Department of Health
and Human Services (HHS)
and Human Services (HHS)
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
UC2 High Impact Research and Research Infrastructure Cooperative Agreement Programs
None
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.
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.
Not Applicable
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.
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:
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:
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:
See Section VIII. Other Information for award authorities and regulations.
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.
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.
Not Allowed: Only accepting applications that do not propose clinical trials.
Need help determining whether you are doing a clinical trial?
NINDS intends to fund 1 award.
Making an award is contingent upon NIH appropriations and the submission of meritorious applications.
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.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
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.
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.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with 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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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:
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.
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:
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
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 |
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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.
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:
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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:
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:
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:
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:
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:
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:
, with the following modifications:
Applicants may include the following items in the Appendix:
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.
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
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
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.
This initiative is not subject to intergovernmental review.
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.
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:
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.
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.
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.
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).
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.
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?
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?
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?
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?
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?
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.
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.
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:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
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.
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.
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:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Areas of Joint Responsibility include:
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.
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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: 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
Devon Crawford
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1917
Email: devon.crawford@nih.gov
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: nindsreview.nih.gov@mail.nih.gov
Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.