Part 1. Overview Information

Key Dates

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

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overarching goal of this UE5 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs.

To accomplish the stated over-arching goal, this Notice of Funding Opportunity (NOFO) will support creative educational activities with a primary focus on:

• Curriculum or Methods Development: The NINDS Materials to Enhance Training in Experimental Rigor (METER) UE5 will support curriculum development in the form of innovative educational materials that will be incorporated into a new cutting-edge online resource that aims to promote awareness, understanding, and practice of fundamental principles of rigorous biomedical research for researchers and other scientists in various career stages and learning environments. 

Educational materials from METER recipients will be incorporated into the educational resource in collaboration with NINDS and the center for Creating an Educational Nexus for Training in Experimental Rigor (CENTER). CENTER was established through a related UC2 NOFO (RFA-NS-21-009) and is currently working to coordinate logistics and other aspects of the entire initiative, build the online educational resource to host educational units based on scholarly materials provided by METER recipients, produce digital content for the units (e.g., animations, graphics, interactive activities), evaluate the effectiveness of the resource’s educational components, and disseminate the resource to the scientific community.

Overview:

This is one of two NOFOs that together aim to facilitate teaching of fundamental principles of rigorous biomedical research by developing an innovative online educational resource for a broad range of scientists across multiple career stages and an array of learning environments. This resource is meant to be user-friendly, freely available, comprehensive, modular, adaptable, and upgradeable, with individual components ready to be used flexibly by individuals asynchronously online, in laboratory meeting presentations, or by classroom educators. The purpose of this NOFO is to support the compilation and refinement of Materials to Enhance Training in Experimental Rigor (METER), which comprise the core scholarly content of educational units within this online resource. These materials will enable the acquisition of knowledge and skills to recognize and conduct rigorous experimental research by focusing on core practices that promote scientific rigor and transparency. NINDS METER UE5 recipients serve as the primary subject matter experts for one or more educational unit(s) focused on individual principles of rigorous research and provide scholarly material to CENTER, which is already supported by a separate NOFO to build the final web-based platform, produce the digital elements (e.g., animations, graphics, interactive components) of the online resource, and ensure optimal educational effectiveness and harmonization across units. Multiple cohorts of three-year METER awards have already been selected to produce materials in a staggered timeline encompassed by the longer funding period of CENTER. More information about the ongoing initiative, including current CENTER and METER recipients, can be found at https://www.ninds.nih.gov/current-research/trans-agency-activities/rigor-transparency/initiative-improve-education-principles-rigorous-research. 

Background:

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). This lack of transparency in reporting, and potential lack of practice, may contribute to difficulties in building upon research findings and has been partially attributed to incomplete training in the principles of rigorous research. For example, a survey of institutions holding training grants funded by NINDS found that formal training in the principles of rigorous research was scarce (https://elifesciences.org/articles/55915). A lack of comprehensive educational tools to impart the principles of rigorous research likely arises, at least to some extent, from the difficulty for individual investigators and educators to construct a training program or curriculum de novo. Numerous training materials are available online, but identifying suitable materials for integration into a unified set of courses and workshops requires expertise, motivation, funds, and time from course developers, commodities that are often in short supply. This NOFO aims to provide the scientific and informational content for an innovative and comprehensive online educational resource that will provide real-world, relevant information and skills to help biomedical researchers enhance the rigor and transparency of their research.

Objectives and Main Requirements:

The objective of METER is to support subject-matter experts who compile and refine scholarly material pertaining to one or more practice(s) or principle(s) of rigorous experimental research and provide these materials to CENTER for incorporation into educational units as part of a cutting-edge online educational resource that aims to transform training and education in the practice of biomedical research. Principles of rigorous biomedical research are cross-cutting concepts, processes, and practices that promote rigorous, transparent, and robust scientific experiments. These principles (e.g., randomizing subjects or samples to treatment groups, properly handling outliers, creating standard operating procedures for laboratory workflows) apply across a wide variety of scientific disciplines, techniques, and approaches and tend to fall within broad categories of research practice that include, but are not limited to, understanding the philosophical foundations of science, evaluating existing scientific evidence, designing rigorous experiments with validated methods and materials, reducing the effects of a broad range of cognitive biases, planning and executing appropriate analyses, conducting experiments and collecting data, understanding and measuring uncertainty, managing data and project workflows, and reporting methodology and results transparently.

Applicants will propose a set of deliverables that can be shared with CENTER within the first year of funding and iteratively improved over the course of the project period in collaboration with CENTER as described in Section IV.2 of this NOFO. These deliverables must include educational content for one or more educational unit(s), and a typical METER award is expected to propose content for 2-4 educational units to be developed over a 3-year award period. For the purpose of this NOFO, an educational unit is defined as an assortment of educational materials, lessons, and activities that collectively address a single practice or principle of rigorous research which is independently incorporated into the online resource by CENTER. It is estimated that one educational unit, at its maximal breadth and depth of material, will provide the equivalent of one week of instructional material if used as part of a traditional undergraduate or graduate course (typically about 8 subunits), although real-world users will also be able to select intermediate-length (e.g., 45-minute or 3-subunit versions for use in laboratory meetings) or short, individual components of the unit (e.g., 5-minute videos, sets of step-by-step instructions) with which to interact. Initial scientific examples within each educational unit (e.g., case studies) should be related to neuroscience to ensure relevance to the NINDS mission, but members of the scientific community will also be able to add examples from their own fields to the units after the units are publicly available.

If applicants propose creating materials for more than one educational unit/principle of rigorous research, each unit may be thematically distinct (i.e., they do not need to be encompassed by a single overarching theme, as each unit is meant to be an independent and modular contribution to the resource). CENTER is expected to incorporate 30-50 total educational units into the online resource, so a breadth of topics is expected to be covered by the total body of funded METER applications. High-priority rigor principles/practices that remain to be incorporated into the educational resource include, but are not limited to:  

• Creating testable scientific hypotheses (i.e., to ensure clear, feasible, interpretable experiments)
• Defining and assessing scientific models to make predictions
• Prospectively registering/Preregistering experimental design plans
• Validating research resources, tools, methods, and outcome measures
• Pursuing multiple lines of evidence to bolster inferences (i.e., experimental triangulation/robustness and sensitivity analyses/orthogonal experimental and analytical approaches)
• Considering the effects of biological and environmental variables (e.g., age, sex, weight, physiological state, diet) on experimental outcomes
• Blinding/Masking to reduce expectation bias
• Understanding the implications of biological vs. technical replicates (e.g., avoiding and/or accounting for pseudoreplication)
• Conceptualizing and quantifying uncertainty
• Accounting for missing data (i.e., identifying, reporting, and minimizing potential bias due to attrition)
• Preventing the selective reporting of experimental approaches and outcomes to maximize perceived statistical significance ("p-hacking")
• Emphasizing biological/clinical significance over statistical significance
• Reproducing, replicating, and generalizing results to strengthen inferences
• Overcoming the challenges of implementing and integrating new rigor practices in a laboratory (e.g., via quality management systems, standard operating procedures, infrastructure, mentorship)

The materials provided by METER recipients will be integrated into the online platform by education, technology, media, and evaluation experts coordinated by CENTER, and CENTER is responsible for building the digital interface, producing digital elements, and harmonizing the resource across educational units. You may follow CENTER's current progress at https://c4r.io/. As digital components of the educational units are developed, METER recipients will collaborate with CENTER to ensure accuracy and efficacy of the learning materials produced and recommend modifications as necessary. After the educational units are refined enough to begin formal evaluation, METER recipients will participate in evaluation and dissemination efforts organized by CENTER as agreed upon by the Steering Committee [see the related UC2 NOFO (RFA-NS-21-009) for more information about CENTER responsibilities and below for more information about the Steering Committee].

A successful METER application will have strengths in five major areas: (1) identification of important and widely applicable practices or principles that improve scientific rigor and transparency in biomedical research that can be addressed within individual educational units, (2) expertise in implementing or applying the proposed rigorous research practice(s) or principle(s), (3) evidence of effective communication with a variety of scientific audiences, (4) evidence of effective collaboration across a variety of stakeholders, and (5) balance between a strong vision for effective and engaging learning materials and the flexibility to adapt and reformat materials to meet the needs of the resource as directed by CENTER. Each METER application should include individuals with expertise in (1) the biomedical research environment (including neuroscience research relevant to educational unit examples), (2) one or more scientific rigor and transparency practice(s) or principle(s), (3) application of the identified practice(s) or principle(s), and (4) effective pedagogy relevant to the targeted learner population. 

Activities under this NOFO must include:

• Coordinating expertise related to the foundations and application of the practice(s) or principle(s) of rigorous biomedical research proposed to be addressed in each educational unit
• Generating, compiling, and communicating educational information about the relevant practice(s) or principle(s) of rigorous research which can be converted to a variety of formats (e.g., text, video, graphics, animations, interactive activities)
• Developing educational materials that incorporate the highest educational principles and serve a diverse audience, including those from underrepresented backgrounds
• Managing project timelines, including delivering enough scholarly content to CENTER within the first year of funding for CENTER to begin production of educational units and then assessing and modifying materials as necessary over the entire project period
• Collaborating effectively with technology, education, media, evaluation, and other relevant experts supported by CENTER to produce educational units that are interactive, engaging, and effective at conveying, demonstrating, and encouraging adoption of fundamental principles of rigorous research
• Communicating regularly with CENTER, NINDS staff, and the Steering Committee as appropriate to ensure effective collaboration and coordination
• Attending annual meetings organized by CENTER to enhance communication and collaboration between METER recipients, CENTER, and the scientific community (which includes active researchers, users and evaluators of the educational resource, champions of rigorous research, education professionals, and educational technology developers)
• Assisting CENTER in the evaluation, modification, and dissemination of the educational resource as determined by the initiative's Steering Committee

Because this is a cooperative agreement, extensive collaboration and management input from the NINDS will occur, and milestones will be used to assess progress. This overall structure is intended to ensure that stakeholders including academic and industry scientists, educational institutions, and non-profit organizations will be well-served by the educational units included in the online resource.

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 that do not propose educational materials that address one or more practice(s) or principle(s) of rigorous research
• Applications that propose materials that cannot be incorporated into the online educational resource produced by this initiative (e.g., requisite proprietary software, physical products) 

METER Governance

The initiative to develop an educational resource on the principles of rigorous research is governed by a Steering Committee organized by CENTER (see RFA-NS-21-009 and https://www.ninds.nih.gov/current-research/trans-agency-activities/rigor-transparency/initiative-improve-education-principles-rigorous-research for more information). The Steering Committee includes representatives from each METER award (funded through this NOFO) and CENTER as well as NINDS staff members. For details on the composition and responsibilities of the Steering Committee, see Section VI.2 under Cooperative Agreement Terms and Conditions of the Award.

An important aspect of METER is the cross-initiative activities, including regular teleconferences, working group meetings in areas of interest across the initiative, and the annual meeting organized by CENTER or NIH. METER recipients will be required to participate in this annual meeting.

Engagement in initiative activities as determined by the Terms and Conditions of the Award, Steering Committee guidance, and CENTER leadership will be critical for the proposed METER recipients so that they may better understand the scope of educational materials supported by this NINDS initiative, the requirements for the final product to be created, and the activities METER recipients engage in to further support and amplify the efforts of the CENTER evaluation and dissemination team(s).

Important Note: Because NINDS METER UE5 recipients will be required to interact closely with the NINDS CENTER, it is imperative that all applicants responding to this NOFO familiarize themselves with the related UC2 NOFO for CENTER (RFA-NS-21-009) and follow initiative updates at https://www.ninds.nih.gov/current-research/trans-agency-activities/rigor-transparency/initiative-improve-education-principles-rigorous-research.

Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. UE5 programs may augment institutional research training programs (e.g., T32, T90) but cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs,

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

Section II. Award Information

Other Award Budget 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 Governments

• 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 Institutions)

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving federal support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.

Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply

Non-domestic (non-U.S.) components of U.S. Organizations are 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 NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

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

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

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

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

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

An individual may be designated as a PD/PI (or one of multiple PDs/PIs), Co-Investigator, or other senior/key personnel on more than one UE5 application submitted in response to this NOFO. However, an individual designated as a PD/PI (or one of multiple PDs/PIs), Co-Investigator, or other senior/key personnel on a UE5 application submitted in response to this NOFO must not be also designated as a PD/PI (or one of multiple PDs/PIs), Co-Investigator, or other senior/key personnel on the funded application in response to the related UC2 NOFO, RFA-NS-21-009.

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.

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 How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions will not be reviewed.

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
• List of tentative rigor/transparency practice(s) or principle(s) to be proposed as educational units in the application

The letter of intent should be sent to:

Devon Crawford

National Institute of Neurological Disorders and Stroke (NINDS)

Email: [email protected]

All page limitations described in the How to Apply - Application Guide and the Table of Page Limits must be followed.

The following modification apply: for this specific NOFO, the Research Strategy Section is limited to 12 pages.

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.

Follow all instructions provided in the How to Apply - Application Guide.

Follow all instructions provided in the How to Apply - Application Guide.

Follow all instructions provided in the How to Apply - Application Guide with the following additional modifications:

Facilities & Other Resources. Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

Follow all instructions provided in the How to Apply - Application Guide.

The following additional instructions apply:

METER Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) or other senior/key personnel must describe their expertise in the foundations and application of one or more relevant practice(s) or principle(s) of rigorous biomedical research. Additionally, highlight how the PD(s)/PI(s) and other senior/key personnel have appropriate expertise in:

• Development, evaluation, and/or dissemination of educational materials
• Effective collaboration and communication with a variety of scientific stakeholders
• Teaching and mentoring related to the practice of biomedical research, preferably in a neuroscience-related field
• Theory behind the relevant practice(s) or principle(s) of rigorous biomedical research 
• Promotion of free and open sharing of research resources for training and education

Follow all instructions provided in the How to Apply - Application Guide with the following additional modifications:

• Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.

• Applicants must budget travel funds in each funding year for the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) (and Co-Investigators or senior/key personnel as appropriate) to attend annual multi-day meetings in the continental U.S. organized by CENTER or NINDS.
• Applicants should include an estimate of costs to develop educational materials that is commensurate with the number and complexity of educational units that are being proposed.
• Budget categories should not include inflationary escalation for recurring costs in out years.

Follow all instructions provided in the How to Apply - Application Guide.

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

Research Strategy

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

• Proposed Research Education Program
• Program Director/Principal Investigator
• Institutional Environment and Commitment
• Milestones

Research Education Program Plan

Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program.

Describe the goals, objectives, and activities proposed under this application, and explain how the proposed activities will achieve the goals and objectives of the research education program.

Describe how applicants will provide educational materials to CENTER for conversion and integration into innovative educational units for the online educational resource aimed at transforming training and education in the practices and principles of rigorous biomedical research. Describe how the educational materials will promote awareness, understanding, and utilization of one or more principle(s) of rigorous research and how the applicants will effectively collaborate with CENTER to provide feedback during development of the educational units and ensure that each unit remains scientifically accurate and represents scientific best practice.

Applicants must describe the scope of the educational materials they propose to develop, including the specific practice or principle of rigorous research being addressed in each educational unit, and justify the relevance and priority for inclusion of the proposed principle(s)/unit(s) in the online resource being compiled by CENTER. Specify the number of educational units the applicant is proposing to develop (i.e, the number of practices or principles being addressed). As described in Section I, typical METER applications are expected to propose 2-4 educational units, although no formal limit is imposed, and the educational units/principles of rigorous research within an application are not required to be focused collectively on a single category of research practice due to the expected modularity of the units. Applicants, however, must demonstrate expertise in each practice or principle proposed. High-priority practices or principles of rigorous research that have not yet been incorporated into the online resource include, but are not limited to:

• Creating testable scientific hypotheses (i.e., to ensure clear, feasible, interpretable experiments)
• Defining and assessing scientific models to make predictions
• Prospectively registering/Preregistering experimental design plans
• Validating research resources, tools, methods, and outcome measures
• Pursuing multiple lines of evidence to bolster inferences (i.e., experimental triangulation/robustness and sensitivity analyses/orthogonal experimental and analytical approaches)
• Considering the effects of biological and environmental variables (e.g., age, sex, weight, physiological state, diet) on experimental outcomes
• Blinding/Masking to reduce expectation bias
• Understanding the implications of biological vs. technical replicates (e.g., avoiding and/or accounting for pseudoreplication)
• Conceptualizing and quantifying uncertainty
• Accounting for missing data (i.e., identifying, reporting, and minimizing potential bias due to attrition)
• Preventing the selective reporting of experimental approaches and outcomes to maximize perceived statistical significance ("p-hacking")
• Emphasizing biological/clinical significance over statistical significance
• Reproducing, replicating, and generalizing results to strengthen inferences
• Overcoming the challenges of implementing and integrating new rigor practices in a laboratory (e.g., via quality management systems, standard operating procedures, infrastructure, mentorship)

It is strongly advised that applicants either choose educational unit topics from this list or discuss their desired topics in advance with NINDS program staff to determine programmatic fit with this initiative. Applicants may also find additional information about current initiative progress and recipients (e.g., to help prevent topic overlap with already funded awards) here: https://www.ninds.nih.gov/current-research/trans-agency-activities/rigor-transparency/initiative-improve-education-principles-rigorous-research.   

Although the final format of each educational unit will be directed by CENTER with input from METER recipients, each educational unit is expected to include:

• Measurable and attainable learning objectives that communicate what the user will learn and be able to do after interacting with the unit
• An overview that covers breadth and depth of the practice or principle of rigorous biomedical research suitable for audiences with prerequisite knowledge from basic to advanced levels
• Guidance on why the relevant practice or principle needs to be implemented or applied
• Guidance on how to implement or apply the relevant practice or principle
• Relevant and realistic examples of using the practice or principle in a neuroscience laboratory setting
• Interactive components to engage the user and assess learning
• Effective multi-modal media (e.g., text, graphics, animations, video, active learning exercises) that will be digitally produced by CENTER
• Instructional supports for learners with various educational needs and opportunities to relearn and master material
• Additional resources for added detail, advanced users, or specific disciplines

Applicants must describe how the scholarly content they create for each educational unit will incorporate and address the requirements and goals listed above. Applicants must describe how their educational content could be adapted into several brief, well-organized, and learner-centered instructional videos, active learning exercises, infographics, or other formats as required by CENTER. Applicants must include a proposed set of learning objectives for each educational unit; complex and realistic neuroscience-relevant scientific examples that demonstrate the importance of the practice or principle and how to implement or apply it; as well as creative, engaging, and effective educational and narrative ways to approach digital delivery of the content (e.g., text, videos, graphics, activities, resources, exercises, other interactive approaches) that could potentially be incorporated in collaboration with CENTER platform developers and education specialists. It is important to keep in mind that learning objectives are most effective when they are measurable, attainable, and active (i.e., describing what the learner should be able to do with what they have learned and not just what they should know). Also note that applicants do not need to specify specific software applications or digital tools (e.g., coding languages, statistical or graphing software, online platforms), as CENTER is responsible for the technical logistics of developing the digital components of the resource that applicants propose.

Applicants must describe how each educational unit will provide information differentiated by level of expertise (e.g., introductory overviews appropriate for novices, more detailed information available to those with a deeper baseline familiarity with the subject) and how each educational unit could adapt to serve as a quick reference or as a complete and thorough mini-course, depending on the user’s learning goals. Applicants must also describe how the materials could be adapted to various contexts, including learners from different career stages (e.g., undergraduate students, graduate students, senior researchers), learning environments (e.g. classroom, individual self-direction, laboratory meetings, synchronous or asynchronous use), research environments or experimental experience (e.g., in silico, in vitro, in vivo animal, translational, or clinical research), and diverse backgrounds, perspectives, and accessibility requirements. Materials must focus on online learning formats and employ evidence-based approaches to promote effective learning, such as:

• Outlining measurable and attainable learning objectives and evaluating achievement of those objectives
• Accommodating various backgrounds and perspectives, such as prior levels of knowledge and skills, preferences for learning modalities, and motivations to learn and implement the principles of rigorous research
• Emphasizing inquiry-based and active learning, where students engage in developing questions, identifying tools to answer those questions, collecting evidence, and interpreting and communicating results
• Ensuring relevance by using interactive, realistic, and nuanced scientific examples and, where possible, providing feedback to the user on their own experiments to encourage engagement and retention
• Providing a positive learning environment that challenges the learner to progress through confusing material and develop self-efficacy, emboldens the learner to acknowledge and learn from mistakes, and encourages collaborations and connections with the intellectual community
• Promoting inclusion and success of individuals with a wide variety of backgrounds and perspectives (e.g., all trainees feel integrated into and supported by the biomedical community)

Formal evaluation and dissemination plans are not required, as CENTER is responsible for providing leadership and coordination of these activities. However, applicants must describe plans to collaborate with CENTER in order to ensure adequate evaluation of the effectiveness of educational units developed under this award, to improve and update the content in each unit over time, and to help disseminate the finished online educational units at no cost to individuals. This includes ensuring that the educational units integrate various backgrounds and approaches and that the resource serves the scientific community in an equitable fashion. Applicants may, but are not required to, propose specific assessment, evaluation, and dissemination approaches relevant to the proposed educational units that could also be considered by CENTER for the wider initiative. Applicants must also describe plans to collaborate effectively with other participants in this initiative, including external stakeholders (e.g., educators) and other METER recipients, to create a cohesive and effective educational product.

Program Director/Principal Investigator. Describe arrangements for administration of the program.  Provide evidence that the Program Director/Principal Investigator is actively engaged in research and/or teaching in an area related to the mission of NIH, and can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple PDs/PIs, describe the complementary and integrated expertise of the PDs/PIs, their leadership approach, and governance appropriate for the planned project.

Describe how diversity across multiple dimensions will bring unique and varied perspectives to the team. Include a plan to forge successful collaborations with externally funded CENTER and METER recipients in order to produce effective educational units on practices or principles of rigorous research.

Institutional Environment and Commitment. Describe any additional aspects of the Institutional Environment and Commitment not addressed under “Facilities & Other Resources” or the required “Institutional Commitment Letter of Support,” described below. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. This section should not duplicate information provided elsewhere.

Where appropriate, describe any unique features of the scientific or educational environment or other collaborative arrangements that may be leveraged to the advantage of the proposed UE5. If multiple institutions are participating, describe how this will enhance the quality of the proposed UE5, as well as how activities will be coordinated, including the approach to effective communication among the sites.

Milestones

Specific milestones must be proposed as part of the Research Education Program Plan/Research Strategy section that will need to be met to accomplish the aims. These milestones will provide clear and quantitative indicators of a project's continued success or emergent difficulties. Milestones must include timely development and iterative improvement of the educational materials and clear communication timelines with NINDS, CENTER recipients, and other stakeholders. Applicants should propose a set of deliverables that can be shared with CENTER within the first year of funding and iteratively improved over the course of the project period in collaboration with CENTER. Applications should include plans for critically evaluating and revising these milestones on an annual basis. Applications lacking this information will be considered incomplete and will not be reviewed.

Letters of Support

A letter of institutional commitment must be attached as part of Letters of Support (see section above: Institutional Environment and Commitment). Appropriate institutional commitment should include the provision of adequate staff, facilities, and resources that can contribute to the proposed activities. Applications lacking a letter of institutional commitment will not be reviewed. If appropriate, also include letters describing collaborations with other institutions, resources and programs, nongovernmental organizations, and philanthropic entities.

Resource Sharing Plan
Note: Effective for due dates on or after January 25, 2023, a Data Management and Sharing Plan is not applicable for this NOFO.

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

All applications must include a Resource Sharing Plan. Include plans for freely sharing the educational materials produced under this award, including via collaboration with CENTER.

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. However, the software dissemination plan should address, as appropriate, the following goals:

• Software source code should be freely available to biomedical researchers 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 the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators 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.

Appendix

Only limited Appendix materials are allowed. Follow the instructions for the Appendix as described in the How to Apply - Application Guide.

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 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 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 How to Apply - Application Guide must be followed.

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

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). 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.

7. Other Submission Requirements and Information

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

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.

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.

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 components of participating organizations, NIH. Applications that are incomplete, non-compliant, and/or nonresponsive will not be reviewed.

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

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

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

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 announcement, note the following:

The goal of this UE5 program is to support activities that create educational units for researchers and other scientists in various career stages and learning environments to promote awareness, understanding, and implementation of the practices and principles of rigorous biomedical research. These units will be harmonized and incorporated into an online educational resource overseen by a separately funded center for Creating an Educational Nexus for Training in Experimental Rigor (CENTER).

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to strongly advance research education by fulfilling the goal of this research education program, in consideration of the following review criteria and additional review criteria, as applicable for the project proposed.

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Significance

Does the proposed program address a key audience and an important aspect or important need in research education? Is there convincing evidence in the application that the proposed program will significantly advance the stated goal of the program?

Specific to this NOFO:

How relevant, high-priority, and broadly applicable is the rigor practice or principle addressed in each educational unit? How convincing is the evidence that the proposed plan for educational materials will stimulate understanding and utilization of practices or principles of rigorous research by creating comprehensive, engaging, and effective educational content related to the principle(s) proposed? How much potential exists for the proposed educational materials to measurably improve scientific research and training?

Investigator(s)

Is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? 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:

What level of expertise do the applicants have related to the foundation(s) and implementation or application of the proposed practice(s) or principle(s) of rigorous biomedical research? What track record do applicants have of effective communication with a variety of scientific audiences, including teaching or mentoring in a biomedical research field? How much experience do the applicants have in developing, evaluating, and/or disseminating effective educational materials? To what extent are the PD(s)/PI(s) committed to the proposed activities and the principles of free and open sharing of research resources for training and education? How well are the applicants poised to foster effective collaboration with internal and external stakeholders, such as CENTER and other METER recipients?

Innovation

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

Approach

Does the proposed program clearly state its goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome?  Is there evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? Is the plan for evaluation sound and likely to provide information on the effectiveness of the program?  If the proposed program will recruit participants, are the planned recruitment, retention, and follow-up (if applicable) activities adequate to ensure a highly qualified participant pool?

Specific to this NOFO:

How well will the proposed educational materials promote awareness, understanding, and utilization of the rigor practice or principle addressed in each educational unit? How well will each unit promote scientifically accurate information and best scientific practice? How appropriate and feasible are the proposed number, scope, and subject matter of educational units, and does each unit have appropriate independence and modularity? 

Do the educational materials effectively incorporate effective learning objectives and complex and realistic neuroscience-relevant scientific examples that demonstrate the importance and implementation or application of the practice or principle? How engaging and interactive will the content be? How easily could the proposed educational materials be converted to a wide variety of digital content formats (e.g., text, video, graphics, animations, interactive features, activities)? How conducive will the materials be for educating a variety of intended audiences (e.g., those with disabilities, from underrepresented backgrounds, at different career stages, in synchronous vs. asynchronous environments, in different fields), including differentiation to different levels of detail based on the learner's baseline knowledge? How extensively will the materials employ evidence-based approaches to promote effective learning? 

How effective are the proposed plans for collaboration with various participants in the initiative, including external stakeholders and other METER recipients? How likely is it that the applicant will effectively share materials with CENTER, provide feedback during the development of the educational units, and then assist CENTER in evaluating, modifying, and disseminating educational units produced from the educational materials, including equitably serving the scientific community?  

In the Resource Sharing Plan, do the applicants describe suitable plans for freely sharing the educational materials produced under this award as applicable, including via collaboration with CENTER?

Environment

Will the scientific and educational environment of the proposed program contribute to its intended goals? Is there a plan to take advantage of this environment to enhance the educational value of the program? Is there tangible evidence of institutional commitment? Is there evidence that the faculty have sufficient institutional support to create a sound educational environment for the participants? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, and institutions?

Specific to this NOFO:

If multiple institutions are participating, how strong are the plans for coordination of activities and effective communication across the sites? 

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.

Milestones

How appropriate are the milestones for the Research Education Program? How clear, quantitative, and timely are the milestones and their indicators of success, including for sharing and iterative improvement of the educational materials and for communication with NINDS, CENTER recipients, and other stakeholders? Are there additional key components that need to have milestones?

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

Biohazards

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

Training in Methods for Enhancing Reproducibility

Not Applicable 

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.

Revisions 

Not Applicable

Renewals 

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.

Recruitment Plan to Enhance Diversity 

Not Applicable

Training in the Responsible Conduct of Research

Not Applicable

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Resource Sharing Plans

.Not Applicable. 

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), 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. 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. 

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Planning, organizing, coordinating, and administering the described activities of the award, including setting project milestones with specific timelines and criteria for evaluation. The recipient agrees to accept close coordination, cooperation, and participation of NINDS staff in technical, educational, and scientific aspects of the award as described in the terms and conditions.
• Facilitating collaborative interactions between the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) and senior/key personnel, Creating an Educational Nexus for Training in Experimental Research (CENTER) recipients, NINDS Staff, Steering Committee members, External Advisory Committee members, other METER recipients, and external stakeholders to foster collaborations and exchange information and ideas to accelerate progress towards the goals the program.
• Participating in regular meetings or phone calls of the Steering Committee and other committees as needed. 
• Compiling, transmitting to CENTER, and refining educational materials to promote awareness, understanding, and utilization of one or more principle(s) of rigorous biomedical research.
• Participating in evaluation and dissemination activities organized by CENTER to promote efficacy and utilization of the educational resource as agreed upon by the Steering Committee.
• Attending annual meetings organized by CENTER or NIH staff, which will promote collaboration and harmonization of educational units across the resource and foster partnerships with the broader scientific community.
• Completing annual progress reports (RPPR) and providing written evidence of progress when requested by NINDS staff.
• Preparing abstracts, presentations, and publications and collaborating with CENTER recipients and other METER recipients in making the public and scientific community aware of activities under this award.
• Making data, software, and access to educational materials broadly available and at no financial cost to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
• Recipients(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• Discussing proposed milestones with the applicant prior to funding an application to resolve concerns raised by the NINDS review panel or NINDS program staff. A final set of NINDS-approved milestones will be specified prior to award.
• Working closely with the PD(s)/PI(s), CENTER, Steering Committee, and other METER recipients to ensure proper governance and conduct of the activities under this award.
• Participating in External Advisory Committee and Steering Committee meetings.
• Providing advice and guidance to recipients to facilitate award activities and achievement of goals, disseminate information about award progress, serve as a source of information and a point of contact with the NINDS, and ensure compliance with the NINDS mission and NIH policies and procedures.
• Monitoring the project on a regular basis. Monitoring may include regular communication with the PD(s)/PI(s), periodic site visits, meetings, fiscal review, evaluation of progress reports, and other stewardship activities.
• Formally assessing award progress on an annual basis through review of the annual RPPR, including evaluating progress toward achievement of milestones. NINDS program staff may consult with independent experts as necessary. If justified, future milestones may be revised based on data and information obtained during the previous budget period. If, based on the progress report, a project does not meet the milestones, funding for the project may be reduced or discontinued. In addition to milestones, the decision regarding continued funding will also be based on overall progress, NINDS portfolio balance and program priorities, and availability of funds.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• The government retains ownership of all digital content (e.g., educational materials) developed under this project that are associated with the proposed educational materials and are not already released under public domain or similarly permissive licenses. NINDS and the recipient will jointly develop a plan to transfer materials to a new operator at the termination of this award if subsequent funding and continued approval has not been secured.
• METER recipients, CENTER recipients, and NINDS staff will participate in the Steering Committee formed by CENTER for the purpose of providing regular guidance and feedback on initiative progress. The Steering Committee will include at least one voting individual each from CENTER, NINDS staff (excluding the Program Official), and each of the METERs. Membership, frequency, and governance of the Steering Committee will be negotiated with the rest of the Steering Committee after funding decisions have been made.
• Changes to existing policies and procedures may be developed jointly by the recipient and NINDS staff and must be in compliance with relevant HHS, PHS, and NIH policies.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

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

Not applicable for UE5 research education program awards.

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. Continuation support will not be provided until the required forms are submitted and accepted. Programs that involve participants should report on education in the responsible conduct of research and complete a Training Diversity Report, in accordance with the RPPR Instruction Guide. 

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 200.301.

Failure by the recipient institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

A final RPPR 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.

5. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH or its Institutes and Centers will periodically evaluate their UE5 research education programs, employing the measures identified below. In assessing the effectiveness of its research education investments, NIH may request information from databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be contacted after the completion of a research education experience for periodic updates on participants’ subsequent educational or employment history and professional activities.

Upon the completion of a program evaluation, NIH and its ICs will determine whether to (a) continue a program as currently configured, (b) continue a program with modifications, or (c) discontinue a program.

In evaluating this research education program NINDS expects to use the following evaluation measures:

For Programs Focusing on Curriculum or Methods Development:

• Aggregate number and demographic characteristics of participants exposed to the new curricula or methods
• General educational level of participants
• Effectiveness of the new curricula or methods assessed by skills/competencies gained compared to existing curricula or methods
• Dissemination and/or adoption of the new curricula or methods

Section VII. Agency Contacts

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

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

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

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

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

SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg

Devon Crawford
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

Section VIII. Other Information

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

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