Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title
Creating an Educational Nexus for Training in Experimental Rigor (CENTER) (UC2 Clinical Trial Not Allowed)
Activity Code

UC2 High Impact Research and Research Infrastructure Cooperative Agreement Programs

Announcement Type
New
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-NS-21-009
Companion Funding Opportunity
RFA-NS-21-033 , UE5 Education Projects - Cooperative Agreements
Assistance Listing Number(s)
93.853
Funding Opportunity Purpose

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 online educational resource for use by a broad range of researchers in an array of learning environments. The purpose of this FOA is to support the establishment of a center for Creating an Educational Nexus for Training in Experimental Rigor (CENTER), which will build, evaluate, and disseminate a user-friendly, harmonized, and openly accessible educational resource to promote awareness, understanding, and utilization of the principles of rigorous biomedical research.

Key Dates

Posted Date
August 10, 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 Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
October 21, 2021 Not Applicable Not Applicable March 2022 May 2022 July 2022

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.

Expiration Date
October 22, 2021
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

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 use by a broad range of researchers in an array of learning environments. The purpose of this FOA is to support a center for Creating an Educational Nexus for Training in Experimental Rigor (CENTER), which will build, evaluate, and disseminate a user-friendly, harmonized, and openly accessible educational resource to promote awareness, understanding, and utilization of the principles of rigorous biomedical research. CENTER will provide comprehensive administrative oversight, expertise required to establish and maintain the educational platform, and infrastructure to create cutting-edge digital educational components (e.g. videos, interactive activities, relevant scientific examples). These components will be adapted from content provided by subject matter experts supported by the companion Materials to Enhance Training in Experimental Rigor (METER) UE5 FOA (RFA-NS-21-033). CENTER will assemble and manage a team of platform developers, specialists in creating and evaluating engaging digital content, and experts in pedagogy and educational techniques in order to carry out these CENTER activities. CENTER will create, modify, and maintain the educational resource’s digital platform and coordinate collaborations between the external subject matter experts providing the scholarly content, champions of rigor in the scientific community, and CENTER’s technical and educational experts ensuring high-quality educational delivery and impact.

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 build an educational resource, under the leadership of CENTER, that is comprehensive, interactive, openly accessible, and demonstrably effective at fostering high-quality education in the principles of rigorous research.

Scope

The objective of CENTER is to provide the scientific community with an open and freely available, easily discoverable, engaging, modular, adaptable, and upgradable educational resource on the principles of rigorous research and to partner with the scientific community during development, evaluation, and dissemination. Applicants will produce a set of deliverables that can be shared with the research community by the end of the five-year project period. These deliverables will include an educational platform, encompassing the platform interface and website; a suite of interactive and engaging educational units on the principles of rigorous biomedical research; and evaluations of the platform and the effectiveness of its educational approaches. An educational unit is defined as an assortment of educational materials, lessons, and activities that collectively address a single principle of rigorous research and whose content will be developed in collaboration with externally funded subject matter experts [see the companion METER UE5 FOA (RFA-NS-21-033) for more information]. It is estimated that one educational unit, at its maximal depth and breadth 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). It is expected that the individual educational units will relate to general topics on performing rigorous biomedical research, including, but 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

For example, the principles of (1) randomizing subjects or samples to treatment groups and (2) blinding investigators during experimentation and analysis could be developed as separate educational units that relate to the general topic of "Reducing the effects of a broad range of cognitive biases" [see METER FOA (RFA-NS-21-033) for more information].

A successful CENTER application will have strengths in four major areas: (1) leadership and project management, (2) building and dissemination of digital interfaces and educational materials, (3) evaluation of educational effectiveness, and (4) collaboration with and outreach to the scientific community. Qualifications for CENTER applicants should include familiarity with the research environment and expertise in project management, digital platform and educational technology development, pedagogy, evaluation of educational products, and technology dissemination.

Activities under this FOA must include:

  • Recruiting and coordinating expertise pertinent to building and disseminating a new online educational resource, including but not limited to software and website development, multimedia production, pedagogy and other educational approaches, and evaluation of educational effectiveness.
  • Managing project timelines, including building infrastructure and capacity within the first year of funding so that CENTER is prepared to release the basic platform within the first year of funding, compile the first set of educational units during the second year of funding, and evaluate and disseminate the first set of educational units during the third year of funding. The remaining educational units should be evaluated and disseminated by the fourth and fifth years of funding.
  • Effectively collaborating with subject matter experts supported by the companion METER FOA to create educational units that are interactive, engaging, and effective at promoting awareness, understanding, and utilization of fundamental principles of rigorous biomedical research. This includes effective use of multi-modal media (e.g. text, video, graphics, animations, interactive features, activities).
  • Developing an educational resource that is user-friendly, free to use, and accessible to all individuals (i.e. Section 508 compliant).
  • Building and sustaining cutting-edge and attractive digital interfaces to support effective educational content that is harmonized across educational units.
  • Coordinating and implementing tests of the resource platform,?evaluation of?its?performance?and educational impact, and iterative improvement in response to feedback?from potential users of the resource,?including?educators and scientists?at various?career stages and institutions that could implement the resource in their programs.
  • Disseminating the resource and its open-source components to?the broader scientific community, including?performing outreach to academic institutions, researchers, non-profit organizations, and education professionals.
  • Facilitating regular communication with the Steering Committee, External Advisory Committee, METER awardees, NINDS staff, and other stakeholders.
  • Partnering with rigor champions in the scientific community who are actively seeking to change the culture to advance the quality of science more broadly.
  • Organizing and coordinating annual?meetings, beginning one year after initial funding,?to enhance communication?and collaboration between CENTER and the scientific community, including METER awardees, active researchers, rigor champions, resource users and evaluators, education professionals, and educational technology developers.

The administrative structure of CENTER should provide leadership and management to the entire project. 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 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.

Responsiveness Criteria

Applications deemed non-responsive will not proceed to review. The following are considered non-responsive for this FOA:

  • Centers that do not incorporate expertise in digital platform development, education, and evaluation.
  • Centers that do not provide project timelines that include building capacity and infrastructure within the first year of funding so that CENTER is prepared to release the basic platform within the first year of funding, compile the first set of educational units during the second year of funding, and evaluate and disseminate educational units during the third, fourth, and fifth years of funding.
  • Centers without a collaboration plan, including the organization of annual meetings.
  • Centers without a resource evaluation plan.
  • Centers without a resource dissemination plan.

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
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 trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NINDS intends to fund 1 award.

Making an award is contingent upon NIH appropriations and the submission of meritorious applications.

Award Budget
Application budgets are not limited but need to reflect the actual needs of the proposed project.
Award Project Period

The maximum project period is 5 years.

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)

Local Governments

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

Federal Governments

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

Other

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

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

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

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

Required Registrations

Applicant organizations

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

  • 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 underrepresented racial and ethnic groups as well as individuals with disabilities 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.

An individual designated as a PD/PI (or one of multiple PDs/PIs), Co-Investigator(s), or other senior/key personnel on a UC2 application submitted in response to this FOA must not be designated as a PD/PI (or one of multiple PDs/PIs), Co-Investigator(s), or other senior/key personnel on an application submitted in response to the companion UE5 RFA-NS-21-033.

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 may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Devon Crawford

National Institute of Neurological Disorders and Stroke (NINDS)

Telephone: 301-496-1917

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 25 pages.

Component Page Limit
Specific Aims 1 page
Research Strategy 25 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

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Facilities & Other Resources. Describe the scientific, technical, and 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 resource. List all related sources of support following the format for Current and Pending Support.

Other Attachments.

A one-page attachment must be included with the timeline for resource development and major milestones. The timeline should include hosting annual meetings and building capacity and infrastructure within the first year of funding so that CENTER is prepared to release the basic platform within the first year of funding, compile the first set of educational units during the second year of funding, and evaluate and disseminate educational units during the third, fourth, and fifth years of funding. This attachment supplements but does not replace the Milestones section of the 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 Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

SF424(R&R) Senior/Key Person Profile

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

CENTER Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) or other senior/key personnel must describe their expertise in digital platform development, education, and evaluation. Additionally, highlight how the PD(s)/PI(s) and other senior/key personnel have appropriate expertise in:

  • Creation and dissemination of educational technology
  • Building and maintenance of digital interfaces
  • Multi-media production
  • Pedagogy and evidence-based educational techniques
  • Familiarity with laboratory-based biomedical research, preferably in a neuroscience-related field
  • Definitions and refinement of ontologies related to biomedical research and education
  • Development of educational courses or training programs
  • Evaluation of educational approaches and effectiveness of educational materials
  • Coordination of and effective collaboration across large, complex projects
  • 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 CENTER. See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html.

R&R Budget

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

  • Applicants should include an estimate of total development and production costs needed in each budget year for the online resource, which includes the website/platform and digital components of the educational units. The budget should specify the number of educational units used to estimate these costs.
  • Applicants should include funds in the year 1 budget for the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) (and Co-Investigators as appropriate) to attend an initial 2-day kick-off meeting hosted by NINDS in the Washington, D.C. area.
  • Applicants should include funds in year 2 and future budget years for hosting and attending an annual 2-day meeting in the continental U.S., which will begin one year after initial award. The budget for this meeting should also include travel costs for no more than 20 invited attendees not supported by CENTER or METER funding.
  • The budget should not include inflationary escalations for recurring costs in out years.
R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Provide a succinct description of the overall scientific, technical, educational, and collaboration goals of the center for Creating an Educational Nexus for Training in Experimental Rigor (CENTER). Describe the planned activities, expected outcomes, and impact should those goals be achieved.

Goals should include:

  • Providing leadership to the entire project. This requires overall project management of the educational resource, the ability to create and sustain a free online educational platform that contains multiple units on principles of rigorous biomedical research, coordination of appropriate expertise for each component of the resource, dovetailing efforts with ongoing and future training initiatives of interest to the NINDS, and plans for working with a range of stakeholders including government, academic institutions, research scientists, trainees, educators, non-profit organizations, and software and technology experts.
  • Recruiting educational and technical expertise. This project will require the skills and flexibility to build and modify a cutting-edge digital interface as well as components that are harmonized across educational units. It will additionally require implementation of evidence-based educational techniques to provide engaging modes of delivering digital content to users in a variety of contexts, including educators employing the resource as part of coursework or individual users searching for relevant and practical guidance for designing their own experiments. This project will also require evaluation of the educational content and dissemination of the resource.
  • Coordinating collaborations among platform developers, educational experts, evaluators, and external subject matter experts providing scholarly content for the educational units [supported under the Materials to Enhance Training in Experimental Rigor (METER) UE5 (RFA-NS-21-033)]. This will require maintaining regular communication between internal and external collaborators as well as planning and coordinating an annual meeting that brings together CENTER representatives, METER awardees, and experts in a variety of fields including educational technology, digital content creation, accessibility, experimental design, statistics, biomedical research methods, philosophy of science, pedagogy, evaluation, implementation and championing rigorous research practices. See the requirement for a Collaboration Plan under CENTER Administration.
  • Creating and disseminating a user-friendly, accessible, educational, and effective resource to promote awareness, understanding, and utilization of the principles of rigorous biomedical research. The resource must be open-source and freely available, easily discoverable, harmonized across educational units, engaging, modular, adaptable, and upgradeable. A successful resource will be interactive, Section 508 compliant for users with disabilities, and capable of integrating new or modified educational units over time. It will also provide high-quality examples of scientific practice that are relevant to the NINDS scientific and training communities (i.e. neuroscience-relevant). There must be a clear plan to test the interface, perform outreach and disseminate the resource to the scientific community, and evaluate whether users improve their knowledge and utilization of rigorous experimental design and scientific practice after interacting with the content. See the requirements for a Resource Evaluation Plan and Resource Dissemination Plan under Approach.

Research Strategy:

This section should state the main challenge(s) CENTER is working to address, the outputs to be delivered by the end of the project, and an overview of integration and synergy of CENTER activities. The Research Strategy should be organized into sections that address Significance, Innovation, and Approach.

Significance:

Describe the main challenge(s) that this resource plans to address related to providing education in the principles of rigorous biomedical research for members of the scientific community. Describe the deliverable(s) planned from CENTER, how the proposed structure of CENTER will achieve the funding opportunity goals, and how this educational resource will advance scientific practice. Justify the proposed interdisciplinary strategy.

Innovation:

Describe the technical and/or conceptual innovation(s) that will be brought to this project through aspects including, but not limited to, novel approaches and technologies, unique or novel collaborations, and innovative approaches to fostering relationships between educational technology experts and the broader biomedical research community. Describe how these innovative aspects will advance the goals of CENTER and improve the proposed educational resource as well as overall education in the principles of rigorous biomedical research and the practice of high-quality scientific research.

Approach:

Provide an overview of the proposed CENTER structure, plans, and resulting educational resource, and describe how these will address the overall goals of CENTER. Provide evidence that supports the feasibility, formation, and successful implementation of CENTER that encompasses appropriate expertise, technologies, approaches, and evidence-based educational techniques. Address each of the following key areas:

CENTER Administration:

Describe the proposed administration of CENTER, including but not limited to the following activities, and how the team composition and organization are best suited to accomplish the goals of CENTER:

  • Provide leadership, governance, and oversight of CENTER, including through effective conflict resolution.
  • Promote the successful function and integration of CENTER components and effectively manage project timelines.
  • Build and maintain resources and infrastructure to support the development of the educational resource, including its digital platform, associated educational units, evaluation, and dissemination.
  • Plan to organize a Steering Committee, to be formed after funding decisions have been made, consisting of CENTER leadership, METER awardees, and appropriate NINDS program staff. This Steering Committee will help set the scope of the educational resource, provide guidance on CENTER governance and implementation, and ensure the production of a harmonized and high-quality educational resource, in addition to other activities it deems necessary.
  • After funding decisions have been made, work with NINDS program staff to identify an External Advisory Committee. Do NOT list potential names in the application or contact potential committee members.
  • Manage CENTER committees and components by organizing timely meetings of the Steering Committee, External Advisory Committee, and other groups that may best support the activities of CENTER.
  • Organize annual meetings, beginning one year after initial award, to enhance communication and collaboration between CENTER, METER awardees, and the scientific community, including but not limited to technology developers, education professionals, subject matter experts, potential resource users, rigor champions, resource evaluators, and other relevant stakeholders.
  • Coordinate the testing of the resource platform and its content,?evaluation of?its?performance?and educational impact, and iterative modification in response to feedback. Include plans to partner with METER awardees and potential users of the resource, including educators, scientists?at various?career stages, and institutions that could implement the resource in their programs.
  • Establish and maintain the resource website and coordinate the dissemination of the resource and its open-source components to the broader scientific community in an equitable fashion (i.e. inclusion of underrepresented groups), including academic institutions, educational technology developers, non-profit organizations, researchers, and education professionals.
  • Maintain an accounting of resource component development, related utilization and impact, effectiveness, and steps taken to maximize research utilization of the educational resource in the scientific community as well as educational equity among diverse scientists and institutions.
  • Provide advance notice of manuscripts and publications to the NINDS program officer and work with the NINDS Office of Neuroscience Communications and Engagement on press releases highlighting CENTER accomplishments.
  • Prepare and submit annual progress reports.
  • Provide assurance of compliance with NIH policy requirements.

Describe the composition of the project team, how their expertise is complementary and synergistic to meet the goals of CENTER, and how diversity across multiple dimensions (such as gender, race/ethnicity, career stage, and background/expertise) will bring unique and varied perspectives to the team. Include a plan (entitled “Collaboration Plan”) to forge successful collaborations with externally funded subject matter experts (METER awardees) in order to create the educational units, and describe how CENTER will foster fruitful collaborations with a diverse range of potential users of the resource and other rigor champions in the broader scientific community to ensure successful evaluation, dissemination, and adoption of the educational resource as well as advance the quality of science more broadly (see the NINDS Rigor Champions and Resources website and https://elifesciences.org/articles/55915 for more information on rigor champions). Include plans for organizing and hosting the annual meeting in the Collaboration Plan.

Technical Features of the Educational Resource:

Describe how CENTER will build and host an online educational resource with features including, but not limited to:

  • An attractive, web-accessible, user-friendly, organized, and practical electronic interface that fits the training goals of CENTER, which can be built de novo or integrate existing open-source platforms
  • Compatibility and interoperability across multiple devices (e.g. desktop, mobile), operating systems, and internet browsers, including the capacity to handle a large volume of simultaneous users
  • Compliance with Section 508 of the Rehabilitation Act (29 U.S.C. §794 d), as amended by the Workforce Investment Act of 1998 (P.L. 105 – 220), to provide accessibility to a diverse set of users
  • Broad and open access at no financial cost to individual users, including through use of open-source components
  • Capacity to be translated into languages other than English
  • Ability to insert, organize, and integrate multiple educational units, each conveying an important principle of rigorous biomedical research and including specific scientific examples for how to optimally apply and adhere to the principle
  • Harmonization across the platform, including the educational units, that ensures functionality, seamless navigation among related units, effective user experiences, and uniform appearance and organization
  • Multiple modes of effective and engaging educational content delivery, including but not limited to explanatory text, graphics, videos, animations, activities, and interactive features
  • Customizability by users to create individualized curricula containing a subset of educational units and select differentiated levels of information detail and depth based on learning goals
  • Policies and procedures for updating educational content over time, including modifications to existing educational units and creation and integration of new educational units
  • User-friendly mechanisms for educators to customize scientific examples associated with individual educational units to personalize illustration of the rigorous research principle and increase relevance to their students
  • Methods for soliciting, analyzing, and integrating feedback from users and evaluators of learning effectiveness
  • Strategies for tracking performance of the resource, including website traffic, user learning, resource dissemination and integration into training programs, publications and other communication venues citing the resource, and other forms of resource utilization and impact
  • Compliance with applicable laws and NIH policies

Resource Platform Development:

Describe proposed activities for platform development, piloting and refinement, evaluation, dissemination, and maintenance. Describe how the online resource will be created and adapted to different educational settings, including utilization as part of lectures, independently performed problem-based coursework, and seeking practical advice in the laboratory. Include features of the platform that make it ideal to host the educational resource, including but not limited to its capability to support the features listed above, flexibly adapt to technological advances over time, and be attractive, user-friendly, and easily accessible to the community. This includes access at no cost to individuals, broad discoverability online, and equitable access by individuals with disabilities and individuals from underrepresented and disadvantaged backgrounds. Describe how CENTER will provide customer support for users and how it will solicit feedback from the user community on features and functionality of the platform. Applicants may include visual examples of the proposed platform and features, for example in the form of website design layouts, in the appendix as instructed in the Appendix section below.

Integration of Educational Units into the Resource:

CENTER will collaborate with METER awardees to design and create an expected total of 30-50 educational units on principles of rigorous research (described in more detail below under Educational Features of the Resource), and CENTER should plan to begin release of the basic platform within the first year of funding and beta versions of the first set of educational units within the second year of funding. Describe how CENTER will manage these collaborations and streamline the process for integrating educational content from METER awardees into the educational units hosted on the resource platform. Describe the process for harmonizing format and user experience across educational units, including an attractive and standardized appearance, similar modes of information delivery and user engagement in each unit, seamless transitions between educational units, standardized methods for solicitation of feedback, and plans for updating, modifying, and adding educational units over time. Provide an estimate for how many educational units CENTER will have the capacity to release in each funding year.

Educational Features of the Resource:

Explain how CENTER will utilize educational and technical expertise to produce engaging and effective educational units for the resource from content provided by METER awardees. Biomedical researchers across various disciplines and career stages should be able to use these educational units easily and effectively. Describe the intended audience(s) and how the educational resource and its units can be adapted to various educational and laboratory settings. Provide specific, measurable, and attainable training goals.

Scope:

Although the final list of subject matter to be included in the educational units will be developed after funding decisions have been made, CENTER should outline its vision for producing 30-50 educational units to be included in the online resource.

Educational components for each unit will include, but not be limited to, the following:

  • 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, video, animations, active learning exercises)
  • Instructional supports for all learners and opportunities to relearn and master material
  • Additional resources for added detail, advanced users, or specific disciplines

Applicants should describe a vision for how the educational resource will address each of these components and achieve the educational needs of a variety of users. Explain how CENTER will ensure that an individual user can easily select the differentiated content with which they wish to interact, an individual educator can incorporate their own customized and practical scientific examples, and diverse and culturally sensitive perspectives are included in scenarios and examples.

Educational Approaches:

Describe how CENTER will collaborate with METER awardees to produce effective digital content delivered with the highest educational principles for each educational unit. Describe plans to incorporate expertise in educational technology, educational techniques, curriculum design, and pedagogy into CENTER and to provide assistance in these areas to METER awardees while they develop scholarly content for the educational units. Explain how CENTER will produce digital materials using effective and engaging educational approaches, including but not limited to video production, creation of interactive activities, train-the-trainer dissemination strategies, and learning assessment.

Describe how CENTER will ensure conceptual breadth and depth within educational units, including how the content will be differentiated and provide instructional supports according to the educational needs of individual users at different career stages and baseline ability or familiarity with the subject matter. Clarify how educators will be able to compile individual educational units into customized curricula, including the ability to substitute examples, and how individual users will be able to specify the exact units, modes of learning, and level of detail with which they would like to engage the material.

Describe how CENTER will employ evidence-based methods to promote an effective, supportive, and inclusive learning environment within the resource. Educational approaches and principles that should be integrated into all applicable aspects of the resource include, but are not limited to:

  • 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)

Resource Evaluation Plan:

Describe in a section entitled “Resource Evaluation Plan” the plans and proposed timelines for piloting and assessing the educational resource and individual educational units. Collaboration with experts in higher education assessment design is encouraged. Applicants should plan to test functionality in an iterative fashion, measure educational effectiveness, and update content on an ongoing basis and with input from members of the scientific communities that will potentially use the resource (e.g. graduate students, laboratory scientists, educators, rigor champions, and academic institutions). Describe how CENTER will evaluate the resource and its educational units for usage, the ability to foster user learning, inclusion of diverse and underrepresented individuals, and effectiveness in raising awareness and empowering utilization of the principles of rigorous research. The applicants must specify baseline metrics as well as measures to gauge the short- and long-term success of the resource in achieving its objectives. If possible, the evaluation plans should include a comparator group (e.g. individuals with similar demographics and aptitude metrics who are at a similar training level but did not participate in the training) or provide a framework for determining whether the training activities were effective and did not simply recruit talented individuals already on a successful trajectory. Metrics should go beyond self-reported gains and include independently verified outcomes. Describe how CENTER plans to partner with METER awardees and other relevant stakeholders, including subject matter experts, rigor champions, educators, evaluators, those from underrepresented groups, and potential users, to devise and execute evaluation activities. Applicants should also describe plans for responding to assessments, evaluations, and feedback, including by integrating changes into the resource over time. Applicants may include evaluation instruments, including blank surveys, questionnaire forms, interview questions, or systematic review protocols in the appendix as instructed in the SF424 (R&R) Application Guide.

Resource Dissemination Plan:

Describe in a section entitled “Resource Dissemination Plan” the specific plans to publicize and freely disseminate the educational resource and relevant associated materials (e.g. open-source software, syllabi, handouts, train-the-trainer materials, evaluation outcomes) broadly to the research and higher education communities. Plans must be provided to ensure a diverse group of individuals benefit from the educational resource. Efforts may include web postings, publishing of articles in relevant peer-reviewed science or education journals, presentations at scientific meetings, public demonstrations, collaborations with non-profit organizations or institutions of higher education, workshops for educators and laboratory leaders, and other activities. These activities should aim to increase the awareness of and adoption of the resource, create buy-in from the scientific community, measure and improve relevance of the resource to the scientific communities it serves, increase understanding of and appreciation for the principles of rigorous biomedical research, and maintain transparency about progress. Describe how CENTER plans to collaborate with METER awardees and other stakeholders to devise and execute dissemination activities and evaluate their effectiveness. See also the expectations for sharing resources in the instructions for the Resource Sharing Plan below.

Additional Application Elements:

Milestones

A detailed set of specific milestones must be proposed as part of the Research Strategy section that will need to be met to accomplish the aims. Annual milestones must cover all aspects of CENTER with metrics that document progress toward the achievement of the ultimate goals. Milestones should include timely development, evaluation, release, and expected usage of the educational resource and individual educational units as well as clear communication and outreach timelines with NINDS and other stakeholders. 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. The clarity and completeness of the application with respect to specific goals and milestones are critical.

Letters of Support

A letter of institutional commitment must be attached as part of the Letters of Support. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned resource. 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: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, must address a plan for freely sharing the educational resource, associated data, and open-source components produced from the proposed project. The data and resource sharing/dissemination plan should minimally include the following elements:
    • Plans for monitoring the timely accomplishment of the activities described in the sharing plans.
    • An overall description of the anticipated deliverables, including the digital platform, and how they will be advertised and made available to a broad, diverse community. All data and resources produced by CENTER should be open-source where possible and widely distributed to the national and international scientific community at no cost to individuals, consistent with achieving the goals of this program. The resource must also be compliant with Section 508 of the Rehabilitation Act (29 U.S.C.§794 d) as amended by the Workforce Investment Act of 1998 (P.L. 105 – 220) to ensure accessibility by individuals with disabilities.
    • A plan for clarifying the mechanism(s) by which external stakeholders will be able to customize, modify, and update the resource content over time, including the educational units, consistent with this initiative.
    • Policies for access and sharing, including for appropriate protection of user privacy, confidentiality, and security.
    • Availability of all standard operating procedures, documentation, resource parameters, source materials, open-source components, and guidance documents, including those that allow for harmonization across units, to maintain full transparency regarding the structure and development of the resource.
    • Equitable dissemination to the broader research community of any technology, data, educational content, and resources generated from CENTER educational resource components.
    • A plan for sharing software that is not open source developed under this award. There is no prescribed single license for software produced through grants responding to this FOA, but a plan for dissemination of software produced through this award should address, as appropriate, the following goals:
      • Software source code should be well-annotated and freely available to biomedical researchers and educators in the nonprofit 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 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 award recipients 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 GPF 8.2.3 will apply.
    • Applications which do not describe resource sharing plans with all the required elements will be considered incomplete to this FOA.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

, with the following modifications:

Applicants may include the following items in the Appendix:

  • Screenshots of graphic designs, website layouts, or storyboards for digital platform components
  • Standard operating procedures and documentation for software development
  • Blank surveys, questionnaire forms, interview questions, systematic review protocols, or other validated instruments used in the evaluation of educational technology
PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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. See Section III of this FOA for information on registration requirements.

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. 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:

  • Centers that do not incorporate expertise in digital platform development, education, and evaluation.
  • Centers that do not provide project timelines that include building capacity and infrastructure within the first year of funding so that CENTER is prepared to release the basic platform within the first year of funding, compile the first set of educational units during the second year of funding, and evaluate and disseminate educational units during the third, fourth, and fifth years of funding.
  • Centers without a collaboration plan, including the organization of annual meetings.
  • Centers without a resource evaluation plan.
  • Centers without a resource dissemination plan.

 

Prior Consultation with Scientific/Research Staff

Consultation with relevant Scientific/Research staff is strongly encouraged, not later than the Letter of Intent due date. This is not the same as the Letter of Intent and should be included as a separate communication to the Scientific/Research Contacts (see Section VII). If requested by the applicants, staff can advise whether the proposed project meets the goals of this FOA and the mission of NINDS and discuss responsiveness questions. Staff will not evaluate the technical and scientific merit of the proposed project; technical and scientific merit will be determined during peer review using the review criteria indicated in this FOA. During the consultation phase, if the proposed project does not meet the programmatic needs of this FOA, applicants will be strongly encouraged to consider other Funding Opportunities.

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:

Applications responsive to this FOA support the development, maintenance, and dissemination of an educational resource imparting tools for understanding and utilizing the principles of rigorous biomedical research, which will play a significant role in improving the quality of basic, translational, and clinical studies. Accordingly, since the educational resource will be broadly distributed to the biomedical research community, reviewers will emphasize the technical features, educational approaches, scientific utility, resource effectiveness, and outreach strategies evident in applications to ensure the research value of this educational resource.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the proposed Center address the needs of the project that it will serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research resource?

Specific to this FOA:

Is there convincing evidence that the proposed plan for the Center will stimulate understanding and utilization of the principles of rigorous biomedical research by creating a harmonized, user-friendly, effective, and freely accessible resource? How well does the proposed educational resource address the needs of the scientific community? Is there strong potential for the proposed educational resource to measurably improvescientific research and training?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well-suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in developing and managing digital interfaces and implementing effective educational approaches? Do the applicants demonstrate significant experience and success with coordinating collaborative educational technology development, designing user-friendly web-based applications, evaluating educational impact, and serving the needs of the biomedical research community? If the Center is multi-PD/PI, do the applicants have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Specific to this FOA:

To what extent are the PD(s)/PI(s) committed to the Center and the principles of free and open sharing of research resources for training and education? Does the Center have appropriate expertise in digital platform or educational technology development, multi-media production, pedagogy and other educational approaches, laboratory-based biomedical research, development and evaluation of educational programs, and coordination of complex projects? Does Center leadership have adequate expertise in producing engaging and effective educational products? How are a diversity of perspectives represented in the Center leadership and team? Are the PD(s)/PI(s) poised to provide effective leadership to the entire project, including through coordination of Center expertise and collaboration and partnership with external stakeholders including government, academic institutions, research scientists, trainees, educators, non-profit organizations, and software and technology experts?

Innovation

Does the application propose novel organizational concepts, management strategies, or technology in coordinating the research resource the Center will develop? Are the concepts, strategies, or technology novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies, or technology proposed?

Specific to this FOA:

To what extent does the proposed Center employ technical and/or conceptual innovation(s) for the production and sharing of the educational resource on the principles of rigorous research? How well will the proposed Center employ novel approaches and technologies, unique or novel collaborations, and innovative approaches to fostering relationships between educational technology experts and the broader biomedical research community? Will the educational resource be innovative and novel? Is there a high likelihood that the educational resource proposed will remain nimble and scientifically current to the greatest extent possible, given rapid advances in scientific research, educational approaches, and information technologies?

Approach

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research resource the Center will develop? Will the applicants promote strategies to ensure a robust and unbiased approach across the Center, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the Center is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the Center? Are an appropriate plan for work-flow and a well-established timeline proposed? If applicable, have the applicants presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

Specific to this FOA:

How will the administrative structure of the Center, including any advisory committees, contribute to its probability of success? Are appropriate leadership, governance, and oversight of the Center proposed? Is the proposed structure adequate to support and encourage optimal interactions and collaborations across components of the Center and among investigators, industries, and fields of expertise, including the coordination, integration, and evaluation of activities and progress in a timely manner? Is there an appropriate plan to maintain communication and collaboration throughout the project, including through Steering Committee meetings? Is the plan for organization of annual meetings likely to foster collaboration, partnership with the scientific community, and the highest quality educational resource?

How well does the proposed Center provide adequate infrastructure and support to produce a platform and set of educational units that will be of high educational value to diverse scientists (e.g. those with disabilities, from underrepresented backgrounds, at different career stages) in a variety of educational and research contexts (e.g. classroom, individual learning, laboratory)? Will the proposed educational resource be open-source and freely available, accessible, easily discoverable, user-friendly, attractive, representative of diverse perspectives, engaging, modular, adaptable, and upgradable? Will effective and engaging multi-modal approaches be employed in the educational units (e.g. text, video, graphics, animations, interactive features, activities)? How well does the proposed educational resource employ evidence-based and effective educational techniques? Will the educational units be effectively harmonized across the educational resource and modifiable, including by updating outdated content, adding new educational units, and customizing scientific examples over time? Will users easily be able to select the educational units, individual components within educational units, and differentiated levels of detail with which they would like to interact?

Is there an adequate plan for evaluating and modifying the resource in response to user feedback and to technological, scientific, and educational advances? Are evaluation criteria reasonable and likely to measure how effectively the resource improves both understanding and practice of principles of rigorous biomedical research? Will the Center effectively partner with external stakeholders (including those from underrepresented groups, rigor champions, and active scientists) to ensure a resource that is of the utmost relevance to the biomedical research community? Are plans for disseminating the educational resource to the scientific community appropriate and likely to promote awareness, understanding, and utilization of rigorous research practices? Will dissemination of the resource be equitable among diverse scientists and institutions (including underrepresented groups)? How likely is the plan for the educational resource and outreach to the scientific community to change scientific practice in biomedical research? If applicable, does the application provide an adequate strategy to address any intellectual property issues?

Is the Resource Sharing Plan reasonable? Does the proposed sharing plan take existing resources into account, and is it responsive to the broad sharing requirements as described in this FOA? Will the educational resource and any accompanying materials be provided open-access where applicable and freely to the scientific community?

Environment

Will the institutional environment(s) in which the Center will operate contribute to the probability of success in facilitating the consortium it serves? Are the institutional support, equipment, and other physical resources available to the applicants adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling and information resources?

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 that will need to be met to accomplish the work set out above in a five-year time frame, including release of the basic platform within the first year of funding, compilation of the first set of educational units during the second year of funding, and evaluation and dissemination of the educational units during the third, fourth, and fifth years of funding? Are the milestones for the Center robust and associated with clear, quantitative criteria for success? Will the overall milestones provide adequate information to evaluate annual progress of the Center 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

Not applicable.

Renewals

Not applicable.

Revisions

Not applicable.

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

See the Approach Criterion above.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Neurological Disorders and Stroke, 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 (NINDS). 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.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this 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.

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 awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. 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, 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 awardees 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees 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 CENTER, including setting project milestones with specific timelines and criteria for evaluation. The awardee 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 CENTER personnel, NINDS staff, Steering Committee members, External Advisory Committee members, Materials to Enhance Training in Experimental Rigor (METER) UE5 awardees, and external stakeholders as appropriate to foster collaborations and exchange information and ideas to accelerate progress towards the goals of CENTER.
  • Organizing and participating in regular meetings or phone calls of the Steering Committee, External Advisory 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.
  • Hosting and organizing, with programmatic and logistical input from the Steering Committee, annual meetings of CENTER investigators, METER awardees, and external subject matter experts, and attending and reporting on CENTER progress at these meetings.
  • Building, evaluating, and disseminating an educational resource on the principles of rigorous biomedical research, including integration of an estimated 30-50 individual educational units, that is effective, easily discoverable, user-friendly, attractive, engaging, modular, adaptable, and upgradable as required to meet the educational goals of CENTER.
  • Completing annual progress reports and providing written evidence of progress when requested by NINDS staff.
  • Preparing abstracts, presentations, and publications and collaborating with METER awardees and other stakeholders to make the public and scientific community aware of this resource.
  • Making data, software, and access to the educational resource 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 CENTER PD(s)/PI(s), Steering Committee, and METER awardees to ensure proper governance and conduct of CENTER.
  • Participating in External Advisory Committee and Steering Committee meetings.
  • Providing advice and guidance to awardees to facilitate CENTER activities and achievement of goals, disseminate information about CENTER 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 CENTER PD(s)/PI(s) or team, periodic site visits, meetings, fiscal review, evaluation of progress reports, and other stewardship activities.
  • Formally assessing CENTER progress on an annual basis, 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 CENTER 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:

  • Establishing a Steering Committee to provide regular guidance and feedback on CENTER activities, including the development, evaluation, and dissemination of the educational resource and planning of annual meetings. The committee should include at least one individual each from CENTER, NINDS staff, and the METER awards. Specific committee members should not be named in the grant application. Membership, frequency, and governance will be negotiated with NINDS staff after funding decisions have been made.
  • Establishing an External Advisory Committee to provide the Steering Committee guidance and feedback on CENTER activities, accomplishments, and areas for improvement. The committee should include individuals with relevant scientific, education, evaluation, and technical expertise who are not funded by CENTER or METER awards. Specific committee members should not be named in the grant application or contacted prior to award. Membership, frequency, and governance will be negotiated with NINDS staff after funding decisions have been made.
  • The government retains ownership of all data and tangibles developed under this project that are associated with the educational resource. NINDS and the awardee will jointly develop a plan to transfer components of or the entire educational resource to a new operator at the termination of this award if subsequent funding and continued approval have not been secured.
  • Changes to existing policies and procedures may be developed jointly by the awardee 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 awardee. This special dispute resolution procedure does not alter the awardee's 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 and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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.

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.

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

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 and 45 CFR Part 75.


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