Part 1. Overview Information

Key Dates

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

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

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

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

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



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The purpose of this initiative is to support the development of innovative research centers to foster nursing-led programs that promote community-partnered research to address persistent health challenges. Center applications developed in response to this NOFO should propose strategies to strengthen the research infrastructure by establishing or expanding centralized research resources in Schools or Colleges of Nursing (SON/CONs), developing and enhancing nurse-led interdisciplinary teams, and building expertise in community-partnered research through conducting pilot research that applies NINR's research lenses. Center strategies should be informed by NINR’s mission and should meaningfully engage the community throughout all activities.

Key Definitions for this NOFO 

Community-Partnered Research – Community Engaged Research (CEnR) frameworks are typically presented as existing on a continuum that spans from traditional investigator driven inquiries (with outreach or education provided to the community partners) to consultation, involvement/cooperation, and then those that rely on true partnership and collaboration. At the core of community-partnered research (e.g., Community-Based Participatory Research [CBPR] and other partnership models) is a strong bidirectional relationship that meaningfully involves all partners throughout the research process from identification of the research question to study design, planning, and implementation through interpretation of results, dissemination, and translation. The relationship is built on trust and mutual respect. All partners are valued, benefit from the research, and share decision-making, power and resources through strong partnership processes.

This NOFO requires involvement of not only a SON/CON but also one or more non-academic, non-research organizations that provide goods, services, support, resources, or advocacy to members of a defined community. Examples include community or faith-based organizations, local businesses, neighborhood authorities and associations, labor unions, patient or consumer advocacy groups, school districts, law enforcement or criminal legal agencies, or social service agencies. Governmental organizations at the local, regional, tribal, state, or federal level fall within this definition. At least one partner should be a community organization representing the population whose health and well-being is the focus of the research.

Nursing Research - Nursing research leverages the unique knowledge and perspectives inherent to the discipline to solve pressing health challenges and inform practice and policy. It is based on a holistic contextualized approach to optimizing health for all people, spans health care and public health, and encompasses the many settings where nurses partner with individuals, families, and communities. NINR's research lenses leverage the strengths of nursing research to promote multilevel approaches, multidisciplinary and multisectoral collaboration, and community engagement in research.

Background

Research grounded in strong community partnerships is critical to advancing health and reducing health disparities. Meaningful community engagement ensures that the community’s perspective, expertise, and priorities are at the forefront of research development, implementation, and sustainability efforts to improve individual and community health. Such approaches require researchers in nursing and other disciplines to establish trusting relationships with community partners to foster effective and meaningful collaborations to conduct rigorous and impactful research.

Interdisciplinary teams led by nurse scientists in partnership with the community are needed to develop solutions to address complex health challenges that consider the conditions where people live, learn, work, and play (i.e., social determinants of health). These interdisciplinary teams must incorporate community as authentic partners to more meaningfully enhance health and address the barriers that limit its optimization. Cumulatively, these efforts can build a track record of successful researcher-community partnered interdisciplinary teams.

Community partnerships have long been recognized by SON/CONs as central to both nursing education and service delivery. These education and service partnerships have facilitated opportunities to work collaboratively with community partners to identify and meet the health needs of community members. Despite this legacy of successful academic-community partnerships in education and service delivery, the number of nurse researchers engaged in community-partnered research is inadequate to address the many health challenges that individuals, families, and communities experience. Further, SON/CONs with research programs or research capacity-building opportunities focused on community-partnered research are rare. The relationships forged in strong academic-community partnerships provide a foundation to advance impactful nurse-led research in this area. Success of this critical research approach will require infrastructure to support the conduct and advancement of this research, including protected time and resources, enhanced investigator knowledge of community-partnered research approaches, and opportunities to develop and sustain community partnerships for conducting research to improve the health of all people.

Research Objectives

The P20 Exploratory Centers will aim to foster nursing-led programs that promote community-partnered research to address persistent health challenges. This will be accomplished by developing and enhancing capacity for interdisciplinary, community-partnered research that advances the NINR mission by:

• Establishing centralized research resources in SON/CON.
• Building the Center's community-partnered research expertise.
• Developing nurse-led, interdisciplinary research teams that partner with the community in the development, implementation, and evaluation of research efforts.

Program Description and Requirements
The goal of the P20 Exploratory Centers is the development of sustainable research infrastructure to advance community-partnered research programs. Centers should foster collaborations between scientists within the SON/CON, and across other disciplines and institutions to promote a multifaceted approach toward the common goal of addressing persistent health challenges. The NINR P20 Exploratory Center must be an identifiable unit within a School or College of Nursing (SON/CON). The Center Director must demonstrate a proven track record of NIH or other funding at a similar scale (e.g., NIH R01, P01 or U-series awards or other significant peer-reviewed funding from Federal or private sources) to show the capacity for advising new and early-stage investigators and post-doctoral fellows.

The Center should be built on one or more existing community partnerships. A representative from the community (e.g., community organization) must serve as a co-investigator and key personnel of the Center overall. Each pilot must involve at least one academic investigator and one community investigator as a co-investigator and key personnel.

Center Structure

Administrative Core
Applications must include an Administrative Core that will be responsible for allocation and oversight of Center resources, coordination and integration of Center activities, and evaluation. The Administrative Core must have processes to: 1) Evaluate the productivity, effectiveness, and appropriateness of Center activities and components; 2) Determine criteria for Center affiliations (e.g., Center faculty, members, affiliates); and 3) Foster community-partnerships and collaborations within and across disciplines. The budget must be appropriately allocated to the SON/CON and community partners.

All Centers will be required to maintain a separate web page within the respective SON/CON or institutional website with the Administrative Core taking primary responsibility for its creation and maintenance. This web page should include descriptions of the pilot research, links to resources, and announcements of events.

The P20 Center Director, who is the Program Director/Principal Investigator/Contact Principal Investigator on the P20 application and the Director of the Administrative Core, must be a nurse and hold a research doctorate degree. The Director must have a demonstrated record of effective administrative and scientific leadership, and proficiency in managing a large, multi-component project. The Director must also be a faculty member at the applicant SON/CON. The Director will be responsible for the organization and operation of the Center and for communication with the NINR on programmatic matters. Only the Contact PI must be a nurse and hold a research doctorate degree.

NINR P20 Center PI(s) are required to attend and to budget accordingly for the annual Center meetings to be held at a location to be determined by the NINR (See Section IV. for details).

One or more Associate Directors should be named who will be involved in all aspects of the Center and who will serve as Acting Center Director in the absence of the Director. The Associate Director should have an appointment at the SON/CON. A process must be in place that would be used to recommend a permanent successor to the Director, if needed.

An Internal Executive Committee, consisting of the heads of all proposed Center Cores and Programs, one or more community member, and appropriate business official(s) should be established to assist the Center PI(s) in the allocation of Center resources, the identification and selection of key personnel, and the planning and execution of Center activities.

A Community Advisory Board (CAB), consisting of representatives from community partner organizations should be established to assure that the Center reflects the principles of community-partnered research. In this approach, the CAB should be integrated into the planning, implementation, evaluation, and dissemination of all Center activities.

A Scientific and Operational Advisory Committee (SOAC) of scientists, administrators, and community partners should be established to provide guidance on selection of pilots and scientific advancement, and for efficient operation of the Center, and plans for sustainability.

Pilot Core
The Pilot Core is responsible for the overall management of all Center pilot projects. The Core: 1) solicits, selects, and supports community-partnered pilot studies, including providing scientific support for development, implementation, and evaluation of the pilot; 2) coordinates pilot investigator oversight; 3) guides dissemination of pilot project results; 4) monitors and tracks the progress of pilot project success and evaluates the career development of academic pilot investigators and subsequent NIH grant funding. The pilot project program, administered through the Pilot Core, provides modest support for pilot studies focused on NINR’s research lenses. Pilot studies are required to address SDOH, encompassing the conditions of people’s lives. These pilot studies should generate preliminary data that can inform subsequent NIH grant submissions. New and early-stage investigators are strongly encouraged to serve as Pilot PIs as the intent of this program is to provide opportunities to gain research experience and preliminary data, through the conduct of pilot studies, that may inform subsequent grant submissions. (https://grants.nih.gov/grants/new_investigators/#definition). Efforts to increase the number of pilot project awards for the program using program income or alternative funding sources are particularly encouraged. Each pilot must have an academic investigator and a community co-investigator who will have leadership in the pilot.

Pilot Projects
Each Center must complete at least 3 pilot projects during the period of the award. At least one (1) pilot project must be detailed in the application and this project must be started in the first year of the award. Details about pilot projects can be found in Section IV. A proposed pilot must be completed within 2 years, include an academic PI and a community co-investigator and other community partners, and lead to a NIH application for an R-series (R15, R21, R01) award at the completion of the pilot. The specific aims of the proposed pilot cannot include overlap with current or previously funded projects (either Federal or non-Federal funding).

Pilot projects must include gathering data from primary sources. Pilots may not be exclusively secondary analysis of existing data, and may not include:

• Development of research methodology as a primary focus
• Development of new research technology as a primary focus
• Basic biomedical research including animal models
• Human embryonic stem cells

Capacity Building Core
The Capacity Building Core is responsible for continued and coordinated professional development and scientific enrichment of pilot investigators, Center members, community partners, and SON/CON staff. This Core is responsible for providing tailored scientific technical assistance to pilot research teams and planning and organizing seminars, guest speakers, visiting scientists, scientific consultants, workshops, etc. including notification of these events to community partners, multidisciplinary partners, and the broader nursing research community. Activities must be designed to advance community-partnered research on topics related to the Center’s specific aims, support scientific exchange among those with interest in these topics, and facilitate interactions between Center scientists, investigators within and across universities, and community members.

Additional Information
Each P20 Center will be expected to plan for team (e.g., Center Directors, Community Partner(s), pilot project PIs) attendance at an Annual Meeting at a location to be decided, comprising all funded centers to allow coordination, collaboration and information sharing across the initiative.

Applications Not Responsive to this NOFO
Applications that do not meet the following criteria will be deemed non-responsive and will not be reviewed.

• Applications that do not include a community partner as a co-investigator and key personnel in the Overall application.
• Applications that do not include at least one pilot project described in the application.
• Applications that do not include a Community Investigator as co-investigator of the pilot(s) described in the application. 

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions - Includes all types

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

Other

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

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

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

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

Applicant organizations

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

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for 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 How to Apply - Application Guide.

The Center Director (Program Director/Principal Investigator/Contact PI) must be a nurse and hold a research doctorate degree. The applicant must also be a faculty member at the applicant School/College of Nursing. Only the contact PD/PI must be a nurse researcher and hold a research doctorate degree. A community member must be a co-investigator and key personnel for this application.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Page Limitations

All page limitations described in the How to Apply- 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 How to Apply- Application Guide and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall
• Administrative Core
• Pilot Core
• Pilot Project(s)
• Capacity Building Core

Overall Component

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

All instructions in the How to Apply - 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.

Facilities and Other Resources: Describe the existing environment and facilities available to the Center. The Institutional Commitment at the applicant institution will be a major consideration in ensuring the goals of the Center. The parent institution should recognize the Center as a formal organizational component and provide documented evidence of space dedicated to the needs of the Center, protected time to devote to Center activities, staff recruitment, dedicated equipment, or other financial support for the proposed Center.

The parent institution should provide assurance of its commitment to continuing support of the Center in the event of a change in directorship and a well-defined plan for this eventuality should be in place.

Other Attachments:
Grant Support: Please title this attachment "Grant Support". There should be four sections to this attachment: "Active Grant Support", "Related Grant Support", "Other Grant Support", and "Pending Grant Support". Under "Active Grant Support" list all current Federal and non-federal grant support for the Center investigators. Complete and organize alphabetically by the last name of the Center investigator who is listed as the contact Program Director/Principal Investigator (PD/PI) on the grant. Include Supporting Organization/Grant Numbers, Complete Grant Title, Project Period, Annual Direct Costs). Applicants are strongly encouraged to provide this in a table format. The "Related Current Grant Support" table should include a brief description of each project and how it relates to community-engaged research. “Other Grant Support”' should include infrastructure/services grants (other Centers) and other grants awarded to the SON/CON that would not be direct users of Center services. "Pending Grant Support" should provide information on pending support for Center investigators.

Center Collaborations: Please title this attachment “Center Collaborations” and organize alphabetically by name. List all individuals and organizations affiliated with the Center. Provide primary affiliation, key words for research interests, names of other Center members who are collaborators (through publications, grants or research projects), the number of collaborative publications (only those relevant to the Center), and how their work relates to the theme of the Center and the objectives of this NOFO. Include existing community partners, listing their organization, role, and areas of expertise. Applicants are strongly encouraged to use a table format.

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 NOFO) for the entire application.

The Center Director (PD/PI/Contact PI) must be a nurse and hold a research doctorate degree. The applicant must also be a faculty member at the applicant School/College of Nursing (SON/CON). Because the NINR P20 Exploratory Center has a large and complex administrative structure, the Center Director must have strong leadership abilities and demonstrate proficiency in managing large, multi-component programs. The Center Director should be an experienced scientist with a proven track record for obtaining NIH or other funding at a similar scale (e.g., NIH R01, P01 or U-series awards or other significant peer-reviewed funding from Federal or private sources). The Center Director must be able to coordinate, integrate, and provide guidance in the establishment of new programs in nursing research. Only the contact PD/PI must be a nurse and hold a research doctorate degree. A community member or representative of a community organization must be included as a co-investigator and key personnel of the Overall application and be included in the Internal Executive Committee.

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)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: Describe the overall specific aims of the Center.

Research Strategy: The research strategy should:

• Describe the rationale for the Center including the resources that will be used to build interdisciplinary research capacity for nurse researchers to support a community-partnered research portfolio at the institution.
• Describe existing community partnerships and the milestones for community engagement in each year of the award.
• Describe the overall Organization and Management Plan for the Center which should clearly convey the strategy by which the goals of the Center will be met and will be aligned with NINR’s research lenses.
• Describe the structure and plans for the Center, including:
  • An Internal Executive Committee, consisting of all PI(s), the heads of all proposed Center Cores and Programs, a community co-investigator, and appropriate business official(s), should be established to assist the Center PI(s) in the allocation of Center resources, the identification and selection of key personnel, and the planning and execution of Center activities. Other members may be added to the Executive Committee at the Director’s discretion.
  • A Community Advisory Board (CAB), including representatives of community-partner organizations should be established to assure that the Center reflects the principle of community-partnered research. The CAB should be integrated into the planning, implementation, evaluation, and dissemination of all Center activities. Details about the planned activities and evaluation of the CAB should be included in the Administrative Core.
  • A Scientific and Operational Advisory Committee (SOAC) of scientists and administrators should be established to provide guidance on selection of pilots and scientific advancement, and for efficient operation of the Center, and plans for sustainability. Details about the planned activities and evaluation of the SOAC should be included in the Administrative Core.
• Describe the coordination and interaction among the Administrative Core, the Pilot Core, the Pilot Projects, and the Capacity Building Core.
• Provide a justification and description for each component in terms of the overall goals of the Center.
• State how Center resources will provide a unique contribution to the research infrastructure at the applicant School or College of Nursing.

If applicable, a MPI leadership plan that describes the roles, responsibilities, communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts between the overall MPIs should be included in the overall plan.

Letters of Support: Overall letters of support should be obtained from individuals, institutions, and community organizations providing resources to the Center. Letters from the Institution, Dean of the College/School of Nursing, the Community Advisory Board, and the Scientific and Operational Advisory Committee members must be included. The letter of support from the Institution should include the commitment to continuing support of the Center in the event of a change in Directorship and support for the implementation and sustainability of the Center. Letters of support from community partners should include a statement of commitment to the Center.

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

Other Plan(s): 

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

Appendices titled "Grant Support" and "Center Collaborations" must be included.

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 How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, 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 How to Apply - Application Guide must be followed.

Human subjects and clinical trials Information for the Pilot(s) should be included in the "Pilot Project" section of the application, unless the project with human subjects information spans multiple components of the Center (e.g., the Pilot Core and the Capacity Building Core). Human subjects and clinical trials information for the delayed onset Pilots 2 and 3 should be entered into the Pilot Core, unless the information of the pilot spans multiple components of the Center. 

Delayed Onset Study

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

Pilots not proposed in this application (e.g., pilot 2 & 3) will be delayed onset and will require prior approval from NINR as per NIH policy.

PHS Assignment Request Form (Overall)

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

Administrative Core

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

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

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

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions. NOTE: No human subjects activities take place in the Administrative Core.

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.

Project /Performance Site Location(s) (Administrative Core)

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 (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project 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 Center Director (contact PD/PI) must also be the Administrative Core Director.
• A community member or representative from a community organization must serve as a co-investigator and key personnel overall.
• The complex nature of administrative requirements of Centers will necessitate the assistance of a person with business management expertise. It is important that such an official is identified and is directly involved with the fiscal aspects of the application and grant. An appropriate amount of this individual's time and effort should be committed for this purpose. The institutional business official should be a member of the internal Center Executive Committee. The business official should be involved in the budgeting process and should provide consultation in matters of fiscal administration and evaluate such issues as equipment on hand versus that requested for the Core facilities. Additionally, this institutional official can assist the Center PI(s) in determining the compliance with NIH research guidelines.

Budget (Administrative Core)

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

• The Administrative Core Director (Center Director) must contribute no less than 1.8 person months out of 12 months (15% time and effort) to the Center’s activities.
• The Administrative Core budget must include travel expenses for the Center PI(s), Core Directors (as necessary), key community partners and the current Pilot PIs community co-investigators to attend each annual NINR Center Meeting.
• The budget should include appropriate compensation for the community member listed as a co-investigator and for any community members serving on the Internal Executive Committee.

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 (Administrative Core)

Specific Aims: The specific aims for the Administrative Core should be described.

Research Strategy: Clearly state how the Administrative Core will contribute to the goals of the Center and outline interactions of the Administrative Core with each of the other Cores. Provide an overview of how the Administrative Core will play a key role in the coordination and functioning of the Center, including managing the overall activities of the Center, including developing, promoting, and managing use of Center resources.
The Administrative Core must contain the following:

• A presentation of the administrative structure. Include the role of the Administrative Core in 1) establishing and maintaining all collaborations, and 2) working with the institution and local regulatory bodies to ensure that the research complies with appropriate regulations and guidelines governing studies involving human subjects research.
• A description of how the Administrative Core will ensure the synthesis of findings and activities from research projects and cores.
• A process must be in place, and should be described in the application, that would be used to recommend a qualified successor to the Director, if needed.

The Administrative Core must describe how they will meet their responsibilities to:

• Review utilization of funds, including funds for pilot projects, Cores, and other Center activities, and assure the appropriate expenditure of funds.
• Optimize the utilization of the shared resources of the Center, such as all Core resources.
• Develop and execute a Center evaluation plan that includes ongoing evaluation of all Center activities.
• Develop and execute a sustainability plan that includes ongoing evaluation of the progress toward: 1) Outcomes for sustaining science including leveraging additional research grants and products; 2) Outcomes for sustaining infrastructure including leveraging resources for short-term continuation such as a business model approach, development of an effective budget model, cost sharing, partnerships with other Centers and, 3) Outcomes for sustaining science including publications, presentations, policy briefs, measurement methods and scientific methods.

The organization of the Administrative Core must encompass a supportive structure sufficient to accomplish the following:

• Coordinate and integrate the Center components and activities.
• Review the utilization and quality of Core resources.
• Review utilization of funds, including funds for pilot projects and other Core(s) activities, and assure the appropriate expenditure of these funds.
• Establish a Center web page, with the Administrative Core taking primary responsibility for its development and maintenance.
• Plan for the sustainability of the Center after the period of support is completed, including development of collaboration(s) and preparation for seeking NIH R-series (R15, R21, R01) support and other federal or private research funding.
• Oversight of the Internal Executive Committee.
• Oversight of the Community Advisory Board (CAB).
• Oversight of the Scientific and Operational Advisory Committee (SOAC).

The application should describe the role and activities of the Community Advisory Board (CAB). The CAB should:

• Be composed of at least three community members or representatives of community organizations.
• Be involved in evaluation of the effectiveness of the Center in being responsive to community needs; partnering with community organizations; and integrating community voices in the planning, implementation, evaluation, and dissemination of research.

Describe the specific role of the Community Advisory Board (CAB) and how its work will support and reflect the principles of community-partnered research and its collaborative approach. Explain how the CAB is integrated into all phases of the research process with particular attention to descriptions of co-creation, bi-directional learning and shared power and decision making throughout all endeavors, including pilot studies. Outline how the activities of the CAB will ensure that community voice is integrated into the planning, implementation, evaluation, and dissemination of the research. Include attention to involvement of community members as co-authors and creation of materials that are timely, relevant, and impactful for community members. Describe the planned frequency of CAB meetings.

The minutes or summary of the CAB meetings, as well as a response from the Center PD/PI concerning CAB recommendations must be submitted to the NINR Program Officer within 30 calendar days of the CAB meeting.

The application should describe the role and activities of the Scientific and Operational Advisory Committee (SOAC). The SOAC should:

• Be composed of at least two (2) scientists from outside the applicant organization, with expertise and experiences relevant to the scientific program and administration of the Center.
• Include the chair of the Community Advisory Board or another community member.
• Be involved in evaluating the overall research programs of the Center, the development and utilization of research resources, the effectiveness of communications within the Center, and any activities in which problems arise for which expertise is required or desirable.
• Describe the specific role of the Scientific and Operational Advisory Committee (SOAC) and how it contributes to the scientific and operational development of the Center. Describe the planned frequency of SOAC meetings.

The minutes of the meeting of the SOAC, as well as a response from the Center PI(s) concerning SOAC meeting recommendations must be submitted to the NINR Program Officer within 30 calendar days of the SOAC meeting. The SOAC may also serve as the external review group for Pilot Project Selection.

The Center PI(s) and other Center leaders, as the Director deems appropriate, are responsible for the Evaluation Plan. A plan for ongoing evaluation of progress toward meeting the aims and goals of all pilot projects, and the overall Center is required. The Evaluation Plan should include:

• The specific criteria and methods that will be used for the evaluation.
• A plan for collecting data to evaluate progress. Specify the types of evaluation information that will be submitted in the Center's annual progress report. At minimum, the plan should include the following information to be submitted with the Center's annual progress report to the NINR: federal and non-federal grant applications and peer-reviewed publications from pilot PIs, presentations of pilot results, products, and new partnerships with other Centers, progress towards milestones.
• Measurable goals and milestones for each project year relating to the progress of each Core, each pilot project, and all programs, collaborative research activities and efforts to facilitate sustainability.
• A plan for evaluating success, which must include maintaining a detailed record of the pilot projects, grant submissions and funding resulting from Center activities, peer-reviewed publications, oral and poster presentations derived from Center activity and funding, and collaboration by Center investigators with other schools and institutions.
• An accounting of resources and resource utilization, as well as efforts taken to maximize the research resulting from use of these resources.
• A section addressing sustainability of the Center and its research, including plans for attracting new investigators and resources into Center research activities.
• An annually updated plan that addresses and incorporates the suggestions of the Community Advisory Board and Scientific and Operational Advisory Committee for the success and sustainability of the Center.
• An annual evaluation of Center successes and plans for changes to achieve and/or maintain success.

The final administrative structure of the Center will be left largely to the discretion of the applicant institution. However, experience has demonstrated that the effective development of the Center programs requires close interaction between the Center PI(s), Core Leaders, appropriate institutional administrative personnel, and the members of the community in which the Center is located. Therefore, the Center should establish an administrative structure that will permit the development of such interactions.

Letters of Support: Letters of support should be obtained from those providing resources to the Administrative Core.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

Pilot Core

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

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

SF424 (R&R) Cover (Pilot Core)

Complete only the following fields:

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

Research & Related Other Project Information (Pilot Core)

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

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.

Project /Performance Site Location(s) (Pilot Core)

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 (Pilot Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project 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 Pilot Core Director must hold a research doctorate and have an appointment at the applicant College/School of Nursing.
• Pilot Project Investigators will be listed in the appropriate Pilot Project Component.

Budget (Pilot Core)

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.

Pilot project funds cannot be used to supplement research that has already been funded, regardless of the source.

Efforts to increase the number of Pilot awards and the availability of funds for the program using program income or alternative funding sources are particularly encouraged.

Personnel: This category should include salary support for key personnel, including the Pilot Core Director, and other professional and administrative personnel. The Pilot Core Director must devote a minimum of 1 person months out of 12 months to the Program to ensure adequate oversight. The salary amount charged to the grant for the Pilot Core Director must be commensurate with the time spent on Pilot Administrative Core activities and is subject to institutional and NIH salary policies.

Pilot Projects: Up to $50,000 in direct costs per project, per year for up to two years can be budgeted for each approved pilot project. The amount for the pilot projects should be budgeted as an annual lump sum for all years of the award to accommodate the additional pilot projects, which will be implemented in future years as delayed onset awards. The annual lump sum should be budgeted under Other Expenses as “Pilot Projects.”

Within this lump sum, there must be appropriate compensation for community partners including the community lead for the pilot and support for the Pilot PI, or the SON/CON may offer in-kind support of the Pilot PI time. The budget justification should state the minimum amount planned for community partners and the plans for support of Pilot PI time.

Consultants: Include costs associated with consultants (e.g., consultant fees/honoraria, per diem, or teleconferences) when their services are required by the Pilot Core. Consultant costs associated with a pilot project should be budgeted in the Pilot Project section.

PHS 398 Research Plan (Pilot Core)

Specific Aims: Describe the aims of the Pilot Core. The Pilot Core facilitates the selection, planning and oversight of all pilot projects funded under the Center grant mechanism.

Research Strategy: Each Center may determine their administrative framework for management of the pilot projects program, but certain minimal requirements must be met. Please describe how the major responsibilities of the Pilot Core will:

• Prepare and ensure appropriate distribution of announcements of the availability of pilot project funding to appropriate potential applicants.
• Assure that pilot projects will enhance community-engaged research capacity in the areas of clinical research and/or, behavioral and social sciences research related to health.
• Arrange and preside over the scientific merit review of pilot proposals. This may be carried out by the Internal Center Executive Committee, Community Advisory Board, Scientific and Operational Advisory Committee, or an ad hoc Review Committee, in person or by mail, or with a combination of methods. For any method, inclusion of community representation must be described. At least two scientists with expertise relevant to the scientific area of inquiry including at least one reviewer from outside the parent institution must be used to review each proposal. All reviewers should assign impact scores in accordance with the NIH system. Copies of all the proposals with written documentation of their reviews, impact scores, and final action must be retained by the Center.
• Assure that advising and oversight plans are followed for all pilot studies and evaluate the effectiveness of this plan in preparing the pilot investigator for a successful research career.
• Maintain oversight and review of progress for ongoing pilot studies.
• Keep appropriate records for all pilot projects with Human Subjects and/or Clinical Trials.
• Provide support to the pilot project investigators to facilitate the completion of annual progress reports on pilot project activity.
• Guide the development and implementation of pilot projects that will foster interdisciplinary communication and collaboration between academic investigators, community investigators, and researchers from other disciplines.
• Make recommendations or convey funding decisions to the Internal Executive Committee and retain a record of funding recommendations/decisions and actions.
• Make recommendations regarding change of scope, termination, or other actions of pilot projects to the Internal Executive Committee.
• Maintain records of the outcome of Center pilot project success (e.g., pilot PI applications for federal and non-federal funding, peer-reviewed pilot project-related publications, pilot PI presentations, pilot investigator promotions, etc.).

All applicants should:

• Describe how the above requirements will be met.
• Describe how community partnership will be incorporated into all pilot projects, from the identification of the research question to design, planning, implementation, interpretation of results, dissemination and translation, including the role of an academic investigator and a community investigator for each project as MPI.
• Describe the number, academic rank, and active funding of potential academic pilot investigators. Investigators who have been selected to conduct a pilot should include their biosketch in the "Pilot Project" component.
• Describe the experience of the Pilot Core Director in overseeing the selection and management of delayed onset awards, and in advising nurse researchers.
• Describe plans for overseeing dissemination of pilot findings in academic and community venues, including scientific and professional conference, Annual Center meetings, community meetings, etc.

At least one pilot project should be detailed in the "Pilot Project" section of the application. This pilot should begin in the first year of Center support. This pilot should be reviewed internally and selected in the manner proposed for all future pilot applications.

Since pilot projects can be awarded for varying periods of time, these studies may end at various times. In addition, the studies may also be terminated by the Center administration before their approved time limit for various reasons: e.g., (1) the investigator has received outside funding for the project; (2) the project was found not to be feasible; or, (3) the investigator has left the Center institution. When this occurs, the Center contact PI must contact the NINR Program Officer. Prior approval must be requested from NINR to make new awards for pilot studies with the remaining funds.

Letters of Support: Letters of support should be obtained from consultants and pilot project reviewers who will be providing services to the Pilot Core.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Pilot Core)

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 How to Apply- Application Guide, with the following additional instructions:

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

Human Subjects and Clinical Trial Information for the pilot proposed in the "Pilot Project" section of the application should be included in the "Pilot Project" section of the application.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Note that any pilot projects not included in the "Pilot Project(s)" section of the application will be delayed onset studies. If this application details one pilot in the "Pilot Project" section, there should be at least two delayed onset studies. These should be named "Pilot 2" and "Pilot 3", etc.

Prior Approval of Pilot Projects (Delayed Onset)

All awardee-selected pilot projects require prior approval by NINR prior to initiation. Prior approval should be requested according to the NIH Policy (https://grants.nih.gov/grants/guide/notice- files/NOT-OD-15-129.html). NINR will review prospective pilot projects for fit with the NINR mission, human subject protection, inclusion plans and data and safety monitoring plans, as appropriate.

• The awardee institution will provide NINR with written study protocols and the plan for addressing risks and protections for human subjects.
• The awardee institution with provide NINR with specific plans for Inclusion of Women, Minorities, and Individuals Across the Lifespan, including planned enrollment tables for each project.
• For pilot projects that are NIH-defined clinical trials, the awardee institution will provide NINR with:
  • Specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies and NINR DSMP policies.
  • Good Clinical Practice training should be documented (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html).

Pilot Project

When preparing your application, use Component Type ‘Pilot Project.’ If more than one pilot project is being proposed, there should be a separate "Pilot Project" section for each pilot, which should be titled, "Pilot Project 1", “Pilot Project 2.”

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

SF424 (R&R) Cover (Pilot Project)

Complete only the following fields:

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

Research & Related Other Project Information (Pilot Project)

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

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.

Project /Performance Site Location(s) (Pilot Project)

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 (Pilot Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Pilot PI’ 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 Academic PI and Community co-investigators together should have a minimum of 2.4 calendar months or 20% time and effort to pilot project activities.
• Each pilot should include a community investigator as a co-investigator.

Pilot award Academic PI eligibility:

• Investigators eligible as Academic Pilot Investigators must be a nurse and have an appointment with the SON/CON. This includes:
  • NIH-defined early-stage and new investigators without current or past individual NIH research support.
  • Investigators who have received individual NIH support as PI for no more than one project.
  • The Center Director and Center Core Directors are not eligible as pilot PIs.

Budget (Pilot Project)

The budget for the pilot projects should be included in the Pilot Core budget. No budget should be included for the Pilot Projects.

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 (Pilot Project)

Specific Aims: Describe the specific aims for the pilot project.

Research Strategy: A proposed pilot study should be a discrete, well-defined project that can realistically be completed in two years or less and that requires limited levels of funding. The pilot proposal should clearly delineate the question being asked, detail the procedures and approaches to be followed, and discuss how the data will be analyzed. The role of the community investigator in the development, implementation, evaluation, and dissemination of findings must be described. Projects should be focused, with sample sizes that are statistically justified and with reasonable accrual success within the time constraints of a pilot study and within the level of funding support. The pilot project must include gathering data from primary sources. Pilots may not be exclusively secondary analysis of existing data, and may not include:

• Development of research methodology as a primary focus
• Development of new research technology as a primary focus
• Basic biomedical research including animal models
• Human embryonic stem cells

Applications must propose a minimum of one pilot project to be started during the first year of award. New projects should be developed with a minimum of one ongoing project per year and a minimum of three (3) pilot projects over the course of the award. Up to $50,000 in direct costs per year for up to two years may be budgeted for the approved pilot projects (total of up to $100,000 in direct costs over 2 years). Pilot awards are not intended to serve as 'bridge' funding for established nurse scientists who may be experiencing a gap in research funding. Details about appropriate pilot projects are listed below under PHS 398 Research Plan (Pilot Project), Research Strategy.

Each pilot project must follow these guidelines:

• The pilot should have an Academic PI and a Community Co-Investigator, who serve as leaders of the project.
• The theoretical or conceptual basis for the pilot study must be clearly explicated.
• An interdisciplinary approach to promote the collaboration of nurse researchers with scientists of other disciplines is encouraged.
• For investigators without current or past NIH research support as a PD/PI, an advising and oversight plan should be described. The advising and oversight plan should extend to include advising the pilot investigator through the submission of a subsequent NIH RPG funding application.

The application must:

• Indicate how the proposed pilot study incorporates community engagement from the identification of the research questions through dissemination and translation of the findings, and addresses the NINR research lenses, specifically the health disparities and/or social determinants of health lenses.
• State the justification for eligibility of the academic investigator under the criteria stated in Research & Related Senior/Key Person Profile (Pilot Project) above.
• Include a detailed timeline for the pilot project.

Pilot Projects that are clinical trials must adhere to all NIH and NINR policies on Clinical Trials and must include a Data and Safety Monitoring Plan and a Dissemination Plan.

Annual milestones for pilot progress and community partnership in the pilot should be described.

Pilot projects selected after the Center Grant is awarded require prior approval by NINR prior to initiation (see the NIH Grants Policy Statement 8.1.3 Requests for Prior Approval and https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-129.html for instructions on submitting a request).

Letters of Support: Letters of support should be obtained for each specific pilot project. Letters of support from the Pilot Investigator's supervisor and all community organizations involved are strongly recommended.

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

Other Plan(s):

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Pilot Project)

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 How to Apply- Application Guide, with the following additional instructions:

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

If the proposed pilot is not delayed onset and is a clinical trial, a Data and Safety Monitoring Plan and Dissemination Plan must be included in the Pilot Project section of the application.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Pilot studies not included in this application should be included as Delayed Onset Studies in the Pilot Core, when the title and PI are not known, they should be listed as “Pilot Project 2” and “Pilot Project 3.”

Prior Approval of Pilot Projects (Delayed Onset)

All awardee-selected pilot projects require prior approval by NINR prior to initiation. Prior approval should be requested according to the NIH Policy (https://grants.nih.gov/grants/guide/notice- files/NOT-OD-15-129.html). NINR will review prospective pilot projects for fit with the NINR mission, human subject protection, inclusion plans and data and safety monitoring plans, as appropriate.

• The awardee institution will provide NINR with written study protocols and the plan for addressing risks and protections for human subjects.
• The awardee institution with provide NINR with specific plans for Inclusion of Women, Minorities, and Individuals Across the Lifespan, including planned enrollment tables for each project.
• For pilot projects that are NIH-defined clinical trials, the awardee institution will provide NINR with:
  • Specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies and NINR DSMP policies.
  • Good Clinical Practice training should be documented (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html).

Capacity Building Core

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

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

SF424 (R&R) Cover (Capacity Building Core)

Complete only the following fields:

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

Research & Related Other Project Information (Capacity Building Core)

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

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.

Project /Performance Site Location(s) (Capacity Building Core)

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 (Capacity Building Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project 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.

Budget (Capacity Building Core)

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.

Personnel: This category should include salary support for key personnel, including the Capacity Building Core Director and any other professional and administrative personnel. Salary support charged to the Center grant must be commensurate with the time spent on Capacity Building activities and is subject to institutional and NIH salary policies.

Other Expenses: Include funds to support Capacity Building activities such as workshops, research fora, symposia, Center retreats and seminar series. Funds for Capacity Building-associated activities such as the printing and distribution/mailing of brochures, programs, and meeting materials, as well as posters and other advertisement materials, may be requested.

PHS 398 Research Plan (Capacity Building Core)

Specific Aims: Applications should describe how the Capacity Building Core (CPC) impacts the development of academic investigators at all stages and roles, community investigators, and community partners and provides resources for the successful conduct of meaningful community-partnered research.

The Capacity Building Core will be responsible for continued and coordinated professional development and scientific enrichment to ensure Center members, pilot investigators, community members, and staff are prepared to conduct community-partnered research. The Capacity Building Core is responsible for planning and organizing the various events, including seminars, webinars, guest speakers, visiting scientists, consultants, meetings, and workshops, including notification of these events to the community and other Schools, Colleges, Institutions, and NINR-supported Centers, as appropriate. These events should provide knowledge and build skills in community-partnered research including shared power and decision-making from the identification of the research question through dissemination of the results.

Research Strategy: A description of the plans for conferences, meetings, webinars, educational programs and materials should be submitted. At least annually an event (webinar, workshop, conference, meeting, etc.) that includes both investigators and community partners must be planned. Pilot project investigators should be included in these events. Events that allow the registration of researchers from outside the institution (such as from other Centers, or researchers at other universities) are encouraged. Applicants should describe any educational opportunities offered by the Center and document ways the Center may facilitate, enhance, or foster the institutional educational environment (e.g. F30, F31, F32, T32) and the contribution of other organizations such as private foundations, commercial companies, and community organizations. Annual milestones for progress that show incorporation of the community partners in this Core must be described.

Letters of Support: Letters of support should be obtained from institutions providing resources to this core, and to any ongoing faculty or external consultants for this core.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Capacity Building Core)

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 How to Apply- Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

For information on how applications will be automatically assembled for review and funding consideration after submission, refer 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 How to Apply - Application Guide. 

See more tips for avoiding common errors.

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

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to 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?

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?

Is the Center Director a nurse with a research doctorate, an appointment at the SON/CON, and appropriate experience and leadership abilities to manage and lead a complex center? What experience does the Center Director have in coordinating, integrating, and providing guidance in the establishment of new programs in nursing research? Is a community member listed as co-investigator and key personnel overall and included as part of the Internal Executive Committee? Is the effort of the Center Director appropriate to lead the Center activities? Does the Pilot Core Director have a research doctorate and appropriate experience in mentoring researchers? Has a community investigator been incorporated in the Pilot study as a co-investigator? Is the academic pilot PI a nurse with an appointment in the SON/CON?

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? 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?

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?

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, 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?

How well does the application describe:

• The process to name a qualified successor to the Center Director?
• The process to develop and execute a Center evaluation plan that includes record of pilot projects, grant submissions, and funding resulting from Center activities, along with peer-reviewed publications, presentations, and collaborations with other schools and institutions?
• Structure sufficient to manage the key activities of the Center?
• The plans for management of the pilot core, including selection of and oversight of pilot projects?
• Inclusion of community representation in the pilot projects?
• Annual milestones showing incorporation of community partners in each core?
• For the pilot project, in addition to the criteria above:
  • How well described is the role of the Community Advisory Board in the development, implementation, evaluation, and dissemination of findings?
  • Does the pilot describe gathering data from primary sources?
  • Does the theoretical or conceptual basis provide foundation for the study?

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, sex, 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 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?

Is there evidence of support from members of the Community Advisory Board and the Scientific and Operational Advisory Committee? 

In addition, for applications involving clinical trials

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

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

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

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

Additional Review Criteria - Overall

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 Human Subjects Policies

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. 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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medicine Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

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

Not Applicable

Additional Review Considerations - Overall

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.

Budget (Administrative Core)

Have appropriate funds been budgeted to support travel for annual NINR Center meetings?

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

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 the Center for Scientific Review in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for Nursing Research. 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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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 Delayed Onset Pilot Projects

Recipient-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient 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 NIH DSMP policies.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

Not Applicable

3. Data Management and Sharing

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

• 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 Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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

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

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

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

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

Joshua Wolff, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-793-5758
Email: [email protected]
 

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807
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 2 CFR Part 200.