Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title
Materials to Enhance Training in Experimental Rigor (METER) (UE5 Clinical Trial Not Allowed)
Activity Code

UE5 Education Projects – Cooperative Agreements

Announcement Type

New

Related Notices

August 3, 2021 - Notice of Informational Webinar for Funding Opportunities to Build and Provide Content for a New Educational Resource on the Principles of Rigorous Research. See Notice NOT-NS-22-006.

NOT-OD-19-109 - Requirement for ORCID iDs for Individuals Supported by Research Training, Fellowship, Research Education, and Career Development Awards Beginning in FY 2020.

Funding Opportunity Announcement (FOA) Number
RFA-NS-21-033
Companion Funding Opportunity

RFA-NS-21-009 - High Impact Research and Research Infrastructure Cooperative Agreement Programs

Assistance Listing Number(s)

93.853

Funding Opportunity Purpose

The NIH Research Education Program (UE5) supports research education activities in the mission areas of the NIH.  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 FOA 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.

This UE5 FOA runs in parallel with a companion UC2 FOA that solicits applications for the NINDS center for Creating an Educational Nexus for Training in Experimental Rigor (CENTER), described in detail in RFA-NS-21-009.

Key Dates

Posted Date
July 28, 2021
Open Date (Earliest Submission Date)
September 21, 2021
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

October 21, 2021

October 11, 2022

October 10, 2023

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2022

March 2023

March 2024

Advisory Council Review

May 2022

May 2023

May 2024

Earliest Start Date

July 2022

July 2023

July 2024

Expiration Date
October 11, 2023
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

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

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

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


  4. Table of Contents

Part 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 FOA 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. 

A companion UC2 FOA (RFA-NS-21-009) will support a center for Creating an Educational Nexus for Training in Experimental Rigor (CENTER) 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 awardees, produce digital content for the units (including videos and 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 Funding Opportunity Announcements (FOAs) 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. The purpose of this FOA is to support the compilation and refinement of Materials to Enhance Training in Experimental Rigor (METER), which will comprise the core scholarly content of educational units within this online resource. These materials will enable acquisition of knowledge and skills to recognize and conduct rigorous experimental research. NINDS METER UE5 awardees will serve as the primary subject matter experts for one or more educational unit(s) focused on individual principles of rigorous research and will provide scholarly material to CENTER, which will be supported by a separate FOA to build the final web-based platform and produce the digital elements (e.g. videos, graphics, and interactive components) of the online resource.

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 FOA 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 will compile and refine scholarly material pertaining to one or more 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 research (e.g. randomizing subjects or samples to treatment groups, handling outliers, creating standard operating procedures for laboratory workflows) tend to be encompassed by general topics that include, but are not limited to:

  • Understanding the philosophical foundations of science
  • Evaluating existing 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
  • 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 FOA. These deliverables must include educational content for one or more educational unit(s), and a typical METER award is expected to propose content for 2-5 educational units to be developed over a 3-year award period. For the purpose of this FOA, an educational unit is defined as an assortment of educational materials, lessons, and activities that collectively address a single 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, although real-world users will also be able to select short, individual components of the unit with which to interact (e.g. a single 5-minute video or set of step-by-step instructions).

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 general topic listed above or even by any of the general topics listed above, as the topics provided here are only for illustrative purposes to help clarify the definition of rigorous biomedical research for this FOA). 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. See Section IV.2 for additional examples of potential principles of rigorous research/educational units that could be proposed.

The materials provided by METER awardees 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. As digital components of the educational units are developed, METER awardees 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 awardees will participate in evaluation and dissemination efforts organized by CENTER [see the companion UC2 FOA (RFA-NS-21-009) for more information].

A successful METER application will have strengths in four major areas: (1) identification of important elements of rigorous biomedical research practice that can be developed into individual educational units, (2) expertise in implementing or applying relevant rigorous research principles, (3) evidence of effective communication to a variety of audiences, and (4) development of effective educational materials. Each METER application should include expertise in the biomedical research environment, one or more principle(s) of rigorous research, application of the principle(s), effective pedagogy, and evaluation of educational interventions.

Activities under this FOA must include:

  • Recruiting and coordinating expertise related to the foundations and application of one or more principle(s) of rigorous biomedical research
  • Generating, compiling, and communicating information about one or more principle(s) of rigorous research that 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 evaluating and modifying materials as necessary over the entire project period
  • Collaborating effectively with technology, education, media, and evaluation 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 or NIH to enhance communication and collaboration between METER awardees, CENTER, and the scientific community, including 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

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.

Non-Responsive Applications

Applications with one or more of the characteristics listed below will be considered non-responsive and will not be reviewed:

  • Applications that do not incorporate expertise related to the foundations and application of one or more principle(s) of rigorous biomedical research
  • Proposed educational materials that do not address one or more principle(s) of rigorous research
  • Proposed educational materials that do not address required elements of an educational unit
  • Applications that do not propose materials for adaptation into a variety of media formats
  • Project timelines that do not include producing draft material within the first year of funding and participating in evaluation, improvement, and dissemination of educational units thereafter

METER Governance

The initiative to develop an educational resource on the principles of rigorous research will be governed by a Steering Committee organized by CENTER (see RFA-NS-21-009). The Steering Committee will include representatives from each METER award (funded through this FOA) 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 trans-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 awardees will be required to participate in this annual meeting.

Engagement in the activities of the initiative will be critical for the proposed METER awardees to better understand the scope of topics supported by this NINDS initiative as well as the areas in which the proposed METER awardees can develop educational activities to further support and amplify the efforts of the CENTER evaluation and dissemination team(s).

Important Note: Because NINDS METER UE5 awardees will be required to interact closely with the NINDS CENTER, it is imperative that all applicants responding to this FOA familiarize themselves with the companion UC2 FOA for CENTER (RFA-NS-21-009).

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

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
Resubmission
New

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

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

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

Award Budget

Application budgets may not exceed direct costs of $250,000 over the course of the project period.

Award Project Period

The maximum project period is 3 years.

Other Award Budget Information

Personnel Costs

Individuals designing, directing, and implementing the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. (If mentoring interactions and other activities with participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with participants are not allowable costs from grant funds).

Participant Costs

Not Applicable

Other Program-Related Expenses

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.

Note that consultants may include individuals serving in a variety of roles, such as faculty, lecturers, advisors, etc., and that consultant costs are included in the $250,000 limit for total Direct Costs for all personnel and consultants involved in the project. See Personnel Costs section above for details.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, expenditures for equipment and consortium costs in excess of $25,000), rather than on the basis of a negotiated rate agreement.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

  • 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)

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)
  • 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.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) 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. 

Required Registrations

Applicant organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.

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

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 FOA. 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 FOA must not be also designated as a PD/PI (or one of multiple PDs/PIs), Co-Investigator, or other senior/key personnel on an application submitted in response to the companion UC2 FOA, RFA-NS-21-009.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

 

 

 

Section IV. Application and Submission Information

1. Requesting an Application Package

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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions 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

The letter of intent should be sent to:

Devon Crawford

National Institute of Neurological Disorders and Stroke (NINDS)

Telephone: 301-496-1917

Email: devon.crawford@nih.gov

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

, with the following exceptions or additional requirements:

For this specific FOA, the Research Strategy Section is limited to 12 pages.

Component Page Limit
Specific Aims 1 page
Research Education Program Plan/Research Strategy 12 pages
Instructions for Application Submission

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

SF424(R&R) Cover

Follow all instructions provided in the SF424 (R&R) Application Guide.

SF424(R&R) Project/Performance Site Locations

Follow all instructions provided in the SF424 (R&R) Application Guide.

SF424(R&R) Other Project Information Component

Follow all instructions provided in the SF424 (R&R) 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.

Other Attachments.

A one-page attachment must be included with the timeline for educational material development and major milestones. The timeline should include producing draft material that can be shared with CENTER within the first year of funding so that CENTER can begin development of educational units and participating in evaluation, improvement, and dissemination of educational units thereafter. This attachment supplements but does not replace the Milestones section of the Research Education Program Plan/Research Strategy.

A one-page attachment must be included listing which personnel fulfill the required and strongly encouraged areas of expertise listed under SF424 (R&R) Senior/Key Person Profile.

The filename provided for each "Other Attachement" will be the name used for the bookmark in the electronic application in eRA Commons.

SF424(R&R) Senior/Key Person Profile Expanded

Follow all instructions provided in the SF424 (R&R) 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 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 dissemination of educational materials
  • Teaching and mentoring related to the practice of biomedical research, preferably in a neuroscience-related field
  • Theory behind relevant principle(s) of rigorous biomedical research, including defining and refining ontologies between major concepts
  • Diverse perspectives. Applicants from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged at all levels of leadership and conduct of METER awards. See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html
R&R Budget

Follow all instructions provided in the SF424 (R&R) 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 should budget travel funds in each funding year for the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) (and Co-Investigators as appropriate) to attend annual 2-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.
PHS 398 Cover Page Supplement

Follow all instructions provided in the SF424 (R&R) Application Guide.

PHS 398 Research Plan

All instructions in the SF424 (R&R) 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 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 principle(s) of rigorous research being addressed, and justify the relevance and priority for inclusion of the proposed principle(s) in the online resource being compiled by CENTER. Include the number of educational units the applicant is proposing to develop. As described in Section I, typical METER applications are expected to propose 2-5 educational units, although no formal limit is imposed, and these units/principles of rigorous research are not required to be encompassed by a single general topic listed in Section I. Applicants, however, should demonstrate expertise in each principle/educational unit proposed. Examples of principles of rigorous research that are encompassed by these general topics and could be developed into individual educational units include, but are not limited to:

  • Defining an important and clear scientific question
  • Identifying assumptions and sources of error
  • Standardizing variable definitions
  • Formulating hypotheses and plans to refute them through experimentation
  • Pursuing multiple lines of evidence to bolster inferences
  • Ruling out alternative explanations
  • Discerning differences between hypothesis-generating (exploratory) and hypothesis-testing (confirmatory) research
  • Performing comprehensive literature reviews
  • Assessing evidence through systematic reviews
  • Using mathematical models to make scientific predictions
  • Creating standard operating procedures for laboratory workflows
  • Using validated resources, methods, and outcome measures
  • Identifying and implementing proper controls
  • Calculating sample size
  • Randomizing subjects or samples to treatment groups
  • Blinding investigators during experimentation and analysis
  • Identifying and minimizing confounding variables
  • Choosing inclusion and exclusion criteria
  • Handling outliers
  • Creating an analysis plan
  • Using appropriate descriptive statistics
  • Making inferences from data
  • Conceptualizing probability and uncertainty
  • Differentiating frequentist and Bayesian statistics
  • Understanding null hypotheses, p-values, and statistical significance
  • Preventing p-hacking and HARKing (hypothesizing after results are known)
  • Appropriately documenting machine learning algorithms
  • Sharing data and practicing open science
  • Reproducing and replicating experiments
  • Displaying data transparently during presentations
  • Identifying experimental details that are important to report
  • Reporting project workflows, methods, and divergence from plans
  • Pre-registering experimental protocols, plans, and analyses
  • Using emerging technologies to improve rigor and transparency
  • Reducing publication bias

This is not an exhaustive list, but it serves to illustrate generally accepted principles of rigorous and transparent biomedical research for the purpose of this FOA. Although the final format of each educational unit will be developed by CENTER with input from METER awardees, each educational unit will 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 principle of rigorous biomedical research
  • Guidance on why the relevant principle needs to be implemented or applied
  • Guidance on how to implement or apply the relevant principle
  • Relevant and realistic examples of using the principle in a 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 all learners 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 provide will incorporate and address the educational unit requirements and goals. Applicants should propose how their educational content could be adapted into several brief, well-organized, and student-centered instructional videos or resources and active learning exercises. Applicants should include a proposed set of learning objectives for each educational unit; complex and realistic neuroscience-relevant scientific examples that demonstrate the importance of the principle and how to implement or apply the principle; as well as creative, engaging, and effective educational and narrative ways to approach digital component delivery in each educational unit (e.g. videos, graphics, activities, resources, exercises, and interactive techniques) that could potentially be incorporated in collaboration with CENTER platform developers and education specialists. 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).

Each educational unit will provide information differentiated by level of expertise (e.g. more detailed information should be available to those with a deeper baseline familiarity with the subject), and the educational unit should be able to serve as a quick reference or as a complete and thorough mini-course, depending on the user’s learning goals. Describe how the applicants will provide materials that meet these goals. Applicants must also describe how the materials can 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, laboratory groups), and diverse backgrounds, perspectives, and accessibility requirements. Materials should also employ evidence-based approaches to promote effective learning, such as:

  • Outlining measurable and attainable learning objectives and evaluating achievement of those objectives
  • Accommodating diverse backgrounds and perspectives, 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 complex 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
  • Enhancing diversity and promoting inclusion through an environment that promotes the success of individuals with a wide variety of backgrounds and perspectives (i.e. trainees from all backgrounds feel integrated into and supported by the biomedical community)

Although formal evaluation and dissemination plans are not required because CENTER will provide leadership and coordination of these activities, applicants should describe plans to collaborate with CENTER to evaluate the effectiveness of educational units developed under this award, improve and update the content in each unit, and disseminate the finished online educational units at no cost to individuals. This includes ensuring that the educational units integrate diverse perspectives and the resource serves the scientific community in an equitable fashion.

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 awardees in order to produce effective educational units on 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 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.

 

 

 

 

Additional Application Elements:

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 should include timely development, release, and testing of the educational materials and clear communication timelines with NINDS, CENTER awardees, 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. Propose quantifiable goals for providing feedback on digital components and educational units produced by CENTER and for assisting in evaluation and dissemination activities. 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 Plans

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

All applications must include a Resource Sharing Plan. Include plans for freely sharing the educational materials produced under this award.

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 SF424 (R&R) 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 SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

The following are considered non-responsive for this FOA:

  • Applications that do not incorporate expertise related to the foundations and application of one or more principle(s) of rigorous biomedical research
  • Proposed educational materials that do not address one or more principle(s) of rigorous research
  • Proposed educational materials that do not address required elements of an educational unit
  • Applications that do not propose materials for adaptation into a variety of media formats
  • Project timelines that do not include producing draft material within the first year of funding and participating in evaluation, improvement, and dissemination of educational units thereafter

In order to expedite review, applicants are requested to notify the NINDS Referral Office by email at nindsreview.nih.gov@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD(s)/PI(s) name(s), and title of the application.

 

Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  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 materials for researchers and other scientists in various career stages and learning environments that promote awareness, understanding, and practice of the principles of rigorous biomedical research. These materials will be incorporated into an online educational resource by a separately funded center for Creating an Educational Nexus for Training in Experimental Rigor (CENTER).

Overall Impact

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 UE5 Education Program, in consideration of the following review criteria and additional review criteria, as applicable for the project proposed.

Scored Review Criteria

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

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 FOA:

Is there convincing evidence that the proposed plan for educational materials will stimulate understanding and utilization of the principles of rigorous research by creating comprehensive, engaging, and effective educational content related to the principle(s) proposed? How well do the proposed educational materials address the needs of the scientific community? Is there potential 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 FOA:

How are a diversity of perspectives represented in the leadership team? Do the applicants have appropriate expertise related to the foundation(s) and implementation or application of the proposed principle(s) of rigorous biomedical research and mentoring others on rigorous research practice? Do applicants have a track record of effective communication of scientific concepts to a variety of audiences? Do the applicants have adequate experience in developing, evaluating, and 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? Are the applicants poised to foster effective collaboration with internal and external stakeholders, such as CENTER awardees, the Steering Committee, other METER awardees, active researchers, champions of rigorous research, education professionals, and educational technology developers?

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?

Specific to this FOA:

Are the educational concepts and approaches innovative? Are the proposed educational materials creative, engaging, and innovative?

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 FOA:

Will the proposed educational materials address one or more high-priority principle(s) of rigorous biomedical research and convey engaging, interactive, and effective content? Are the proposed number, scope, and subject matter of educational units appropriate and feasible? Do the educational materials address the requirements of each educational unit, including effective learning objectives and complex and realistic neuroscience-relevant scientific examples that demonstrate the importance and implementation or application of the principle? Will the proposed educational materials be convertible to a wide variety of digital content formats (e.g. text, video, graphics, animations, interactive features, activities)?

Will the materials be conducive for a variety of intended audiences (e.g. those with disabilities, from underrepresented backgrounds, at different career stages), including differentiation to different levels of detail based on baseline knowledge of the learner, career stage, and learning environment? Have the materials employed evidence-based approaches to promote effective learning as described in the FOA? Are the educational materials likely to promote awareness, understanding, and utilization of rigorous research practices?

Are plans for collaboration and optimizing interactions across investigators, the Steering Committee, CENTER, and other stakeholders, including by attending the annual meeting and participating in Steering Committee meetings, likely to lead to positive outcomes? How effective is the plan for collaborating with CENTER to provide feedback during the development of the educational units and then to evaluate, modify, and disseminate educational units produced from the educational materials? Are the plans to collaborate with CENTER to ensure that the educational units developed from the materials are scientifically accurate, represent the best scientific practice, and equitably serve the needs of the scientific community likely to be effective?

Are there feasible and adequate plans to deliver enough material to CENTER within the first year of funding for CENTER to begin production of the educational units and then to evaluate and modify materials as necessary over the rest of the project period?

Is the Resource Sharing Plan reasonable? Do the applicants describe suitable plans for freely sharing the educational materials produced under this award as applicable? If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the proposed software dissemination plan.

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 FOA:

If multiple institutions are participating, how strong are the plans for coordination of activities and effective communication across the sites? Are there unique features of the environment(s) that will be leveraged to the advantage of the proposed activities?

Additional Review Criteria

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

Milestones

Does the application provide appropriate milestones for the Research Education Program that will need to be met to accomplish the work in the proposed time frame? Are the milestones robust and associated with clear, quantitative criteria for success? Will the overall milestones provide adequate information to evaluate annual progress of the Program as a whole? Are the timelines proposed for achieving the milestones realistic and inclusive of necessary steps, but also efficient without adding unnecessary steps? 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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

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

Revisions

Not Applicable

Renewals

Not Applicable

Additional Review Considerations

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

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

See the Approach Criterion above.

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 FOA.

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 FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Neurological Disorders and Stroke (NANDS) Council. The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Awardees must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

2. Administrative and National Policy Requirements

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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

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

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

Cooperative Agreement Terms and Conditions of Award

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 (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR 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 award 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 the 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. The membership, frequency, and governance of these meetings will be negotiated with NINDS staff after funding decisions have been made.
  • 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.
  • 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.

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 or IC program official 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 data and tangibles developed under this project that are associated with the proposed educational materials. 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.
  • 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 award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: 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 right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16. 

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.

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

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.

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

 

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.

4. 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.

Application Submission Contacts

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

Finding Help Online: http://grants.nih.gov/support/ (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: 301-945-7573

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

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

Scientific/Research Contact(s)

Devon Crawford
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1917
Email: devon.crawford@nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

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

Authority and Regulations

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


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