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.

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

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

Conformance to all requirements (both in the 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.

IMPORTANT: Per NOT-OD-24-086 updated application forms (FORMS-I) will be used for this opportunity. The updated forms are not yet available and will be posted 30 calendar days or more prior to the first application due date. Once posted, you will be able to access the forms using one of the following submission options:

1. NIH ASSIST
2. An institutional system-to-system (S2S) solution
3. Grants.gov Workspace

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Overview

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. 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., recognition 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, public recognition for desirable practices, 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

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

• 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

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are 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 the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

• 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 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 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the 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 How to Apply- Application Guide and the Table of Page Limits must be followed.

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Other Attachments:

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

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 How to Apply- 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): 

All instructions in the How to Apply-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 How to Apply- Application Guide.

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

Part I. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

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

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

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

Important reminders:

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

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply-Application Guide.

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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.

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 grantdisclosures@oig.hhs.gov.

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 applicant entities are expected to propose programs of multiple sizes, focuses, and/or scopes, reviewers should calibrate evaluations of impact to the proposed resources, goals, and potential scalability of each program. 

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). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Review Criteria

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. 

Factor 1: Importance of the Research

Significance

• Evaluate the importance of the proposed research in the context of current scientific challenges and opportunities, either for advancing knowledge within the field, or more broadly. Assess whether the application addresses an important gap in knowledge in the field, would solve a critical problem, or create a valuable conceptual or technical advance.
• Evaluate the rationale for undertaking the study, the rigor of the scientific background for the work (e.g. prior literature and/or preliminary data) and whether the scientific background justifies the proposed study.

Innovation

• Evaluate the extent to which innovation influences the importance of undertaking the proposed research. Note that while technical or conceptual innovation can influence the importance of the proposed research, a project that is not applying novel concepts or approaches may be of critical importance for the field.
• Evaluate whether the proposed work applies novel concepts, methods or technologies, or uses existing concepts, methods, technologies in novel ways, to enhance the overall impact of the project.

Specific to this NOFO:

• Assess the likelihood that the proposed program will achieve community buy-in and measurably stimulate new and/or enhanced rigor and transparency practices in the target scientific cohort. 
• Assess how well the proposed intervention(s) address(es) the application's identified areas of need related to scientific rigor and transparency practice and how tailored the described program activities are to the needs of the target scientific cohort. 
• Assess whether the scope of expected outcomes is appropriate given the goals, resources, and activities proposed. Evaluate how likely it is that the program will change local research practice, the local research culture, and/or the broader scientific culture, both during and after the period of funding.
• Evaluate how likely it is that any successful program activities to enhance scientific rigor and transparency practices will be sustained and continually improved beyond the period of funding. 
• Assess whether the proposed evaluation and dissemination plans, respectively, will measure and communicate program outcomes effectively and, together, facilitate behavior and culture change around rigor and transparency practices within and outside the applicant entity. Evaluate whether the dissemination plan will provide the broader scientific community with adequate information so that other entities could scale and/or adopt the program. 

Factor 2. Rigor and Feasibility

Approach

• Evaluate the scientific quality of the proposed work. Evaluate the likelihood that compelling, reproducible findings will result (rigor) and assess whether the proposed studies can be done well and within the timeframes proposed (feasibility).

Rigor:

• Evaluate the potential to produce unbiased, reproducible, robust data.
• Evaluate the rigor of experimental design and whether appropriate controls are in place.
• Evaluate whether the sample size is sufficient and well-justified.
• Assess the quality of the plans for analysis, interpretation, and reporting of results.
• Evaluate whether the investigators presented adequate plans to address relevant biological variables, such as sex or age, in the design, analysis, and reporting.
• For applications involving human subjects or vertebrate animals, also evaluate:
  • the rigor of the intervention or study manipulation (if applicable to the study design).
  • whether outcome variables are justified.
  • whether the results will be generalizable or, in the case of a rare disease/special group, relevant to the particular subgroup.
  • whether the sample is appropriate and sufficiently diverse to address the proposed question(s).
• For applications involving human subjects, including clinical trials, assess the adequacy of inclusion plans as appropriate for the scientific goals of the research. Considerations of appropriateness may include disease/condition/behavior incidence, prevalence, or population burden, population representation, and/or current state of the science.

Feasibility:

• Evaluate whether the proposed approach is sound and achievable, including plans to address problems or new challenges that emerge in the work. For proposed studies in which feasibility may be less certain, evaluate whether the uncertainty is balanced by the potential for major advances.
• For applications involving human subjects, including clinical trials, evaluate the adequacy and feasibility of the plan to recruit and retain an appropriately diverse population of participants. Additionally, evaluate the likelihood of successfully achieving the proposed enrollment based on age, racial, ethnic, and sex/gender categories.
• For clinical trial applications, evaluate whether the study timeline and milestones are feasible.

Specific to this NOFO:

• Evaluate the proposed program’s plans to implement, evaluate, optimize, and sustain a demonstrably more rigorous and transparent research community by measurably changing local laboratory culture.  
• Evaluate whether the applicant entity has shown sufficient long-term commitment to the program and whether resources will be equitably accessible by the local scientific community.
• Assess how well the proposed program fits within the mission and goals of the applicant entity and everyday workflows of the scientific community.  
• Assess whether the program targets a scientific cohort performing research relevant to the NINDS mission.  
• Assess the effectiveness of the applicant's plan to evaluate the program throughout and beyond the funding period, including how clear, objective, tangible, and appropriate the selected evaluation metrics are for measuring short- and long-term program impact and success. Assess whether the metrics include independently verified outcomes and not just self-reported gains as well as whether these metrics distinguish between program effectiveness and a cohort on an already successful trajectory. 
• Evaluate how well the applicant will optimize the program iteratively both throughout and beyond the funding period in response to evaluation results.
• Assess whether the activities described in the dissemination plan are adequate to educate the scientific and research administration communities beyond the applicant entity about lessons learned from the proposed program, including by making freely available and publicizing information about implementation, evaluation, scalability, and sustainability throughout and beyond the funding period. Assess how easily external entities will be able to design similar programs based on the disseminated information provided by the applicant.
• Evaluate how well the applicant entity and/or institution will sustain the program and any gains in research rigor and transparency practices, culture change, and institutional assistance to support these behaviors beyond the period of funding, including by providing long-term support for evaluation and dissemination activities. 
• Evaluate how clear, quantitative, and appropriate the milestones are for implementation, evaluation, dissemination, and sustainability, including activities that extend beyond the period of funding. 

Factor 3. Expertise and Resources

Investigator(s)

• Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.

Environment

• Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.

Specific to this NOFO:

• Evaluate whether the proposed institutional entity will effectively target the proposed scientific cohort, coordinate the project, and carry out the activities in the proposal, including by possessing the authority to implement such changes. 
• Evaluate the extent to which the leadership team members are committed to the proposed activities and the NOFO goal of improving local research culture to better value and incentivize rigor and transparency practices.
• Assess whether the applicant entity or target scientific cohort supports or performs neuroscience research relevant to the NINDS mission. 
• Evaluate how well the institution beyond the applicant entity has demonstrated tangible commitment to the goals and activities of the proposed program to improve research rigor and transparency practices, including beyond the period of the award.

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, 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, 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.

Vertebrate Animals

When the proposed research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals 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. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and 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

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.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

Evaluate 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.

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 his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

Section VI. Award Administration Information

1. Award Notices

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.

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

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.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

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. 

Not Applicable

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

4. Reporting

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

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: GrantsInfo@nih.gov (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: support@grants.gov

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

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

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.

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.