Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title
NINDS Sustainable Transformation of Institutional Research Rigor (STIRR) Program (RC2 - Clinical Trial Not Allowed)
Activity Code

RC2 High Impact Research and Research Infrastructure Programs

Announcement Type
New
Related Notices
  • October 26, 2022 - Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available. See Notice NOT-OD-23-012.
  • August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 8, 2022 - New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023. See Notice NOT-OD-22-195.
  • August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
Notice of Funding Opportunity (NOFO) Number
RFA-NS-24-020
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.853
Funding Opportunity Purpose

This Notice of Funding Opportunity (NOFO) aims to support the establishment of programs to enhance research rigor and transparency practices within academic and research institutions to promote a culture of high-quality neuroscience research. Attention to principles of rigorous study design and transparent reporting are essential to enable the neuroscientific community, as well as the biomedical community at large, to design and perform valid experiments and to assess the value of scientific findings. Awards are intended to support the implementation of innovative programs, strategies, and approaches at the departmental, inter-departmental, or equivalent intra-institutional entity level. 

Key Dates

Posted Date
May 02, 2023
Open Date (Earliest Submission Date)
September 17, 2023
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
October 17, 2023 October 17, 2023 Not Applicable March 2024 May 2024 July 2024
October 17, 2024 October 17, 2024 Not Applicable March 2025 May 2025 July 2025
October 17, 2025 October 17, 2025 Not Applicable March 2026 May 2026 July 2026

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

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

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

Expiration Date
October 18, 2025
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ).

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

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

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

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

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


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Overview

This n otice of f unding o pportunity (NOFO) aims to support the establishment of programs to enhance research rigor and transparency practices within academic and research institutions to promote a culture of high-quality neuroscience research. Attention to principles of rigorous study design and transparent reporting are essential to enable the neuroscientific community, as well as the biomedical community at large, to design and perform valid experiments and to assess the value of scientific findings. Awards are intended to support the implementation of innovative programs, strategies, and approaches at the departmental, inter-departmental, or equivalent intra-institutional entity level. These organizational entities will provide clarity of vision, comprehensive assistance, effective evaluation, and sustainable commitment to transforming the local scientific culture. Such transformation should improve demonstrably the scientific rigor and transparent reporting of neuroscience research studies performed by investigators within the organizational entity and encourage the adoption of similar measures by the broader research community.  

Background

Current scientific career and research incentives often are not aligned with fostering the most rigorous and transparent research practices. Many biomedical publications do not transparently report complete methodologies, analyses, and measures taken at various stages of the research project to ensure rigor and minimize risks of bias (see NINDS guidelines for grant applications for examples of such measures), and recent surveys of researchers suggest this often is due to a lack of practice. This apparent insufficiency of rigor in experimental execution and transparency in reporting may contribute to difficulties in building upon research findings and subsequently may hinder scientific progress. The NINDS Office of Research Quality has implemented prior initiatives and programs to facilitate improved scientific approaches, including the development of educational materials on the principles of rigorous research and support for a community of scientists who champion better research practices. For any such individual efforts to be successful and sustainable, institutions must support and incentivize best practices in performing rigorous research, education in these practices, and community reinforcement.

Scope

The objective of this NOFO is to provide resources to create model programs for the broader neuroscience community to evaluate, modify, and emulate. Successful programs from this NOFO that are then adopted by multiple institutions have the potential to transform the scientific enterprise and promote a culture that more highly values rigor and transparency. Promising practices and principles derived from the literature or from existing programs at other institutions may be leveraged to inform applicants’ approaches and/or expansion of past efforts in novel ways. This initiative is intended to allow institutional entities to develop and pilot innovative approaches to improving research rigor and transparency through changes in community resources, policies, and/or practices. It is envisaged that sharing impactful initiatives and lessons learned broadly will encourage other institutional entities to adopt similar measures.

Applicant entities must support or perform neuroscience research that is relevant to the NINDS mission, although the research does not need to be exclusive to these fields [e.g., a Cell Biology Department containing a critical mass (i.e., at least 25%) of faculty members working on neuroscience projects relevant to the NINDS mission would be eligible to apply]. Applicant entities may include departments, offices, libraries, inter-departmental collaborations, or equivalent intra-institutional organizational structures, but the program’s goals must include increasing rigor and transparency of neuroscience research performed by investigators within the institution or organization. Support from this NOFO should catalyze sustainable culture change at the level of the intra-institutional entity applying for the award and the cohort of researchers in the local scientific community targeted by the program. The proposed activities, therefore, must be implemented by and/or applicable to more than one laboratory or scientific group. 

Scientific rigor and transparency, for the purpose of this NOFO, refer to improving the design, execution, analysis, and reporting of experiments to minimize the risk of bias and/or chance observations, especially for confirmatory or hypothesis-testing experiments (see NINDS applicant guidelines for specific example practices). Program activities should be generally applicable to a wide variety of scientists and projects and should aim to change scientists' knowledge, behavior, and culture around scientific rigor and transparency. Examples of activities responsive to this NOFO include, but are not limited to:

  • Implementing recognition or awards to promote awareness of best practices in rigor and transparency (e.g., prizes for publication of null results, special opportunities for researchers who champion better research practice)
  • Hiring or appointing dedicated personnel to integrate new rigor and transparency practices into research workflows (e.g., statisticians, data managers, research methodologists, quality control specialists)
  • Restructuring trainee program requirements to incentivize high-quality research over novelty and quantity of research outputs
  • Modifying hiring, promotion, and tenure criteria to emphasize research rigor, transparency, and quality and to deemphasize bibliometrics and journal impact factor
  • Developing standard operating procedures (SOPs) and incorporating new infrastructure to support good research practice (e.g., error reporting software, electronic lab notebooks, quality management systems)
  • Updating policies to better enforce rigor and transparency (e.g., minimal reporting standards for publication submissions, required dissemination of null results to reduce publication bias, course releases for time spent on championing rigor or replicating important experiments)
  • Creating comprehensive educational and/or professional development programs on the principles of rigorous research for trainees, faculty, and other scientific staff
  • Partnering with external organizations to provide transformative rigor and transparency-focused services to research personnel within the institution and improve how the applicant entity operates

This NOFO is not meant to support:

  • Replication or simple expansion of existing programs at applicant institutions (e.g., increasing the number of participants in current training programs) 
  • Specific research projects within laboratories (e.g., reagents, animal housing costs, specialized scientific equipment) 
  • Research integrity activities focused on ethics related to animal use, human subjects, or research misconduct [e.g., training and activities already required under NIH Responsible Conduct of Research (RCR) policies]
  • Large multi-institutional or field-wide initiatives to develop best practices that are implemented during the award period beyond the applicant institution (e.g., new common data elements, recommendations for publishers or funders, national or international networks)
  • Programs focused on activities that could be supported through other NIH funding mechanisms 

Programs of variable size, focus, or scope are encouraged: from highly focused, smaller programs to broader, more comprehensive activities, based on the demonstrated needs of the institutional entity applying and the ability to commit resources to the program. Smaller, more focused programs, which will have commensurately smaller budgets, will likely implement less resource-intensive activities (e.g., simple policy changes, small prizes, part-time personnel commitments) and/or involve a smaller scientific community in the program. Broader, more comprehensive programs, which will have commensurately larger budgets, are expected to pursue more resource-intensive activities (e.g., new infrastructure, large personnel investments, multiple simultaneous activities of the scope listed in the examples above) and/or involve a much larger scientific community. Programs of differing sizes or scopes are expected, in aggregate, to provide proofs-of-concept for balancing scalability (i.e., easier implementation) with greater impact (i.e., more extensive or effective behavior change), thereby providing valuable information to other entities looking to adopt successful programs. Therefore, projects with smaller scope and higher scalability potential are considered valuable to the overall program. Lessons learned from both more and less effective programs will also likely be publicized through NINDS-specific communication channels throughout program progress to maximize transparency. 

Successful applicants to this NOFO will demonstrate effective project coordination and modeling of behaviors, high likelihood to change research practice, strong feasibility, and clear and quantitative benchmarks to evaluate the effectiveness of the proposed activities to ensure that improvements in research rigor and transparency are achieved. This includes ensuring equitable distribution of resources and incentives to eligible recipients in the local scientific community and inclusion of diverse perspectives in leading and guiding the program. A successful applicant will also demonstrate clear commitment to the overall goals of the NOFO, including plans for sustaining successful activities beyond the period of the award and for identifying barriers and/or enablers to scaling beyond the applicant entity. This includes disseminating data on the effectiveness and longevity of the intervention(s) and sharing lessons learned and best practices with the wider scientific community (both during and beyond the funding period) to ensure that successful programs can be replicated or modified by other institutions or organizations. 

Effective programs, regardless of size or scope, will be characterized by measurable culture change that lasts far beyond the period of financial support, whereby the scientific community associated with the applicant entity successfully obtains the necessary resources (e.g., education, infrastructure, financial support, policy change) for implementing the desired behavior change(s), improves in awareness and execution of research rigor and transparency, receives positive reinforcement for these behaviors, and displays enthusiasm to champion and sustain continual improvement in this area. 

Due to the unique requirements of this project, applicants are strongly encouraged to consult with NINDS program staff early during the planning process for an application.

Applications Not Responsive to this NOFO

Non-responsive applications will not be reviewed for this NOFO.

The following are considered nonresponsive for this NOFO:

  • Applications outside the scope of the RC2 program
  • Applications proposing multi-institutional, national, or international programs 
  • Applicant entities without a demonstrated relationship with multiple laboratories performing research in the NINDS mission space 
  • Proposals to support or expand currently available programs without substantial modification or innovation to those programs
  • Applications without explicit plans for program evaluation, dissemination, and sustainability

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

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

Funds Available and Anticipated Number of Awards

NINDS intends to commit an estimated $3.5 million in direct costs annually for at least 5 awards. The number of awards is contingent upon the submission of a sufficient number of meritorious applications, the size and scope of the most meritorious applications, and NIH appropriations.

Award Budget

Application budgets need to reflect the actual needs of the proposed project; however, it is anticipated that most awards will be between $150,000-$800,000 direct costs per year, commensurate with the scope of the proposed program.

Award Project Period

The maximum project period is 3 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Government

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

Other

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

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

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

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

Required Registrations

Applicant Organizations

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

  • 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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Devon Crawford
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-827-7758
Email: devon.crawford@nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

The following modifications also apply:

  • Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
  • Participant support costs, consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.
  • Budget categories should not include inflationary escalation for recurring costs in out years.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims:

Briefly describe the overall rationale, goals, and plans for implementing, evaluating, optimizing, and sustaining the proposed program, focusing on how the applicant entity plans to transform the culture of the target scientific cohort to create a demonstrably more rigorous and transparent research community. Explain why the proposed program is uniquely suited to the objectives of this funding opportunity.

Research Strategy:

This section should state the main challenge(s) the applicant entity is working to address, the proposed approach(es) for addressing the challenge(s), any expected outcomes to be realized by the end of the project, and the intended commitment to sustainability beyond the period of the award. The Research Strategy should be organized into sections that address Significance, Innovation, and Approach.

Significance:

Describe the main challenge(s) the program plans to address related to rigor and transparency within the applicant entity and/or target scientific cohort and the rationale for why the challenge(s) is important and/or relevant to address. Provide evidence for identified critical gaps or areas of need, and justify the intervention and program scope, including plans to tailor the program to the needs of the target cohort. Describe the rationale, significance, expected outcomes, and potential impacts of the proposed activities and how these activities meet the goals of this NOFO. This includes how the program is expected to transform rigor and transparency practices within the target scientific cohort and how this transformation is expected to improve research quality in a sustainable way within the applicant entity. Be clear about which outcomes are expected to be achieved within the funding period and which are long-term goals that will continue to be pursued beyond the period of funding. Describe how evaluation will support program optimization, how scalable the program is anticipated to be, and how lessons learned could impact the broader scientific community. Explain how the program, if successful, could reasonably affect broader culture change beyond the applicant entity inside and outside the applicant institution.

Innovation:

Describe the technical and/or conceptual innovation(s) that will be brought to this project through aspects such as novel approaches and/or technologies, unique or novel collaborations, or innovative approaches to engaging the scientific community in culture change. Describe how these innovative aspects will advance the goals of the program and improve culture within the applicant entity and/or target scientific cohort to enhance rigor and transparency of scientific research.

Approach:

Provide an overview of the proposed program goals, structure, plans, and expected deliverables. Provide evidence that supports the feasibility of successful implementation, evaluation, dissemination, and sustainability, and describe the expected program expertise, technologies, approaches, and optimization. Address each of the following key areas:

Implementation:

Define and justify the intra-institutional entity implementing the program (i.e., the level at which the program is being led) and the scientific community being engaged and/or targeted by the program (i.e., the level at which the program is being implemented), and include a detailed and quantitative description of how the applicant entity supports or performs neuroscience research relevant to the NINDS mission. Describe the composition of the program leadership team and expected implementation team, including relevant expertise and evidence of commitment to diverse perspectives and the overall goals of the NOFO. Briefly summarize how the institution beyond the applicant entity will provide resources and support for implementing the proposed program, if applicable. 

Describe proposed activities, intervention(s), and other approaches planned under this program. Emphasize how the applicant intends to change the local culture of laboratories to achieve community buy-in and enhancement of research rigor and transparency, including how program activities will be tailored to the applicant entity and/or target scientific cohort. Explain how the scope of activities corresponds to the scale of expected outcomes from the program, and describe how the proposed program will fit within the mission and goals of the applicant entity and everyday workflows of the local scientific community. If building upon previously implemented activities, provide clear justification for how the proposed program offers a novel, innovative, and/or substantially modified approach to solving the identified gap or area of need within the local scientific community. 

Provide evidence of feasibility for the proposed program, including descriptions of potential barriers to success and how they will be addressed. Include detailed descriptions of the resources, support, and/or infrastructure that will be provided by the applicant entity and how these will be equitably distributed, provided, or applied to the targeted scientific community. Describe plans for ensuring community buy-in for the proposed program, how an inclusive environment will be fostered, and how the applicant entity plans to engage the community in short- and long-term program efforts.

Programs are expected to demonstrate the following:

  • The work cannot reasonably be expected to be carried out successfully without support provided by this NOFO.
  • Specific outcomes of the proposed program promote and advance rigor and transparency in NINDS-relevant neuroscience research.
  • Funding will accelerate culture change and improvements in research practice to focus better on research quality across laboratories affiliated with the applicant entity.
  • The proposed program will help catalyze local research quality improvement.
  • The program or generated results and resources can be expected to become integrated into the local scientific community and potentially more broadly beyond the applicant entity.
  • There is a plan for evaluation, dissemination, and sustainability of applicable efforts and resources beyond the RC2 funding.

Evaluation:

Describe a clear plan to evaluate the program throughout and beyond the funding period. List key metrics and measures of success to be utilized to evaluate the overall impact of the program, including how implementation effectiveness and changes in research practice will be measured in an objective and tangible manner and how likely contributors to success or failure will be identified. Specify baseline metrics as well as measures to gauge the short- and long-term effectiveness of the program in achieving its objectives. If possible, evaluation plans should include a comparator group (e.g., a scientific community with similar structure and resources that did not participate in program activities). If a comparator group is not possible, then plans must provide a framework for determining whether the program activities were effective and did not simply include a cohort already on a successful trajectory. Metrics must go beyond self-reported gains and include independently verified outcomes. Collaboration with experts in relevant evaluation approaches is strongly encouraged. Provide a timeline for evaluation that includes continuous, ongoing activities as well as discreet, time-limited activities, and describe how the results of evaluation will be used to improve and optimize the program iteratively during and after the period of the award. Be clear about which evaluation and optimization activities will occur during the project period and which are expected to continue beyond the period of funding.

Dissemination:

Describe plans to disseminate lessons learned from the proposed program, including the results of evaluation efforts. Plans must include how information about implementation, evaluation, scalability, and sustainability will be publicized and made freely available to the scientific community, even in cases where the program does not achieve its goals. Such information should be available on an ongoing basis throughout the program duration, including after funding has ended (i.e., program plans are publicized at the beginning of the project, program implementation and short-term outcomes are publicized throughout the project, and long-term outcomes and sustainability are publicized after the period of funding has ended). Include how barriers to or enablers of success identified during program implementation will be clearly communicated to facilitate modification, scaling, or adoption of the program by other entities inside or outside the applicant institution. Dissemination efforts must go beyond simple posting of information in a public location and should include proactive efforts to educate the scientific and research administration communities external to the applicant entity.

Scalability and Sustainability:

Describe how the applicant entity intends to ensure continuation of successful program activities to solidify culture change, including long-term support of evaluation and dissemination activities beyond the period of the award (i.e., after grant funding ends). Include plans for sustained assistance, continual process improvement, and maintenance of buy-in from the local scientific community. Describe the feasibility of implementing or expanding the proposed program beyond the applicant entity, within or outside the applicant institution, even if there are no plans by the applicant entity for scaling up the program themselves. Outline the anticipated expertise, resources, and additional financial and non-financial support necessary for such expansion. 

Milestones:

Provide a table or chart with key milestones to be achieved throughout the RC2 program period. Include a timeline and metrics to document progress toward achievement of the ultimate goals, including clear benchmarks and quantitative criteria for success. Milestones must include major implementation, evaluation, dissemination, and sustainability goals, including those that extend beyond the period of funding. Applications lacking this information will be considered incomplete and will not be reviewed.

Additional Application Elements:

Letters of Support:

A letter of institutional commitment must be attached as part of the Letters of Support. Appropriate institutional commitment should include the provision of adequate staff, facilities, and other tangible resources to support the proposed program during and beyond the period of the award. Such letters should be provided by institutional representatives committed to the long-term success of the program in a manner commensurate with the scope of the program, such as department chairs, deans, or provosts. Applications lacking a letter of institutional commitment will not be reviewed. If appropriate, include letters describing planned contributions from or collaborations with additional entities or individuals outside of the applicant entity for the proposed program.

Resource Sharing Plan:

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

The following modifications also apply:

All applications, regardless of the amount of direct costs requested for any one year, must address a plan for freely sharing the lessons learned, evaluation outcomes, and other associated results and/or toolkits produced from the proposed project. The resource sharing plan, without duplicating information in the Research Strategy dissemination plan, must minimally include the following elements:

  • Plans for monitoring the timely accomplishment of the activities described in the sharing plan.
  • An overall description of the anticipated deliverables and how they will be publicized and made available to a broad, diverse community.
  • When relevant, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced through grants responding to this NOFO, but a plan for dissemination of software produced through this award should address, as appropriate, the following goals:
    • Software source code should be well-annotated and freely available to biomedical researchers, administrators, and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.
    • The terms of software availability should permit enhanced or customized versions of the software or incorporation of the software or pieces of it into other software packages.
    • To preserve the utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original developers are unwilling or unable to do so.
    • If any proprietary software is developed, it will be reportable as a research tool, and the Research Tools Guidelines outlined in the NIH GPS 8.2.3 will apply.
  • Applications which do not describe resource sharing plans with all the required elements will be considered incomplete to this NOFO.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

  • A Data Management and Sharing Plan is not applicable for this NOFO.
Appendix:

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

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.
PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

For this particular funding opportunity, note the following:

Applications responsive to this NOFO support intra-institutional entities to implement, evaluate, and disseminate innovative programs to change the local scientific culture within academic and research institutions to better incentivize and reinforce rigorous and transparent research practices. Accordingly, since effective programs may be emulated by other institutions in the future, reviewers should emphasize the feasibility, potential impact, expected outcomes, likelihood of community buy-in, scalability, and sustainability of the program. Because programs of multiple sizes, focuses, and/or scopes are expected to apply, reviewers should calibrate critiques of impact to the proposed resources, goals, and potential scalability of each program. 

Overall Impact

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

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is 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?

Specific to this NOFO:

How likely is the proposed program to achieve community buy-in and measurably stimulate new and/or enhanced rigor and transparency practices in the target scientific cohort? How justified is the proposed intervention(s), and how well does the intervention(s) address the identified critical gaps or areas of need identified by the applicant entity? How well are the program activities tailored to the needs of the target scientific cohort? Is the scope of expected outcomes appropriate given the goals, resources, and activities proposed? How transformative will the program be for changing local research practice, the local research culture, and/or the broader scientific culture if successful, both during and after the period of funding?  

How likely are successful program activities to be sustained and continually improved beyond the period of funding? How likely are the proposed evaluation and dissemination plans to measure and communicate program success effectively and facilitate behavior and culture change within and outside the applicant entity? Does the dissemination plan provide adequate information about implementation, evaluation, and sustainability so that the program could scale to and/or be adopted by other entities and institutions if successful? If adequate information is provided, how feasible would it be to scale the program to other entities? 

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?

Specific to this NOFO:

How appropriate is the institutional entity for coordinating the project and carrying out the activities in the proposal? How appropriate is the expertise available for implementing, evaluating, disseminating, and sustaining the program? How well are a diversity of perspectives represented in the leadership and implementation teams? Are there unique or novel collaborations that will benefit the program? To what extent are the leadership team members committed to the proposed activities and the NOFO goal of improving local research culture to better value and incentivize rigor and transparency?

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?

Specific to this NOFO:

How well will technical and/or conceptual innovation(s) be brought to this project, for example through novel approaches and/or technologies, unique or novel collaborations, or innovative approaches to engaging the scientific community in culture change? How well will these innovative aspects advance the goals of the program and improve culture within the applicant entity and/or scientific cohort to enhance rigor and transparency in scientific research? If building upon previously implemented activities, how well does the applicant provide a novel, innovative, and/or substantially modified approach to solving the identified critical gaps or areas of need within the local scientific community?

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/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO:

How justified and appropriate are proposed program activities for changing local laboratory culture and achieving enhancement of research rigor and transparency? To what extent does the implementation plan describe appropriate activities for addressing the goals, scope, and projected outcomes of the program, taking into account that more focused programs may have more focused expected outcomes while broader programs should have broader expected outcomes? How well has the applicant demonstrated feasibility for implementing the program activities, including plans for overcoming potential barriers to success? Are the resources, support, and/or infrastructure provided by the applicant entity sufficient and appropriate for carrying out the program, and will resources be equitably accessible by the local scientific community?  

How appropriately are program activities tailored to the applicant entity and/or scientific cohort targeted by the program, and how well does the proposed program fit within the mission and goals of the applicant entity and everyday workflows of the scientific community? How well will the program activities create community buy-in, an inclusive environment, and community engagement in short- and long-term program efforts? How appropriately does the program target a scientific cohort performing research relevant to the NINDS mission?  

How effective is the applicant's plan to evaluate the program throughout and beyond the funding period? How clear, objective, tangible, and appropriate are the selected evaluation metrics for measuring short- and long-term program impact and effectiveness, including relevant changes in rigor and transparency research practices by the local scientific community? Do the metrics include independently verified outcomes and not just self-reported gains as well as distinguish between program effectiveness and a cohort on an already successful trajectory? How well will the program be optimized iteratively both throughout the funding period and beyond in response to evaluation results?

How likely are the activities described in the dissemination plan to adequately educate the scientific and research administration communities beyond the applicant entity about lessons learned from the proposed program? How well will information about implementation, evaluation, scalability, and sustainability be made freely available and proactively publicized throughout and beyond the funding period, even in cases where the program does not meet its goals? How well will external entities be able to modify, scale, or adopt the same or similar programs based on the disseminated information provided by the applicant?

How likely is the applicant entity to ensure sustainability of the program beyond the period of funding, including long-term support of evaluation and dissemination activities? How likely to persist are gains in research rigor and transparency practices, culture change, and institutional assistance to support these behaviors? How well will the applicant entity be able to maintain community buy-in and continual process improvement? How scalable is the program likely to be beyond the applicant entity, and how feasible will it be for other entities to implement a similar program? 

How reasonable is the timeline for implementation, evaluation, dissemination, and sustainability, including activities that extend beyond the period of funding? How clear, quantitative, and appropriate are the milestones for the proposed program?

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?

Specific to this NOFO:

To what extent does the applicant entity support or perform neuroscience research relevant to the NINDS mission? How well has the institution within and beyond the applicant entity demonstrated tangible commitment to the goals and activities of the proposed program, including beyond the period of the award, if applicable? 

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

For 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 National Institute of Neurological Disorders and Stroke (NINDS), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

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

Applications will be assigned to the National Institute of Neurological Disorders and Stroke (NINDS). 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 Neurological Disorders and Stroke (NANDS) Council. The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that 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.

2. Administrative and National Policy Requirements

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

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html .

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

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

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Data Management and Sharing

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

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

4. Reporting

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

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

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

Scientific/Research Contact(s)

Devon Crawford
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-827-7758
Email: devon.crawford@nih.gov

Peer Review Contact(s)

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: nindsreview.nih.gov@mail.nih.gov

Financial/Grants Management Contact(s)

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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

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