.g., protocol development, pilot and feasibility testing, data system development), not the conduct of such a definitive trial.

Required Elements of the Application

The data management work must plan to take advantage of the Long-Term Care Data Cooperative (part of the NIA IMPACT Collaboratory).

The proposed network activities must serve the broader community of clinical trials, neuroscience and epidemiological researchers engaged in NIA-relevant research beyond a single institution or set of institutions.

Clinical Research Operations Management System

The National Institute on Aging (NIA) supports a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. This resource, the Clinical Research Operations Management System (CROMS), is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects. It is the expectation by NIA that all successful applicants will interface, integrate, or adapt their information system(s) and processes to interact with existing and future components of the CROMS as necessary, including the use of a CROMS data templates as specified.

Non-Responsive Criteria

The following types of applications will be considered non-responsive and will be withdrawn prior to review:

• Applications that propose activities that only serve investigators at one or two institutions, rather than the field at large
• Applications that conduct definitive multicenter randomized clinical trials
• Applications that do not plan to take advantage of the Long-Term Care Data Cooperative

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 NOFO.

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 Government

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

Other

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

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

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

2. Cost Sharing

This NOFO 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, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions 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 NIA staff to estimate the potential review workload and plan the review.

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

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

The letter of intent should be sent to:

Marcel E. Salive, M.D., MPH 
National Institute on Aging (NIA)
Telephone: 301-496-5278
Email: [email protected]

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 NOFO.

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

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

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

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

The PD(s)/PI(s) must have appropriate experience and training, with demonstrated experience and an ongoing record of accomplishments in managing transdisciplinary clinical research projects and coordinating collaborative research at a national level.

The team must include both established and emerging leaders in the scientific area of focus; expertise in data extraction from EHRs and other clinical systems; experience in design, conduct, and analysis of clinical research studies; and experience in collaborative research with a variety of stakeholders and background in nursing home settings and AD/ADRD research.

If the network is multi-PD/PI, the investigators should have complementary and integrated expertise and skills, and plans must include an appropriate leadership approach, plans for conflict resolution, and organizational and governance structure.

The PD(s)/PI(s) should have experience overseeing the selection and management of subawards.

R&R Budget

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

R&R Subaward Budget

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

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

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

The application should identify the specific problems or limitations that will be addressed by the proposed network, with particular attention on the potential to conduct randomized clinical trials involving nursing home residents who may live with MCCs and/or AD/ADRD.The application must describe areas of opportunity that will be fulfilled by specific activities of the network, including how it will challenge and take into account current AD/ADRD and MCC research or clinical practice paradigms, enlarge participation in clinical research, and impact current AD/ADRD data management strategies. The application must address how its plans incorporate novelty and creativity to address the challenges of the research endeavor and its flexibility in dealing with those challenges across the geographic regions. The application must address how the proposed network will have a substantial impact on the progress and quality of clinical trials research of relevance to treatment of AD/ADRD in persons living in nursing homes with MCCs.

The application should describe the strategy for addressing the aims of the network. The application should describe how existing components at center sites, and newly proposed components supported through this NOFO, will interact to accomplish the goals of the network. The application should identify metrics that will be used to assess progress toward specific goals. The application should provide timelines and an organizational chart, referencing, but not repeating, information submitted on PHS Human Subjects-Clinical Trial Information form.The application must describe the organizational structure of the network, including a leadership body that will have primary responsibility for overseeing the network. The application should describe plans for day-to-day operations overseen by the leadership body, such as the following:

• Coordination across relevant centers and collaboratory programs
• Allocation and review of resource utilization across the network
• Convening of an external advisory panel, as appropriate
• Review and selection of pilot projects, if applicable
• Preparation and submission of administrative documents related to the award

The application should describe other infrastructure and specific activities that will be established within the network, how they will function, and how they will interact with existing and newly created components. The outreach plans must include a broad swath of nursing home research sites, with the potential for data to be collected over a range of age groups and populations defined by the NIA Health Disparities Framework.

Describe procedures for coordination across institutions and for effectively engaging with other relevant activities at participating institutions and across the field at large. Describe plans for research and/or pilot projects to reach and include a broad range of investigators from diverse fields, backgrounds, and career stages. 

Describe resources in the participating scientific environment to support electronic information handling and development of web resources for dissemination of network products. 

If the network will support scientific meetings, the application should describe procedures for developing and selecting meeting topics, identifying potential participants, developing meeting agendas, selecting meeting venues, and monitoring and disseminating meeting outputs.

If the network will award research and/or pilot projects, the application must describe the types of projects that will be supported. The application must provide a plan that describes processes for solicitation, review, selection, and monitoring of pilot projects. The application should describe plans for monitoring the progress of pilot projects and translating their results into subsequent applications for funding where appropriate. Brief descriptions of potential projects should be illustrative.

Applicants must describe the resources available within the participating scientific environment to support electronic information handling and development of web resources for dissemination of network products.

Milestones and Progress Evaluation: Applications must clearly describe milestones and criteria for evaluating the success of their collaboration and research progress.

NIA's process for approval of pilot projects may be developed after award.

The application should describe the leadership role played by PD(s)/PI(s) and other Senior/Key personnel, if applicable, and the impact they would have on the success of their center as well as on the overall network.

Letters of Support: Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. For activities to be conducted at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the institutional officials, must be submitted with the application.

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.

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

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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

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

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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. See Section III of this NOFO for information on registration requirements.

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

See more tips for avoiding common errors.

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

In order to expedite review, applicants are requested to notify the NIA Referral Office by email at [email protected] when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

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.

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.

Overall Impact

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).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the proposed application address the needs of the research network that it will administer? Is the scope of activities proposed for the network appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research network?

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?

For this particular NOFO, note the following additional questions:

How well do the proposed activities advance collaboration and coordination among researchers conducting clinical research and/or clinical trials in the nursing home setting?

How appropriately does the application address how the proposed network will have a substantial impact on the progress and quality of clinical trials research of relevance to treatment of AD/ADRD in persons living in nursing homes with MCCs?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the network? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing aging research? Do the investigators demonstrate significant experience with coordinating collaborative clinical research? If the network is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach and organizational structure appropriate for the network? Does the applicant have experience overseeing selection and management of subawards, if needed?

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?

For this particular NOFO, note the following additional questions:

How appropriate is the breadth of expertise and experience held by personnel, including, but not limited to, experience with data extraction in meaningful ways from EHRs and other clinical systems, experience in design, conduct, and analysis of explanatory clinical trials and research studies, experience in collaborative research with a variety of stakeholders and background in AD/ADRD research?

How appropriate are the proposed leadership approach, staffing, governance and organizational structure for the project? 

How strong are the investigators' demonstrated records of ongoing accomplishments in support of coordination, collaboration, and communication of national-level inclusive networks or consortia?

Innovation

Does the application propose novel organizational concepts or instrumentation in coordinating the research network? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or instrumentation 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?

For this particular NOFO, note the following additional questions:

How well does the application challenge and take into account current AD/ADRD and long-term care research or clinical practice paradigms, and enlarge participation in clinical research by utilizing novel theoretical concepts, approaches, methodologies, interventions, or tools?

How well does the application include mechanisms for leveraging novel collaboration and communication strategies for AD/ADRD and nursing home care researchers?

How well does the application indicate creativity and flexibility to innovate on an ongoing basis?

How well does the design/research plan include innovative elements, as appropriate, that enhance its clinical utility, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research network? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the network is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the network? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of 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?

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?

For this particular NOFO, note the following additional questions:

How adequately are outreach plans designed to reach and include a broad swath of persons living in nursing homes, over a range of age groups and priority populations defined by the NIA Health Disparities Framework?

How appropriate are the procedures in place for coordination across institutions and for effectively engaging with other relevant activities at participating institutions and across the field at large?

How likely are the plans for research and/or pilot projects to reach and include a broad range of investigators from diverse fields, backgrounds, and career stages?

If applicable, to what extent is the approach for soliciting and reviewing research and/or pilot projects  appropriately aligned with network goals, appropriately impartial and rigorous, and likely to advance progress in the field at large? 

Environment

Will the institutional environment in which the network will operate contribute to the probability of success in facilitating the research network? Are the institutional support, equipment and other physical resources available to the investigators adequate for the network proposed? Will the network benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

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?

For this particular NOFO, note the following additional questions:

How adequate are the resources available within the participating scientific environment to support electronic information handling and development of web resources for dissemination of network products?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Milestones

How feasible, well developed, and quantifiable are the proposed milestones regarding the specific goals and accomplishments of the resource network? How appropriate are they for assessing the ongoing value of the proposed activities? How appropriate are the specified criteria specified to evaluate the network’s progress in advancing the field to a point where network support is no longer needed for sustained growth?

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

Not Applicable

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

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 networks  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 NOFO.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Aging. 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.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the 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).

2. Administrative and National Policy Requirements

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

• 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 condition of receiving the grant, to administer 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. 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 NOFO.

• 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.”

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Developing objectives, approaches, and goals for network infrastructure development, including all required components.
• Designating investigators to serve as members on a Network Steering Committee and other subcommittees with NIH staff, as appropriate.
• Complying with Federal regulatory requirements, including, but not limited to, those relating to human subjects protections.
• Attending quarterly (or as needed) virtual Network Steering Committee meetings.
• Accepting the participatory and cooperative nature of the collaborative research process and complying with policies and practices of NIH. Agreeing to accept close coordination, cooperation, and management of the project with NIA Staff. The PD/PI(s) will be expected to maintain close communications with the NIA Project Scientist(s) and, where appropriate, the Program Officer. The Project Scientist(s) will have substantial scientific involvement that is above and beyond the normal stewardship role in awards.
• Cooperating in the reporting of the study progress and findings. Where warranted by appropriate participation, plans for joint publication with NIA of the results and conclusions are to be developed by the Principal Investigator or Steering Committee, as applicable. NIH policies governing possible co-authorship of publications with NIH staff will apply in all cases. In general, to warrant co-authorship, NIH staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; and (c) preparation and authorship of pertinent manuscripts.
• Overseeing the overall budget, activities, and performance of the cooperative agreement.
• Sharing data, resources, and software as appropriate and consistent with achieving the goals of the program and the approved sharing policies for NIH.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below: 

NIA Project Scientist

• The NIA Project Scientist will participate as a member of the resource development network and assist the PD/PI(s) in the identification of relevant NIA/NIH-funded researchers and longitudinal studies for potential involvement in network activities. The NIA Project Scientist will serve as liaison to other NIA components to promote collaborations. The NIA project scientist will also facilitate the involvement of representatives from other NIH institutes, as appropriate, in network activities.
• The NIA Project Scientist(s) will work with the PD(s)/Pl(s) and participate in the Network Steering Committee to ensure the objectives and milestones of the program are being met.
• NIA will assign a Program Officer(s) who will be responsible for retaining overall programmatic responsibility for the award and will clearly specify to the recipient the name(s) and role(s) of any additional individuals with substantial involvement in the project and the lines of reporting authority.
• NIA may designate additional staff to provide advice to the recipient on specific scientific and/or administrative issues to optimize the conduct of network activities.
• NIA will serve as a resource with respect to other ongoing NIH activities that may be relevant to the protocol to facilitate compatibility and avoid unnecessary duplication of effort.
• NIA staff will interact with the PD(s)/Pl(s) on a regular basis to monitor progress. Monitoring may include regular communication with the PD(s)/Pl(s) and their staff.
• NIA staff (i.e., Project Scientist(s)) will provide input, expert advice, and suggestions in the design, development, and coordination, and implementation of the network objectives.

NIA Program Official

• An NIA program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIA Program Officer will make recommendations for continued funding based on: a) overall networks progress; b) cooperation in carrying out the research; c) assessing the progress toward the accomplishment of specified milestones and/or d) maintenance of high quality of research in alignment with the goals of this RFA.

Areas of joint responsibility include:

• The primary responsibility for the program resides with the recipient, although specific tasks and activities will be shared among the recipient and the NIH Project Scientist(s).

Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Data Management and Sharing

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

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

4. Reporting

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

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 NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 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 $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

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: [email protected] (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: [email protected]

Marcel E. Salive, MD, MPH
National Institute on Aging (NIA)
Telephone: 301-496-5278
Email: [email protected]

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: [email protected]

Laura Pone
National Institute on Aging (NIA)
Telephone: 301-451-9956
Email: [email protected]

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.