Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)

Funding Opportunity Title

Examining Diversity, Recruitment and Retention in Aging Research (R24 Clinical Trial Not Allowed)

Activity Code

R24 Resource-Related Research Projects

Announcement Type

New

Related Notices
Funding Opportunity Announcement (FOA) Number

PAR-18-749

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.866

Funding Opportunity Purpose

This funding opportunity announcement encourages collaborative teams to target gaps in methods and outcomes regarding research participant recruitment and retention. The team approach encouraged by this initiative will be used to generate a research resource to advance processes for high yield recruitment, formulate breakthrough ideas, concepts and approaches to research participant recruitment and retention, strengthen outreach and community engagement practices, and devise improved communication strategies. Teams will demonstrate the success of these improvements by engaging a large diverse population. The primary outcome will be the development of a population of diverse community members ready to engage in NIA funded clinical research studies.

Key Dates

 

Posted Date

April 10, 2018

Open Date (Earliest Submission Date)

August 25, 2018

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review
Advisory Council Review
Earliest Start Date
Expiration Date

January 26, 2021

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) 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.


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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    Background

    Participation of diverse volunteers for many different types of studies has taken center stage as one of the leading challenges in aging research. Both clinical trials and natural history studies have yet to demonstrate anywhere near adequate representation of diverse cohorts. A complete study of a disease state requires the inclusion of diverse cohorts of research participants in terms of race, ethnicity, gender, age, and status of disease. Diversity among research participants broadens scope and improves the generalizability of scientific investigations. In particular, classifications of race, ethnicity, socioeconomic status, sex/gender are multifactorial and dynamic in their influence on disease state warranting their abundant representation in research. The NIA Health Disparities Research Framework calls for studies that incorporate factors at environmental, sociocultural, behavioral and biological levels of analyses with robust diversity of the research participants. Many research areas of focus supported by the program divisions of NIA will benefit from this active effort in enhancing recruitment and retention of research participants.

    The Division of Behavioral and Social Research supports social, behavioral, and economic research and research training on the processes of aging at both the individual and societal level. There is a need to have persons of a wide array of characteristics included in clinical trials and related research: small and large family groups, racial, ethnic, social, economic, linguistic, gender, cultural, educational and neighborhood.  

    The Division of Geriatrics and Clinical Gerontology supports clinical and translational research on health and disease in the aged, and research on aging over the human life span, including its relationships to health outcomes. Investigators often exclude children (defined here as individuals under age 18) or older adults (individuals ages 65 and older) either (1) explicitly, by limiting the age range of eligible participants in their exclusion criteria, or (2) implicitly, by excluding those with co-morbid conditions or polypharmacy use, both which are common in older populations. As a result, many interventions are inadequately tested in the very old and the very young. Recruitment needs to consider the age distribution of the disease/condition/study topic in the general population. Investigators should seek to understand better the historical and social context of historically vulnerable and consistently underrepresented groups to ensure their improved recruitment and representation in clinical trials and research.

    The Division of Neuroscience fosters and supports extramural and collaborative research and training to further the understanding of neural and behavioral processes associated with the aging brain. Increased public and private investment in Alzheimer's disease and related dementias research has spurred a rise in the number of therapeutic targets, drugs and other interventions that need to be tested in clinical trials. Further, a new challenge has emerged in recruiting healthy normal volunteers, as prevention trials seek to enroll subjects prior to evident symptoms of cognitive decline and dementia. For healthy volunteers, there is limited evidence base of optimal ways to reach these cohorts, which must also include underrepresented groups. Additionally, modern clinical trials in neurodegenerative disease research can be very invasive, requiring lumbar punctures and brain scans and sometimes infusions, surgical procedures and requests for brain donation after death. Much more work is needed to understand how to motivate participation, particularly in underrepresented groups for such invasive procedures.

    Overall, NIA seeks investigators who are focused on improving the research tools, research methods and recruitment practices to produce a significant number of committed research participants to aging research. This targeted initiative seeks to focus teams of investigators and community members on the development and evaluation of innovative recruitment and retention methods and strategies that enhance diversity of research participants and ensure adequate representation of underrepresented populations in aging research. A priority of NIA is to advance the evidence base for strategies and processes that will increase enrollment in clinical studies. This initiative addresses Goal F.3. of NIA's Strategic Directions for Research on Aging: "develop and implement strategies to increase inclusion of diverse populations in research.".

    Objectives

    This initiative will foster a collaborative network of teams to engage large diverse populations and accelerate research participant recruitment into aging research and NIA funded clinical studies. Collaboratory teams will support the creation of a portfolio of timely and essential enabling resources designed to enhance the recruitment and retention of a large diverse community population for aging research. The teams will be required to implement these resources either in a regional (community of greater than 20,000) or national scope (more than one geographic area) by organizing numerous local activities as part of the assembled team.

    The team assembled must have the necessary expertise to pursue multiple questions or generate new knowledge regarding multiple problems, focus on innovative approaches, design multiple interventions, or develop multiple resources relevant to recruitment. It is expected that this collaborative network will result in a greater contribution to the initiative goals of enhancing diverse recruitment, than would occur if each team member worked independently. Teams should address recruitment challenges with expertise across multiple field domains that may exist outside of science (marketers, community organizers, pollsters, advertisers, communications, etc.). Teams should include community members and patient/volunteer liaisons to provide training on research participation with a primary goal of incorporating community members and patient/volunteer liaisons into the recruitment infrastructure.

    A team should not include groups of investigators at the same institution who would normally interact and collaborate in the absence of a collaborative initiative. Additionally, the team should not focus on a single community population or single strategy for a single clinical trial/study.

    The goal of this initiative is to improve research participant recruitment through method development, community engagement, evaluation strategies and community incorporation. Primary activities that should be completed by the teams within the project period are:

    • Develop and evaluate innovative approaches to recruitment and retention
    • Test new approaches and disseminate methods to the field
    • Engage, educate and motivate community members to participate in research; facilitate their enrollment and demonstrate measurable success
    • Incorporate community members and patient/volunteer liaisons into the recruitment infrastructure and enable them to be active partners in recruiting additional community members.
    • Provide sustainable participants to active NIA funded clinical research

    In order to successfully complete the primary activities above, teams are required to engage in three or more of the following types of activities; other team created activity types can also be utilized:

    • Review progress of the last 10 years and evaluate successful methods
    • Create a comprehensive analysis of populations across published studies
    • Identify and address challenges that require expertise across multiple domains
    • Design research programs that seek to understand cultural distinctions (values and beliefs) that hinder research participants and build cohesion with potential research participants
    • Create collective goals between the research institution and the community members to enhance trust within the communities.
    • Develop innovative strategies for increasing knowledge and awareness
    • Support pilot studies to validate concepts and approaches
    • Develop data sharing and information exchange platform
    • Disseminate results and provide technical assistance
    • Hold workshops and focused assistance forums, webinars
    • Partner with community business entities to create active education centers
    • Trial start up services, master agreements, central IRB training, protocol development, quality assurance checks
    • Create mobile applications/technology, social media, visual, video or multimedia recruitment materials
    • Establish a volunteer call center
    • Increase physician awareness about the availability of clinical studies and enhance referrals to studies/registries Initiative Milestones
    • Prepared a team with innovative outreach and recruitment plans
    • Engaged community members in research participation education
    • Inspired and recruited community members and patient/volunteer liaisons to become part of the recruitment infrastructure
    • Enrolled community members into trial/research ready cohorts
    • Facilitated enrollment of research participants into NIA funded clinical research
    • Documented and evaluated approaches and disseminated information

    An important goal is to build research capacity in recruitment and retention practice. Therefore, it is expected that research teams will provide opportunities for mentoring and career development to early career researchers and underrepresented populations poised to make contributions to this field of inquiry.

    Applicants are strongly encouraged to contact NIA Program Staff before submitting application.

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

    Section II. Award Information
    Funding Instrument

    Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

    Application Types Allowed

    New
    Resubmission
    Revision

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

    Not Allowed: Only accepting applications that do not propose clinical trials

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

    NIH intends to fund an estimate of 1-3 awards, corresponding to a total of $3 million, for fiscal year 2019. Future year amounts will depend on annual appropriations.

    Award Budget

    Application budgets are not limited but need to reflect the actual needs of the proposed project.

    Award Project Period

    The maximum project period is 3 years. 

    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
    Eligible Organizations

    Higher Education Institutions

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

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

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   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)

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

    Other

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

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
    Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

    Required Registrations

    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.

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM) (formerly CCR) – 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. 
    • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities 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.  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 NOT-OD-11-101).
    Section IV. Application and Submission Information
    1. Requesting an Application Package

    Buttons to access the online ASSIST system or to download application forms are 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 Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

    Letter of Intent

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

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

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

    The letter of intent should be sent to:

    Cerise Elliott, Ph.D.
    Division of Neuroscience
    National Institute on Aging (NIA)
    Telephone: 301-496-9350
    Email: elliottce@mail.nih.gov 

    Page Limitations

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

    Instructions for Application Submission

    The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

    SF424(R&R) Senior/Key Person Profile

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

    R&R Budget

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

    • Budgets should include sufficient staffing required for maximized community engagement, supported maintenance of contacts, and completed evaluations of recruitment approaches.
    • Budgets should provide sufficient resources to the proposed community partners to maximize community engagement.
    • Budgets should include sufficient resources for printing and communication expenses (radio, tv, newsprint, social media, mailings, etc.) to maximize community engagement.
    • Budgets should include travel for 3 - 4 team members to attend one grantee meeting at NIH per year.
    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

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

    Specific Aims: Describe the overall goals of collaborative teams examining factors related to the improvement of recruitment and retention practices. Detail the team visions, team characteristics and final outputs of their collaborations. Provide an overview on how the teams will engage community members as partners in aging research. Identify the diverse community members that will be ready to engage in NIA funded clinical research studies.

    Research Strategy:

    Significance: Address why the selected recruitment methods are best suited for a collaborative team approach. Provide an explanation of how the project will fill a gap in the current knowledge in the field, or contribute a significant resource or technology that is currently lacking. Demonstrate knowledge of the challenges and successes of recruitment and retention efforts in aging research. Detail selection of populations and how the teams will work to improve the research participation of these populations. Specify the selected methods and approaches that will improve the success of recruitment and produce a population of diverse community members ready to engage in NIA funded clinical research studies.

    Team Expertise: Without duplicating information provided on individual biosketches, document the experience and expertise of the assembled teams as a whole in recruitment, retention, community engagement/empowerment/education, and building research capacity. Describe characteristics and specify evidence that the team is experienced and successful recruiters of research participants. Present demonstrated success in recruitment of the proposed communities and/or populations. Describe how the proposed approaches and methods match the abilities of investigators.

    Innovation: Describe innovative processes and partnerships that will produce high yield community engagement. Specify how the impact of recruitment quality and efficiency will be altered by proposed innovations. Indicate how the new strategies and approaches will provide new motivations to participate in research. Identify how innovative approaches will allow interaction with study investigators and planned community members. State innovative strategies for engaging community members as active partners in the recruitment infrastructure and how the team will include relevant communities across the entire lifecycle of the project. Indicate how the team will test the hypothesis that such partnerships do accelerate participant recruitment with the communities of interest, in order to ascertain which methods are most successful in accelerating recruitment and whether there are study specific characteristics that impact particular strategies.

    Approach: Describe recruitment as a scientific problem, requiring the appropriate sequence of historical analyses, hypothesis formulation, intervention, measurement, and development of next steps based on data generated. Data and publication of data on recruitment hypotheses, methods and results will be essential. Outline innovative tools and methods proposed to recruit research participants, recruitment strategies designed, and the process of continuous improvement and dissemination of the tools and methods. Demonstrate a multidisciplinary approach to ensure a wide range of expertise will address the multifactorial challenges of recruitment and retention. Describe the development and testing of recruitment strategies in a broad range of diverse populations.

    Describe the community populations that will be engaged, including details about geography, demographics, and languages spoken. State the anticipated number of people who will be reached. State the anticipated number of community members who will become part of the research infrastructure. Identify the various community partners (key influencers, community leaders, patient advocates, media, agencies, etc.) and strategies for outreach by the teams. Identify other relevant stakeholder communities, such as clinicians, patients or community organizations, to advance novel recruitment materials or media. Present the broad range of diverse populations that are proposed to be recruited by the teams.

    Describe the plans to work with team members and highlight their purpose, function and role to the goal of the proposed approach. Document a standard operating procedure that delineates the scope of work for each team member and enable close efficient collaboration. Provide an estimate of the team's capacity planned by indicating the average number of participant recruitment in feasibility analyses anticipated being about to provide per month, as well as the number of recruitment strategies designed and implemented per year. Propose innovative approaches that will allow rapid access to information across the collective teams and communities of interest. Indicate generalizable solutions to recruiting community members that can be flexibly adapted to local guidelines and local policies. Provide innovations while maintaining ethical standards, and while safeguarding privacy and autonomy.

    Address the planning and implementation of innovative methods. Describe the activities, methods, tools and approaches that will be used to engage the community members. Outline events and organizations that will include a diverse population for aging research. Submit the approaches that will be used to engage populations and outline how the approaches will be evaluated. Explain how the teams will gather feedback and foster engagement. Outline how community awareness will be maximized and transformed into measurable commitments. Detail the process to track and catalog these commitments. Describe the process for retention and community follow up. Describe how community members' burden can be minimized and still maximize the participation of the members.

    Provide a timeline for method development, community engagement, evaluation strategies and community incorporation into the recruitment infrastructure (initiative goals). Submit initiative goals and initiative milestones to reflect quarterly reporting. Address potential recruitment shortfalls and barriers to community participation that will affect initiative goals and milestones. Document potential alternative approaches to offer research opportunities to community members.

    Provide a plan to educate community members that become part of the recruiting team and infrastructure. State clearly how the teams will incorporate community members into the recruiting infrastructure in efforts to recruit and retain for aging research. Detail how the team will maximize the enrollment of community members learning about biomedical research participation and supporting the recruitment infrastructure.

    Outline the selected evaluation metrics used to analyze the cumulative impact that the team's approaches had on recruitment participation. Demonstrate how the approaches described are aligning with the community of interest. Detail evaluation processes and indicate how the community members are involved in this evaluation. List methods and plans to identify strengths and weaknesses in efforts and the approaches to exemplify strengths and improve weaknesses. State metrics tracking recruitment success.

    Adaptability: Describe approaches making the teams successful, productive and adaptive to change. Indicate how to develop feasible and adaptable solutions, and efficient means of communications and coordination with the team members. Describe how the community incorporation into the recruitment infrastructure will be supported and maintained.

    Consortium/ Contractual Arrangements:  Demonstrate compensation to community organizations that is sufficient to the level of effort the organizations are engaging and empowering the community members and providing feedback to recruitment methods and approaches.

    Letters of Support: Document all potential community partners and team members participation in letters of support for the team effort. State the overall expected participation level of each partner and specify what compensation has been provided to the partner or what compensation the partner is providing to the teams. Provide a master list of all partners of the teams who are not Senior/Key Personnel or Other Significant Contributors and a brief description of their efforts as the first page of the file.

    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, with the following modification:

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

    Appendix:

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

    Indicate agreement to participate in the annual consortium meeting and incorporating community members in a significant role at the meetings.

    PHS Human Subjects and Clinical Trials Information

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

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

    PHS Assignment Request Form

    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). 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.

    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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

    All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number 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.

    Requests of $500,000 or more for direct costs in any year

    Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide. 

    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
    1. Criteria

    Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

    Overall Impact

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

    Scored Review Criteria

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

    Significance

    Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

    Are the selected populations appropriate? Does the project have adequate representation of underrepresented populations?? Is the outreach described at a regional/national scope? Will the project fill a gap in current knowledge and current recruitment efforts? Does the team demonstrate expert knowledge of the challenges and successes of recruitment and retention? Will the primary outcome, a population of diverse community participants ready to engage in NIA funded clinical research studies, be produced? 

    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?

    Are the teams comprised of well suited individuals to the target communities? Are the community and its organizations significant members of the team? Do people have experience and history in the target communities? Did the team demonstrate an understanding of matching community organizations with their target communities? Is there variety of expertise that reflects the community? Is there sufficient outreach staff to robustly engage the community members and meet expected enrollment goals or perhaps have high yielded enrollment? Is the organization of the teams reflective of the communities that are planned for engagement? Do the proposed teams have the knowledge to educate, motivate and facilitate community member recruitment? Does the leadership of the teams provide evidence of collaborative skills necessary to interact productively with partners? Do past experiences highlight success? Do the methods fit the abilities of the investigators? 

    Innovation

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

    Will high yield community engagement happen with the approaches described? Do the team plans have the ability to motivate potential community members? Are there innovative media/technology use or partnerships for outreach? Are there novel recruitment and retention methods? Is the innovation likely to create successful and generalizable solutions for participant recruitment? Is recruitment quality improved by these innovations? Are the interactions with community members improved?  Are the community members active partners of the recruitment infrastructure and do they remain the entire lifecycle of the project? Are community members being utilized to develop and evaluate the approaches?  

    Approach

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

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

    Are the approaches likely to engage and incorporate the community into the recruitment infrastructure following the execution of planned approaches? Are the approaches likely to increase in enrollment success? Are the proposed plans likely to improve recruitment and retention in aging research? Is the approach to recruitment described as a scientific problem? Are the teams testing hypotheses and measuring that their partnerships are accelerating recruitment? Are the recruitment methods suited for a collaborative team approach or could a single investigator complete the methods? Has there been historical analysis, hypothesis formulation, intervention and measurement? Will there be a demonstration of efficacy and effectiveness in the tools and methods presented?  Are the evaluations planned significant and able to have the teams draw a conclusion about efficacy and effectiveness in the tools and methods presented? Will the proposed solution increase the likelihood of successful participant recruitment? Is there a plan to address recruitment shortfalls? Is there a proposed sound strategy to track and collect metrics? Is there a plan to track and evaluate the success of novel recruitment strategies and materials such that improvements can be made and best practices implemented? Are there retention activities planned to maintain maximum community members participation?

    Are there adequate plans to engage community members as active partners in the recruitment infrastructure? Do plans include relevant communities and underrepresented communities? Are the community populations described significant and will the anticipated number of people represent a high yield community engagement?  Are the community partners the best partners for the effort? Is this a broad range of diverse populations to be recruited? Is community awareness going to be maximized with this effort and produce measurable commitments? Are the education plans maximizing research participation? Are the approaches aligning with the community of interest? Is the team prepared to address weaknesses of the approaches? Are the contributions of the community such that it will allow the teams to succeed at engagement?

    Is team communication planned efficiently and is there flexibility in its management? Is the scope of work for each team member clear, useful and supporting the goals of the project? Does the estimated recruitment capacity match the team's availability? Is infrastructure in place that allows rapid access to information? Have local guidelines and local polices been considered? Is there evidence of ethical standards?

    Is the timeline for the project acceptable and realistic? Does the presented approach have the necessary resources for initiative goals and milestones to be accomplished? Is there a plan to address shortages to meeting the initiative goals and milestones? Are the alternative approaches acceptable?

    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? 

    Is there evidence of adequate institutional support to suggest the teams will have appropriate success? Is there evidence the institution(s) will commit to this activity past the project period? What opportunities are there that the community will adapt this effort? Are the professional staffing and workforce support sufficient to complete the priorities of this initiative? Are the geographic regions described adequately and significant enough to encapsulate a broad diverse community of participants? In the defined geographic region, have the teams maximized the variety of community organizations that can assist in the recruitment efforts? Does the environment lend to maximized engagement and outreach to the underrepresented populations described?   

    Additional Review Criteria

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

    Communication

    Are the proposed interactions/communications between the leadership, community and the teams clearly described and optimized?

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the six 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 six 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 Children 

    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 children 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

    For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

    Renewals

    Not Applicable.

    Revisions

    For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

    Additional Review Considerations

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

    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:

    • 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.
    • Will receive a written critique.

    Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. 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 grantee's business official.

    Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

    Any application awarded in response to this 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.

    A required element of this initiative is an annual consortium meeting through which investigators can share ideas, best practices and lessons learned as well as discuss a national research agenda on recruitment and retention practices. This consortium meeting will allow program staff and team members the opportunity to foster greater collaboration and will help leverage existing resources and platforms to further the work of the consortium. The annual consortium meeting must also include a community population of potential research participants and incorporate their participation in the meeting. 

    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    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 "Federal awarding agency review of risk posed by applicants."  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable

    3. Reporting

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

    A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

    Section VII. Agency Contacts

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

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

    Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Scientific/Research Contact(s)

    Cerise Elliott, Ph.D.
    National Institute on Aging (NIA)
    Telephone: 301-496-9350
    Email: elliottce@mail.nih.gov

    Peer Review Contact(s)

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

    Financial/Grants Management Contact(s)

    Jennifer Edwards
    National Institute on Aging (NIA)
    Telephone: 301-827-6689
    Email: edwardsj@mail.nih.gov

    Section VIII. Other Information

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

    Authority and Regulations

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

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