Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)

National Institute on Minority Health and Health Disparities (NIMHD)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)

Funding Opportunity Title
Research Collaboration Network in Structural Racism Measurement and Modeling (U24 Clinical Trial Optional)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices
  • August 31, 2022- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 5, 2022- Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
Funding Opportunity Number (FON)
RFA-AG-25-003
Companion Funding Opportunity
None
Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.866, 93.307
Funding Opportunity Purpose

This Notice of Funding Opportunity (NOFO) invites applications to form an interdisciplinary network of scholars from a variety of disciplines to collaborate with each other in the measurement and modeling of structural racism to facilitate research on life course health and aging.  

Applicants should propose activities that include the following:

  1. Expansion of structural racism measures and methods through input from the broader research community and development of a publicly available data repository for use by researchers, community members, and policy makers through a data portal to facilitate research on life course health and aging.
  2. Support of activities that bring together scholars in the behavioral/sciences, humanities, education, political science, and the public health sciences to improve measurement and methods for the study of structural racism in life course health and aging research.
  3. Engagement with national and international scientific organizations to promote further advances in measurement and methods of structural racism in research on life course health and aging.
  4. Pilot projects on measurement and methods of structural racism in life course health and aging research, incorporating interdisciplinary approaches from the behavioral/social sciences, humanities, education, and political science with the public health sciences.
  5. Collaboration with NIA Centers and other NIA research networks on measurement and methods for the study of structural racism.
  6. Serving as a central resource for the organization of meetings and other educational activities (e.g., intensive summer institutes, series of workshops, advanced seminars on methodology, or short-term residential opportunities) on measures and methods of structural racism for aging research.

Key Dates

Posted Date
June 12, 2024
Open Date (Earliest Submission Date)
September 17, 2024
Letter of Intent Due Date(s)

September 17, 2024

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
October 17, 2024 Not Applicable Not Applicable March 2025 May 2025 July 2025

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

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

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Expiration Date
October 18, 2024
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

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

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background 

This Notice of Funding Opportunity (NOFO) for a Cooperative Resource-Related Research Project invites applications to form an interdisciplinary network of scholars from a variety of disciplines to collaborate with each other in the measurement and modeling of structural racism to facilitate research on life course health and aging. The resource support will facilitate activities such as meetings, conferences, small-scale pilots, short-term educational opportunities (such as intensive workshops, summer institutes, or visiting scholar programs), and dissemination to encourage the growth and development of aging research focusing on structural racism and build resources for the advancement of the field at large.  

Structural racism has been studied in the humanities, sociology, education, and political science for decades. While the field of public health has measured structural racism, there is ample opportunity to integrate approaches from these other fields to better understand the influence structural racism may have on health disparities in aging, including disparities in Alzheimer’s disease (AD) AD-related dementias (ADRD).    

The National Advisory Council on Aging (NACA) 2019 Review of the NIA Division of Behavioral and Social Research notes, “The shocking extent of growing SES [socioeconomic status] and regional differences in mortality and life expectancy, as well as persistent racial inequalities, have been documented, and increasing understanding of the sources and approaches to ameliorating these needs to be a major research focus going forward.” The NACA review also encourages, “Exploration of select causes of disparities should include stigma, bias, discrimination, racism, and inequity.” In response to the recommendations from NACA, the National Institute on Aging sponsored a National Academies of Sciences, Engineering, and Medicine (NASEM) Committee on Population (CPOP) Workshop on Structural Racism and Rigorous Models of Social Inequity. The committee described structural racism as “the public and private policies, institutional practices, norms and cultural representations that inherently procure opportunity, value, advantage or disadvantage to individuals and populations according to their race/ethnicity both across the life course and between generations.” The workshop also highlighted that structural racism and discrimination are broad constructs that can be further informed by thought leaders in the humanities, sociology, education, political science, and other disciplines not traditionally included in public health. The assembled experts commented on the need for: 

  1. More rigorous models of social inequity in poor health outcomes to inform policy at the national, state, and local levels; 
  2. Intersectional research to understand the multidimensional effects of racism on racial/ethnic minority subgroups; 
  3. Enhanced data infrastructure for developing validated measures of health among racial and ethnic minorities, for implementing effective survey techniques that avoid self-selection bias, for coding historical data to measure racism, and for incorporating longitudinal studies in the analysis of relationships; and
  4. Better understanding of the complexity of how racism is expressed. 

An important insight from the workshop was the potential for interdisciplinary research teams, including experts in the humanities, sociology, education, political science, and public health sciences, to enhance health disparities research through improvement in structural racism measurement and modeling. Following the expert comments from the workshop, measurement is a key driver in facilitating better research on health disparities. The population health and aging field is moving toward more frequent use of an approach that captures multiple indices to better understand cultural and structural racism, both spatially and temporally—for example, via racial segregation (e.g., historical residential redlining) and contemporary and historic racial terror, surveillance, and control. There is also a need to incorporate measurement of “race-neutral” institutional policies (i.e., policies that do not consider race in outcomes) that may nonetheless function to keep elements of historically racialized social systems in place. Data are available on these phenomena but have been underutilized for the study of how structural racism influences health. In addition, Census data, administrative data, and vital statistics hold potential to studying individuals across the life course. However, more research is needed to construct and validate measures using these and other data resources, as well as to develop new measures to support aging research.

A variety of science development activities (e.g., intensive summer institutes, workshops on the development of measures capturing specific historical structural factors, advanced seminars on methodology, annual conferences to disseminate information on new findings or measures, or pilot research to validate a measure or test a new methodology) engaging an interdisciplinary network of experts that integrate scholarship from the humanities, sociology, education, political science, and public health sciences to assess existing measures/methods and develop new measures/methods could significantly advance health disparities research in aging. 

A key recommendation from the NASEM CPOP Structural Racism and Rigorous Models of Social Inequity workshop was to build a publicly available data repository. A data repository would help researchers discover existing measures of structural racism as well as measures developed/validated by the network, provide summaries of conference and science workshops highlighting new areas for development, and solicit input from the field to improve measurement of structural racism. Pilot support for small projects intended to develop and validate new measures and methods can also help jumpstart research and engage expertise from outside experts, including researchers that have not traditionally collaborated with public health researchers. In addition, network activities could involve collaborations between international and national scientific organizations. Such collaborations would help disseminate the latest findings on structural racism measurement and modeling from a variety of disciplines and could further expand network expertise and generalizability of some measures/methods across different contexts. A network with flexible resources could propose additional science development activities.    

Research Objectives  

The purpose of this NOFO is to build collaborations between public health sciences and fields not traditionally included in the health sciences in the operationalization of structural racism. Specifically, this NOFO encourages experts from these fields to collaborate with each other in a formalized network to improve measures and methods intended to advance structural racism research in aging and life course health through activities including but not limited to: 

  1. Building a publicly available data repository 
  2. Supporting interactive multidisciplinary science development activities to improve measures and methods
  3. Engaging with international and national scientific organizations to expand the network of experts
  4. Piloting projects in the measurement and modeling of structural racism in aging research
  5. Leveraging existing NIA Centers and networks
  6. Serving as a central resource for the dissemination of methods/measures and related educational activities.

The objectives of this NOFO are to build a network to identify new measures and models of structural racism with input from scholars across the humanities, sociology, education, political science, and public health sciences to create new measures and conceptual frameworks and catalyze new aging research on structural racism via proposed activities. This program will be supported via the U24 Cooperative Resource-Related Research Project, intended to provide investigators with the flexibility to design innovative network activities and bring the unique resources necessary to achieve this NOFO's objectives. Applications will include plans for the following activities: 

Administration/Governance Activities: Administrative/Governance activities include establishing an organizational governance structure to support proposed administration, developmental, and dissemination activities to improve aging research on structural racism. A key aspect of network administration will be the recruitment of experts from the health sciences and the humanities, sociology, education, and political science to propose plans to develop measures and test existing measures and associated methods to conduct novel aging research on structural racism. 

Developmental Activities: Developmental activities include creating a plan for measure development around a topic and providing a justification for each topic proposed. Developmental activities also include workshops, literature reviews, and pilot research, as well as activities intended to support the development and use of network-developed measures within NIA-supported infrastructure projects (such as center grants, research networks, and large-scale primary data collections) and for future adoption by other NIA-supported studies.  

Dissemination Activities: Dissemination activities include strategies that the network will take to ensure wide dissemination of all products and resources developed by the network to the broader community, including but not limited to sharing data, creating websites, and hosting annual meetings. 

Collaborative Activities: Collaborative activities include collaboration with NIA Centers and other NIA research networks on measurement and methods for the study of structural racism. 

NIA supports several research center and network programs designed to develop aging research across several fields that attract researchers and resources that can advance the goals of the network. Applicants are encouraged to partner with these programs to leverage these resources:

  • Centers on the Demography and Economics of Aging program supports the infrastructure and pilot data necessary for research and program development by investigators within an institution, and/or across domestic and international institutions, in the areas of demography and economics of aging.
  • Edward R. Roybal Centers for Translational Research in the Behavioral and Social Sciences of Aging program supports the translation and integration of basic behavioral and social research findings into interventions to improve the lives of older people and the capacity of institutions to adapt to societal aging.   
  • Resource Centers for Minority Aging Research (RCMAR) are designed (1) to support the career development of early-career scientists from diverse backgrounds, including those from groups underrepresented in the aging research workforce, by mentoring promising scientists for sustained careers in aging research, and (2) to develop infrastructure to promote advances in these areas while simultaneously increasing the number of researchers focused on health disparities and the health and well-being of minority elders.
  • NIA IMPACT Collaboratory seeks to build the nation’s capacity to conduct pragmatic clinical trials of interventions embedded within health care systems for people living with dementia and their care partners.
  • Alzheimer’s Disease Research Center (ADRC) program translates research advances into improved diagnosis and care for people with Alzheimer's disease, as well as working to find a treatment or way to prevent Alzheimer's and other types of dementia.
  • Claude D. Pepper Older Americans Independence Centers (OAICs) program establishes centers of excellence in geriatrics research and research career development to increase scientific knowledge leading to better ways to maintain or restore independence in older persons.   
  • Nathan Shock Centers of Excellence in the Basic Biology of Aging provide leadership in the pursuit of basic research into the biology of aging.   
  • Artificial Intelligence and Technology Collaboratories (AITC) program is designed to serve as a national resource to promote the development and implementation of artificial intelligence approaches and technology through demonstration projects to improve care and health outcomes for older Americans, including persons with dementia and their caregivers.
  • NIA-sponsored Research Networks encourage growth and development in emerging areas through meetings, conferences, small scale pilots, training, educational activities, and dissemination of resources to the field at large.  

Staff in the Office of Planning, Analysis, and Evaluation at NIA may evaluate the network and may provide recommendations for continuation of the network.

Non-Responsiveness Criteria   

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

  • Applications that are not focused on development of measurement and methods to enhance the study of structural racism in aging.  
  • Applications that are not focused on developing measures or models that present a potential solution to health-related outcomes. 
  • Applications that do not have multidisciplinary collaborations and input between the health sciences and humanities, sociology, education, and political science.   
  • Applications that do not propose measure/method development activities that engage the required multidisciplinary experts. 
  • Applications that do not include the administration/governance, developmental, dissemination, and collaborative activities described in the Research Objectives section above.

Clinical Research Operations Management System 

NIA uses a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. NIA 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. NIA investigators of grants, contracts, and cooperative agreements that are active as of July 1, 2021, including clinical trials funded as pilots, exploratory studies, or other projects through this Consortium, and support human subjects research as defined by the DHS HHS OHRP regulations at 45 CFR 46 will be required to interact with and use existing and future components of CROMS as required by NIA throughout the lifecycle of the grant, as described in NOT-AG-23-017. Data to be submitted to NIA CROMS includes those elements reported in the standard NIH requirement annual progress report (GPS 4.1.15.7). Details regarding the standard operating procedures for CROMS can be found on the NIA CROMS website

When applicable, all NIA grantees must ensure: 

1. The study’s Informed Consent Document (ICD) lists “The National Institutes of Health (NIH) and its authorized representatives” as one of the organizations that may look at or receive copies of information in participants’ study records. According to DHS HHS OHRP 45 CFR 46 §46.116, all ICDs must contain “A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.” If using the NIA informed consent template, please see Section 6: Statement of Confidentiality.  

2. An assigned NIH ClinicalTrials.gov identifier (NCT number) is reported in its respective CROMS study record within three months after assignment, and the reporting of final enrollment data to CROMS is consistent with final enrollment data reported in ClinicalTrials.gov. 

NIA's Commitment to Inclusivity in Research Involving Human Subjects

NIA is committed to supporting and conducting research on aging that improves the health and well-being of all people. Therefore, NIA will prioritize the advancement of science that represents, in terms of race, ethnicity, sex, age, and comorbidity, the population affected by the condition being studied. Applicants should ensure as applicable that they 1) include proposed planned enrollment tables identifying the population(s) affected by the disease/condition, and 2) address the NIH Inclusion Policies for Research Involving Human Subjects and NIH-designated Populations with Health Disparities, as appropriate; as well as other populations that experience health disparities.

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

Funding Instrument

Cooperative Agreement: A financial assistance 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
New

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

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Funds Available and Anticipated Number of Awards

NIA intends to commit $1,600,000 in fiscal year 2025 to fund 1 award. 

Award Budget

Application budgets are limited to $1,000,000 in direct costs per year and need to reflect the actual needs of the proposed project. 

Award Project Period

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

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

  • 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
Foreign Organizations

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; 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 their organization to develop an application for support. Individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

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

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

The letter of intent should be sent to:

Frank Bandiera, Ph.D., MPH
National Institute on Aging (NIA)
Telephone: 301-402-7629
Email: frank.bandiera@nih.gov

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Applications must propose Senior/Key Personnel and other personnel well suited to implement the activities of the Network Expert Committee (NEC). Specifically, the Senior/Key Personnel (s)/PI(s) must have the following experience:

  • Demonstrated experience in measuring and modeling structural racism from the humanities, sociology, education, and political science fields
  • Demonstrated experience in measuring and modeling structural racism from the public health sciences
  • Experience coordinating multidisciplinary collaborative research

If the application is multi-PD/PI, the investigators must have complementary and integrated expertise, as well as clear governance plans, for the administration of the proposed NEC.

NOTE: Applicants are strongly encouraged to limit the number of key personnel with substantial roles in the NEC to avoid establishing conflicts of interest throughout the field. Participation in NEC activities, including attending meetings to offer scientific consultation, receiving pilot funding, or collaborating on measure or data development activities will not constitute formal collaboration from the perspective of NIH, with the exception of those key personnel listed on the application. Applications should not include the names of proposed members of the NEC or contact proposed members but rather describe the expertise needs for the NEC.

R&R Budget

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Applications must explain:

  • How experts from the health sciences will collaborate with experts from the humanities, sociology, education, and political science in the measurement and modeling of structural racism in life course health and aging
  • How the proposed activities will enable the researchers to lead, coordinate, and manage the establishment of guidance and practices for the use and harmonization of a publicly available data repository of new and existing structural racism measures in life course health and aging
  • How experts will utilize activities, such as series of workshops, advanced seminars on methodology, or short-term residential opportunities, from the humanities, education, political science, and the health sciences in life course health and aging
  • How the researchers will engage national and international scientific organizations to promote further advances in measurement and methods of structural racism in research on life course health and aging
  • Pilot projects on measurement and methods of structural racism in life course health and aging research, incorporating interdisciplinary approaches from the behavioral/social sciences, humanities, education, and political science with the public health sciences 
  • How the proposed activities will enable researchers to lead, coordinate, and manage the development of innovative and novel exposure measures across NIA-supported Centers and Networks 

Administration/Governance Activities: Applications must propose an innovative organizational governance structure to support proposed administration, developmental, and dissemination activities to improve aging research on structural racism. A key aspect of network administration will be the recruitment of experts from the health sciences and humanities, sociology, education, and political science to propose plans to develop measures and associated methods to conduct novel aging research on structural racism through engagement with researchers in the field and relevant research resources (e.g., longitudinal studies, NIA-supported centers/networks of relevance, etc.).

Activities shall include arranging and hosting virtual calls/meetings around specific research or administrative topics, as needed, to accomplish the following:

  • Facilitate network objectives (e.g., interactions with NIA-supported studies, center programs, etc., on measure development or sharing, etc.).
  • Respond to queries by the NIH staff regarding network activities and respond to information requests generated by the NIH, the scientific community, and the public.
  • Plan and administer project aims with NIH staff.
  • Organize and maintain the Network Expert Committee (NEC) to provide comments regarding the activities and priorities of the network to the network investigative team.

Administrative activities should include serving as the point of contact for the activities of the network for NIH staff and the broader scientific community. Applications must describe how the institutional environment is appropriate for leading, coordinating, and managing a highly collaborative research network.

Developmental Activities: Applications must plan for measure development around a topic and provide a justification for each topic proposed. The justification must describe each topic's relevance to structural racism and aging research, how each topic is substantive in its own right, and the extent to which there are synergies between proposed topics. Describe the approach for the selection of measures for each topic. All applications should include plans for pilot program activities, described below.

Activities employed to develop and test measures/methods (e.g., workshops, literature reviews, pilot research, etc.), engaging relevant experts including the multidisciplinary network investigators, and the processes to share output from network developmental activities should be described with relevant milestones. Specifically, plans to share measure and method guidance (e.g., website, conferences, trainings, etc.) should be included in measurement development descriptions.

Applications must propose activities intended to support the development and use of network-developed measures within NIA-supported infrastructure projects (such as center grants, research networks, and large-scale primary data collections) and for future adoption by other NIA-supported studies. 

Pilot Program Activities – Applications must describe how the network will administer and manage the pilot study program to support 12-month pilot research projects in an inclusive and accessible research environment for all  investigators, including those from underrepresented racial and ethnic groups, those from disadvantaged backgrounds, and those living with disabilities (see Notice of NIH's Interest in Diversity, NOT-OD-20-031), to develop, test, or implement measures and methods in support of the network’s goals. Describe how pilot projects will be solicited, reviewed, and selected prior to their submission to NIH for approval. Describe outreach strategies designed to recruit prospective researchers from diverse backgrounds, including those from underrepresented groups described in NOT-OD-20-031. Describe how pilot project grantees will be supported through all phases of their projects, including the implementation and closeout phase, to assure all resources, materials, protocols, data, best practices, and lessons learned, as well as software or sets of code, are disseminated broadly through the AD/ADRD and aging research community. NIA's Program and Grants Management staff must review pilot projects selected by the Network Expert Committee (NEC) prior to initiating work to ensure that the pilot projects are within scope, consistent with the goals of the initiative, and have appropriate human subjects protections in place.  Please note that consistent with NIH practices and applicable law, funded programs may not use the race, ethnicity, or sex (including gender identity, sexual orientation, or transgender status) of investigators or other program participants as a factor in the review or selection of pilot projects.     

Dissemination Activities: Applications must describe the innovative strategies that the network will take to ensure wide dissemination of all products and resources developed by the network to the broader community. Applications must describe approaches for disseminating scientific and methodological advances, activities, and resources produced by the network to the research community, policymakers, and other relevant stakeholders. Applications should include descriptions of sharing, website, annual meeting, and additional dissemination activities.

Sharing Activities – Applications must describe how the network will engage in activities to share any guidance, practices, measures, and data resources developed by the network, and make them discoverable by the research community, to promote data sharing, broad use, and replication, including in NIA-supported studies. Specifically, network activities that directly develop new data sources should include planning and implementation of sharing data as broadly as possible to the research community while providing reasonable protections against inappropriate or illegal disclosure of data. Though the network will not directly share data produced by pilots and other NIA-supported infrastructure projects, the network will facilitate the use of shared data resources by: (1) promoting data assets via the network website and (2) sharing protocols and programs used to obtain and use third-party data. In instances where captured/re-used data is not directly shareable by the network, the network must support the development and sharing of plans for providing access protocols and programs to allow third-party researchers to replicate proposed research data files. Specifically, the network is required to provide the following:

  • Information describing the data source and how any investigator can apply for data access.
  • Computer code used to convert data from the capture source into research data files.
  • Explanations of any constructed variables.
  • Other relevant information required to assist the use of data from the source for replication studies.

The network will provide expertise to support these activities and share them on the network's website. NIH requires researchers and publishers to make their publications immediately accessible in PubMed Central.

Website Activities – Applications must describe their approach to development and maintenance of an active website that provides information about the network, including all activities and products supported by the network, such as guidance, workshop summaries, etc. Additionally, information about supported pilot projects and data-related resources relevant to NIA-supported studies must be provided. The website must include a structural racism data repository featuring information on domains developed by the network – along with domains developed by the broader science community – to promote data discoverability of both existing and newly developed structural racism research resources. Applications should describe plans to produce and maintain the structural racism data repository that categorizes structural racism characteristics by data source and includes key information to support research use (e.g., information on populations studied, item concordance, timing of measures, etc.).

Annual Meeting Activities – Applications must describe how the network will implement annual in-person meetings, planned in coordination with relevant NIH program staff. The purpose of the meeting is to accomplish the following:

  • Share updates and scientific advances.
  • Discuss and plan collaborative activities with NIA-funded studies, including the development/sharing of structural racism measures.
  • Host expert sessions on measurement advancement.
  • Present results from the pilot program, discuss and plan activities to develop new research activities to advance the field relevant to NIH research priorities, etc.

The meeting will be attended by PD/PIs of structural racism-related projects and members of the network. The network will create the agenda and chair the meeting, with guidance from NIH program staff. The annual meeting should feature a combination of network investigators, PD/PIs of relevant NIA-supported projects (e.g., population-based longitudinal studies, pilot awardees, etc.) to provide updates on, and inform, future activities to achieve the innovation and dissemination functions of the network. Proceedings of each annual meeting should be recorded and subsequently made available through the network website to promote dissemination of presentations and foster discussion within the research community.

Additional Dissemination Activities – Applications must propose a plan for other types of dissemination activities (e.g., research briefs, blogs, webinars, or other means to highlight and disseminate advances, activities, and resources) via the website and other platforms geared towards the broader structural racism research community, policymakers, and other relevant stakeholders. The network should serve as a central resource for the organization of meetings and other educational activities (e.g., intensive summer institutes, series of workshops, advanced seminars on methodology, or short-term residential opportunities) on measures and methods on structural racism for aging research. Applications should describe how the network will facilitate access to secondary data relevant to this initiative by NIA-supported infrastructure project investigators.   

Collaborative Activities: Applications must describe how the network will collaborate with one or more NIA Centers and other NIA research networks on measurement and methods for the study of structural racism.

  • Data Resources for Behavioral and Social Research on Aging: NIA supports a variety of longitudinal studies, harmonization projects, archives, and repositories to facilitate research on aging in the behavioral and social sciences. Data from these studies are available to qualified researchers, subject only to restrictions imposed for some linked administrative data. 

Milestones: Applications must propose a series of specific, quantifiable, and scientifically justified milestones, and a timeline for milestone completion, during the five-year award period to assess progress towards achieving the proposed administration, developmental, and dissemination activities as described in this section. The process for how the network will work with NIA and the NEC to further develop milestones relevant to the activities and refine the milestones as necessary must be described. Examples of such milestones must include, but are not limited to, the following:

  • Initiating and carrying out activities associated with measure development.
  • Establishing the NEC.
  • Conducting and supporting data development activities in collaboration with NIA-supported infrastructure projects.
  • Awarding pilot projects to achieve network objectives, including pilots to investigators from groups underrepresented in aging and/or AD/ADRD research.
  • Developing the network’s website and other dissemination activities.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - 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 How to Apply - 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.

Sharing Activities – Applications must describe how the network will engage in activities to share any guidance, practices, measures, and data resources developed by the network, and make them discoverable by the research community, to promote data sharing, broad use, and replication, including in NIA-supported studies. Specifically, network activities that directly develop new data sources should include planning and implementation of sharing data as broadly as possible to the research community while providing reasonable protections against inappropriate or illegal disclosure of data. Though the network will not directly share data produced by pilots and other NIA-supported infrastructure projects, the network will facilitate the use of shared data resources by: (1) promoting data assets via the network website and (2) sharing protocols and programs used to obtain and use third-party data. In instances where captured/re-used data is not directly shareable by the network, the network must support the development and sharing of plans for providing access protocols and programs to allow third-party researchers to replicate proposed research data files. 

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Section 2 - Study Population Characteristics

2.2 Eligibility Criteria

Applications in response to this funding opportunity must provide a rationale supporting eligibility criteria that are 1) representative of the population affected by the disease/condition, and 2) address the populations outlined in the  NIH Inclusion Policies for Research Involving Human Subjects and NIH-designated Populations with Health Disparities, as appropriate; as well as other populations that experience health disparities. The goal is for clinical trials to address inclusion, so that researchers can determine whether the variables being studied affect women or members of any racial and ethnic population group in accordance with the NIH Inclusion Policies.

Study teams must demonstrate that they have considered the NIH Inclusion Policies including proposed planned enrollment tables representative of the population affected by the disease/condition. Where applicable, study teams should also demonstrate that they have critically evaluated whether eligibility criteria from an earlier phase trial should be carried forward into a later phase trial. The eligibility criteria section should:

  • Describe how the study results generalize to the wider patient population with this disease/condition.
  • Explain how the rationale for selected eligibility criteria justify the level of restriction in the study compared to clinical practice.
  • Provide evidence that the eligibility criteria support the proposed research and encourage inclusion of NIH-designated Populations with Health Disparities.

2.5 Recruitment and Retention Plan

Applications in response to this funding opportunity should propose innovative and proactive recruitment strategies for involving understudied populations to promote representation as applicable and justified by the scientific goals.  Applicants should ensure that they 1) include proposed planned enrollment tables identifying the population(s) affected by the disease/condition, and 2) address the populations outlined in the NIH Inclusion Policies for Research Involving Human Subjects and NIH-designated Populations with Health Disparities, as appropriate; as well as other populations that experience health disparities. Recruitment and retention plans should demonstrate an understanding of the participant burden involved in research participation and strategies for minimizing this burden, as well as leveraging community partners and outreach efforts. The recruitment and retention plan should:

  • Describe potential barriers to participation and plans to minimize these barriers.
  • Describe a detailed plan for the recruitment of understudied populations and a plan to leverage existing relationships with and/or conduct outreach to a broad range of community groups.
  • Describe staff training to address cultural and linguistic competence

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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

Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

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

See more tips for avoiding common errors.

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

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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.

 

Does the proposed network address the needs of the research programs that it will serve? 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 programs?

In addition, for applications involving clinical trials

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?

Specific to this NOFO: 

Where applicable, how well does this study consider important public health questions related to the measurement and modeling of structural racism in aging research? 

If achieved, how effective will the proposed multidisciplinary collaborations be in combining input from the health sciences and humanities, sociology, education, and political science to promote further measurement and modeling of structural racism in aging research? 

How well suited are the proposed activities to enhance measurement and modeling of structural racism in aging research?  

 

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 structural racism research ? Do the investigators demonstrate significant experience with coordinating collaborative research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the network? Does the applicant have experience overseeing selection and management of subawards, if needed?

In addition, for applications involving clinical trials

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?

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 structural racism research? Do the investigators demonstrate significant experience with coordinating collaborative research? If the network is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the network? Does the applicant have experience overseeing selection and management of subawards, if needed?

Specific to this NOFO: 

How appropriate is the collection of multidisciplinary experts from the health sciences and humanities, sociology, education, and political science? 

 

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research programs the network will serve? 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, management strategies or instrumentation proposed?

In addition, for applications involving clinical trials

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?

Specific to this NOFO: 

How innovative and novel are the activities proposed to enhance the measurement and modeling techniques from the health sciences and humanities, sociology, education, and political science for use in aging research? 

 

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research programs the network will serve? 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?

In addition, for applications involving clinical trials

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?

Specific to this NOFO: 

How well will the network incorporate interdisciplinary approaches from the health sciences with the humanities, sociology, education, and political science? 

How well will the network build a publicly available data repository through input from the broader research community? 

How well will the network make use of various resources and activities, such as intensive summer institutes, workshops, advanced seminars on methodology, and annual conferences in aging research? 

How well will the network build collaborations between national and international societies in the measurement and modeling of structural racism in aging research? 

How strong are the proposed aging research pilot projects in collaboration between the health sciences and the humanities, sociology, education, and political science?  

How well will the network form new measures of structural racism and/or test existing measures of structural racism in aging research? 

How well will the network solicit and review pilot projects to use innovative methods in aging research? 

How well will the network disseminate activities related to structural racism measurement and modeling, such as publications, presentations at scientific meetings, and  training materials and workshops? 

For applications proposing clinical trials:

Eligibility Criteria

To what extent do the eligibility criteria promote inclusion of the population affected by the disease/condition? To what extent is justification provided for eligibility criteria, including inclusion and exclusion of NIH-designated Populations with Health Disparities? Have barriers to participation been assessed adequately?

Recruitment and Retention Plan:

How well does the recruitment and retention plan demonstrate efforts to engage understudied populations in the clinical trial, as applicable and justified by the scientific goals? To what extent will the recruitment efforts increase community engagement, reduce identified barriers, and sustain the engagement of understudied populations? To what extent are plans described to train staff to be sensitive to NIH-designated Populations with Health Disparities?

 

Will the institutional environment in which the network will operate contribute to the probability of success in facilitating the research programs it serves? 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?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria

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

 

Specific to applications involving clinical trials

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)?

 

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

 

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

 

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

 

Not applicable. 

 

Not applicable. 

 

Not applicable. 

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

 

Not applicable 

 

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).

 

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

 

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.

 

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 policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

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

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

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

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding. 

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

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

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

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:

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

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

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 (HHS) grant administration regulations at 2 CFR Part 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 purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the 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 recipients and NIH as defined below.

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

  • The PI will have the primary responsibility for the design and details of the study/studies funded from this NOFO and will retain primary responsibility for performance of the activities, including collecting, producing, and sharing resultant data/results; developing the data repository and making it publicly available; establishing metrics and timelines for accomplishing the activities and achieving the objectives of the central resource; planning and participating in outreach and dissemination activities, including developing, hosting, and maintaining a public website; hosting and attending meetings to discuss the project's progress; coordinating the publication of research results; and other coordination, outreach, and dissemination activities; responding promptly and cooperatively to requests for information or input from NIH; participating in ongoing conference calls with Project Scientist(s) and/or other NIH program staff, as scheduled and agreed upon; and maintaining ownership over data collected. The recipient agrees to accept assistance from the designated NIH/NIA Program Official in aspects of the scientific and technical management of the network and in coordinating with other Federal agencies. Further, the recipient agrees to accept recommendations on scientific activities under the award from the NIA Project Scientist as described below. Finally, a committee of experts from outside of NIA i n areas of relevance to the study aims will provide guidance to the recipient on the conduct of study aims. 
  • 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: 

Project Scientist: The NIA Project Scientist will assist in activities including refining network objectives, methodologies, and aims; setting priorities in the measurement development;  facilitating cross-project coordination and cross-project analyses; analyzing and publishing results of the study as appropriate.  

Program Official: An IC/Agency 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 Official will approve all major stages of the study and all new major additions/changes to content and methods. In addition, this individual will assist in initiating and maintaining collaborative relationships with relevant federal agencies, as necessary. Prior approval is required by the NIA Program Official for any replacements of key personnel or other changes in subcontracts. Co-funding NIH institutes may appoint representatives/liaisons to monitor award progress, but all programmatic decisions for this award are made by the NIA Program Official. The NIH Program Official is an ex officio member of the Network Expert Committee (NEC) and will approve the membership and agendas of the NEC.   

Areas of Joint Responsibility include: 

  • Organizing and coordinating scientific and annual meetings for the network, as required. Coordinating and facilitating the interactions between participants under this cooperative agreement and other NIA recipients.  
  • Considering the network comments for modifying the network's focus to accommodate new scientific opportunities and directions.  
  • Sharing and reviewing annual progress among components of the network, and with external stakeholders.  
  • Meeting at least once per month by teleconference. 

Network Expert Committee (NEC): In order to ensure that the network achieves its objectives under the cooperative agreement, the NEC will be comprised of independent scientific experts in areas appropriate to the multidisciplinary content areas of the network to provide input and advice to the network. Experts, including, but not limited to, the Principal Investigator, Co-Investigators, NIA staff, and invited independent experts, will make presentations to the NEC on scientific and administrative issues regarding the development and implementation of network aims. The NEC will do the following:  

  • Review and comment on the conduct of the network aims and discuss progress in meeting the developmental and dissemination goals of the network, as well as activity milestones.  
  • Where appropriate, provide recommendations to the Principal Investigator on procedures and policies necessary to successfully accomplish the network objectives; this is not binding on the Principal Investigator who retains primary responsibility for scientific direction and implementation.  
  • Comment on activities to improve coordination approaches to achieve the network's goals, and advance relevant scientific approaches to aging research on structural racism.  
  • Make comments on redirection of the network’s focus to accommodate new scientific opportunities and directions within the scope of the award.  
  • Other guidelines for the NEC, such as a quorum and frequency and type of meetings (in-person, remote), will be determined at its initial meeting. It is anticipated that the NEC will meet at least annually, with intermittent conference calls as needed.  
  • The NEC may establish subcommittees as needed to advance the network’s goals.  
  • The NIA Program Official and the PIs may request that the NEC  assist the network on specific issues. The investigators will consider the comments of the NEC regarding implementation of network aims, as well as additions or changes to content and methods, during the execution of the cooperative agreement. Any new NEC Chair and members will be appointed by vote when necessary. NIA will provide a charter for the NEC that describes the selection, composition, tenure, and responsibilities of the NEC membership. The NIA Program Official will serve as a non-voting member  and the Project Scientist will have one vote on the NEC.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: 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 HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

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 2 CFR Part 200.301.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

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

Scientific/Research Contact(s)

Frank Bandiera, PhD
Division of Behavioral and Social Research (DBSR)
National Institute on Aging (NIA)
Telephone: 301-402-7629
Email: frank.bandiera@nih.gov

Crystal Barksdale, PhD
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: 301-402-1366
E-mail: crystal.barksdale@nih.gov

Peer Review Contact(s)

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: ramesh.vemuri@nih.gov

Financial/Grants Management Contact(s)

Ryan Blakeney
National Institute on Aging (NIA)
Telephone: 301-451-9802
Email: ryan.blakeney@nih.gov

Priscilla Grant, JD
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: 301-594-8412
E-mail: pg38h@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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

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