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
NINDS Research Education Programs for Residents and Fellows in Neurological Disorders and Stroke (UE5 - Clinical Trial Not Allowed)
Activity Code

UE5 Education Projects - Cooperative Agreements

Announcement Type
Reissue of PAR-20-311
Related Notices
  • April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084
  • July 22, 2019- Requirement for ORCID iDs for Individuals Supported by R esearch Training, Fellowship, Research Education, and Career Development Awards Beginning in FY 2020. See Notice NOT-OD-19-109.
Funding Opportunity Number (FON)
PAR-24-079
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.853
Funding Opportunity Purpose

The NIH Research Education Program (UE5) supports research education activities in the mission areas of the NIH. The overarching goal of this UE5 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs.

 

To accomplish the stated over-arching goal, this NOFO will support educational activities with a primary focus on:

  • Research Experiences
  • Workshop for Career Development

Key Dates

Posted Date
February 14, 2024
Open Date (Earliest Submission Date)
March 15, 2024
Letter of Intent Due Date(s)

30 days before the application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
April 15, 2024 April 15, 2024 Not Applicable July 2024 October 2024 December 2024
January 28, 2026 January 28, 2026 Not Applicable July 2026 October 2026 December 2026

All applications are due by 5:00 PM local time of applicant organization.

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

Expiration Date
January 29, 2026
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 How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

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

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

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

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

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


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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

 

 To accomplish the stated over-arching goal, this NOFO will support educational activities with a primary focus on:

  • Research Experiences: The primary goal of this UE5 program is to provide participants with the skills, education, research experience and preliminary data needed to successfully compete for individual research funding. As preparation for a career as a leading clinician-scientist, the following subjects should be included as formal educational elements of this program: principles of experimental design, principles of statistical methodology, data analysis skills that are specifically tailored to the applicant’s needs, grant writing and presentation skills. In addition, participants and faculty are expected to engage in regular discussions about ethical and successful scientific practices. Formal training in the responsible conduct of research is required. Other than for these specific purposes, or for those participating in a Ph.D.-granting program, it is expected that participants will engage in little or no coursework while participating in this research education program. Supported activities should be restricted to those that will directly aid the participant in developing a significant research project and the skills that will allow them to obtain individual research funding for the proposed project.
  • Workshop for Career Development: All participants in the NINDS UE5 program, including PD/PIs and supported residents and fellows, are expected to attend and participate in the annual UE5 workshop specific to this NOFO. This workshop will bring together the residents, fellows and faculty in this program to discuss research project development, navigation of a career as a clinician-scientist, and the transition from residency and fellowship to successful competition for individual research career development and research awards. The workshop will feature presentations by, and targeted discussions among, both junior and established researchers, including some who have recently transitioned to career development awards. The meeting will also include sessions that are individualized for each specialty, small group breakout sessions and many opportunities for networking and mentoring. All residents and fellows in attendance will also present a poster or oral presentation of their on-going or planned research and discuss their planned, next grant submission specific aims with designated mentors.

Overview of this NINDS Research Education Cooperative Agreements (UE5) Program
There is critical need for physician-scientists with the medical training and research experience to conduct basic, clinical, and translational research on the mechanisms, cure, and treatment of neurological disorders. NINDS provides mentored career development awards (K08 and K23 mechanisms) to highly qualified physician-scientists who have early training and experience in research, and who generally have one or more significant, original research publications. However, there is need for a mechanism to support the early education of clinicians during the residency/fellowship period, which will help them develop a highly significant research project and research-related skills that are needed 1) to develop sophisticated research skills and 2) to compete successfully for the mentored career development awards. Earlier education in the development of a research program will speed the transition from residency to K award, and consequently from mentored to independent research position. Moreover, early strong education in the scientific method, which includes a thorough understanding of experimental design, statistical methodology and quantitative analytical approaches, will promote the conduct of valid, reliable, robust research that is needed to successfully move scientific fields forward, as well as develop treatments and cures for neurological disorders and diseases. This UE5 Program is designed to foster the development of clinician-scientists through research and educational experiences, and to prepare clinicians to successfully compete for individual NIH mentored career development awards in neuroscientific research areas.

It is expected that participants will conduct basic, clinical, or translational research in a well-funded (NIH or comparable) research laboratory and have one or more mentors with a strong track record in the training of future scientists. As part of their research education, it is expected that participants will obtain strong, formal education in experimental design, statistical methodology and general principles of rigorous data analysis, which are necessary to conduct rigorous experimental studies in their chosen research area. In addition, it is expected that participants will receive education in the non-research tools and skills necessary for a successful transition to an individual award. Hallmarks of these programs will be the immersion of participants in a significant research problem and an environment that provides high quality mentoring in all aspects of research, ethical scientific conduct and career development required for success as a physician-scientist. The immediate goal of this program is to prepare clinicians to successfully compete for individual mentored career development awards. Such success will facilitate their transition from resident/fellow to independent physician-scientist, and thus foster contributions to research into the mechanisms, etiology, and treatment of neurological diseases by investigators with a profound clinical knowledge of those diseases.

Participants are expected to apply for individual funding (either a mentored career development award (NIH K equivalent) or individual research grant (NIH R01 equivalent) by the end of their involvement in this UE5 program (described in more detail below).

Research Education Program Structure
Applications will be accepted for this notice of funding opportunity from accredited Medical Schools and/or hospitals that oversee residency programs that support outstanding opportunities for residents and fellows to participate in intensive, mentored research education experiences during residency and fellowship training. It is anticipated that most supported participants will be in Neurology, Pediatric Neurology, Neurosurgery, Neuropathology, Neuroradiology, Anesthesiology or Emergency Medicine. Programs should encourage residents and fellows from these and other subspecialties to participate, as long as they are conducting research clearly within the mission of NINDS and are committed to fulfilling all requirements of the program. Programs should seek to ensure that there are strong scientific interactions among the entire cohort of participants and mentors, from all participating residencies, where discussions among the group about scientific methodology, data analysis, ethical issues in research  and scientific content will enhance the education  of all within the research environment. The PD/PIs, as well as program leadership, must have a full-time faculty appointment at a Medical School and be a member of a Neurology, Neurosurgery and/or Pathology Department or Program.

The structure of the research education program at each institution will be unique and should focus on resources and faculty expertise at the applicant institution. All programs should include extensive laboratory and/or clinical research experience, including the collection of data that can be used by the participant in an application for individual funding. All participants must be thoroughly educated in the principles of experimental design and hypothesis testing, data analysis, the many sources of bias in experimental studies, grant writing and presentation skills. Although this program does not provide sufficient time to obtain an expert knowledge in statistics, programs must ensure that all participants have a thorough understanding of the basic principles of statistical methodology (e.g. the importance of, and determination of adequate sample size, sources of error due to inadequate sample size, the value and limitations of correlations, the appropriate use of frequentist or Bayesian statistical tests, an understanding of statistical significance, etc.).

As the primary goal of this UE5 program is to provide participants with the skills and experience needed to successfully compete for individual research funding, grant writing and presentation skills (both oral and written) should be treated as critical components of the program. Formal activities to hone these skills should occur at the UE5 institution and should be addressed prior to the UE5 workshop, during which activities will further enhance these skills.

Training in the responsible conduct of research (RCR) is required, and regular discussions about ethical and successful scientific practices (ESSP) are expected to occur among all participants and program faculty. Other than for these specific purposes, or if enrolled in a Ph.D.-granting program (see below), it is expected that participants will engage in little or no coursework while participating in this UE5 program. Supported activities should be restricted to those that will directly aid the participant in developing a significant, high quality research project and the skills that will allow them to obtain individual research funding for this project.

UE5 programs may focus on research education applicable to basic, clinical, or translational research, or any combination of these three, depending on their area(s) of research strength. Applicants are encouraged to clearly explain the reasoning and goals behind the choice of program focus.

Prospective applicants are strongly encouraged to contact the NINDS Director of Training and Workforce Development early in the application preparation phase to discuss award provisions. Such contact can help ensure that applications reflect the goals expressed in this announcement.

Participant Support
Participating residents and fellows must be supported for a minimum of 6 months during residency and may be supported up to a maximum of 36 months (up to 72 months for those enrolled in Ph.D.-granting programs by the start of the first fellowship year). Support occurs in increments. Each increment (or period) of funding occurs between July 1 and June 30, in order to coincide with clinical schedules.

  • The first increment of funding, which must occur during residency, may be for 6 to 12 months in duration; at least 6 months of UE5-supported research education during increment 1 must be contiguous.
  • A second increment of funding may be requested for support during a fellowship year (or where applicable, a 2nd residency year). The duration of the second period of support, combined with the duration of the first period of support, must total a minimum of 18 months.
  • A third and final increment of support may be requested for an additional fellowship year. Thus, up to 24 months of support may be obtained during fellowship years (up to 60 months for those enrolled in a Ph.D.-granting program). However, to obtain more than 18 months of post-residency (or post first-increment) support by this UE5 program, participants must submit a high quality individual mentored K award application (or NIH R01 or equivalent) within the first 18 months of post-residency support (within the first 30 months for those enrolled in a Ph.D.-granting program).For example, a typical, but not required, support path for a neurologist might be 6 months during residency, then 12 months during a first fellowship year and 12 months during a second fellowship year. However, the last 6 months of support during this example 30-month path would be contingent on submission of a high quality, individual mentored K or R01-equivalent award application during the first 18 months of post-residency UE5 support. Thus, to maintain UE5 support between the 18th and 24th month of post-residency UE5 participation, most individuals must submit an NIH K or R01 equivalent at the October grant due date during the 3rd increment of support. 

During any supported period, participants must devote 80% of full-time professional effort (e.g. during a 6 month support period, this would equal 4.8 person months; during a 12 month supported period, this would equal 9.6 person months etc.) to this research education program. This 80% commitment by the participant must occupy 4 full, uninterrupted days during the Monday through Friday workweek. Supported time during residency must include at least one block of time with a minimum continuous duration of 6 months. Support during residency may occur during a single Post-Graduate Year (PGY) or in a contiguous period split between two PGY years. This 80% effort requirement also applies to neurosurgery residents. However, neurosurgeons may reduce their effort to a minimum of 6 person-months (50%) full-time professional effort after having had a total of 12 months of UE5 support at 80% effort. This is consistent with the Career Development (K) award accommodation that allows neurosurgeons to devote a minimum of 50% of full-time professional effort to research while supported by a K award.

Eligibility for continuation of support for participants
Participants must commit 80% effort for a minimum period of 6 months during residency to be eligible for continued support during a fellowship period. The program’s intent is to provide up to 2 years of fellowship funding (or a second year of residency and subsequent year of fellowship funding) to all participants who are initially funded during residency by the UE5, provided satisfactory progress and adherence to UE5 program expectations and deadlines are met. A one to two-year gap in time between the end of residency and UE5 support during fellowship is acceptable if the gap is required to obtain clinical subspecialty training. Research activity between a second and third increment of support must be continuous (i.e. a gap between the second and third increment years is not allowed). Whereas the UE5 is intended to support fellows and not faculty, funds may be used for those in junior, non-tenure track faculty positions when the faculty position immediately follows a UE5 fellowship year. However, even if in a faculty position, the UE5 will provide a PGY 7 level of salary support (the 80% effort requirement will remain and any salary differential between the PGY 7 salary and the faculty level salary will be expected to be made up by the institution).

In addition to the on-site research education they will receive, participants are expected to attend national and/or international meetings to present their work and network with other researchers in their fields. Participants are also expected to attend the annual NINDS UE5 workshop designed for this program once for each increment of funding that they receive (more information on this below).

Selection of participants for support
Programs should select participants proposed for support based on evidence of well-conceived plans to develop a strong research project under the guidance of a mentor who has provided plans for effective mentorship towards the goals of the participant. These plans should include a specific timeline of accomplishments that can be anticipated to lead to transition to an NIH K award, R01 or equivalent by the end of the 3rd increment of UE5 support. Once participants are selected, requests for support of selected participants are submitted to the NINDS Office of Training and Workforce Development (OTWD) for approval. The due date for support requests for participants is October 15th in the year prior to the July 1 start date of funding. Funding is provided for a single year at a time, running from July 1 to June 30 in order to coordinate with clinical schedules. The following information must be provided to NINDS OTWD for each proposed participant, both new (increment 1) and continuing (increments 2, 3), for consideration of support:

1. A letter from the PD/PI introducing the applicant (name, residency, career stage, increment of support requested).

2. A plan for the research project and any education/training intended to lead to a K award application, written by the resident/fellow (4 page maximum).

3. If the request is for continued support of a previously supported participant, a brief progress report written by the resident/fellow (up to 3 pages). This must include a description of participation in ESSP discussions.

4. A statement written by the mentor that describes the mentorship and training plan and plan for transition to a K award

5. If there are multiple mentors, a description of each mentor’s role, including frequency of meetings with the participant and with all other mentors.

6. A description of the source of funds that will be made available for the project, and confirmation of availability by the individual providing the funds.

7. For any resident or fellow who is not from one of the primary residency programs in the application, a letter from the Chair of that resident’s home department describing the oversight and support that will be provided for that individual to facilitate success in achieving the goals of this program.

8. Facilities and/or resources that are necessary to conduct the research and permissions, where required, to access these facilities and/or resources.

9. If the participant is enrolled in a PhD program, a description of the PhD program specific to the participant.

10. Updated biosketches for the participant and all mentors.

In general, any candidate who is approved by NINDS for initial support during residency (increment 1) will be supported for up to 2 more increments, if requested. However, continuation of support in 2nd and 3rd increments is contingent upon timely (i.e. by October 15 of the appropriate year) submission by the PD/PI of a high-quality application for continuation and appropriate progress by the participant during the prior increment, which includes participation in all UE5 program activities and the UE5 annual meeting. Note that budgetary limitations make it likely that not all applications submitted by PD/PIs will be supported by NINDS. Moreover, depending on the number and quality of requests received for support of individuals within the program, it is possible that, in any particular year, institutional programs will not receive support for any candidates for which funding is requested.

Availability to residents from multiple departments/clinical specialties
Multiple residency programs at a single institution are encouraged to submit an application together. It is encouraged, but not required, that each participating residency (of neurology, neurosurgery and/or neuropathology) contribute to the leadership structure. It is expected that residents from any clinical specialty who are doing research within the NINDS mission and who wish to participate will have access to the program. These residencies may include, but are not limited to, Neurology, Neurosurgery, Pediatric Neurology, Neuropathology, Neuroradiology, Anesthesia and Emergency Medicine. Structurally, programs should be designed with a focus on one or more primary residencies (for example, Neurology, Neurosurgery, Pediatric Neurology, Neuropathology or some combination of these), but have a plan by which residents from any clinical specialty can participate. Programs must describe not only how they will select and oversee participants within the primary residencies supported but also have a plan for selection and oversight of residents/fellows from outside the primary residencies to ensure that they have an equal chance of both support and success. Programs should also have a plan by which residents and leadership from other relevant departments will be informed annually about the availability of this program. For participants from non-primary residencies their Chair, in coordination with the PD/PIs, should design an approach to contribute to the support and success of its own residents/fellows.

Participant enrollment in a Ph.D.-granting program 
Participants who have a clinical doctorate, but not a research doctorate, may wish to enroll in a Ph.D.-granting program during the UE5 period. Whereas clinicians can obtain outstanding research education and experiences without a research doctorate, obtaining the research doctorate can provide educational opportunities, as well as outstanding research skills, not easily obtained without one. Participants may be supported by this UE5 if simultaneously enrolled in a Ph.D.-granting program as long as the goals, research and educational activities of the two programs are overlapping, and the goals of the UE5 research education program are met. Participants simultaneously enrolled in a Ph.D.-granting program may be supported by this UE5 for up to 5 years post-residency. As with all participants, support is provided on a yearly basis contingent on appropriate progress. To obtain this benefit, participants must be enrolled in the Ph.D.-granting program by the start of the first fellowship year.

Transfer of support to other institutions with similar UE5 programs
In some cases, participants who begin in this UE5 program during residency may wish to change institutions for fellowship training. If the proposed fellowship training institution has a UE5 program supported by this NOFO, residents and fellows may continue their research education program at this new institution. As in all cases, support must be requested by the new, sponsoring institution via the standard process associated with this UE5 award.

Participation in the annual NINDS workshop for this UE5 program
NINDS organizes an annual workshop, typically held in March, for all supported UE5 participants, the PD/PIs and other invited faculty. Acceptance of funding by the PD/PI for participants is made with the understanding that supported participants will attend and fully participate in all aspects of this workshop. This includes, but is not limited to; registering for the UE5 workshop by the set deadline, submitting a polished specific aims page for their anticipated upcoming grant application (for all second and third increment participants), presenting a poster or oral presentation that conforms to workshop guidelines, promptly attending all assigned meetings and mentoring sessions etc. Attendance at the annual meeting during each year in which a participant received UE5 support is a mandatory component of the UE5 program, and those who do not attend will not be automatically eligible for continuation of funding by additional increments (note that exceptions will not be made for clinical responsibilities, but under rare and unusual circumstances that involve health-related issues or unavoidable conflicts, participants may request approval from the NINDS Director of Training and Workforce Development to attend in a different year). The PD/PI(s) or a program representative are also expected to attend this workshop every year, as their participation in all aspects of the workshop are critical to its success. Funds are provided in the award each year specifically intended to support PD/PI attendance at the workshop.

Evaluation of program success
The primary indicator of success of these programs will be the ability of participants to 1) successfully compete for individual, NIH career development awards, equivalent individual awards or an NIH R01, and 2) in the long term, continue their research career beyond the career development stage. It is anticipated that many applicants will publish original research papers that result from work done during this research education period, and in addition, many will obtain academic faculty positions. However, the most important outcome of this UE5 research education program will be the successful competition for major individual funding award, such as an NIH K or R01, for continued research by the participants. Programs will be evaluated primarily on the success of participants in obtaining individual funding and secondarily on progress made by its participants towards this goalin  progress made by its participants towards this goal.

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

Section II. Award Information

Funding Instrument

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New
Renewal
Resubmission

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 NOFO.

Clinical Trial?

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

Funds Available and Anticipated Number of Awards

Because the nature and scope of the proposed research education program will vary from application to application, it is anticipated that the size and duration of each award may vary. Although the financial plans of the NINDS include providing support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations.

Award Budget

Application budgets must reflect the actual needs of the proposed program and may not exceed $850,000 direct cost annually.

Although the size of the award will vary among research education programs, applications must stay within the budgetary guidelines described in the Participant Costs section below. Each year, programs will request approval to support identified individuals based on the program’s selection process. These requests will then be evaluated by NINDS and final decisions provided. Note that NINDS may choose not to approve funding for all individuals selected by the program, and moreover, it is possible that NINDS may choose not to approve funding for any of the proposed participants within a particular program in a given year.

Institutions with active UE5s under this NOFO will be eligible to request support for participants each year by submitting requests to the NINDS Office of Training and Workforce Development. In addition, for every year in which a participant is supported, $10,000 will be provided for program costs. This is provided to support travel of the PD/PI (or program representative) to the annual NINDS-sponsored workshop and can also be used for PD/PI salary, support personnel or other allowable costs (funds may not be used to support mentor salary).

This award will provide funds to support salary plus fringe to the participants at the appropriate PGY level for 80% full-time professional effort (4 days per week during the Monday through Friday workweek) for between 6 and 12 months per year (e.g. 4.8 - 9.6 person-months). Salary support must be calculated as the duration of 80% research effort multiplied by the base salary level of the participant according to the PGY salary level set by the institution. Funds can only be used for participants while they are participating in this research education program, and cannot be transferred to individuals other than those approved for participation in this program. Note that, although funds are provided to support the PGY salary of the participant, they may be used to support other allowable research education costs as long as 1) the participant’s salary is fully funded for the required 80% effort during the program participation and 2) it is deemed advantageous to the success of the participant (funds provided for the participant must be used to directly support the participant’s research education and may not be used for mentor, PD/PI or administrative support). If the supported participant is enrolled in a Ph.D.-granting program, additional funding of up to $12,800 may be requested to defray expenses directly associated with enrollment in the Ph.D. program (note that this support will be prorated, based on a maximum of $12,800 being provided for a participant who devotes 80% effort for 12 months to the UE5 research education program while incurring these expenses)

Up to $4,000 per year may be requested for each participant to travel to the NINDS-sponsored workshop for UE5 participants and other scientific conferences or educational opportunities that will directly enhance the experience provided by this program and which will lead towards the stated goal of this award. This support is provided with the understanding that the participant will attend the NINDS-sponsored workshop, which is a required component of this research education program.

Expenses for foreign travel are allowable but must be justified.

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

Award Project Period

The maximum period is 5 years.

Other Award Budget Information

Personnel Costs

Not applicable

Participant Costs

This UE5 award will provide funds to support salary plus fringe to the participants at the appropriate PGY level for 80% full-time professional effort (4 days per week during the Monday through Friday workweek) for between 6 and 12 months per year (e.g. 4.8 - 9.6 person-months). 

Salary support should be calculated as the duration of 80% research effort multiplied by the base salary level of the participant according to the PGY salary level set by the institution. 

Funds can only be used for participants while they are participating in the research education program, and cannot be transferred to individuals other than those approved for participation in this UE5 program. Note that, although funds are provided to support the PGY salary of the participant, they may be used to support other allowable research education costs if as long as the participant is fully funded for the required 80% effort during UE5program participation and it deemed advantageous to the success of the participant (funds must be used to directly support the participant’s research education and may not be used for mentor, PD/PI or administrative support). 

If the supported participant is enrolled in a Ph.D.-granting program, additional funding of up to $12,800 may be requested to defray expenses directly associated with enrollment in the Ph.D. program (note that this support will be prorated, based on a maximum of $12,800 being provided for a participant who devotes 80% effort for 12 months to the UE5 research education program while incurring these expenses). 

Up to $4,000 per year may be requested for each participant to travel to the NINDS-sponsored workshop for UE5 participants and other scientific conferences or educational opportunities that will directly enhance the experience provided by this program and which will lead towards the stated goal of this award. This support is provided with the understanding that the participant will attend the NINDS-sponsored workshop, which is a required component of this research education program. 

Expenses for foreign travel are allowable but must be justified.

Other Program-Related Expenses

Not applicable

Indirect Costs

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

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

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)


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

Only one UE5 application per institution will be accepted for review. It is anticipated that applications will generally come from an accredited medical school. However, it is recognized that many accredited medical schools are affiliated with one or more hospitals, and that funding for residents may be managed by an affiliated hospital. If necessary, the hospital that manages the funding of residents may be the applicant institution. However, the PD/PI of the UE5 application must have a full-time appointment in the appropriate academic department in the medical school and an appointment at the applicant institution. 

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

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

Foreign Organizations

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

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

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

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF424 (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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

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

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

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

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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019

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

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

The Project Director/Principal Investigator (PD/PI) designs the research education program and provides oversight for the entire program. This person must hold a health professional degree (e.g., M.D. or equivalent), and must have a full-time faculty appointment in a Neurology, Neurosurgery, or Pathology Department in a medical school. If the sponsoring institution is a hospital affiliated with a medical school, the PD/PI must have an appointment in both the medical school and at the sponsoring institution.

The PD/PI will be expected to ensure that all participants fulfill all requirements of the program and attend the NINDS-sponsored workshop, and will submit all documents and reports as required. The PD/PI is expected to actively monitor participant progress and receipt of strong mentorship to ensure the highest likelihood of success for each participant. In addition, the PD/PI is responsible for ensuring that residents and leadership from other clinical specialties in which NINDS-relevant research is done are aware of the existence of the program and their ability to participate.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Program FacultyTo provide a wide range of perspectives to the residents and fellows, the program is encouraged to recruit researchers from diverse backgrounds, experiences, and perspectives to participate as program faculty and mentors. Mentors should have research expertise and experience relevant to the proposed program, be thoroughly aware of the goals of this program, and be committed to the success of their participant mentees in achieving the goal of this program. Ideally, mentors from multiple departments will be available, including non-clinician scientists. For many residents/fellows, it can be advantageous for gaining experience, different perspectives and building collaborations to work in a strong neuroscience-related laboratory and research environment outside of their home residency department. Consequently, participants are encouraged to consider selecting mentors with strong training records who are not clinician-scientists.  If participants do have non-clinician primary mentors, they should include a clinician-scientist from their specialty who has a record of research funding on their mentoring team to provide career-guidance, even if not scientific expertise.


 

Participants

It is expected that participants will be educated in, and conduct research in, areas that are relevant to the NINDS mission. Participants must be employed by the institution to which this award is made.

To be eligible to participate in this program, individuals must hold a clinical doctorate and be practicing clinically. They are typically in neurology, neurosurgery, pediatric neurology, neuropathology, neuroradiology, anesthesiology, or emergency medicine, but can be from any clinical specialty, as long as they are doing research that falls within the NINDS mission. Participants must be dedicated to pursuing a career as physician-scientists.

Participants must begin this research education program during clinical residency. Participants who complete at least 6 months of UE5-supported research during residency and fulfill the expectations and commitments of this UE5 program plan, which includes full participation in the annual UE5 workshop, will be eligible to obtain additional support during residency and/or fellowship years.

Support from this UE5 mechanism may be provided to both U.S. and non-U.S. citizens. However, this UE5 program is intended to facilitate transition of participants primarily to NIH mentored Career Development awards. Because non-U.S. citizens are ineligible for most of these awards, proposals to support non-U.S. citizens or permanent residents should be accompanied by a plan to transition to individual research career support equivalent to an NIH K08, K23 or R01.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed in this Notice of Funding Opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions will not be reviewed.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Director, Office of Training and Workforce Development
National Institute of Neurological Disorders and Stroke (NINDS)

Email: [email protected]

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information Component

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

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

Other Attachments

Applicants must submit the following attachments, as applicable.

Mentor Training History. Applications must provide the following information in tabular form: a list of research trainees sponsored by the proposed mentors over the last 5-10 years, and the outcome (subsequent position, independent funding), to the extent known, of this training. Only list the primary research trainees of the mentor. Trainees who have done rotations, brief training sessions or exclusively clinical training with the mentor should not be included. For each trainee, outcomes should be clearly listed (e.g. K award, other independent funding, independent research or non-research academic faculty, non-independent research faculty, private practice, etc.). For individuals who have mentored participants in this research education program previously (i.e. supported by the NINDS R25 for residents and fellows), outcomes of their previous R25/UE5 mentees should be included and clearly identified. Applicants may wish to use the sample format found at UE5 Template Table or may create their own table. This attachment should be submitted in PDF format and titled, “Mentor Training History.pdf”

Research Education History under the former NINDS R25 for residents and fellows (and subsequent conversion to UE5 program). Applications from institutions that received support from the former NINDS R25 Research Education Program for Residents and Fellows must provide specific details regarding all previous participants supported by that program. This information, which may be submitted in tabular form, should include the participant name, number of months supported by the R25/UE5, mentor name, project title, publications resulting from the R25/UE5 research education program, any awards or research funding obtained by the participant during, or subsequent to, R25/UE5 support, whether the participant attended the NINDS workshop for R25/UE5 participants and current position and institution of the participant. Applicants are advised to indicate which participants have completed the R25/UE5 program and which participants remain in training and eligible for additional R25/UE5 funding, so that reviewers have a clear understanding with which to evaluate outcome.

The application should present aggregate results that summarize the success of participants at obtaining research funding (i.e. NIH K, R01 or equivalent awards) for all participants who have completed the R25/UE5 research education program (i.e. those who are no longer in training positions and are not currently supported by the R25/UE5). If results have been less than desired by the PD/PI(s), the application should describe strategies to improve outcomes. This attachment should be submitted in PDF format and titled, “R25/UE5 Research Education History.pdf”

Chair Support for this UE5 program. Applications should include letters from Chairs of the Primary Specialties submitting the application as well as supporting letters from Chairs of other clinical specialties invested in the program. Chairs who express interest in participating in this program should state 1) their commitment to providing each selected resident/fellow with the full 80% protected time for research, as defined in this NOFO, during the supported period, 2) their commitment to providing sufficient time for the PD/PIs of the program to manage and oversee the both the program and the progress of each individual selected participant as designed in the application and 3) any financial or non-financial resources provided to the program and/or participants to facilitate their success. Letters should be written in collaboration with the UE5 PD/PI to clearly explain how interested residents from different residencies will be fully supported with respect to mentorship, oversight and application preparation. These letters should be in pdf format and attached within a single file titled, “Chair Letters of Commitment.”

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 Expanded

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

R&R Budget

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

  • Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
  • Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.
PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy

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

  • Proposed Research Education Program
  • Program Director/Principal Investigator
  • Program Faculty
  • Program Participants
  • Institutional Environment and Commitment
  • Recruitment Plan to Enhance Diversity
  • Plan for Instruction in the Responsible Conduct of Research
  • Plan for ethical and successful scientific practice
  • Evaluation Plan

Research Education Program Plan

Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program. As a reminder, applicants may choose to address one or more of the activities listed in Section I. Funding Opportunity Description.

Overall Program
The information should include a description of the education and/or career levels of the planned participants. Specifically, if residents in different clinical specialties will be supported in different training years, or will have different education levels at the time of participation, this should be clearly described.

A detailed description of the program must be presented. The description should include the timeline of participant training, including information on clinical and research education activities to be performed in all residency years (and fellowship years, if applicable). The program description should cover topics such as the selection of potential participants, plans for oversight of both the program and each individual participant’s progress by the PD/PI, the specific approach taken in the program regarding choice of project, choice of mentor, guidance for project completion, plans for skills training (grant writing, oral presentation, etc.), anticipated timeline for participant submission of an individual mentored or other award, and strategies designed to help participants meet this timeline and foster participant success.

Oversight of Mentoring and Participant Progression
The program description should include the approach by which program leadership will ensure that all mentors understand the goals of the program and understand the necessity of developing a mentorship and training plan that will foster success of the participant. As this is a fast-paced program, with an expectation of rapid transition from residency to NIH K award funding, applications should describe how program leadership will monitor the mentor-mentee relationship and progress made by the participant towards achieving the goals of the program on the expected timeline. The PD/PI should describe how the oversight approach (e.g. frequency of meetings, interface between program oversight individuals and mentors, etc.) is expected to ensure that the applicant and mentor have a productive relationship that will lead to a high likelihood of success in meeting program goals. In addition, the application should describe the approach to ensuring that all supported participants have “ownership” of their project, such that they will be able to pursue their UE5 project, and use the data collected during the UE5 support period towards that project, for their own individual research career development and funding, without competition on that project from their mentor.

Applications should describe the program’s approach to ensuring that participants being guided in their research by non-clinician mentors also have strong guidance in navigation of their dual clinical and research careers by a successful clinician-scientist.

Cohort Building
Applications should describe the programmatic approach to promoting strong interactions among the entire cohort of participants and mentors from all involved residencies. Applications should describe plans to facilitate regular meetings that will foster an exchange of ideas, experiences, and knowledge among all members of the program, including participants and mentors. These regular meetings could include, or be in addition to, program-wide discussions of Ethical and Successful Scientific Practices (see below).

Experimental Design, Statistical Methodology and Professional Skills
The application must describe the plan for ensuring that each participant receives a thorough education in principles of experimental design and hypothesis testing (with emphasis on the proper inclusion and design of controls), basic principles of statistical methodology (e.g. the importance of, and determination of, adequate sample size, sources of error due to inadequate sample size, the value and limitations of correlations, the appropriate use of frequentist or Bayesian statistical tests, an understanding of statistical significance, etc.), data analysis, the many sources of bias in experimental studies (both due to flaws in experimental design and implementation and issues such as publication bias), grant writing and presentation skills.

Initial Participant Details
Applications must provide the name, qualifications, mentor information and brief description of the research project of the first intended participant in this program (an award will not be made unless there is a named participant appropriate for the research education program in year 1; it is acceptable for applications to include an individual entering increment 2 or 3 as the named participant). A statement must be included from the named participant’s proposed mentor that describes the mentorship plan and the anticipated path by which the project will be suitable for a career development award application.

Ethical and Successful Scientific Practices (ESSP) 
Programs are expected to engage both participants (and optionally, others at a similar career stage) and participating faculty in regular discussions on building and navigating a scientific career both ethically and successfully. These discussions are in addition to NIH-mandated education in responsible conduct in research (RCR) and should extend and amplify upon topics covered by RCR. Applications must describe the specific plan and approach to meeting this expectation. Issues related to ethical and successful scientific practice are plentiful and constantly emerging. Examples related to the conduct of science would be anticipated to cover a wide range of topics, and might include, for example, issues related to the design, analysis and interpretation of experiments, reporting of analyses conducted and their results, acceptable and unacceptable practices in manipulating data for analysis, working in collaborative arrangements, storing information, sharing data, the inclusion and exclusion of data, working with animal and/or human subjects, negotiating about ownership of projects or reagents, responsibilities of mentors and mentees, acceptable and unacceptable practices when writing or reviewing manuscripts or grants, understanding how to interact with funding agencies, publishers and potential donors, how to successfully and ethically present data to different audiences, how to respond successfully and ethically to reviewer critiques of both grant applications and manuscripts, how to identify conflicts of interest when reviewing grants and/or manuscripts and, where relevant, how to interact with the public, patient population and potential donors about research and research funding. ESSP is not intended to be incorporated into a course or workshop. Rather, programs are expected to implement a process designed to create an environment in which these discussions become part of the regular educational culture among both faculty and participants within this UE5 program (and ideally, among all researchers within the residency/fellowship structure that forms the environment of the UE5 program).

The program must describe how regular discussions among faculty and participants (and potentially other relevant individuals) of the many issues that foster the ethical and successful practice of science will be fostered, describe an initial, tentative list of topics to be discussed, and describe the format of discussions (i.e., how discussions will occur, who will lead discussions, format of discussions, etc.). When multiple residencies are involved, applications should specifically describe plans for the implementation of ESSP across all participating residencies. Please note that the ESSP plan is distinct from the one-time RCR requirement which must occur once every 4 years described in section V. Completed activities, and the participants who fully participate in the activities associated with ESSP, must be fully described yearly in the Annual RPPR.

Coexistence of NIH T32 programs and this UE5 program 
When an applicant's department, or departments in related, clinical disciplines, have T32 training grants for the training of clinician-scientists, the PD/PI should briefly describe the purpose of those training programs, and what overlap, if any, exists. The PD/PI should also clearly describe the distinction between intended participants of this research education program and the intended population that would constitute trainees in the T32 program(s). Note that institutions may not have both UE5 and T32 programs that support an overlapping pool of potential candidates.

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

The application should provide a narrative description of the PD/PI record(s) in research and training that does not duplicate supportive information in the biosketch or Other Attachments, and should explain why the PD/PI(s) are the appropriate individuals to coordinate this program.

Program Faculty. To bring a wide range of perspectives to the education of participants and create vibrant intellectual environment, the program is encouraged to recruit researchers from diverse backgrounds, including individuals from underrepresented backgrounds and various disciplines and scientific perspectives to  participate as program faculty. Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles. The application should describe the basis for including and excluding faculty as potential mentors, and the process by which quality control of mentorship, and interventions if needed, will be determined. The application should provide a summary description of the participating faculty records in research and training as it refers to this selection process, which may reference but does not duplicate supportive information in biosketches and Other Attachments. Applications should also clearly describe how the program faculty as a whole will provide a wide range of scientific perspectives to the participants and intellectual environment of the program. If mentors will include faculty who are not clinician-scientists, provide an explanation as to how appropriate guidance specific to the needs of clinician-scientists will be provided to each participant.

The application must describe how the program will promote diversity of thought and an inclusive research environment. The program is encouraged to recruit faculty who can share divergent experiences, perspectives and backgrounds with program participants.

Program Participants. Applications must describe who the intended participants are (e.g. clinical specialties from which participants will be recruited, and the residency and fellowship year(s)) of the intended participants from each clinical specialty) and what specific educational and/or research background characteristics will be considered essential for participation in the proposed UE5 program. Applications should describe the approach to identification and selection of potential participants who are likely to succeed in the goals of the UE5 program.

The application must describe the track record of all participating residency programs in training clinician-scientists (e.g. how many individuals in previous 5-10 years, their names, the level of training [resident, fellow, mentored K, other], how many trainees received support from individual research grants, how many remain in research, and other details that will help the review committee determine the experience and prior success of the research training environment in advancing clinician-scientists).

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

The Institutional commitment to providing UE5 faculty time to achieve the goals of this program should be stated clearly. Specifically, the proposal should address the plans to ensure that UE5 faculty have time to participate in programmatic activities, such as ESSP, activities to educate participants in principles of experimental design and statistics, etc., and regular meetings that will foster an exchange of ideas, experiences and knowledge among all members of the program, including participants and mentors.

Because the goal of this research education program is to help transition participants from a research project started in residency to an individual K award, the application must describe the institutional commitment that will foster the ability of the participant to achieve this goal. For example, if there will be gaps in participation between increments of support, or between UE5 support and submission of an individual career development or research grant application, the application must describe any planned efforts by the institution, as well as any financial and/or non-financial resources provided, that will help participants maintain, and even advance, an on-going project during these gaps.

Recruitment Plan to Enhance Diversity (NOT-OD-20-031):

The applicant must provide a recruitment plan to enhance diversity. Include outreach strategies and activities designed to recruit prospective participants from diverse backgrounds, e.g. those from groups described in the Notice of NIH's Interest in Diversity. Describe the specific efforts to be undertaken by the program and how the proposed plan reflects past experiences in recruiting individuals from underrepresented groups.
 

Renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period, including successful and unsuccessful recruitment strategies.

For this UE5 program, it is recognized that the pool of potential participants is defined by the residents who joined the residency based on a complex, national matching mechanism. Applications must include a description of the institutional strategies and efforts to recruit individuals historically underrepresented in the clinical specialty into the involved residency programs. The application should describe the success of these strategies in recruiting individuals with a variety of backgrounds, perspectives, and experiences. If success has been limited, the planned changes intended to improve the representation of individuals with different backgrounds, perspectives and experiences should be described.Additional information on the required Recruitment Plan to Enhance Diversity is available at Frequently Asked Questions: Recruitment Plan to Enhance Diversity (Diversity FAQs).

Applications lacking a diversity recruitment plan will not be reviewed.

Plan for Instruction in the Responsible Conduct of Research. All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR).  The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction – instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019 and NOT-OD-22-055. The plan should be appropriate and reasonable for the nature and duration of the proposed program. Renewal (Type 2) applications must, in addition, describe any changes in formal instruction over the past project period and plans to address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

Applications lacking a plan for instruction in responsible conduct of research will not be reviewed. The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019. If such instruction is not appropriate for the proposed research education program, then the PD/PI must provide a strong justification for its exclusion.

Evaluation Plan. Applications must include a plan for evaluating the activities supported by the award.  The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.

Letters of Support

A letter of institutional commitment must be attached as part of Letters of Support (see section above: "Institutional Environment and Commitment.")

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

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

PLEASE DELETE TEXT

Appendix

Only limited Appendix materials are allowed. Follow the instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the 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 form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

The goal of this UE5 program is to support educational activities that will enable physician-scientists to compete successfully for mentored career development awards, or similar major research awards.

Overall Impact

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

Scored Review Criteria

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

Significance

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

Specific to the NOFO:

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

Investigator(s)

Is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

Specific to this NOFO:

  • Are the PD/PIs highly qualified to oversee this program, with the organizational and administrative experience and positions to achieve success in the goals of this program for all residencies represented? If this program has multiple PD/PIs, are the roles and commitment of each PD/PI clearly described?
  • Do the PD/PIs have the seniority and status in their respective departments to successfully enforce program policy and oversee and intervene, where necessary, in the mentorship of participants?
  • Do the PD/PIs have a strong record in training, education and mentoring that has led to successful development of clinician-researchers?
  • Do most mentors in the program have strong, recent histories of NIH or equivalent funding?
  • Do most mentors have a track record in the successful training of clinician-scientists?
  • What are the plans to ensure that mentors who lack a strong recent history of funding and/or a successful training/mentorship record will provide strong and successful mentoring?
  • Is there an adequate plan by the program to ensure that participants working with non-clinician mentors will obtain knowledgeable guidance regarding navigation of a clinician-scientist career?
  • How successful have the named mentors been in preparing trainees/mentees to compete for independent fellowships, career development awards and/or research funding?
  • How strong is the record of the primary residencies/departments in mentoring career development (K) awardees, and have those with K awards in this department obtained academic research appointments and launched successful research careers?

Innovation

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

Specific to this NOFO:

  • What is the plan by the program to facilitate the ability of residents and fellows to overcome obstacles and progress to career development awards and subsequent independent research careers?
  • If the applicant department has T32 training programs, did the applicant clearly describe 1) the distinction between this research education program and the T32 training programs and 2) the distinction between intended participants of this research program and the intended population that would constitute trainees in T32 training programs?

Approach

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

Specific to this NOFO:

  • Do the plans by the proposed program take advantage of existing strengths of the department(s) and mentors involved?
  • How feasible and appropriate are the programmatic plans to achieve the stated research education goals?
  • Are there well-designed are plans to facilitate regular meetings among all members of the program, including all participants and mentors from all involved residencies, that will foster an exchange of ideas, experience, and knowledge?
  • Is there a well-conceived plan by which the PD/PI will incorporate regular discussion throughout the course of the research education program that covers issues related to the ethical and successful practice of science (ESSP), which will include participants (and potentially others at a similar career stage) and program faculty, and which is designed to ensure that thoughtful consideration of the ethical and successful practice of science will become part of the environmental background within which research education occurs (note that this is distinct from the RCR requirement described below)?
  • Does the application describe a well-conceived plan for oversight of the program, participant education and progress, and the mentorship obtained by each individual participant supported, to maximize the potential of every participant to obtain individual funding and launch a robust research career?
  • Does the program have a well-developed plan to ensure that each participant will receive a thorough education in principles of experimental design, the principles of statistical methodology, an understanding of the sources of experimental bias, and rigorous approaches to data analysis and interpretation, that will enable them to conduct highly significant and experimentally sound scientific investigation?
  • Are there concrete plans to educate participants in various types of written and oral presentation that will ensure that they have the communication skills necessary to succeed in obtaining research funding and launching a scientific career?
  • For the specific participant named in the application for whom support is requested in the first year, 1) is the project suitable to foster the participant's transition to individual career development funding? 2) does the candidate have the background to successfully conduct the proposed project? 3) does the mentor statement for the proposed participant and project suggest a strong understanding of the needs for the participant to successfully transition to an individual award?

Environment

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

Specific to this NOFO:

  • Does the application present a plan to encourage all interested residents, regardless of residency, to participate in the program?
  • Does the application provide evidence that each primary participating residency/department has a history of research activity and success in transitioning residents and/or junior faculty into research careers?
  • Does the application provide comprehensive, well-conceived plans for facilitating success of participants in achieving the goals of this program?
  • Are there letters from Chairs of other NINDS-relevant subspecialties (listed in the NOFO), and do they demonstrate awareness of the program, and if interested in participation, clear plans for oversight of the potential participants from their departments that will maximize the potential for success? If relevant, how well well-conceived are the plans to ensure that coordination and communication between multiple residencies/departments will ensure that all participants in each component will obtain appropriate oversight, education, and mentorship?
  • Does the application describe an approach (such as the provision of financial and/or non-financial resources and/or the ability of participants to continue to oversee the continuation of their research project) that is likely to help participants maintain and/or advance their research projects during a gap period between funding increments or between UE5 funding and individual funding?
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.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Training in Methods for Enhancing Reproducibility

Does the Instruction in Methods for Enhancing Reproducibility plan describe how trainees will be instructed in principles important for enhancing research reproducibility including, at a minimum, evaluation of foundational research underlying a project (i.e., scientific premise), rigorous experimental design, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, data and material sharing, record keeping, and transparency in reporting? Are the rigor and transparency components sufficiently well integrated into the overall curriculum? Are they taught at multiple stages of trainee development and in a variety of formats and contexts? Does the teaching synergize with elements of the curriculum designed to enhance trainees' abilities to conduct responsible research? Is there evidence that all program faculty reiterate and augment key elements of methods for enhancing reproducibility when trainees are performing mentored research in their laboratories?

Resubmissions

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

Revisions 

Not Applicable

Renewals 

For Renewals, the committee will consider the success of the program in meeting its goals during the last funding period and the plans to evolve the program based on experiences gained during prior funded periods.

Additional Review Considerations

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

Recruitment Plan to Enhance Diversity 

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of prospective participants from underrepresented groups. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the proposed research education program, the level of participant experience, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years.  See also: NOT-OD-10-019 and NOT-OD-22-055. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable. If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the proposed software dissemination plan.

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 NINDS, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned to NINDS for review. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. 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 2.4.4 Disposition of Applications.

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.

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

Any application awarded in response to this NOFO 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 recipient 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: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website.

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

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 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.”

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 (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

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

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

  • Adhering to the overall objective of the NINDS Research Education Program for Residents and Fellow in Neurological disorders
  • Implementing a selection process by which residents and fellows will apply for support from the program and proposing these residents and fellows to the NIH Project Coordinators for approval of support.
  • Developing and implementing research experiences that provide participants with the skills, education, and preliminary data need to successfully compete for individual funding.
  • Implementing a formal oversight process to ensure that all participants receive active and effective mentorship to help them achieve their career goals.
  • Managing programmatic activities such as, but not limited to:
    • Providing a formal education in the principles of experimental design, principles of statistical methodology, data analysis skills, grant writing, and presentation skills.
    • Formal training in the responsible conduct of research
    • Facilitating regular discussions about ethical and successful scientific practices
    • Ensuring strong scientific interactions among the entire cohort of participants and mentors from all participating residencies
    • Ensuring all supported participants fully take part in the annual NINDS workshop for this UE5 program.
  • Evaluating their program's activities and approaches that are designed to achieve the goals of the UE5 program.
  • Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
  •  

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

Project Coordinator: NIH Project Coordinator(s) with expertise in relevant areas will:

  • Help guide the development of each Research Education Program for residents and fellows and this UE5 network by providing overall advice and coordination;
  • Facilitate a partnership with NIH and ensure that the directions taken by the research education program for residents and fellows are consistent with NIH missions and goals;
  • Organizes an internal NINDS review committee who will make the final decision on the participants proposed for support;
  • Promote communication between NIH and the recipient;

Program Officer: The NIH Program Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the Notice of Award. 

Areas of Joint Responsibility include:

  • During the course of the award period, the recipient(s) will meet with NIH staff at the UE5 workshop for residents and fellows to review progress, share outcomes and discuss challenges.  Recipients will help choose the location and venue of the meeting (typically one of the UE5 recipient institutions). NIH project Coordinator(s) will help facilitate the meeting logistics (e.g. registration, agenda, inviting speakers, etc.) with the host recipient institution.

Dispute Resolution:

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

3. Data Management and Sharing

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

4. Reporting

NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR 200.301.

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

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

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, 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 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. Programs that involve participants should report on education in the responsible conduct of research and complete a Trainee Diversity Report, in accordance with the RPPR Instruction Guide. In addition, programs must report (in the RPPR) on the progress of each participant towards achieving the goals of the program, the format and faculty involvement in the activity that constitutes the Ethical and Successful Scientific Practice component of the program, the specific efforts to educate participants in scientific methodology (e.g. sound experimental design, principles of statistics, sources of experimental bias, proper data analysis and interpretation, etc.), efforts undertaken to coordinate among multiple residencies/departments, if relevant, and regular meetings among all members of the program designed to foster an exchange of ideas, experiences and knowledge.

Other Reporting Requirements

  • The institution must submit a completed Statement of Appointment (PHS Form 2271) for each participant appointed full time for eight weeks or more or the equivalent. Recipients must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
  • Participant Termination Notice: Within 30 days of the end of the total support period for each participant, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each participant appointed full time for eight weeks or more, or the equivalent.

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

5. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH or its Institutes and Centers will periodically evaluate their UE5/R25 research education programs, employing the measures identified below.  In assessing the effectiveness of its research education investments, NIH may request information from databases, PD/PIs, and from participants themselves.  Where necessary, PD/PIs and participants may be contacted after the completion of a research education experience for periodic updates on participants’ subsequent educational or employment history and professional activities.

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

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

Clinical Resident/Fellows and Early Career Investigators:

  • Aggregate number and demographic characteristics of participants
  • Subsequent educational/career progress of participants, including: 

Subsequent participation in research
Subsequent employment in a research or research-related field
Subsequent authorship of scientific publications in a STEM field
Subsequent independent research grant support from NIH or another source    

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

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

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

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

Scientific/Research Contact(s)

Director of the Office of Training and Workforce Development
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

Peer Review Contact(s)

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-4188
Email: [email protected]

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

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

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 2 CFR Part 200.


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