Part 1. Overview Information

Key Dates

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Key Definitions for this Funding Opportunity Announcement (FOA)

Resource Centers for Minority Aging Research (RCMAR) Program: Refers collectively to a Center Core Grants (P30) program to mentor promising scientists from diverse backgrounds, including, but not limited to, individuals from underrepresented groups in the biomedical sciences (see the Notice of NIH's Interest in Diversity, NOT-OD-20-031) for sustained and impactful behavioral and social science research careers focused on aging, health disparities in older adults, and/or Alzheimer’s disease (AD) and AD-related dementias (ADRD). The program is supported by the Division of Behavioral and Social Research (BSR) at the National Institute on Aging (NIA). The program is comprised of the three following types of Centers that operate independently, and in cooperation with all the other Centers:

1. RCMAR(s): P30 Center(s) that focus(es) on behavioral and social science research in a priority research area related to aging and/or to health disparities in older adults. The Center(s) is/are funded through RFA-AG-23-026. Hereafter, the Centers will also be referred to as "RCMAR Center(s)" or "Centers."
2. AD/ADRD RCMAR(s): P30 Center(s) that focus(es) on research related to AD/ADRD in a selected area of behavioral and social science. The Center(s) is/are funded through this FOA, RFA-AG-23-025. Hereafter, the center(s) will also be referred to as "AD/ADRD Center(s)."
3. RCMAR Coordinating Center (CC): A center that provides leadership for the RCMAR program through a cooperative agreement with NIA. The CC is funded through RFA-AG-23-027, using the Resource-Related Research Projects – Cooperative Agreements (U24) funding mechanism.

RCMAR Leadership: The Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) of the CC, the RCMARs, the AD/ADRD RCMARs, and Core Leads within each Center.

Mentors: Individuals who possess research expertise and experience within the scope of the Center's selected area of interest and are members of a multidisciplinary team of RCMAR faculty committed to establishing long-term mentoring relationships with RCMAR Scientists and supporting their professional and scientific career development needs. Mentors provide guidance and advice to Scientists as they conduct RCMAR-funded pilot studies and continued mentorship to ensure successful competition for NIA-funded grants.

RCMAR Scientists: A diverse cohort of early career behavioral and social science faculty members (i.e., assistant professors) who participate in a mentorship program sponsored by a RCMAR Center to receive faculty and peer mentorship, guidance, training and support, and competitive pilot research awards to support preliminary data collection and/or analysis for larger projects proposed in NIA research or training grant applications focused on aging, AD/ADRD, and/or health disparities in older adults.

Background

Progress in aging research, and in reducing health disparities among older adults, requires diverse perspectives. In 1997, NIA established the RCMAR program in appreciation of the importance of inclusion and the value of diversity in the scientific enterprise, and to address and redress health disparities in the growing population of older adults. RCMARs create an infrastructure for providing intellectual leadership, mentorship, training, and career development opportunities for future leaders in aging research, at an early stage in their careers. The success of this program in preparing early-stage investigators for productive research careers motivated the expansion of the program in 2018 to address the needs of faculty from diverse backgrounds, including, but not limited to, those from underrepresented groups in the AD/ADRD research workforce, such as: individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals with disabilities, and women (see, Notice of NIH's Interest in Diversity, NOT-OD-20-031). With the growth in the number of Centers funded, and the expansion in the scope of research, the RCMAR program is now composed of three different organizational partners—the RCMARs, AD/ADRD RCMARs, and CC, which operate independently and in collaboration to meet the goals of the RCMAR program and to serve as BSR's flagship mentoring program for scientists from diverse backgrounds, including, but not limited to, individuals from underrepresented groups.

Since its inception, and with the widespread interest in both mentorship programs and health disparities research across the National Institutes of Health (NIH), the research scope of the RCMAR program has been updated to enhance the diversity ofthe scientific workforce, including scientific leadership, generally, and the community of NIA-supported behavioral and social scientists, specifically, and to advance research and training priorities outlined in the National Advisory Council on Aging’s (NACA) 2019 BSR Review Committee Report.

Despite the success of NIA’s RCMAR program, structural barriers within the greater biomedical research ecosystem continue to impede the full participation of researchers from historically underrepresented groups in the NIA-funded scientific community, including those in the behavioral and social sciences. For example, the lack of institutional programs and resource support, coupled with the “cultural taxation” often imposed on faculty from underrepresented populations, can hinder scientific productivity, which, in turn, can impact retention, promotion, and tenure. These institutional factors have also been purported to contribute to, and exacerbate, disparities in NIH funding.

In the interest of enhancing the potential impact of the RCMAR program, NIA endeavors to support AD/ADRD RCMARs with intentional and holistic approaches that integrate and advance diversity, equity, inclusion, and accessibility (DEIA) principles and practices, which are of critical importance to attract, develop, and retain a diverse scientific community, and to support the cultivation of future research leaders in behavioral and social science research on AD/ADRD. New strategies and infrastructure are also needed to support and foster the inclusion of scientists and mentors from Historically Black Colleges and Universities (HBCUs), Tribal Colleges and Universities (TCUs), and other institutions historically committed to, or that have a demonstrated track record of, training Hispanic students or other students from underrepresented minority groups.These institutions have played an important role in supporting scientific research, particularly on diseases or conditions that disproportionately impact racial/ethnic minorities and other U.S. populations that experience health disparities, though they often lack sufficient capacity to conduct and sustain cutting-edge health-related research. Their researchers are uniquely positioned to bring diverse perspectives and broaden the field of aging research, e.g., by engaging minority populations in research and helping to translate research advances into culturally competent, measurable and sustained improvements in health outcomes for underserved communities.

Purpose

This FOA invites applications from institutions proposing to develop, or renew, a RCMAR that focuses on behavioral and social science research in a key area related to AD/ADRD. The goal of the AD/ADRD RCMAR program is two-fold: (1) to diversify the AD/ADRD research workforce in priority areas of social, behavioral, psychological, and economic research related to AD/ADRD by mentoring promising scientists from diverse backgrounds; and 2) to develop a research and mentoring infrastructure that can foster rigorous research and lead to scientific advances in priority areas of behavioral and social science related to AD/ADRD, including, but not limited to, the following: cognitive and dementia epidemiology, behavioral and social pathways to AD/ADRD, early psychological and functional changes, AD/ADRD prevention, dementia care, caregiving/care partners, and AD/ADRD health disparities and health inequities in populations specified in the NIA Health Disparities Research Framework. The framework identifies priority populations and provides four levels of analysis—environmental, sociocultural, behavioral, and biological—as well as priorities at each level, which together serve as an organizational structure to guide future research focused on AD/ADRD-relevant health disparities, especially in multilevel analysis. Social determinants of health are relevant to all AD/ADRD topic areas. To achieve the goal of the AD/ADRD RCMAR program, applications are expected to propose multipronged, collaborative approaches in a supportive environment that embraces, integrates, and strengthens DEIA.

Research Objectives

The overarching goals of this FOA, and its companion FOAs, RFA-AG-23-026 and RFA-AG-23-027, are to create and sustain a diverse, equitable, inclusive, and accessible aging research community in the behavioral and social sciences, that is skilled in leading and working effectively among multidisciplinary teams, to: address scientific challenges; advance scientific discoveries about aging and AD/ADRD; and identify and develop solutions to eliminate health disparities and health inequities in the growing population of older adults, and improve the health and well-being of older adults.

To meet NIA’s long-range goals, this FOA solicits applications proposing AD/ADRD RCMARs that: 1) develop human capital and infrastructure at institutions with programs on behavioral and social research on AD/ADRD, 2) provide inclusive and effective mentorship and training to promising early career Scientists, and 3) support rigorous behavioral and social research in AD/ADRD-relevant pilot projects.

The primary AD/ADRD RCMAR objectives are to integrate and strengthen DEIA in the scientific workforce, including leadership, in behavioral and social science research on AD/ADRD, and to advance scientific progress in an AD/ADRD-relevant research areas through mentoring, pilot research support, and infrastructure development. The selected research focus area or theme will serve as the scientific foundation for the Center’s research, mentoring, and development activities. Thus, it is expected that this focus area will be congruent with the strengths and expertise of the RCMAR leadership team and mentors, and with the research interests of early career Scientists at the parent and affiliated institutions of the RCMAR.

AD/ADRD RCMARs should be designed to develop or strengthen applicant institutions’ programs that focus on, and sustain progress in, a key area of social, behavioral, psychological, and/or economic research on AD/ADRD. Applications should identify a specific behavioral and/or social scientific area of focus or research theme and specific plans to advance AD/ADRD-relevant scientific discoveries in priority areas of behavioral and social science related to AD/ADRD, including, but not limited to, the following: cognitive and dementia epidemiology, behavioral and social pathways to AD/ADRD, early psychological and functional changes, AD/ADRD prevention, dementia care, caregiving/care partners, and AD/ADRD health disparities and health inequities. For additional information, please visit BSR's AD/ADRD webpage.

NIA is particularly interested in supporting AD/ADRD RCMAR applications that propose a research focus and mentoring activities that address one or more of the AD/ADRD-relevant scientific priorities identified in NACA's 2019 BSR Review Committee Report.

AD/ADRD RCMARs are encouraged to adopt a multidisciplinary approach, and to integrate the perspectives from multiple disciplines (e.g., environmental science, clinical science, physiology, neuroscience, genetics, bioinformatics, technology, etc.). Therefore, interaction among social, behavioral, economic, biological, neural, and clinical sciences is both anticipated and encouraged in addressing a Center’s specific AD/ADRD-relevant research area of focus.

AD/ADRD RCMARs may also support observational or interventional research. Behavioral intervention research proposed within RCMARs, including pilot projects involving behavioral or social interventions, must be based on principles of basic behavioral and social science and designed with the goal of real-world implementation, in line with the NIH Stage Model for Behavioral Intervention Development.

NIA’s Goals, Objectives, and Success Criteria for RCMAR

With the aim of broadening and strengthening the overall reach of the RCMAR program, NIA is particularly interested in supporting new and established AD/ADRD RCMARs that 1) aim to foster longstanding mentorship relationships with Scientists in the parent and affiliated institutions, 2) show evidence of a commitment and investment in a workforce of skilled mentors committed to advancing DEIA, and 3) include Multiple Principal Investigators (MPIs), Core Leads, mentors, and Scientists from multiple local institutions, including from HBCUs, TCUs, and institutions historically committed to, or that have a demonstrated track record of, training Hispanic students or other students from underrepresented minority groups.

NIA expects each AD/ADRD RCMAR to provide mentorship to early-career faculty members from the Center’s parent and affiliated institution(s) who have a demonstrated interest in aging-relevant social, behavioral, psychological, and/or economic research related to AD/ADRD.

It is expected that members of an AD/ADRD RCMAR Scientist’s mentorship team will include, at minimum: 1) a primary mentor who is at the same institution as the Scientist who is primarily responsible for overseeing a Scientist’s success and growth at their institution, and 2) a secondary mentor who is faculty at the AD/ADRD RCMAR’s parent institution, one of the Center’s affiliated institutions within the same AD/ADRD RCMAR, or the scientist's institution, who provides guidance and feedback on scientific, technical, and analytical aspects of the pilot study, and whose research expertise is closely matched to the scientist’s focal research area. In addition, NIA encourages opportunities for Scientists to receive additional guidance, obtain specialized training, and/or establish multidisciplinary collaborative partnerships with mentors and Scientists in other RCMARs.

At the end of the project period, NIA expects that an  AD/ADRD RCMAR will be able to demonstrate the success and impact of mentorship, development and training activities, and pilot funding. Relevant supporting evidence includes, but is not limited to, the following:

1. Impactful scientific advances
2. High-quality first-authored publications
3. Successful competition of one of the following NIA awards, for behavioral and social science research studies focused on AD/ADRD in the dedicated research area of the scientist:

• Exploratory/Developmental Grants (R21),
• Traditional Research Projects (R01),
• Academic Research Enhancement Awards (AREA) (R15),
• Research Education Programs (R25), or a
• Research Career Development Award (K series)

4. An expansion in the talent pool of effective diverse mentors, as demonstrated through the following:

• The successful retention and integration of participating AD/ADRD RCMAR Scientists into the role of AD/ADRD RCMAR mentors, and providing opportunities to receive leadership and mentorship training, and/or
• The successful recruitment of prospective mentors who were former RCMAR Scientists from parent and affiliated institutions and from other local institutions, including HBCUs, TCUs, and institutions historically committed to, or that have a demonstrated track record of, training Hispanic students or other students from underrepresented minority groups.

5. An expansion in the talent pool of leaders contributing to one or more of the following:

• The training of the next generation of behavioral and social science researchers in AD/ADRD, and/or
• The shaping of AD/ADRD-relevant behavioral and social science; and/or
• The development of research insights about social determinants of health in older adults in priority populations in the context of AD/ADRD and with direct application to intervention development or policy.

RCMAR Structure and Governance (Required)

An AD/ADRD RCMAR is required to include, at a minimum, the following three Core components: (1) a Leadership and Administrative Core (LAC), (2) a Research Education Component (REC), and (3) an Analysis Core (AnC). Applicants are also encouraged, but not required, to propose a Community Liaison and Recruitment Core (CLRC).

The AD/ADRD RCMAR PD(s)/PI(s) serve(s) as Core Lead(s) of the LAC and cannot serve in any other position within the Center. An AD/ADRD RCMAR must be composed of at least one PD/PI and at least one Core Lead for each of the other Core components.

Specific details and application instructions for each Core component are provided sequentially in Section IV.2 of this FOA.

Expected Functions and Activities for AD/ADRD RCMARs

NIA’s expectation is that an AD/ADRD RCMAR, in a selected area of behavioral and social research on AD/ADRD, will do the following:

• Demonstrate the potential for visionary leadership and innovation, successful sustainability and impact, and the commitment to serve as a collaborative partner in service of the broad goals of the AD/ADRD RCMAR program.
• Promote and support team science strategies and training throughout the Center.
• Strive to identify mentorship teams richly diverse in perspectives, backgrounds, and academic and technical disciplines, and to provide full opportunity and participation to individuals from underrepresented groups in AD/ADRD research in the behavioral and social sciences.
• Promote and foster the inclusion of mentors and Scientists from non-AD/ADRD RCMAR participating HBCUs, TCUs, and institutions historically committed to, or that have a demonstrated track record of, training Hispanic students or other students from underrepresented minority groups.
• Implement the use of individualized career development plans that spell out professional and leadership goals, with competency needs, and the means and timeframe for when to address them.
• Provide a needs assessment for use in identifying training gaps, objectives, and targets for AD/ADRD RCMAR Scientists and mentors, and for program development and evaluation, and implement key performance metrics to track and measure the progress and productivity of Scientists and in meeting Center objectives.
• Provide and promote: a) research, professional, and leadership development training activities and opportunities that are culturally aware, responsive and sensitive to the Scientists’ needs, and related to the Center’s research area of focus; b) networking activities and opportunities that build meaningful collaborations and partnerships, and c) the use of multidisciplinary research strategies and strategies for overcoming challenges in the team science approach, which together will support the career development of AD/ADRD RCMAR Scientists in their specific area of interest and expertise, and lead to sustained aging research careers in the behavioral and social sciences.
• Foster or enhance the writing, technical, analytical, and methodological skills required to design and implement feasibility and pilot studies with explicit links to publications, next-level pipeline programs, and NIH research applications.
• Identify and encourage career enhancement and leadership opportunities for early career Scientists associated with the AD/ADRD RCMAR.
• Cooperate and collaborate with other RCMARs under the purview of the CC in the: 1) identification and implementation of common metrics and processes for the routine collection, management, and sharing of AD/ADRD RCMAR-related information and data (e.g., the Scientists and mentors, study aims of pilots, other research projects, and publications and other accomplishments associated with each Center) for the analysis of outcomes that can be used for program evaluation across the RCMAR program; 2) development, enhancement, and dissemination of shareable training materials and research resources; and 3) enhancement and augmentation of research, training, and mentorship opportunities for AD/ADRD RCMAR Scientists.
• Interface, where possible, with the NIA Research Centers Collaborative Network (RCCN), and with other NIA-funded programs and centers, including the Claude D. Pepper Older Americans Independence Centers (OAICs), Centers on the Demography and Economics of Aging, Edward R. Roybal Centers for Translational Research in the Behavioral and Social Sciences of Aging, Alzheimer's Disease Research Centers (ADRCs), and the Nathan Shock Centers of Excellence in the Basic Biology of Aging.
• Cooperate with the CC in the development of guidance, templates, information system tools, or other resources to help RCMAR Centers comply with NIH’s new policies on data management and sharing and NIA’s new policies and procedures for reporting human subject enrollment data in NIA-supported clinical research studies.
• Leverage institutional resources, including other NIA- and NIH-supported programs and centers.
• Serve as a source of advice, guidance, and collaboration to other investigators regarding the mentoring of faculty from diverse backgrounds, including those from underrepresented groups and research on NIA priority populations.

Common Evaluation Metrics and Shared Best Practices

The continued success and sustainability of NIA’s AD/ADRD RCMAR program requires that Centers demonstrate their value and impact.

To that end, participation in the AD/ADRD RCMAR program will require a commitment to DEIA, and to the value of team science, multidisciplinary collaboration, and cooperation for the collective good, in the interest of demonstrating measurable progress toward meeting the AD/ADRD RCMAR program's goals. This, in turn, will require coordination, under the aegis of the CC, of the collection, management, and dissemination of information and data related to the Centers in the RCMAR network (e.g., the Scientists and mentors, study aims of pilots, other research projects, collaborations, and publications and other accomplishments associated with Scientists and each Center, and DEIA integration in activities), which will also serve to facilitate tracking and program evaluation, and with benefits of efficiency and cost savings to the Centers.

It is required that the AD/ADRD RCMAR PD/PI attend the Annual Director’s meeting. In addition, it is required that the AD/ADRD RCMAR PD/PI, or a designated representative, participate in regularly scheduled Director’s meetings and consensus building activities led by the CC, in efforts to leverage collective strengths and existing resources.

In the first year of the award, activities will focus on harmonization efforts, including, but not limited to, the following:

1. Identifying performance data and metrics to be collected longitudinally in the RCMAR program to track, monitor, and evaluate progress, and the methods and criteria used to evaluate the short-and long-term success of Scientists and the impact of pilot projects.
2. Identifying standardized methods, strategies, and infrastructure to support data and information collection and sharing.
3. Identifying skills and core competencies, and needs assessment tools, for Scientists and mentors.
4. Identifying best practices for mentorship and recommended training materials for Scientists and mentors.

AD/ADRD RCMAR Training Focal Areas

AD/ADRD RCMARs must develop and implement training activities that can enhance faculty development and address the local and individual developmental needs of its Scientists.

Specific details and application instructions for all required elements are provided under the in Section IV.2 of this FOA.

Although not required, NIA strongly encourages AD/ADRD RCMARs to provide the following training opportunities:

• For AD/ADRD RCMARs focusing in research areas that involve intervention design and development, all Scientists are encouraged to create a specialized behavioral intervention development training plan and to make use of training resources provided on NIA’s NIH Stage Model for Behavioral Intervention Development homepage, which includes references to relevant scientific articles and a link to presentation and slide materials curated by NIA’s Research Centers Coordinating Network (RCCN), and on NIA’s Science of Behavior Change (SOBC) homepage.
• NIA strongly encourages AD/ADRD RCMAR PI/PD(s), mentors, and Scientists to receive training in culturally aware and culturally responsive mentorship. NIA encourages both mentors and Scientists, alike, to make use of free online mentoring tools and learning resources developed by the National Research Mentoring Network, supported by the NIH Common Fund and managed by the National Institute of General Medical Sciences.

Required Elements

The following elements are required. All applications must:

• Provide training to all Scientists in instruction in Responsible Conduct of Research, that is congruent with NOT-OD-22-055: "FY 2022 Updated Guidance: Requirement for Instruction in the Responsible Conduct of Research." Applications lacking a plan for instruction in responsible conduct of research will not be reviewed.
• Provide training to all Scientists in research education in health disparities and health equity in older adults, with relevant ties to health policy, and within the context of the AD/ADRD RCMAR’s scientific area of research focus.
• Identify a scientific and/or methodological focus for research and mentorship grounded in social, behavioral, psychological, or economic research on AD/ADRD that is aligned with NACA's priorities for BSR, as articulated in the 2019 NACA BSR Review Committee Report.

• Describe a program evaluation plan, which specifies clearly defined short-term and long-term goals and objectives for the AD/ADRD RCMAR, and the specific indicators and metrics that will be used to track progress against these goals, to assess Center performance, and to evaluate success in: activities supported by the Research Education Component (REC), and in integrating DEIA into priority areas of behavioral and social research on AD/ADRD in the research education program, and in creating the infrastructure to support rigorous research in these areas.
• Describe existing infrastructure and collaborations with other NIA/NIH-funded Centers and institutional programs that can be leveraged for potential synergy and to advance the goals of the proposed AD/ADRD RCMAR, and the unique role and activities of the proposed AD/ADRD RCMAR.
• Provide information on the Year 1 AD/ADRD RCMAR mentors and Scientists (e.g., career level and demographic characteristics of participants, and the numbers of existing first- or last-authored publications and NIH-funded grants as key personnel).

• Include a brief description, not to exceed two pages in total, of three Year 1 pilot study proposals focused on behavioral, psychological, social, and/or economic research related to AD/ADRD. For specific instructions, see “Research Education Program Pilot Studies” under the `Research Education’ component in Section IV.2.
• All applications must provide a recruitment plan to enhance diversity. Include outreach strategies and activities designed to recruit prospective participants from diverse backgrounds (e.g. those from groups described in the Notice of NIH's Interest in Diversity). Describe the specific efforts to be undertaken by the program and how the proposed plan reflects past experiences in recruiting individuals from underrepresented groups. Applications lacking a diversity recruitment plan will not be reviewed.

Additional Requirements for Renewal applications:

In addition to the required elements listed above, all renewal applications must:

• Summarize the most significant research and professional accomplishments of the AD/ADRD RCMAR and its participants (i.e., Scientists, mentors, and Core component leads) broken down by funding cycle.
• Describe use of infrastructure and collaborations between the AD/ADRD RCMAR’s Core components and other NIA- and NIH-supported programs and centers, as well as other institutions, in the prior funding period. As a convenience to reviewers, applications may, but are not required to, include a diagram  that illustrates existing infrastructure and collaborations. The diagram may be submitted as a single PDF, titled “Existing Infrastructure and Collaborations.” If submitted, the diagram must be uploaded in the “Other Attachments” section under the `Overall’ component (see Section IV.2).
• Describe progress in the AD/ADRD RCMAR’s partnerships and collaborations with HBCUs, TCUs, and institutions historically committed to, or that have a demonstrated track record of, training Hispanic students or other students from underrepresented minority groups over the prior (and previous) funding period(s).

Frequently Asked Questions

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

Clinical Research Operations Management System

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

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

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

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

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

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Melissa S. Gerald, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]

Page Limitations

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required; maximum 1
• Leadership and Administrative Core: required; maximum 1
• Analysis Core: required; maximum 1
• Research Education Component: required; maximum 1
• Community Liaison and Recruitment Core: optional; maximum 1

Overall Component

When preparing your application, use Component Type ‘Overall’.

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project Summary/Abstract: Describe the objectives, the selected research focus area or theme(s) of the AD/ADRD RCMAR, and the need for the Center to support the community(ies) that it proposes to serve. Provide a summary of the specific goals for the proposed AD/ADRD RCMAR and the general plan for achieving them. An overview of the Core components and their primary activities should be integrated into this Summary/Abstract. Note: The project summary should be written in plain language for a diverse set of reviewers while providing a depth of understanding of the science and activities of the Center.

Facilities and Other Resources: Describe the interrelationship of the AD/ADRD RCMAR to other activities in the applicant’s institution (e.g., other relevant research centers and projects) and the extent of institutional, departmental, and interdepartmental cooperation. In addition, describe the administrative relationships of the proposed AD/ADRD RCMAR to the institution. Include relevant issues relating to institutional commitment and settings. Information provided in this section should be limited to describing the resources and environment available to the AD/ADRD RCMAR as a whole. Information pertaining to specific Core components should be described in the respective Core component sections. All applicant institutions should describe an institutional commitment(s) to the AD/ADRD RCMAR and demonstrate a history of commitment to mentoring scientists from diverse backgrounds, including, but not limited to, underrepresented racial and ethnic groups, individuals with disabilities, and women (see Notice of NIH's Interest in Diversity, NOT-OD-20-031). Per NIH policy, the use of hypertext in NIH applications is restricted (see: NOT-OD-20-174).

Equipment: Describe equipment available for the AD/ADRD RCMAR to leverage at the applicant and affiliated institutions, and how the equipment relates to proposed AD/ADRD RCMAR activities. This section should list equipment pertaining to the AD/ADRD RCMAR as a whole. Information pertaining to specific components should be described in those respective component sections.

Other Attachments: This FOA offers an opportunity to attach additional information and materials in ”Other Attachments”, only when indicated. Each attachment must be uploaded separately to the “Overall Component”, in single PDF files, with the filename provided. The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

Other Attachment 1 (optional): Center Organizational Structure (1-page maximum; PDF filename= "Center Organizational Structure"). Applications may, but are not required to, include a diagram of the organizational structure of the proposed AD/ADRD RCMAR for illustrative purposes and as a convenience to reviewers. This diagram should demonstrate how the interactions between the different Core components achieve integration and advance the proposed goals of the Center and the two-fold goal of the AD/ADRD RCMAR program. Applicants are encouraged to cross-reference sections of the application where more details are provided.

Other Attachment 2 (optional): Existing Infrastructure and Collaborations (1-page maximum; PDF filename= "Existing Infrastructure and Collaborations"). Applications may, but are not required to, include a diagram as a convenience to reviewers to illustrate existing infrastructure and collaborations between the AD/ADRD RCMAR’s Core components and other NIA- and NIH-supported programs and centers as well as other institutions. Applicants are encouraged to cross-reference sections of the application where more details are provided.

Other Attachment 3 (optional): AD/ADRD RCMAR Pilot Study Documentation (No page limits; PDF filename= "AD/ADRD RCMAR Pilots"). Applications may, but are not required to, include additional information and materials for each of the three Year 1 pilot studies which are specified below under "Prior Approval of Pilot Projects" in Section VI, which NIA will request in conjunction with NIH’s Just-in-Time procedures for AD/ADRD RCMAR applications within a funding range. Providing additional information related to Year 1 pilot studies, or about more than three pilot studies, should not be included at this time. (See specific details and required pilot project components below in “Prior Approval of Pilot Projects” under Section VI.1).

Project/Performance Site Locations (Overall)

Enter primary site only.

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

Research and Related Senior/Key Person Profile (Overall)

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

The PD/PI should be a scientific leader in the Center's scientific area of focus, have a history of commitment to mentoring early career investigators from diverse backgrounds, including, but not limited to, underrepresented racial and ethnic groups, individuals with disabilities, and women (see Notice of NIH's Interest in Diversity, NOT-OD-20-031), as well as a commitment to DEIA, and be able to coordinate, integrate, and provide guidance in the establishment of programs in the Center’s area of scientific focus.

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

Budget (Overall)

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

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

PHS 398 Research Plan (Overall)

Specific Aims: Describe the aims of the overall Center and outline how the different Core components will contribute to these aims.

Research Strategy

Significance: Focusing on the AD/ADRD RCMAR as a whole, applications are required to address: (a) the importance of the problem or critical barrier to progress in the area of scientific and/or methodological focus that the proposed AD/ADRD RCMAR addresses and how it relates to the 2019 NACA priorities for the BSR as articulated in the 2019 NACA BSR Review Committee Report; (b) how the proposed AD/ADRD RCMAR activities will integrate and strengthen DEIA and improve scientific knowledge, technical capability, and/or practice in one or more priority areas of social, behavioral, psychological, and economic research related to AD/ADRD; (c) how the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field will be changed if the proposed aims are achieved.

Approach: Present the AD/ADRD RCMAR's overall strategy for serving as a sustained resource to the research field in its selected area of focus. Describe how it will accomplish the innovation, intellectual leadership, translational, interdisciplinary, collaborative, and investigator development functions expected of an AD/ADRD RCMAR. Describe how the AD/ADRD RCMAR will provide a supportive environment for early-stage and new investigators from diverse backgrounds, including, but not limited to, underrepresented racial and ethnic groups, individuals with disabilities, and women (see Notice of NIH's Interest in Diversity, NOT-OD-20-031), who are supported through different awards. Describe how the different components of the AD/ADRD RCMAR will interact to help accomplish its aims, how the approaches of the Core components and Research Education Component complement each other or are interdependent, the mechanisms to ensure coherence of the Center and maintenance of scientific focus, and the mechanisms to be used in assessing progress toward the Center's goals. Where appropriate, provide timelines and organizational charts. Note the major AD/ADRD RCMAR Core components and other activities; referencing, but not repeating, appropriate subsequent sections of this application that contain more detail. For illustrative purposes, applications may, but are not required to, include a diagram of the organizational structure of the proposed AD/ADRD RCMAR. The diagram may be submitted as a single PDF, titled “Center Organizational Structure.” If submitted, the diagram must be uploaded in the “Other Attachments” section, as part of the 'Overall’ component (see above).

New applications: This section should be used to present preliminary data or evidence of preparatory activities for establishing an AD/ADRD RCMAR. Applications may describe preliminary organizational work, experience with mentoringnew and early-stage investigators from diverse backgrounds, including, but not limited to, underrepresented racial and ethnic groups, individuals with disabilities, and women (see Notice of NIH's Interest in Diversity, NOT-OD-20-031), for careers in behavioral and social science research related to AD/ADRD, and/or experience with, and potential for, developing new and exciting research in the AD/ADRD RCMAR's scientific area of focus, as well as specific plans for organization and implementation of the new program.

Renewal applications: Applications should present evidence of accomplishment in each of the Core areas for the prior funding period, including publications and grant awards of AD/ADRD RCMAR scientists. Renewal applications from existing AD/ADRD RCMAR sites may use this section to present overall progress and report information not contained in specific Core sections of the application, with citations where appropriate. Tables of AD/ADRD RCMAR activities during the previous funding period can be presented here provided they fit within the page limits of this section. AD/ADRD RCMARs that have been active for more than 5 years may briefly mention overall accomplishments (e.g., numbers of scientists served, number of scientists from prior periods with active AD/ADRD research programs) in the narrative; detailed descriptions of accomplishments should be limited to the prior period of support. If Cores included in the prior period of support are not part of the current submission, describe their progress and explain why they are not included. Identify and justify any substantive differences in approaches from the prior period of support. Identify and justify any changes in research emphasis. If the structure of Cores has changed, show the correspondence to the prior structure.

Renewal applications are required to include the following additional information:

• Describe the most significant research and professional accomplishments of the AD/ADRD RCMAR and its participants (i.e., Scientists, mentors, and Core component leads) broken down by funding cycle.
• Describe use, in the prior funding period, of infrastructure and collaborations between the AD/ADRD RCMAR’s Core components and other NIA- and NIH-supported programs and centers, and other institutions. As a convenience to reviewers, applications may, but are not required to, include a diagram to illustrate existing infrastructure and collaborations. The diagram may be submitted as a single PDF, titled “Existing Infrastructure and Collaborations.” If submitted, the diagram must be uploaded in the “Other Attachments” section under the 'Overall’ component (see Section IV.2).
• Describe progress in the AD/ADRD RCMAR’s partnerships and collaborations with HBCUs, TCUs, and institutions historically committed to, or that have a demonstrated track record of, training Hispanic students or other students from underrepresented minority groups over the prior (and previous) funding period(s).

Innovation: Considering the AD/ADRD RCMAR as a whole, describe how the proposed AD/ADRD RCMAR seeks to shift current research or practice paradigms through use of novel concepts, approaches, methodologies, instrumentation, or interventions. Describe how these concepts, approaches, methodologies, instrumentation, or interventions are novel to the research field or novel in a broad sense. Describe how the proposed work refines, improves, or applies, in a new way, the concepts, approaches, methodologies, instrumentation, or interventions proposed.

Vertebrate Animals: Describe the general principles and policies that will apply to the treatment of vertebrate animals. List the components in the application that involve vertebrate animals. IACUC approval should be submitted as Just-In-Time information.

Letters of Support: Evidence of institutional commitment to the AD/ADRD RCMAR is required. Include letters of support from institutional officials from the applicant institution(s), affiliated institution(s), and institutions of other collaborative partners. Letters should include commitments of time, human capital, and other resources required by the AD/ADRD RCMAR. Letters from the investigators of the research community, or those providing needed resources, may be provided to document their research interests and/or current or planned interactions. Letters may also be from collaborators or communities that would benefit from the Center’s activities and resources, such as knowledge.

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

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Overall)

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

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Section3 - Protection and Monitoring Plans

3.1 Protection of Human Subjects

Describe fully the general principles and policies that will apply to protection of human subjects for the AD/ADRD RCMAR as a whole. List all components of the application that involve human subjects. If the AD/ADRD RCMAR will support human intervention studies, describe general procedures for developing data and safety monitoring plans and notification of NIA staff consistent with NIA Guidance on Clinical Trials. Procedures for the protection of human subjects that are specific to individual Cores should be described in the respective sections of the application.

3.3 Data and Safety Monitoring Plan

AD/ADRD RCMAR applications will present the Overall-specific information on data and safety monitoring using the guidance provided on NIA's Claude D. Pepper Older Americans Independence Centers (OAICs) webpage.

Delayed Onset Study

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

PHS Assignment Request Form (Overall)

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

Leadership and Administrative Core (LAC)

When preparing your application, use Component Type ‘LAC.’

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

SF424 (R&R) Cover (LAC)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (LAC)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (LAC)

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

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

Project Summary/Abstract: Present a brief overview of the LAC.

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

Facilities and Other Resources: Do not repeat information already included in the 'Overall’ section. Only describe or expand on descriptions of facilities and other resources specific to the LAC and how they relate to the organization or activities of the LAC.

Equipment: Do not repeat information already included in the 'Overall’ section. Only describe or expand on descriptions of equipment specific to the LAC and how it relates to activities of the LAC.

Applications may not proceed to review if the Facilities and Other Resources or Equipment sections contain information belonging elsewhere in the application.

Project /Performance Site Location(s) (LAC)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (LAC)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The PD(s)/PI(s) for the AD/ADRD RCMAR application should be the Core Lead(s) for the LAC and not for any other Cores. The Core Lead(s) should have demonstrated leadership and administrative skills and sufficient time to devote to the Core to ensure that the aims are met and required functions are carried out efficiently. An Associate Director may be named who will be involved in the administrative and scientific efforts of the Center.
• The PD/PI(s) must be recognized leaders in behavioral and social science research on AD/ADRD and in the AD/ADRD RCMAR’s scientific area of focus in order to exercise effective scientific judgment and leadership, and have extensive experience in successfully mentoring early career investigators for independent research careers including faculty from diverse backgrounds, including, but not limited to, underrepresented racial and ethnic groups, individuals with disabilities, and women (see Notice of NIH's Interest in Diversity, NOT-OD-20-031). The PD/PI’s biographical sketch should present evidence of scientific expertise relevant to the themes of the AD/ADRD RCMAR and demonstrate the capacity for leadership of an AD/ADRD RCMAR.
• Information must be presented that explains how the leadership team and the workforce of skilled mentors are richly varied and heterogeneous in perspectives, backgrounds, and academic and technical disciplines how they are participating in team science.

Budget (LAC)

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

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

A significant time commitment (2.4 person months is recommended) should be made by the LAC lead(s).

Domestic and foreign travel of project personnel directly related to the LAC and scientific activities of the AD/ADRD RCMAR is allowable. Budgeting should include travel and lodging 1) for relevant Center personnel to attend the RCMAR Scientists' Annual Meeting and the RCMAR Directors' Annual Meeting; 2) for visits of Center investigators or scientists to other RCMARs for the exchange of scientific ideas or planning of multi-Center research projects, or to training sites for mentoring activities; and 3) for Core Lead(s) to attend meetings with Core Lead(s) from other RCMARs.

PHS 398 Research Plan (LAC)

Specific Aims: Describe the administrative structure of the LAC, the administrative relationships between the LAC and all other AD/ADRD RCMAR components, and the activities of the LAC leader(s), the Center Administrator, and other LAC staff in carrying out LAC functions. Provide an overview of how the LAC will implement the theme or scientific focus of the AD/ADRD RCMAR, and the ways in which the LAC will interact with the other Core components to achieve the AD/ADRD RCMAR’s goals, maintain the quality of the AD/ADRD RCMAR, and integrate DEIA throughout the Center.

Research Strategy: Organize the Research Strategy into sections on Significance, Approach, and Innovation.

Significance: Describe the overall role of the LAC in the Center as a whole and as a resource for other ongoing activities in the AD/ADRD RCMAR’s relevant area of behavioral and social scientific focus.

Approach and Innovation: Describe how the LAC will conduct or organize the following activities:

• Provide scientific and intellectual leadership and strategic direction for the AD/ADRD RCMAR.
• Maintain the scientific focus and promote innovation in Center activities in the AD/ADRD RCMAR's relevant area of scientific focus.
• Foster and integrate DEIA throughout the Center.
• Provide administrative oversight and create mechanisms and procedures for ensuring interaction between the site’s Cores and specify the objectives of that interaction.
• Ensure that AD/ADRD RCMAR researchers and pilot investigators interact with colleagues at the parent and affiliated institutions.
• Identify potential areas for collaboration between AD/ADRD RCMAR cores and among other AD/ADRD RCMARs or projects, especially those that are NIA- and/or NIH-funded Centers or programs, and identify any potential collaborative activities, if merited.
• Support interaction between the AD/ADRD RCMAR and other NIA Center programs.
• Promote the recruitment and retention of investigators from diverse backgrounds, including, but not limited to, underrepresented racial and ethnic groups, individuals with disabilities, and women (see Notice of NIH's Interest in Diversity, NOT-OD-20-031), (i.e., AD/ADRD RCMAR Scientists) and the viability of mentoring and collaboration relationships among affiliated institutions.
• Provide oversight of the selection of Scientists, in collaboration with the Research Education Component (REC), and ensure that recommendations for the forthcoming year’s pilot studies are submitted to the NIA with the non-competing continuation (Type 5) application.
• Evaluate the quality, performance, and outcomes of the REC activities, and create infrastructure to support rigorous research in these areas, in collaboration with the REC.
• Create and maintain a system for 1) tracking pilot-study Scientists through and beyond the award of independent research funding and 2) sharing information and data related to scientists and mentors (e.g., study aims of pilots, other research projects, collaborations, and publications and other accomplishments associated with scientists and each Center, as well as DEIA integration in activities) and shareable training materials and research resources with the AD/ADRD RCMAR CC, to facilitate the completion of the CC’s RCMAR Annual Report and for program evaluation.
• Facilitate regular interaction with the CC to complete shared tasks of reporting and presentation to advance RCMAR program goals.
• Select a minimum of two RCMAR participants who, with the PD/PI, will attend an RCMAR’s Annual Scientist’s Meeting, typically lasting a day and a half, to discuss scientific advances, progress, and problems common in the operation of the Centers.
• Interact with the scientific and lay communities to develop relevant goals for the Center.
• Establish and operate AD/ADRD RCMAR advisory panels, including the development of criteria for selecting advisors, how they will be identified, the operating procedures of each panel, and the frequency of meetings.
• Assure compliance with human subjects, animal welfare, scientific integrity, data and sample sharing as appropriate, as well as financial policy requirements of the NIH.

Additionally, the LAC should present plans to establish and operate Center advisory panels including:

1. An Executive Committee, composed of Core Leads and other administrative staff, as appropriate, to assist the Director in making the scientific and administrative decisions relating to the Center and in monitoring and developing the scientific content and direction of the Center.
2. An External Advisory Committee that will meet annually to advise the AD/ADRD RCMAR on its REC and ability to exert significant scientific impact in its area of scientific focus through pilot funding and infrastructure development activities. Summary recommendations from the External Advisory Committee should be included with the non-competing continuation (Type 5) application. New applications should not select committee members prior to peer review of the Center application, but the composition of the committee, including diversity of backgrounds, experience, and area of science of membership, roles, responsibilities, and desired expertise of committee members, should be included . (See additional information below under the REC component.)
3. A review panel to assist in selecting pilot projects. Criteria for selecting committee members, how they will be identified, the operating procedures of the groups, and the frequency of meetings should be described. The review panel should include a statistician as well as scientists from outside the Center. Members from the External Advisory Committee may serve as reviewers for the pilot applications, provided their expertise is appropriate for the submitted applications. New applications should not select committee members prior to peer review of the Center application, to avoid creating conflicts of interest for review.

All applications are required to include the following:

• A program evaluation plan which specifies clearly defined short-term and long-term goals and objectives for the AD/ADRD RCMAR as well as the specific indicators and metrics that will be used to track progress against set goals to assess the Center's performance and to evaluate the success of activities supported by the REC, DEIA integration in priority areas of behavioral and social research related to AD/ADRD in the research education program, and the creation of infrastructure to support rigorous research in these areas.
• A description of the existing infrastructure and collaborations with other NIA- and NIH-funded Centers and institutional programs that can be leveraged for potential synergy and to advance the goals of the proposed AD/ADRD RCMAR and the unique role and activities of the proposed AD/ADRD RCMAR.

New applications: Describe preliminary organizational work, institutional experience with mentoring junior investigators from diverse backgrounds, including, but not limited to, underrepresented racial and ethnic groups, individuals with disabilities, and women (see Notice of NIH's Interest in Diversity, NOT-OD-20-031) for independent research careers, experience in, and potential for, developing new and innovative research in the AD/ADRD RCMAR's scientific area of focus, and specific plans for implementation of the new program.

Renewal Applications: Provide evidence of successful overall integration of cores to promote the goals of the Center. Describe the most important contributions to research in the AD/ADRD's area of scientific focus utilizing Core resources. Reports should include Core objectives and evidence of accomplishment in each of the Core areas for the prior funding period only. The proposal for a Center to expand its network of affiliated institutions may use this section to present preliminary data or evidence of preparatory activities specific to the proposed LAC.

Additionally, Renewal applications are required to describe the following:

• The most significant research and professional accomplishments of the AD/ADRD RCMAR and its participants (i.e., Scientists, mentors, and Core component leads) broken down by funding cycle.
• Use, in the prior funding period, of infrastructure and collaborations between the AD/ADRD RCMAR’s Core components and other NIA- and NIH-supported programs and centers and other institutions. As a convenience to reviewers, applications may, but are not required to, include a diagram to illustrate existing infrastructure and collaborations. The diagram may be submitted as  a single PDF, titled “Existing Infrastructure and Collaborations.” If submitted, the diagram must be uploaded in the “Other Attachments” section under the `Overall’ component (see Section IV.2).
• Progress in the AD/ADRD RCMAR’s partnerships and collaborations with all important partners, includingHBCUs, TCUs, and institutions historically committed to, or that have a demonstrated track record of, training Hispanic students or other students from underrepresented minority groups over the prior, and previous, funding period(s).

Progress Report Publication List: Publications resulting from resources or developmental work carried out in the prior funding period by the LAC should be listed. Renewal applications may include a separate attachment titled "Progress Report Publication List," for any publications/patents/other printed materials to be listed.

Letters of Support: Place letters of support for the LAC in this section.

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

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (LAC)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Analysis Core (AnC)

When preparing your application, use Component Type ‘AnC.’

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

SF424 (R&R) Cover (AnC)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (AnC)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (AnC)

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

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

Project Summary/Abstract: Present a brief overview of the AnC.

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

Facilities and Other Resources: Do not repeat information already included in the 'Overall’ section. Only describe or expand on descriptions of facilities and other resources specific to the AnC and how they relate to the organization or activities of the AnC.

Equipment: Do not repeat information already included in the Overall section. Only describe or expand on descriptions of equipment specific to the AnC and how it relates to activities of the AnC.

Applications may not proceed to review if the Facilities and Other Resources or Equipment sections contain information belonging elsewhere in the application.

Project /Performance Site Location(s) (AnC)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (AnC)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• AnC personnel must have expertise in research methodology and measurement especially related to the ADRD-relevant scientific area of focus upon which the AD/ADRD RCMAR concentrates its efforts, or unique expertise on the use of secondary data of social and behavioral (including biosocial and biobehavioral) datasets.

Budget (AnC)

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

Salary and other expenses for the Core Lead(s) and administrative staff may be requested.

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

PHS 398 Research Plan (AnC)

Specific Aims: Describe the intended role of theAnC in relation to the Center as a whole and to the theme of the Center. Use this section to describe the overarching objectives of the Core and its functions. Describe how the AnC will support the AD/ADRD RCMAR scientists in conducting high-quality, cutting-edge research in priority areas of behavioral and social science research on AD/ADRD .

Research Strategy: Organize the Research Strategy into sections on Significance, Approach, and Innovation.

Significance: Explain the role of the AnC in the Center as a whole and as a mechanism for enhancing the rigor and impact of the work conducted in the AD/ADRD RCMAR's scientific area of focus.

Approach and Innovation: Describe how the AnC will implement a plan to support the rigor and impact of scientific work conducted by AD/ADRD RCMAR Scientists and investigators. This plan may have one or both of the following functions: (1) identifying, cataloging, distributing, and/or creating culturally informed and scientifically valid epidemiological, behavioral, or social measurement tools and data resources, and/or (2) the analysis of newly collected (primary) data or existing (secondary) data, such as economic, behavioral, psychological, biological, or genetic data. A plan for enhancing or disseminating such knowledge should be included in the AnC application.

The application should describe how the AnC will conduct or organize the following activities:

• Support AD/ADRD RCMAR Scientists' development of methodological skills needed for independent research careers through consultation and provision of data resources, as appropriate to the scientific area of focus.
• Create, identify, catalogue, and disseminate scientific information regarding novel methodological developments, measurement approaches, or new data resources produced by the AD/ADRD RCMAR. This plan may include publications and presentations of information, conferences and symposia, and outreach activities to other institutions and Centers conducting social, behavioral, and/or clinical research on aging or AD/ADRD.
• Work with the REC and with cooperating research centers (e.g., NIA Research Centers Collaborative Network (RCCN), Claude D. Pepper Older Americans Independence Centers (OAICs), Centers on the Demography and Economics of Aging, Edward R. Roybal Centers for Translational Research in the Behavioral and Social Sciences of Aging, Alzheimer's Disease Research Centers (ADRCs), Nathan Shock Centers of Excellence in the Basic Biology of Aging).
• Work in conjunction with the RCMAR coordinating center (see RFA-AG-23-027) to develop and disseminate its products.

Letters of Support: Place letters of support for the Analysis Core in this section.

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

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (AnC)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Section–3 - Protection and Monitoring Plans

3.3 Data and Safety Monitoring Plan

AD/ADRD RCMAR applications will present AnC-specific information on data and safety monitoring using the guidance provided on NIA's Claude D. Pepper Older Americans Independence Centers (OAICs) webpage.

Delayed Onset Study

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

Research Education Component (REC) (RL5)

When preparing your application, use Component Type ‘Core.’

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

SF424 (R&R) Cover (REC)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (REC)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (REC)

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

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

Project Summary/Abstract: Present a brief overview of the REC.

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

Facilities and Other Resources: Do not repeat information already included in the Overall section. Only describe or expand on descriptions of facilities and other resources specific to the REC and how they relate to the organization or activities of the REC. Specifically, describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.

Equipment: Do not repeat information already included in the Overall section. Only describe or expand on descriptions of equipment specific to the REC and how it relates to activities of the REC.

Applications may not proceed to review if the Facilities and Other Resources or Equipment sections contain information belonging elsewhere in the application.

Other Attachments: REC External Advisory Committee

An External Advisory Committee is a required component of the REC. Provide a plan, in collaboration with the LAC, for the appointment of an External Advisory Committee to advise the AD/ADRD RCMAR on REC activities and their impact (see description of the External Advisory Committee above).

The composition of the committee, including diversity of backgrounds, experience, and area of science of membership; roles, responsibilities, and desired expertise of committee members; frequency of committee meetings; and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the REC program. New applications should not include the names of proposed Advisory Committee members, and proposed members should not be contacted prior to peer review.

At least one-third of the members of the REC Advisory Committee should be external to the AD/ADRD RCMAR Center and grantee institution(s). REC Advisory Committee membership need not differ, in total or in part, from those of the Center’s other advisory panels.

The REC Advisory Committee description must not exceed one page in length and should only include information related to the REC Advisory Committee.

Project /Performance Site Location(s) (REC)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (REC)

• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component. Core faculty mentors should be listed as Key Personnel in the appropriate sections of the application. Note: REC program faculty and REC participants are not considered Senior/Key personnel in the REC.
  • The Center may also establish relationships with additional mentors at the participating institution(s) over time, depending on the specific pilot projects of the AD/ADRD RCMAR Scientists.
• Include a single NIH Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component. The Biographical sketch for key personnel should include a description and examples of evidence that support 1) expertise in behavioral and social science research related to AD/ADRD, and 2) a history of inclusive mentorship.
• REC Leads should be leaders in behavioral and social science research on AD/ADRD, and in the scientific area of focus of the AD/ADRD RCMAR. They must have experience in successfully mentoring investigators from diverse backgrounds, including, but not limited to, underrepresented racial and ethnic groups, individuals with disabilities, and women (see Notice of NIH's Interest in Diversity, NOT-OD-20-031), and in implementing strategies to promote DEIA.
• REC personnel should include individuals from diverse backgrounds, as well as individuals with expertise in health disparities research in older adults.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• Additional pages containing the standard PHS Biographical Sketch for the AD/ADRD RCMAR scientists should be included with the remainder of the REC Biographical Sketches.

Budget (REC)

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

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

Follow all other instructions provided in the SF424 (R&R) Application Guide, with the following additional modifications, as noted.

• Include all personnel, other than the PD(s)/PI(s), in the Other Personnel section, including clerical and administrative staff.
• Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.

PLEASE NOTE: Indirect costs (Facilities & Administrative costs) for the REC are reimbursed at 8% of modified total amount of direct costs, exclusive of tuition, fees, and expenditures for equipment.

Funds for salaries and other expenses of the Core Lead(s), information resources, and administrative support staff may be requested. Cost-recovery strategies may be proposed, but are not required.

Travel: Applicants should budget to send a minimum of two AD/ADRD RCMAR Scientists and the PD/PI to an Annual Investigators' meeting typically held at one of the sites.

Pilot Project Budgets and Allowable Costs: Pilot costs for each of the three proposed pilot projects should be in the range of $40,000-70,000 total costs per year. Pilot funds may support salary, research expenses, travel, equipment, and supplies, as appropriate to the project. Centers are permitted to leverage support from other sources to increase the amount of pilot funds available for a single project. Funds for the proposed pilot projects should be included under the other expenses. Future-year pilots must be submitted with the annual non-competing renewal applications.

• The REC provides support for REC activities, including mentoring activities and the funding of mentored pilot projects conducted by AD/ADRD RCMAR Scientists. The REC may also offer short courses or workshops for skills development. REC participant costs must be itemized in the proposed budget.
• There is no minimum salary or professional effort requirement for AD/ADRD RCMAR Scientists conducting pilot projects. REC participants may receive salary support from other federal sources consistent with the institution's salary scale (e.g., an NIA Diversity supplement award) as long as those sources do not specifically prohibit such salary supplementation. Individuals supported by NIH training and career development mechanisms (i.e., K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by the REC as participants, but K, T, and F grantees may not receive salary or stipend supplementation from the REC.
• Because the RL5 program is not intended as a substitute for an NRSA institutional training program (e.g., T32), costs to support full-time participants (supported for 40 hours/week for a continuous, 12-month period) are not allowable.

PHS 398 Research Plan (REC)

Specific Aims: Describe how the REC will provide a mentoring mechanism leading to enduring careers and leadership positions for AD/ADRD RCMAR scientists, and to strengthening DEIA, in priority areas of behavioral or social research related to AD/ADRD. Outline the objectives of the program and the program activities that will be used to meet these objectives, and describe how the REC Lead(s) and other mentors will help implement the intended goals of the REC.

The Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components:

Proposed Research Education Program. The research education program should include mentored research experiences supported by pilot projects awarded to AD/ADRD RCMAR Scientists. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are ongoing in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the pre-established training program.

Significance: Explain the role of the REC in the Center as a whole, and as a mechanism for embracing, integrating, and strengthening DEIA, in priority areas of behavioral or social research related to AD/ADRD. Outline the objectives of the REC and how the AD/ADRD RCMAR’s program activities will be used to meet these objectives.

Approach: Describe how early-career faculty in the behavioral and social sciences with an interest in AD/ADRD will be identified and paired with expert mentors that are richly varied and heterogeneous in perspectives, backgrounds, and academic and technical disciplines.

Describe how the REC will implement a mentoring plan to enhance DEIA in the research workforce in a focal area of social and behavioral science relevant to AD/ADRD. Describe how the REC will promote and foster the inclusion of mentors and scientists from non-AD/ADRD RCMAR participating institutions, including HBCUs, TCUs, and institutions historically committed to, or that have a demonstrated track record of, training Hispanic students or other students from underrepresented minority groups.

The application should specify the role of the REC in collaborating with the LAC to implement the solicitation, review, and selection of pilot studies for funding. Applications should provide a site-specific definition of AD/ADRD RCMAR Scientist and articulate the activities and resources available to the scientists throughout their AD/ADRD RCMAR affiliation, both during and after pilot funding.

Describe plans to accommodate differences in preparation among participants. Include information about mentored research experiences and other educational activities that are essential for success in the proposed program.

Specifically, the proposed research education plan should have the following eight components related to research education programming: 1) Pilot Studies for AD/ADRD RCMAR Scientists, 2) Continuing Mentoring Activity, and Mentoring in Research on Health Disparities and Health Equity in Older Adults, 3) Core Lead(s), 4) Program Faculty, 5) Program Participants, 6) Recruitment Plan to Enhance Diversity, 7) Plan for Instruction in the Responsible Conduct of Research, and 8) Evaluation Plan.

1. Pilot Studies for AD/ADRD RCMAR Scientists (Required Activity)

Number of pilots: Each REC should propose a minimum of three pilot projects for Year 1, with named investigators and mentors, and additional information and materials, as described below in “Required Pilot Study Components,” and should anticipate funding a minimum of three pilot studies during each subsequent project year.

NIA approval of the pilot projects is required prior to initiation, and Facilities & Administrative costs will be provided in accordance with these budgets. AD/ADRD RCMAR applications selected for funding will be required to submit a more detailed description of at least three first-year pilot research projects and their budgets, along with other required documentation, through eRA Commons, in conjunction with NIH’s Just-in-Time (JIT) procedures, prior to award. (See specific details and required pilot project components in “Prior Approval of Pilot Projects” under Section VI.1 below).

If awarded, an AD/ADRD RCMAR will submit pilot project applications for NIA approval within 60 days of the start of the award, in conjunction with the Research Performance Progress Report (RPPR). (See specific details under “Other Reporting Requirements” in Section VI.3). NIA will only accept and consider the approval of pilot project proposals at other times during the year when unexpected opportunities or timeliness issues arise, or if the institution wishes to redirect existing funds within the Center.

Required Pilot Study Components: Applications are required to 1) provide information on the Year 1 AD/ADRD RCMAR mentors and Scientists (e.g., career level and demographic characteristics of participants, and the numbers of existing first or last-authored publications and NIH-funded grants as key personnel) and 2) include a brief description, not to exceed two pages in total, of all three Year 1 pilot study proposals, which must be focused on behavioral, psychological, social, and/or economic research related to AD/ADRD. Pilot descriptions must specify a mentorship team that includes, at a minimum, a primary mentor from the scientist’s institution—either the applicant institution or an affiliated institution of the AD/ADRD RCMAR—and a secondary mentor. Descriptions must also include a statement addressing how findings will contribute to the submission of an NIA research grant application to a target NIA FOA. The pilot description must indicate a proposed project period (i.e., start and end date), an estimate of the total cost of the project, and a statement indicating whether the scientist has received prior funding support from a RCMAR.

Note: Applications may include additional information and materials related to the three Year 1 pilot studies, corresponding to information requested by NIA as JIT materials for applications selected for funding. Information must be compiled in a single PDF, titled “AD/ADRD RCMAR Pilots” and uploaded in the “Other Attachments” section under the 'Overall’ component (see Section IV.2).

Duration and Scope of Pilot Projects: This funding mechanism is intended to support 12-18 month pilot projects that enable an investigator to develop preliminary data sufficient to provide the basis for a publication in a major journal and a small NIA grant application. If described and well-justified, two years of support may be requested.

The Pilot Studies portion of the REC application should include the following:

• A plan for recruiting AD/ADRD RCMAR Scientists through solicitation of pilot project proposals in the grant’s out-years. Plans for solicitation of pilot projects should be developed such that, for awarded AD/ADRD RCMARs, the LAC can submit their recommendations for the forthcoming year’s pilot studies to NIA with the non-competing continuation (Type 5) application.
• Selection criteria for the submitted pilot studies. Topics chosen for pilot studies by AD/ADRD RCMAR Scientists should be focused on behavioral and social research germane to the research focus of the AD/ADRD RCMAR.
• A plan for reviewing subsequent pilot applications and for collaborating with the LAC to identify a review panel.
• A plan for continued evaluation of pilot study progress toward eventual research independence.
• Evidence of an adequate pool of high-quality, early-stage, or transitioning investigators to fill at least three pilot study positions each year.
• A description of the announcement for pilot funding, which should include a description of data or research resources available to pilot investigators through the AD/ADRD RCMAR.

2. Continuing Mentoring Activity and Mentoring in Research on Health Disparities and Health Equity in Older Adults (Required Activity)

Each AD/ADRD RCMAR should specify strategies for mentoring AD/ADRD RCMAR scientists to facilitate the process of attaining independent investigator status. The application should specify how continuing mentoring of AD/ADRD RCMAR scientists to the point of an independent research award is to be accomplished.

The application should specify strategies for the following:

• Identifying and providing for Scientists’ individual career and development needs, objectives, and targets, and for identifying and addressing training gaps in mentors.
• Implementing the use of individualized career development plans that spell out professional and leadership goals, including competency needs, and the means and timeframe for when to address them. Implementing key performance metrics to track and measure progress and productivity.
• Mentoring AD/ADRD RCMAR Scientists to the point of receiving independent investigator research awards that build on initial AD/ADRD RCMAR pilot research. Fostering or enhancing the writing and technical, analytical, and methodological skills required to design and implement feasibility and pilot studies with explicit links to publications, next-level pipeline programs, and NIH research applications.
• Identifying and providing career enhancement and leadership opportunities for early career Scientists associated with the AD/ADRD RCMAR.
• Creating and maintaining a system for tracking its pilot study investigators through an award of independent research funding and through reporting, in conjunction with the Administrative Core and the RCMAR Coordinating Center, data and information related to the AD/ADRD RCMAR (e.g., the Scientists and mentors, study aims of pilots, other research projects, collaborations, publications, and other accomplishments associated with Scientists and each Center, including DEIA integration in activities).

In addition, the application must specify strategies for providing and promoting: a) research, professional, and leadership development training activities and opportunities that are culturally aware, responsive, and sensitive to the Scientists' needs, related to the Center's AD/ADRD-relevant research area of focus; b) networking activities and opportunities to build meaningful collaborations and partnerships; and c) the use of multidisciplinary research strategies and strategies for overcoming challenges in team science.

The research education plan must provide AD/ADRD RCMAR Scientists with research training in AD/ADRD-relevant health disparities and health equity issues relevant to the scientific focus of the Center. This should be accomplished either by enhancing the applied research experience of basic behavioral and social scientists, developing the basic research skills and experience of investigators who focus on applied behavioral and social research, or providing a combination of these two approaches. An emphasis on the development of skills for translating basic behavioral and social research findings into the development of interventions that address health disparities and the use of findings from applied behavioral and social research to inform mechanistic studies of behavioral and social drivers of health inequities is encouraged. Regarding the goal of developing researchers with combined expertise in applied and basic behavioral and social research on AD/ADRD, AD/ADRD RCMAR applicants should consider the previous training of the individual candidate in determining the nature and extent of research education activities for which REC support is requested.

AD/ADRD RCMARs focusing in AD/ADRD relevant research areas that involve intervention design and development are strongly urged to create a specialized behavioral intervention development training plan and to make use of training resources provided on NIA’s NIH Stage Model for Behavioral Intervention Development homepage, which includes references to relevant scientific articles and a link to presentation and slide materials curated by NIA’s Research Centers Coordinating Network (RCCN), and on NIA’s Science of Behavior Change (SOBC) homepage.

NIA strongly encourages RCMAR PI/PD(s), mentors, and Scientists to receive training in culturally aware and culturally responsive mentorship. NIA encourages both mentors and Scientists alike to make use of free online mentoring tools and learning resources developed by the National Research Mentoring Network, which is supported by the NIH Common Fund and managed by the National Institute of General Medical Sciences.

Renewal applications: Currently funded AD/ADRD RCMAR Centers, including those with RECs supported by other similar component mechanisms, should present progress report information specific to the REC in this section. The proposal for a Center to expand its network of affiliated institutions may use this section to present preliminary data or evidence of preparatory activities specific to the proposed REC.

3. Core Lead(s)

Describe arrangements for administration of the program. Provide evidence that the Core Lead(s) is/are actively engaged in research and/or teaching in an area related to the mission of NIA and the AD/ADRD RCMAR Center and that the Core Lead(s) can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple Core Leads, describe the complementary and integrated expertise of the Leads, their leadership approach, and governance appropriate for the planned program.

4. Program Faculty

Researchers from diverse backgrounds, including, but not limited to: individuals from racial and ethnic groups underrepresented in biomedical and behavioral research, individuals with disabilities, and women (see, Notice of NIH's Interest in Diversity, NOT-OD-20-031), are encouraged to participate as Program Faculty, who serve as mentors to AD/ADRD RCMAR Scientists. Mentors should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.

Describe how the Program Faculty will serve as mentors and provide guidance and expertise appropriate to the specific scientific area of focus of the AD/ADRD RCMAR and the level of the participants proposed in the application. Describe the complementary expertise and experiences of the proposed Program Faculty, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring and training individuals from diverse backgrounds, including, but not limited to, underrepresented racial and ethnic groups, individuals with disabilities, and women (see Notice of NIH's Interest in Diversity, NOT-OD-20-031), at the proposed career stage(s). Describe the plan for identifying training gaps in the proposed Program Faculty and the plan for ensuring successful participant guidance. Describe the criteria used to appoint and remove individuals as Program Faculty and to evaluate their participation.

Biographical sketches for Program Faculty should not be included in the application, unless they are Senior/Key Personnel in other cCores.

5. Program Participants

Applications must describe the intended participants and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program.

Pilot project funding is intended for scientists who are early career faculty members from the AD/ADRD RCMAR’s parent and affiliated institution(s). AD/ADRD RCMAR research education support should be integrated with other sources of career support that participants may be receiving in concerted programs for research education, when not overlapping with concurrent support, and if allowable (e.g., an NIA-funded Diversity Supplement award, fellowships, non-NIH career awards).

Describe the likely REC participant pool. Present brief descriptions of likely research and training backgrounds and potential mentored research needs. Describe how other AD/ADRD RCMAR cores may contribute to research experiences for REC participants. If a REC participant will engage in a human subject study involving more than minimal risk, a description of the study and plans for data and safety monitoring must be approved by NIA staff prior to initiation of the study (see Human Subjects and Clinical Trials Information below).

Justification must be provided for pilot funding requests for investigators outside of the AD/ADRD RCMAR home, or affiliated institutions, or to support a former recipient of any RCMAR funding. Pilot funding may be awarded to early-career investigators at local institutions that are not affiliated with the AD/ADRD RCMAR sponsor, under certain circumstances, such as an opportunity to initiate collaboration with local HBCUs, TCUs, and institutions historically committed to, or that have a demonstrated track record of, training Hispanic students or other students from underrepresented minority groups.

REC support is intended primarily for early career investigators in the United States, unless there is strong justification based on exceptional relevance to NIH and NIA.

6. Recruitment Plan to Enhance Diversity: All applications must provide a recruitment plan to enhance diversity in the research education program. Include outreach strategies and activities designed to recruit prospective participants from underrepresented communities, such as populations described in NOT-OD-20-031: Notice of NIH's Interest in Diversity. Describe the specific efforts to be undertaken by the program and how the proposed plan reflects past experiences in recruiting individuals from underrepresented groups.

Renewal applications: All renewal applications must include information in aggregate form about the Scientists’ duration of participation in the research education program and the number of individuals who finished the program in good standing.

7. Plan for Instruction in the Responsible Conduct of Research

All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR).

Note: The plan must address the five required instructional components outlined in NIH’s 2010 policy: NOT-OD-10-019: Update on the Requirement for Instruction in the Responsible Conduct of Research, while incorporating NIH’s updated guidance found in NOT-OD-22-055: FY 2022 Updated Guidance: Requirement for Instruction in the Responsible Conduct of Research.

1. Format of Instruction: Describe the required format of instruction (i.e., face-to-face lectures, coursework, online courses, and video conferences). Video conferencing should not be the sole means for meeting the requirement for RCR instruction. As discussed in NOT-OD-22-055, a plan that employs only video conferencing will not be considered acceptable, except in the circumstances described in NOT-OD-10-019, such as short-term research training and research education programs.
2. Faculty Participation: Describe the role of the Program Faculty in the instruction.
3. Duration of Instruction: Describe the number of contact hours of instruction, taking into consideration the duration of the program.
4. Frequency and Timing: Describe the instruction that must occur during each career stage and at least once every four years. See NOT-OD-22-055. The plan should be appropriate and reasonable for the nature and duration of the proposed program.
5. Subject Matter: While there are no specific curricular requirements for instruction in responsible conduct of research, NIA strongly encourages instruction in the following topic areas, which incorporates additional topics that merit discussion (shown in bold), which were added in 2022, per NOT-OD-22-055.

A. Conflict of interest (i.e., personal, professional, and financial) and conflict of commitment in allocating time, effort, or other research resources.

B. Policies regarding human subjects, live vertebrate animal subjects in research, and safe laboratory practices.

C. Mentor/mentee responsibilities and relationships.

D. Safe research environments (e.g., those that promote inclusion and are free of sexual, racial, ethnic, disability and other forms of discriminatory harassment).

E. Collaborative research, including collaborations with industry and investigators and institutions in other countries.

F. Peer review, including the responsibility for maintaining confidentiality and security in peer review.

G. Data acquisition and analysis; laboratory tools (e.g., tools for analyzing data and creating or working with digital images); record keeping practices, including methods such as electronic laboratory notebooks.

H. Secure and ethical data use; data confidentiality, management, sharing, and ownership.

I. Research misconduct and policies for handling misconduct.

J. Responsible authorship and publication.

K. The scientist as a responsible member of society, contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific research.

Renewal applications: The Progress Report must describe the previously supported program and its objectives, results of the outcomes measured, the number and characteristics of participants in the past project period, materials disseminated, and any changes in the administration, objectives, or program activities during the prior project period. The description of the proposed program for the next funding period should highlight how the program continues to evolve as well as any changes in program objectives and/or activities that are planned to maintain the currency of the program offered.

In addition, the Progress Report must describe any changes in formal instruction over the past project period and how the current plan addresses any weaknesses in the former instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.
 

8. Evaluation Plan

Applications must include a plan for evaluating the activities supported by the research education program, in collaboration with the LAC. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures that gauge the short- or long-term success of the research education program in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and provide suggestions for improvements.

Letters of Support: Place letters of support for the REC in this section. Letters of support should be included from mentors on the pilot projects being proposed in the application if they are not proposed as key personnel.

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

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (REC)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Section 3 - Protection and Monitoring Plans

3.3 Data and Safety Monitoring Plan

AD/ADRD RCMAR applications will present REC-specific information on data and safety monitoring using the guidance provided on NIA's Claude D. Pepper Older Americans Independence Centers (OAICs) webpage.

Delayed Onset Study

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

Community Liaison and Recruitment Core (CLRC)

When preparing your application, use Component Type ‘CLRC.’

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

SF424 (R&R) Cover (CLRC)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (CLRC)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (CLRC)

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

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

Project Summary/Abstract: Present a brief overview of the CLRC.

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

Facilities and Other Resources: Do not repeat information already included in the 'Overall’ section. Only describe or expand on descriptions of facilities and other resources specific to the CLRC and how they relate to the organization or activities of the CLRC.

Equipment: Do not repeat information already included in the Overall section. Only describe or expand on descriptions of equipment specific to the CLRC and how it relates to activities of the CLRC.

Applications may not proceed to review if the Facilities and Other Resources or Equipment sections contain information belonging elsewhere in the application.

Project/Performance Site Location(s) (CLRC)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (CLRC)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• CLRC personnel must have expertise interacting in diverse community groups and making impactful scientific advances and significant experience in the coordination of community-based activities and research.

Budget (CLRC)

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

Salary and other expenses for the Core Lead(s) and administrative staff may be requested.

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

PHS 398 Research Plan (CLRC)

Specific Aims: Describe the intended role of the CLRC in relation to the Center as a whole and to the theme of the Center. Use this section to describe the overarching objectives of the Core and its functions.

Research Strategy: Organize the Research Strategy into sections on Significance, Approach, and Innovation.

Significance: Explain the role of the CLRC in the Center as a whole, and as a mechanism for co-learning and reciprocal transfer of expertise and enhancing the Scientists’ research or training goals, and the impact of the work conducted in the AD/ADRD RCMAR’s scientific area of focus.

Approach and Innovation: Describe how the CLRC will provide mentoring and support for the recruitment and retention of research participants from the community, and the specific considerations that must be taken into account when engaging and/or recruiting older adults who are members of NIA’s Priority Populations, as specified in the NIA Health Disparities Research Framework. Techniques for recruiting and retaining diverse, population-representative research participants should be included in the application.

The application should also describe how the CLRC will:

• Generate new knowledge of recruitment and retention techniques to include representative populations in areas of related behavioral and social science research.
• Develop scientifically verifiable techniques for participant recruitment and retention, including among health disparities populations, critical for advancement in the AD/ADRD RCMAR’s area of focus.
• Disseminate scientific information regarding techniques for recruiting and retaining diverse, population-representative research participants as appropriate to the scientific focus of the AD/ADRD RCMAR. The plan may include publications and presentations of information, conferences and symposia, and outreach activities to other institutions and Centers conducting social, behavioral, and/or clinical research related to AD/ADRD.

For community engagement research projects and projects that involve significant interactions with communities, the application should include a "Community Engagement Best Practices" statement. This statement may include the following:

• A description of the defined community of interest or community partner.
• A description of the community's and researchers' roles in the design and implementation of research.
• A description of how the research activity will lead to improved public understanding of research and long-term, bidirectional relationships between the academic institution and the community for the benefit of both.
• A description of how the participating community, or community group, will be involved in the design and approach of the research from the onset through to the conclusion of the activity.
• A management plan for maintaining transparent communications between the community and the academic partners throughout the entirety of the activity, including the dissemination of research findings. The management plan should address methods of building and sustaining community partnerships and community participation, including plans for lines of communication in challenging situations, such as a natural disaster or other emergency. Include community engagement activities with the project timeline to provide a tentative sequence for the community engagement aspects of the research.

Describe how community-based activities are grounded in principles of empowerment, human rights, inclusion, social justice, self-determination, and collective action.

Letters of Support: Place letters of support for the CLRC in this section. Letters of support may be included from community partners to indicate their willing participation.

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

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (CLRC)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Section 3 - Protection and Monitoring Plans

3.3 Data and Safety Monitoring Plan

AD/ADRD RCMAR applications will present CLRC-specific information on data and safety monitoring using the guidance provided on NIA's Claude D. Pepper Older Americans Independence Centers (OAICs) webpage.

Delayed Onset Study

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

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

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Questions Specific to this FOA:

How convincing is the evidence in the application that the proposed AD/ADRD RCMAR Center will adequately prepare AD/ADRD RCMAR Scientists for an independent and sustained research career in priority areas of behavioral and social science research in a key area related to AD/ADRD? How strong is the proposed Center's focus on assuring progress toward meeting Center objectives to include persons of all backgrounds in the AD/ADRD research workforce in the proposed area of scientific focus?

Does the proposed AD/ADRD RCMAR Center address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the selected area of focus? Will the goals set for the AD/ADRD RCMAR over the project period significantly contribute to scientific advances in the behavioral and social sciences in its area of focus? To what extent will the AD/ADRD RCMAR Cores facilitate other ongoing research to advance behavioral and social research related to AD/ADRD?

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?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Questions Specific to this FOA:

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the AD/ADRD RCMAR Center? If Early-Stage Investigators, New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the proposed AD/ADRD RCMAR Center is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise and are their leadership approach, governance and organizational structure appropriate for the project? How well do the investigators and staff provide creative scientific and administrative leadership of the Center and demonstrate a commitment to devote adequate time to the management of the AD/ADRD RCMAR program? Is there evidence of collaboration and interdisciplinary research among the investigators who will be associated with the AD/ADRD RCMAR? Does the application provide evidence that the leadership and mentoring teams of the proposed AD/ADRD RCMAR are varied or heterogeneous in perspectives, backgrounds, and academic and technical disciplines? Does the application provide evidence that the PD/PIs have sufficient scientific expertise relevant to the themes of the AD/ADRD RCMAR, adequate experience mentoring early career investigators from diverse backgrounds, including, but not limited to, underrepresented racial and ethnic groups, individuals with disabilities, and women (see Notice of NIH's Interest in Diversity, NOT-OD-20-031), in these areas, and capacity for the leadership of an AD/ADRD RCMAR?

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?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions in behavioral and social research? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Questions Specific to this FOA:

How innovative is the proposed approach for meeting the goals of each of the Core components? Does the application demonstrate the capacity for the proposed AD/ADRD RCMAR to prepare investigators to make innovative contributions to behavioral and social research related to AD/ADRD in the selected area of scientific focus?

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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Questions Specific to this FOA:

Is the proposed strategy adequate to promote a sustained research program in the selected area of focus, through which the AD/ADRD RCMAR will accomplish the innovation, leadership, collaborative, and research career development functions sought after? Are the goals to be achieved within the five-year AD/ADRD RCMAR award period adequately specified? Is the plan to reach these goals, and the proposed methods to evaluate progress toward these goals, adequate during the course of the AD/ADRD RCMAR award?

Are the individual components of the AD/ADRD RCMAR integrated with each other? Is the whole greater than the sum of the parts?

How clear is the plan for defining sharing of responsibilities among investigators and between institutions (if more than one institution is involved)? If collaborative arrangements are proposed, is there a convincing demonstration that these interactions will be consistent enough to meet the needs of the AD/ADRD RCMAR?

How thoughtfully does the application acknowledge potential problem areas and consider alternative approaches?

How effective are the proposed collaborations with other AD/ADRD RCMARs and other NIA- and NIH-supported programs and centers, and with other institutions?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

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?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Questions Specific to this FOA:

To what extent is there evidence of significant commitment of the institution(s) to fulfilling the objectives of the AD/ADRD RCMAR?

What is the quality of the academic environment as it relates to the potential for interaction among Scientists within the Center and with scientists from other departments, institutions, and AD/ADRD RCMARs? Will the AD/ADRD RCMAR serve as a source of advice in the area of its theme regarding technology, methodology, analysis, or other expertise?

To what extent will the AD/ADRD RCMAR leverage other institution-, NIA-, and NIH-supported resources, including centers and large collaborative projects, particularly in sharing resources (e.g., Resource Cores) and research education opportunities?

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?

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

Study Timeline

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)?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Scored Review Criteria - Leadership and Administrative Core (LAC)

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the LAC core will support RCMAR Scientists in conducting high-quality, cutting-edge research in priority areas of AD/ADRD-relevant behavioral or social science research, in consideration of the following review criteria and additional review criteria, as applicable for the proposed LAC.

Significance

Does the proposed core address the needs of the AD/ADRD RCMAR that it will serve? Is the scope of activities proposed for the core appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the AD/ADRD RCMAR?

Investigator(s)

Are the Core Lead(s) and other personnel well suited to their roles in the core? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing behavioral and social science research on AD/ADRD ? Do the Core Leads have adequate experience in mentoring early career investigators from diverse backgrounds, including, but not limited to, underrepresented racial and ethnic groups, individuals with disabilities, and women (see Notice of NIH's Interest in Diversity, NOT-OD-20-031), and a commitment to DEIA? Do Core personnel demonstrate significant experience with coordinating collaborative research? Is there evidence of ability to successfully cooperate with a Coordinating Center to report on center progress and collaboratively advance AD/ADRD RCMAR program goals? Are the leadership approach, governance strategies, plans for conflict resolution, and organizational structure of the Core Lead(s) appropriate for the Core? Do Core personnel have experience overseeing selection and management of subawards, if needed?

Innovation

Does the core propose novel organizational concepts or management strategies in coordinating the AD/ADRD RCMAR? Are the concepts or strategies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the core? How well do the organization and processes proposed for internal communication and synthesis of Core activities advance AD/ADRD RCMAR objectives? Are potential problems, alternative strategies, and benchmarks for success presented? If the core is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the core? Are an appropriate plan for work flow and a well-established timeline proposed?

Will the proposed LAC staff effectively lead the proposed AD/ADRD RCMAR and interact and/or collaborate with the Core components, CC and other RCMAR Centers, and other organizational components within and outside the institution? Is there an appropriate plan to establish, coordinate, and solicit expert input on program goals through advisory panels? Does the application demonstrate a commitment to participating in regularly scheduled Director’s meetings and consensus building activities led by the CC, and cooperating with the CC and other RCMARs in the identification, and implementation of common metrics and processes for the routine collection, management, and sharing of RCMAR-related information and data? Are the plans for monitoring, stimulating, sustaining, and reporting progress toward the overall goals of the RCMAR adequate? Are they clearly stated and are approaches specified to deal with inadequate progress toward achieving goals, should this occur?

Are the arrangements adequate for internal quality control of ongoing research, allocation of funds, day-to-day management, contractual agreements, internal communication, and cooperation among investigators in the program?

Environment

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

Additional Review Criteria - LAC

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

Additional Review Considerations - LAC

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Scored Review Criteria - Analysis Core (AnC)

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the AnC will support AD/ADRD RCMAR Scientists in conducting high-quality, cutting-edge research in priority areas of AD/ADRD-relevant to behavioral or social science research, in consideration of the following review criteria and additional review criteria, as applicable for the proposed AnC.

Significance

Does the proposed AnC address the needs of the AD/ADRD RCMAR that it will serve? Is the scope of activities proposed for the core appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the AD/ADRD RCMAR? Will the AnC contribute to the success of other Cores? How well integrated is the AnC to the other Cores? To what extent will the AnC contribute to the overall goals of the proposed AD/ADRD RCMAR? To what extent is there evidence of a willingness to work with the RCMAR Coordinating Center in the dissemination of measures, methods, and/or the use of large data sets? To what extent is there evidence that the AnC has the potential for sharing its results with the scientific community?

Investigator(s)

Are the Core Lead(s) and other personnel well suited to their roles in the AnC? Are the leadership approach, governance, plans for conflict resolution, and organizational structure of the Core Lead(s) appropriate for the Core? How extensive is the background of the investigators in research methodology and measurement, especially related to the scientific area of focus upon which the AD/ADRD RCMAR concentrates its efforts, and/or on the use of secondary data of social and behavioral, including biosocial and biobehavioral, datasets?

Innovation

Does the Core propose novel organizational concepts or management strategies in coordinating the AD/ADRD RCMAR? Are the concepts or strategies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?

Will the AnC facilitate and develop novel multidisciplinary and interdisciplinary research strategies? Do the AnC and its associated projects challenge existing paradigms or develop new methodologies or technologies? To what extent will the AnC stimulate translation between basic and clinical research and/or between clinical research and practice? To what degree will the AnC add new research directions in AD/ADRD that are based on insights from basic behavioral and social science research?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the Core? Are both database services and statistical mentoring offered to AD/ADRD RCMAR investigators sufficiently described? Is it clear how the Core will contribute to the goals of the AD/ADRD RCMAR as well as the national efforts of the AD/ADRD RCMAR program? How well-coordinated is the AnC with the Research Education Component (REC) in the mentoring of pilot investigators and other institutionally based researchers in the use of culturally sensitive measurement, research methodology, and or large data sets? Does the AnC enhance the quality of research, research education, and pilot projects? Is the plan adequate for prioritizing access to AnC resources?

If the Core is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the Core? Are an appropriate plan for work flow and a well-established timeline proposed? Are there adequate plans for soliciting, evaluating, and selecting pilot projects for AnC support? If the AnC involves human subjects and/or NIH-defined clinical research, are there plans to address 1) the protection of human subjects from research risks, and 2) 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), justified in terms of the scientific goals and research strategy proposed?

Environment

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

Additional Review Criteria - AnC

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

Additional Review Considerations - AnC

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Scored Review Criteria - Research Education Component (REC)

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the REC to provide a mentoring mechanism that will lead to enduring research careers for AD/ADRD RCMAR Scientists in AD/ADRD-related behavioral and social research, in consideration of the following review criteria and additional review criteria, as applicable for the REC proposed.

Significance

Does the proposed research education program address a key audience and an important aspect or important need in research education? Does the application provide convincing evidence that the proposed program will significantly advance the stated goal of the research education program? How likely is it that Scientists will develop multidisciplinary research strategies and overcome challenges in team science? Will the proposed program adequately support the career development of AD/ADRD RCMAR Scientists in their specific area of interest and expertise and lead to sustained AD/ADRD research careers in the behavioral and social sciences? How effectively will the AD/ADRD RCMAR promote the development of future research leaders in its area(s) of focus, particularly leaders in AD/ADRD-related behavioral and social research?

Investigator(s)

Are the Core Lead(s) capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the Core Leads and participating faculty have experience in fostering longstanding mentoring relationships with early career Scientists from diverse backgrounds, including, but not limited to, underrepresented racial and ethnic groups, individuals with disabilities, and women (see Notice of NIH's Interest in Diversity, NOT-OD-20-031), and teaching science in higher education? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? If the REC is collaborative or involves multiple Core Leads, do the investigators have complementary and integrated expertise, and are their leadership approach, governance, and organizational structure appropriate for the project?

To what extent do potential program participants demonstrate commitment to, and potential for success in, a career in behavioral and social science research related to AD/ADRD? Is there evidence of adequate numbers of outstanding early-career investigators with an interest and commitment to AD/ADRD-relevant research in the behavioral and social sciences?

Innovation

Taking into consideration the nature of the proposed research education program, does the applicant make a strong case for this program effectively reaching an audience in need of the program’s offerings? Where appropriate, is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience?

How effectively will the REC facilitate and develop novel multidisciplinary and interdisciplinary research strategies? To what extent will the REC implement novel mentoring or training strategies?

Approach

How well does the proposed program clearly state its goals and objectives, including the target audience to be reached, the content to be conveyed, and the intended outcome? Is there evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? How feasible is the plan for striving to identify and pair scientists with mentors with expertise in AD/ADRD-relevant behavioral and social research and who are richly diverse in perspectives, backgrounds, and academic and technical disciplines and for fostering inclusion of mentors and Scientists from non-AD/ADRD RCMAR participating institutions, including HBCUs, TCUs, and institutions historically committed to, or that have a demonstrated track record of, training Hispanic students or other students from underrepresented minority groups. Does the REC provide adequate assessments for identifying training gaps in Scientists and mentors and in offering educational and training activities to address them? Does the application demonstrate a commitment to furthering AD/ADRD RCMAR objectives through prior or planned professional activities, and in creating an infrastructure for the mentoring of researchers from diverse backgrounds? How well does the REC provide opportunities for education and skill development? Are there sufficient career enhancement and leadership opportunities for early career Scientists associated with the AD/ADRD RCMAR? How well related are the research, professional, and leadership development training activities and opportunities to the Center's research area of focus, and are they sufficiently culturally aware, responsive, and sensitive to the Scientists' needs? Are there networking activities and opportunities to build meaningful collaborations and partnerships? Is the plan for evaluation sound and likely to provide information on the effectiveness of the program?

Environment

Will the scientific and educational environment of the proposed program contribute to its intended goals? Is there a plan to take advantage of this environment to enhance the educational value of the program? Is there tangible evidence of institutional commitment? Is there evidence that the faculty have sufficient institutional support to create a sound educational environment for the participants? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, and institutions? To what extent will the resources and environment of the REC lead to selection of high-quality Scientists? To what extent will REC resources contribute to the successful development of early career Scientists?

Additional Review Criteria - REC

As applicable for the Core 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.

Pilots and Mentorship

• How well-developed and realistic are plans to advance pilot studies and pilot-funded investigators to successful completion of their projects?
• How viable is the plan for continuing the mentoring of pilot investigators through a successful independent investigator award?
• How strong is the evidence that during years two through five of the AD/ADRD RCMAR, there will be a sufficient pool of researchers to submit excellent pilot study applications?
• What is the quality of the evidence that the pilot study solicitation and selection process will provide scientifically rigorous and potentially fundable projects?
• How likely is the mentoring strategy to produce and retain professionals from diverse backgrounds in AD/ADRD-relevant behavioral or social science research?
• What is the quality of the initial pilot studies and of the mechanisms for review and administration of subsequent pilot studies? How well do the studies and mechanisms match the focus of the AD/ADRD RCMAR Center?
• How strong is the program of mentoring in research on health disparities and health equity in older adults? Is this mentoring appropriately tailored to the scientific focus of the Center?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

Additional Review Considerations - REC

As applicable for the Core 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.

Recruitment Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment plan to enhance inclusion after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of prospective participants from diverse backgrounds, including, but not limited to, underrepresented racial and ethnic groups, individuals with disabilities, and women (see Notice of NIH's Interest in Diversity, NOT-OD-20-031). The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Training in the Responsible Conduct of Research (RCR)

Taking into account the specific characteristics of the proposed research education program and the level of participant experience, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: Format of Instruction, Faculty Participation, Duration of Instruction, Frequency and Timing, and Subject Matter.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Scored Review Criteria - Community Liaison and Recruitment Core (CLRC) (Optional)

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the CLRC will support AD/ADRD RCMAR Scientists in conducting high-quality, cutting-edge research in priority areas of AD/ADRD-relevant behavioral or social science research, in consideration of the following review criteria and additional review criteria, as applicable for the CLRC proposed.

Significance

Does the proposed Core address the needs of the AD/ADRD RCMAR that it will serve? Is the scope of activities proposed for the Core appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the AD/ADRD RCMAR? Will the CLRC contribute to the success of other Cores and to the overall goals of the proposed AD/ADRD RCMAR? Is it clear how the CLRC will work with the REC and with cooperating NIA-funded research centers (e.g., Roybal Centers, Demography and Economics of Aging Centers, Alzheimer's Disease Centers) as appropriate to contribute to the goals of the AD/ADRD RCMAR as well as the national efforts of the AD/ADRD RCMAR program? Does the CLRC serve as a community resource? Is there strong evidence that the CLRC has the potential for sharing its results with the scientific community? To what extent is there evidence that the CLRC is, or has the potential to be, a leader in the field conducting research on recruiting and retaining older diverse individuals for research?

Investigator(s)

Are the Core Lead(s) and other personnel well suited to their roles in the Core? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in creating a strong relationship with different community groups and making impactful scientific advances? Do Core personnel demonstrate significant experience with the coordination of community-based activities and research? Are the leadership approach, governance, plans for conflict resolution, and organizational structure of the Core Lead(s) appropriate for the Core?

Innovation

Does the Core propose novel organizational concepts or management strategies in coordinating the AD/ADRD RCMAR? Are the concepts or strategies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?

Will the CLRC facilitate and develop novel multidisciplinary and interdisciplinary research strategies? Do the CLRC and its associated activities challenge existing paradigms or develop new methodologies or technologies? To what extent will the CLRC stimulate intervention research? To what degree will the CLRC add new research directions that are based on insights from community-based activities and research?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the CLRC? Are interactions of this core with the other cores well described? Will Core personnel promote strategies to ensure a robust and unbiased scientific approach across the Core, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the Core is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the Core? Are an appropriate plan for work flow and a well-established timeline proposed? Are there adequate plans for soliciting, evaluating, and selecting pilot projects for CLRC support?

If the CLRC involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) 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), justified in terms of the scientific goals and research strategy proposed?

Does the CLRC enhance the quality of research, research education, and pilot projects? Is the plan adequate for prioritizing access to CLRC resources? Are plans adequate for the external review of proposed Developmental Projects and monitoring their progress?

Environment

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

Additional Review Criteria - CLRC

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

Additional Review Considerations - CLRC

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

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

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

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

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

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

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

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

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

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

Prior Approval of Pilot Projects

AD/ADRD RCMAR applications selected for funding will be required to submit a more detailed description of at least three first-year pilot research projects and their budgets, along with required documentation, as described below, under “Required Components of Pilot Project Proposals", through eRA Commons, in conjunction with NIH’s Just-in-Time (JIT) procedures, prior to award.

NIA approval of the pilot projects is required prior to initiation. Facilities & Administrative costs will be provided in accordance with the proposed budgets for NIA approved pilot projects. Awardee-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require approval by NIH prior to initiation.

The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIA DSMP policies. Pilot projects with foreign components will require NIH and State Department foreign clearance prior to award.

Required Components of Pilot Project Proposals

• Name, position title, institutional affiliation, AD/ADRD RCMAR affiliation, and ORCID iD of the investigator (the proposed scientist) and the members of the mentorship team, which include, at a minimum, a primary mentor from the scientist’s institution—either the applicant institution or an affiliated institution of the AD/ADRD RCMAR—and a secondary mentor.
• An up-to-date Curriculum Vitae of the investigator.
• Scientist disclosure statement indicating prior, or no prior, funding with the AD/ADRD RCMAR program. For Scientists with a history of prior AD/ADRD RCMAR pilot funding, the name of the AD/ADRD RCMAR and members of the AD/ADRD RCMAR mentorship team must be provided along with the project dates and a justification for why additional pilot funding support is needed.
• A 1-page Project Narrative that addresses the following questions:
  • How will the pilot project contribute to the two-fold goal of the AD/ADRD RCMAR program: 1) to diversify the research workforce in priority areas of social, behavioral, psychological, and economic research related to AD/ADRD by mentoring promising scientists from diverse backgrounds; and 2) to develop a research and mentoring infrastructure to foster rigorous research and lead to scientific advances in priority areas of behavioral and social science related to AD/ADRD, including, but not limited to: cognitive and dementia epidemiology, behavioral and social pathways to AD/ADRD, early psychological and functional changes, AD/ADRD prevention, dementia care, caregiving/care partners, and AD/ADRD health disparities and health inequities.
  • How is the proposed pilot study: relevant to social, behavioral, psychological, and/or economic research on AD/ADRD, and in alignment with the 2019 NACA BSR Review Committee Report, and the Scientist’s research career objectives?
  • How will the findings from the pilot study contribute to the submission of an NIA research grant application to a target FOA?
• A descriptive title of the pilot study, the proposed project period (start and end date), and the estimated total cost of the project, with a 2-page Project Summary/Abstract that provides a succinct and accurate description of the proposed work and includes the following elements: 1) the project’s broad, long-term objectives, 2) specific aims, and a 3) description of the research design and methods.
• A modular budget for the pilot project using the PHS 398 Modular Budget form.
• Inclusion Enrollment Reports(s) and Human Subjects Protections in accordance with NIH’s Instructions for Preparing the Human Subjects Section of the Research Plan and/or Vertebrate Animal clearances.

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:

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

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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

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

• For information on an institution's specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

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

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

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

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

Not Applicable

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

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

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

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

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

Section VII. Agency Contacts

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

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

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Melissa Gerald, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Fax: 301-402-0066
Email: ramesh.vemuri@nih,gov

John Bladen
National Institute on Aging (NIA)
Telephone: 301-402-7730
Email: [email protected]

Section VIII. Other Information

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

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