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 (R25 - Clinical Trial Not Allowed)
Activity Code

R25 Education Projects

Announcement Type

Reissue of PAR-18-346 - NINDS Research Education Programs for Residents and Fellows in Neurological Disorders and Stroke (R25 - Clinical Trial Not Allowed)

Related Notices

July 22, 2019 - Requirement for ORCID iDs for Individuals Supported by Research Training, Fellowship, Research Education, and Career Development Awards Beginning in FY 2020. See Notice NOT-OD-19-109

Funding Opportunity Announcement (FOA) Number
PAR-20-311
Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.853

Funding Opportunity Purpose

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH.  The overarching goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs.

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

  • Research Experiences
  • Courses for Skills Development

Key Dates

Posted Date
October 27, 2020
Open Date (Earliest Submission Date)
December 25, 2020
Letter of Intent Due Date(s)

30 days before the application due date

Application Due Date(s)

January 25, 2021 and January 25, 2023 by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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

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

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review

May 2021 and May 2023

Advisory Council Review

August 2021 and August 2023

Earliest Start Date

September 2021, September 2023

Expiration Date
January 26, 2023
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

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

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

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


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers. The overarching goals of the NIH R25 program are to: (1) complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs; (2) encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research; (3) help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences; and (4) foster a better understanding of biomedical, behavioral and clinical research and its implications.

The overarching goal of this R25 program is to support educational activities that help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences.

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

  • Research Experiences: As the primary goal of this R25 program is to provide participants with the skills, education and experience needed to successfully compete for individual research funding, the following formal training components should be considered critical for this program: experimental design, statistical methodology that is 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. 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.
  • Courses for Skills Development: It is expected that participants of the NINDS R25 will attend and participate in the annual R25 workshop specific to this FOA. This workshop will bring together the participants (typically neurologists, neurosurgeons and neuropathologists) in this program to discuss the transition from residency and fellowship to successful competition for individual research career development and research awards. The workshop will feature presentations by 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 during the workshop and discuss their planned, next grant submission specific aims with designated mentors.

 

Overview of this NINDS Research Education 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 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 fields forward. This Research Education 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 superb track record in the training of future scientists. As part of their research training, 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 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 research education program.

Research Education Program Structure
Applications will be accepted for this funding opportunity announcement from accredited Medical Schools and/or residency programs that propose outstanding opportunities for residents and fellows (“participants”) to participate in an intensive, mentored research education experience during residency and fellowship training. It is anticipated that most participants will be in Neurology, Neurosurgery, Neuropathology, Neuroradiology, Anesthesiology or Emergency Medicine. However, residents and fellows from other subspecialties are encouraged to participate, as long as the mentors and participants are conducting research clearly within the mission of NINDS and they commit to fulfilling all requirements of the program. 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 or Pathology Department or Program.

The structure of the research education program at each institution will be unique and should maximize resources and faculty 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 independent funding. All participants should be thoroughly educated in fundamental concepts of experimental design and analysis, and scientific rigor (for details, see NOT-OD-15-103 and the guidance and resources in the NIH Rigor and Reproducibility statement). Although this program does not provide sufficient time to obtain an expert knowledge in statistics, programs should 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, the value and limitations of correlations, the appropriate use of frequentist or Bayesian statistical tests, an understanding of statistical significance, etc.). Critically, all participants should obtain an understanding of experimental design, statistical methodology and general principles of rigorous data analysis sufficient to enable them to appropriately design and analyze experiments performed during the R25-supported period and proposed for their eventual K award application. As the primary goal of this R25 program is to provide participants with the skills and experience needed to successfully compete for individual research funding, grant writing and presentation skills should be treated as critical components of the program. Formal activities to hone these skills should occur at the R25 institution and should be addressed prior to the R25 workshop, during which activities will further enhance these skills. Training in the responsible conduct of research is required, and regular discussions about ethical and successful scientific practices 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 research education 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.

R25 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 aims expressed in this announcement.

Potential for additional participants
It is anticipated that R25 programs will have one outstanding participant per year. However, NINDS recognizes that, in any given year, programs may have more than one highly qualified candidate for R25 support. Programs can request support for additional participants via an administrative supplement request, using a specific Notice of Special Interest (NOSI) (see NOT-NS-20-038 or subsequent reissue). Similarly, programs that do not have an outstanding candidate for the program in one or more of years 2-5 of the award need not request support. Program success is judged by how many of the supported participants obtain individual funding subsequent to completion of the R25 program, not by how many participants a program supports or by other metrics, such as publications or positions obtained.

R25 programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. R25 programs may augment institutional research training programs (e.g., T32, T90) but cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs.

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 R25-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 R25 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).

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. In this example, the last 6 months of support would be contingent on submission of a high quality, individual mentored K or R01 award application during the first 18 months of post-residency R25 support.

This research education grant is intended to provide a means for participants to begin research education during residency and, if appropriate, continue this education during their fellowship period. 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 should occupy 4 full, uninterrupted days during the Monday through Friday workweek. Supported time during residency should 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 to the program after having had a total of 12 months of R25 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.

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 R25, provided satisfactory progress and adherence to R25 program expectations and deadlines are met. A one to two-year gap in time between the end of residency and 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 R25 is intended to support fellows and not faculty, funds may be used for those in faculty positions when the faculty position immediately follows an R25 fellowship year. However, even if in a faculty position, the R25 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. In addition, participants are expected to attend a special, annual NINDS R25 workshop designed for this program once for each increment of funding that they receive (more information on this below).

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 R25 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 R25 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 R25 research education program are met. Participants simultaneously enrolled in a Ph.D.-granting program may be supported by this R25 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 R25 programs
In some cases, participants who begin a research education program during residency may wish to change institutions for fellowship training. If the proposed fellowship training institution has an R25 program supported by this FOA, residents and fellows may continue their research education program at this new institution. As in all cases, support must be requested by the sponsoring institution via the administrative supplement process associated with this R25 award.

Participation in an NINDS-sponsored workshop for R25 residents and fellows
As part of this research education experience, all participants are expected to attend an annual NINDS-sponsored workshop for R25 residents and fellows. Funds are provided in this award specifically for attendance at this workshop (additional details about this workshop will be provided yearly by the NINDS Director of Training and Workforce Development). This R25 workshop, which has occurred annually since 2009, includes activities for oral and/or poster presentations of the participant’s research, grant writing, sessions related to development of dual, clinician-scientist careers and direct mentorship of each participant on their specific aims page draft for future grant applications.

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 R25 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. Successful engagement in all aspects of the workshop, from timely registration to active participation, will be considered when determining whether participants have met programmatic requirements necessary for additional, future support. 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.

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 R25 research education program will be the successful competition for major individual funding award 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 goal.

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

Section II. Award Information

Funding Instrument

Grant: A support 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 FOA.

Clinical Trial?

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

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

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 need to reflect the actual needs of the proposed project. Direct costs may not exceed $250,000 per year.

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 program will receive support for one participant each year.

Institutions with active R25s under this FOA will be eligible to request support for additional participants each year by submitting an administrative supplement request in response to a separate NOSI (NOT-NS-20-038 or subsequent reissues). In addition, for every year in which a participant is supported, $10,000 will be provided for program costs. This is intended 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).

Award Project Period

The maximum period is 5 years

Other Award Budget Information

Personnel Costs

Not Applicable.

Participant Costs

Participants may be paid salary plus fringe 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. 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 R25 research education program while incurring these expenses).

Up to $3,000 per year may be requested for each participant to travel to 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 travel includes attendance at the NINDS-sponsored workshop for R25 participants. 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 and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

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 R25 application must have a full-time appointment in the appropriate academic department in the medical school and an appointment at the applicant institution. Moreover, regardless of how many affiliated entities are involved, only one R25 application per residency program will be accepted for review. Note: although multiple residencies at a sponsoring institution may submit applications, no more than one R25 program per medical school or sponsoring institution will be supported.

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

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

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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 not allowed. 

Required Registrations

Applicant organizations

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

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

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

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. 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. In addition, the PD/PI is expected to monitor participant progress and access to strong mentorship to ensure the highest likelihood of success for each participant.

Departments other than Neurology, Neurosurgery or Pathology may participate via a joint program with one of these three departments. Multiple residency programs (e.g., neurology and neurosurgery or neurology and neuropathology) at a single institution are encouraged to submit a single application together. Note, however, that the training and research track record, as well as plans for ensuring success of the residency’s participants, will be evaluated in the review process for each residency program represented by a PD/PI.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Program Faculty

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as preceptors/mentors. Moreover, it is expected that women and individuals from diverse backgrounds and with diverse perspectives will be represented among the program faculty. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.

Participants

It is expected that participants will be educated in, and conduct research in, areas that are relevant to the NINDS mission.

To be eligible to participate in this program, individuals must hold a clinical doctorate. They are typically in neurology, neurosurgery, 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 a career as physician-scientists.

Participants must begin this research education program during clinical residency. Participants who complete at least 6 months of R25-supported research during residency, and fulfill the expectations and commitments of this R25 program plan, will be eligible to obtain additional support during residency and/or fellowship years (in addition to the research and research education components of the plan, expectations include full participation at the annual R25 workshop, including registering for the R25 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.).

Because this is an educational and not a training mechanism, non-U.S. citizens may participate in this program. However, unless strongly justified on the basis of exceptional relevance to NIH, research education programs should be used primarily for the education of U.S. citizens and permanent residents. Because this research education program is intended to facilitate transition of participants primarily to NIH mentored Career Development awards, and non-U.S. citizens are ineligible for most of these awards, intentions to support non-U.S. citizens or should be accompanied by a plan to achieve an equivalent transition to appropriate individual research support.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions will not be reviewed.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Stephen Korn, Ph.D.
Director, Office of Training and Workforce Development
National Institute of Neurological Disorders and Stroke (NINDS)
Email: korns@ninds.nih.gov

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

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information Component

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

Facilities & Other Resources. Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.

Other Attachments

 

Applications must submit the following attachments, as applicable.

Mentor Training History. Applications must provide the following information in tabular form: a list of 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 the primary research trainees of the mentor, not trainees who have done rotations, brief training sessions or exclusively clinical training with the mentor, should be listed. 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.). Applicants may wish to use the sample format found at NINDS R25 Template Table or may create their own table.

R25 Research Education History. Renewal applications must provide specific details regarding all previous participants supported by the program. This information, which may be submitted in tabular form, should include the participant name, number of months supported by the R25, mentor name, project title, publications resulting from the R25 research education program, any awards or research funding obtained by the participant during, or subsequent to, R25 support, whether the participant attended the NINDS workshop for R25 participants and current position and institution of the participant. Applicants are advised to indicate which participants have completed the R25 program and which participants remain in training and eligible for additional R25 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 or similar awards) for all participants who have completed the R25 research education program (i.e. those who are no longer in training positions and are not currently supported by the R25).

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 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
  • Diversity Recruitment Plan
  • Plan for Instruction in the Responsible Conduct of Research
  • Plan for ethical and successful scientific practice
  • Evaluation 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.

The information should include a description of the education and/or career levels of the planned participants.

A detailed outline of the program must be presented. The outline 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). This outline should include topics such as the 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, etc.), goals for participant submission of an individual mentored or other award, and other strategies designed to foster participant success. As this is a highly goal-directed R25 program, the PD/PI should describe the oversight approach (e.g. frequency of meetings, interface between program oversight individuals and mentors, etc.) intended to ensure that the applicant has access to outstanding mentorship and has a high likelihood of success in meeting program goals. Applicants should describe plans intended to inform individual mentors of the goals of the program and expectations for progress of R25-supported residents and fellows. The application should describe the plan for ensuring that each participant receives a thorough education in principles of experimental design, the principles of statistical methodology, scientific rigor (for details, see NOT-OD-15-103 and the guidance and resources in the NIH Rigor and Reproducibility statement) and grant writing and presentation skills. The application should describe any financial and/or non-financial resources that will be made available for helping participants who have a gap between funding increments, or a gap between R25 support and individual grant support (such as a mentored K), to maintain and/or advance their research projects during the gap period.

Applications should also 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 renewal applications to include an individual entering increment 2 or 3 as the named participant). A statement should 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.

Programs are encouraged to include mentors with strong training records who are not clinician-scientists. However, a plan must be described that will ensure that participants being guided by non-clinician mentors will obtain the additional guidance needed for successful navigation of their dual clinical and research careers.

Ethical and Successful Scientific Practices. Programs are expected engage both participants (and optionally, others at a similar career stage) and participating faculty in discussions on navigating a scientific career both ethically and successfully. Issues related to ethical and successful scientific practice are plentiful and constantly emerging; therefore it is expected that all faculty associated with these R25 programs will engage in regular, on-going discussions with participants (and optionally, other clinician-scientists at a similar career stage) regarding the many challenges and issues that arise when practicing scientific research. 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, 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, 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 and patient population about research and research funding.

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 R25 program (and ideally, among all researchers within the residency/fellowship structure that forms the environment of the R25 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 occur. Please note that the Ethical and Successful Scientific Practices plan is distinct from the one time RCR requirement which must occur once every 4 years described in section V.

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, as this R25 program is intended to prepare participants to obtain an NIH K award immediately subsequent to completion of participation in the program, it is not intended that R25 participants would transition to a T32 program.

 

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 references, but 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. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged 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 provide a list of all mentors/trainers who are participating in this research education program, as well as a summary description of the participating faculty records in research and training that references but does not duplicate supportive information in Other Attachments. 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.

It is critical that programs ensure that participants are exposed to viewpoints from faculty with a wide range of backgrounds and experiences. Applications should provide aggregated details on the diversity of the R25 program faculty (i.e. potential mentors),

Program Participants.

Applicants must describe who the intended participants are, and what specific educational and/or research background characteristics are essential for participation in the proposed research education program. Identify the career levels (e.g. residency and fellowship year(s)) of the intended participants.

Institutional Environment and Commitment. Describe the institutional environment, reiterating the availability of facilities and educational resources (described separately under “Facilities & Other Resources”), that can contribute to the planned Research Education Program. Evidence of institutional commitment to the research educational program is required. A letter of institutional commitment must be attached as part of Letters of Support (see below). Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

The application should 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 subsequent 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).

Because the goal of this research education program is to help transition participants from residency to an individual K award, with a project being initiated in residency that could lead to a K award, the application should 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 R25 support and submission of an individual career development or research grant application, the application should describe any planned efforts by the institution, as well as any resources provided, that will help participants maintain, and even advance, an on-going project during these gaps.

For those individuals who have participated in the research education program (e.g. prior and current participants), the report should include aggregate information on the number of individuals who finished the program in good standing and who achieved the goals of the R25 program (e.g. to secure post-R25 funding). If results have been less than desired by the PD/PI(s), the application should describe strategies to improve outcomes.

Recruitment Plan to Enhance Diversity(NOT-OD-20-031): Every facet of the United States scientific research enterprise—from basic laboratory research to clinical and translational research to policy formation–requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

Underrepresented Populations in the U.S. Biomedical, Clinical, Behavioral and Social Sciences Research Enterprise
In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences, such as:

  1. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be demonstrated convincingly to be underrepresented by the grantee institution should be encouraged to participate in NIH programs to enhance diversity. For more information on racial and ethnic categories and definitions, see the OMB Revisions to the Standards for Classification of Federal Data on Race and Ethnicity (https://www.govinfo.gov/content/pkg/FR-1997-10-30/html/97-28653.htm).
  2. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in theAmericans with Disabilities Act of 1990, as amended. See NSF data at,https://www.nsf.gov/statistics/2017/nsf17310/static/data/tab7-5.pdf.
  3. Individuals from disadvantaged backgrounds, defined as those who meet two or more of the following criteria:
    1. Were or currently are homeless, as defined by the McKinney-Vento Homeless Assistance Act (Definition: https://nche.ed.gov/mckinney-vento/);
    2. Were or currently are in the foster care system, as defined by the Administration for Children and Families (Definition: https://www.acf.hhs.gov/cb/focus-areas/foster-care);
    3. Were eligible for the Federal Free and Reduced Lunch Program for two or more years (Definition: https://www.fns.usda.gov/school-meals/income-eligibility-guidelines);
    4. Have/had no parents or legal guardians who completed a bachelor’s degree (see https://nces.ed.gov/pubs2018/2018009.pdf);
    5. Were or currently are eligible for Federal Pell grants (Definition: https://www2.ed.gov/programs/fpg/eligibility.html);
    6. Received support from the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) as a parent or child (Definition: https://www.fns.usda.gov/wic/wic-eligibility-requirements).
    7. Grew up in one of the following areas: a) a U.S. rural area, as designated by the Health Resources and Services Administration (HRSA) Rural Health Grants Eligibility Analyzer (https://data.hrsa.gov/tools/rural-health), or b) a Centers for Medicare and Medicaid Services-designated Low-Income and Health Professional Shortage Areas (qualifying zipcodes are included in the file). Only one of the two possibilities in #7 can be used as a criterion for the disadvantaged background definition.

Students from low socioeconomic (SES) status backgrounds have been shown to obtain bachelor’s and advanced degrees at significantly lower rates than students from middle and high SES groups (seehttps://nces.ed.gov/programs/coe/indicator_tva.asp), and are subsequently less likely to be represented in biomedical research. For background see Department of Education data at, https://nces.ed.gov/; https://nces.ed.gov/programs/coe/indicator_tva.asp; https://www2.ed.gov/rschstat/research/pubs/advancing-diversity-inclusion.pdf.

  1. Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See, e.g., From the NIH: A Systems Approach to Increasing the Diversity of Biomedical Research Workforce https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5008902/).

Women have been shown to be underrepresented in doctorate-granting research institutions at senior faculty levels in most biomedical-relevant disciplines, and may also be underrepresented at other faculty levels in some scientific disciplines (See data from the National Science Foundation National Center for Science and Engineering Statistics: Women, Minorities, and Persons with Disabilities in Science and Engineering, special report available athttps://www.nsf.gov/statistics/2017/nsf17310/, especially Table 9-23, describing science, engineering, and health doctorate holders employed in universities and 4-year colleges, by broad occupation, sex, years since doctorate, and faculty rank).

Upon review of NSF data, and scientific discipline or field related data, NIH encourages institutions to consider women for faculty-level, diversity-targeted programs to address faculty recruitment, appointment, retention or advancement.

Applications should include a clearly marked section that describes plans for enhancing diversity. For this R25 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 demographics of the involved residency programs with regard to gender and diversity over the last 5 years and its strategies and efforts to recruit women and individuals from underrepresented backgrounds into the involved residency programs. This description should include strategies used in the past, the success of these strategies in diversifying the residency, and plans for continuation of, or changes in, strategy that will strengthen the diversity of the residency.

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. 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. ),

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").

 

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

When relevant, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application.There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

  • Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.
  • The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
  • To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

 

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

 

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 with the following additional instructions:

Delayed Onset Study

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

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, 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. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

The goal of this R25 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 R25 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?

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?

Is there evidence that the PD/PI is actively engaged in research and can organize and administer the program based on his/her qualifications, capabilities and experiences? Does the PD/PI have a strong record in training/education and mentoring? Does the PD/PI have a strong, recent history of NIH funding? If multiple departments and multiple PDs/PIs are involved, do the PDs/PIs from each department have strong, recent histories of NIH funding? Do the mentors in the program have strong, recent histories of NIH or equivalent funding? Do the mentors have a track record in the successful training of clinician-scientists? If mentors and or one or more PD/PIs have not had a strong recent history of research funding, are mechanisms in place to mitigate potential deficiencies created by this? If there are mentors who are not clinician-scientists, are plans in place to provide knowledgeable guidance regarding being a clinician-scientist to participants who work with these mentors? Is there an appropriate diversity of program faculty, including women, individuals from underrepresented backgrounds (NOT-OD-20-031 ) and faculty at different career stages? If diversity is limited , has the PD/PI provided a plan by which all participants will be exposed to viewpoints from faculty with a wide range of backgrounds and experiences? Have trainees from this department/residency and from this group of mentors been successful in competing for independent fellowship, career development and/or research funding? Do the department/residency and mentors have a record of mentoring career development (K) awardees, and have those with K awards in this department obtained academic research appointments and/or had 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?

 Is the proposed program plan likely to successfully address a critical barrier to progress in the field? 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?

Does the proposed program take advantage of existing strengths of the department and mentors involved? Is the approach feasible and appropriate to achieve the stated research education goals? Are there appropriate opportunities for participants to interact with each other and multiple mentors? Is there a plan for appropriate oversight of the program, participant education and progress, and performance of individual mentors, in all relevant research areas, to maximize the potential of participants to obtain individual funding and continue in a research career? Is there a clear, strong, formalized plan to ensure that each participant receives a thorough education in the principles of experimental design, the principles of statistics and scientific rigor? Did the PI present a well-considered plan that incorporates regular discussion throughout the course of the research education program that covers issues related to the ethical and successful practice of science, 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 plan for oversight of the program, participant progress, mentor performance, and choice of appropriate research projects and education plans for each participant, provide confidence that each participant will transition to individual research career development funding? 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, thoughtful plan to provide the necessary guidance and expertise for successful transition of the participant 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?

If multiple departments, residencies or sites are participating, is this adequately justified in terms of the research education experiences provided? If relevant, are there plans to ensure that coordination and communication between multiple departments, residencies or sites will be adequate to ensure that residents and fellows from each component will obtain appropriate oversight, education and mentorship? Do the departments or institutional units in which the proposed program will take place have records of successfully training physician-scientists and/or transitioning physicians to successful competition for NIH career awards or other individual research awards? 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 R25 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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

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

Revisions

Not Applicable

Renewals

 

For Renewals, the committee will consider the success of the program in meeting its goals during the last funding period, the plans to evolve the program based on experiences gained during prior funded periods, and the success of the program in attracting women and individuals from diverse populations, including populations underrepresented in biomedical, behavioral and clinical research on a national basis.

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

Programs are expected to cover a wide range of topics that fall under the umbrella of RCR, with program faculty or other experts holding in-person discussions with the participants. Reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components (see NOT-OD-10-019): 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, etc.; 3) Faculty Participation - the role of the program faculty, and if relevant, other expert 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. 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

This section is generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Budget and Period of Support

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

2. Review and Selection Process 

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • 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.
  • Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the 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 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 grantee’s business official.

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

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

2. Administrative and National Policy Requirements

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

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

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

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

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

3. Reporting

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

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 should also report (in the RPPR) on the subject matter covered, format and faculty involvement in the activity that constitutes the Ethical and Successful Scientific Practice component of the program.

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

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

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

 

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

4. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH or its Institutes and Centers will periodically evaluate their 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: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

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

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

Scientific/Research Contact(s)

Stephen Korn, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)

Email: korns@ninds.nih.gov

Peer Review Contact(s)

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-4188
Email: nindsreview.nih.gov@mail.nih.gov

Financial/Grants Management Contact(s)

Chief Grants Management Officer

National Institute of Neurological Disorders and Stroke (NINDS)

Email: ChiefGrantsManagementOfficer@ninds.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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


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