It is critical that applicants follow 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 the 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 will not be reviewed

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

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 over-arching 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) enhance the diversity of the biomedical, behavioral and clinical research workforce; (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 over-arching goal of this NINDS 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: 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. Training in the responsible conduct of research is expected. 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 this 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 lectures from 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 of their on-going or planned research during the workshop and discuss their planned, next submission specific aims with designated mentors.

Overview of this NINDS Research Education Program

There is critical need for additional 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. Moreover, 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. This Research Education Program is designed to foster the development of clinician-scientists through research and educational experiences, and 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. 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. Although it is anticipated that most participants will be in Neurology, Neurosurgery, Neuropathology, Neuroradiology, Anesthesiology or Emergency Medicine, residents and fellows from other subspecialties may participate as long as the mentors and participants are conducting research clearly within the mission of NINDS. 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.

Participating residents and fellows must be supported for a minimum of 9 months, 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. 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 support by this R25 program, participants must submit a competitive, individual mentored K award application within the first 18 months of R25 support (within the first 30 months for those enrolled in a Ph.D.-granting program). A typical, but not required, support path, 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 award application during the first 18 months of post-residency R25 support.

During any supported period, participants must devote 80% of full-time professional effort (e.g. during a 12 month supported period, this would equal 9.6 person months) to this research education program. This 80% commitment by the participant should occupy 4 full days during the Monday through Friday workweek. In general, 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 effort requirement also applies to neurosurgery residents. However, neurosurgeons may commit 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.

A one to two year gap in time between the first and second increment of support is acceptable if the gap is required to obtain additional clinical training during residency or fellowship. Research activity between a second and third period of support must be continuous. Although support is intended to be provided during residency and fellowship periods, funds may be used for those in faculty positions if this period of support immediately follows a residency or fellowship period of support.

In addition to the on-site research education participants will receive, they 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 NINDS workshop designed for this program once for each increment of funding that they receive.

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-NS-11-023 and the related NINDS Grants Policy statement). 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 will include the R25 workshop. Training in the responsible conduct of research is required for all participants. 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 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.

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 companion FOA (see PA-17-442 or subsequent reissue).

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 credentials and 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.

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 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). Acceptance of funding by the PD/PI for participants is made with the understanding that supported participants will attend this workshop. The PD/PI(s) are encouraged to attend this workshop whenever possible, as their participation in all aspects of the program are critical to its success.

Participants must begin this program during residency. 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. Consequently, support for any individual participant must begin during residency. Participants must commit 80% effort (4 full days during the Monday through Friday workweek) for a minimum period of 6 months (6 months at 80% effort = 4.8 person-months) during residency to be eligible for continued support during a fellowship period.

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 or equivalent individual awards or fellowships, 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 for continued research and/or research career development 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.

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.

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.

Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. 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.

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

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

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 an 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 (with the exception of programs that began prior to, and are active in, December 2017 - these may renew support even if multiple programs exist at the sponsoring institution).

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

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

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.

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) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

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), must have a faculty appointment in a Neurology, Neurosurgery or Pathology Department, have clearly demonstrated training/education/mentoring credentials in research and have a strong recent history of NIH funding. 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 attend the NINDS-sponsored workshop, and will submit all documents and reports as required.

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 of each residency program represented by a PD/PI will be evaluated in the review process.

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

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

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

• 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).

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women, are encouraged to participate as preceptors/mentors. Mentors should have research expertise and experience relevant to the proposed program and the NINDS mission. Mentors must be committed to continuing their involvement throughout the total period of the mentee’s participation in this award and must be committed to achieving the goals of the award.

Applicants are required to describe who the intended participants are, and what eligibility and/or specific educational background characteristics are essential for participation in the proposed program. It is expected that participants will be educated in, and conduct research in, areas that are relevant to the NINDS mission.

The participants in the research education program are residents and fellows. 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 begin this research education program during residency. If participants complete at least 6 months of R25-supported research during residency, and fulfill the expectations and commitments of their specific R25 program plan, they will have the opportunity to continue in this program during fellowship years, up to a total of 36 months of total support by this R25 program (a maximum of 24 months post-residency; participants enrolled in a Ph.D.-granting program will be eligible for up to 60 months of post-residency R25 support). Participants must be dedicated to a career as physician-scientists and conduct research in an area that fits within the mission of NINDS.

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 these research education programs are intended to facilitate transition of participants primarily to NIH mentored Career Development awards, and non-U.S. citizens or permanent residents are ineligible for most of these awards, intentions to support non-U.S. citizens or permanent residents should be accompanied by an explicitly described plan to achieve an equivalent transition to appropriate individual research support.

Buttons to access the online ASSIST system or to download application forms 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.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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

All page limitations described in the SF424 (R&R) 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.

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

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

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.

Mentor Training History. Applications should 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 should provide specific details regarding all previous participants. 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.

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

Follow all instructions provided in the SF424 (R&R) Application Guide. All applications must also include a biosketch for each participating mentor. In addition to recent funding history and recent publication record, it is encouraged that the personal statement in the biosketch include a summary of the mentor’s record in the training of clinician-scientists, as well as non-clinician scientists, if applicable, as evidence of a mentor's commitment to research education and training. Programs are encouraged to include mentors with strong training records who have not trained clinician-scientists.

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.

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

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

Research Strategy

The 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
• Evaluation Plan

Research Education Program Plan

Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program. 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 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 oversight individuals and mentors, etc.) intended to ensure success in meeting program goals. The overall plan for providing a thorough education in experimental design and analysis, scientific rigor (for details, see NOT-NS-11-023 and the related NIH Grants Policy statement) and grant writing and presentation skills should be described. 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 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 at least one named participant appropriate for the research education program in year 1). A statement should be included from the 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 have not trained 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.

When an applicant's department has T32 training grants for the training of clinician-scientists, the PD/PI should briefly describe the purpose of those training programs, and provide a detailed explanation of the distinction between intended participants of this research education program and the intended population that would constitute trainees in the T32 program(s).

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. Specifically, the application should provide a narrative description of the PD/PI record in research and training that references but does not duplicate supportive information in Other Attachments, and why the PD/PI is the appropriate person 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 of clinician-scientists will be provided to each participant.

Program Participants. Applications must describe the intended participants, and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels for which the proposed program is planned. Applications should describe in detail the participant activities and commitments not associated with this research experience (e.g. clinical duties, etc.), the time committed to these other activities, and when these activities will occur.

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 the residency department(s) in training clinician-scientists (e.g. how many participants, their names, the level of training [resident, fellow, mentored K, other], how many trainees received individual awards, 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 to be made by the institution, as well as any resources provided, that will help participants maintain, and even advance, an on-going project during these gaps.

Recruitment Plan to Enhance Diversity: Fostering diversity in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital (). 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.

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 identified as underrepresented in the biomedical, clinical, behavioral and social sciences, such as:

A. 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, and Native Hawaiians and other Pacific Islanders.

B. 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 the Americans with Disabilities Act of 1990, as amended. See NSF data at, http://www.nsf.gov/statistics/wmpd/2013/pdf/tab7-5_updated_2014_10.pdf.

C. Individuals from disadvantaged backgrounds, defined as:

1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml.

2. Individuals who come from an educational environment such as that found in certain rural or inner-city environments that has demonstrably and directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

The disadvantaged background category (C1 and C2) is applicable to programs focused on high school and undergraduate candidates.

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., Inside the Double

Bind, A Synthesis of Empirical Research on Undergraduate and Graduate Women of Color in Science, Technology, Engineering, and mathematics http://her.hepg.org/content/t022245n7x4752v2/fulltext.pdf).

New applications must include a description of plans to enhance recruitment, including the strategies that will be used to enhance the recruitment of trainees from underrepresented backgrounds and may wish to include data in support of past accomplishments.

Renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period, including successful and unsuccessful recruitment strategies. Information should be included on how the proposed plan reflects the program’s past experiences in recruiting individuals from underrepresented groups.

For those individuals who participated in the research education program, the report should include information about the duration of education and aggregate information on the number of individuals who finished the program in good standing. Additional information on the required Recruitment Plan to Enhance Diversity is available at Frequently Asked Questions: Recruitment Plan to Enhance Diversity (Diversity FAQs).

Applications lacking a diversity recruitment plan will not be reviewed.

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

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

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

Letters of Support

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

Resource Sharing Plans

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

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.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide , as well as NOT-OD-16-129.

Use only for applications with due dates on or before January 24, 2018. When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Use only for applications with due dates on or after January 25, 2018. When involving NIH-defined human subjects research, clinical research, and/or 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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.

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

Important Update: See NOT-OD-18-228 for updated inclusion and human subjects review language for due dates on or after January 25, 2019.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical, behavioral, and clinical research 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 which would enable physician-scientists to compete successfully for mentored career development awards, or similar fellowships or major research awards.

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.

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, 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 there are multiple departments and multiple PDs/PIs 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 there are mentors who are not clinician-scientists, are there plans in place to provide knowlegeable guidance regarding being a clinician-scientist to participants who work with these mentors? 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? Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the proposed research education program? Are potential problems, alternative strategies, and benchmarks for success presented? 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 individual mentors, and the education of each participant, in both basic and clinical 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 for education in experimental design, statistical methodology and scientific rigor? Does the oversight and mentorship plan, including the approach for ensuring 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 sites are participating, is this adequately justified in terms of the research education experiences provided? Are adequate plans provided for coordination and communication between multiple sites (if appropriate)? Does the Department or institutional unit in which the proposed program will take place have a record of successfully training physician-scientists and/or transitioning physicians to successful competition for NIH career awards or other individual research awards? Is the institutional commitment appropriate and adequate for the PD/PI, mentors and participants to achieve the goals of this research education program? Is there a plan, which may include provision of financial and/or non-financial resources, for helping participants who have a gap between funding increments maintain and/or advance their research projects during the gap period?

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 six 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 six 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 Children

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 children 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.

Renewals

For Renewals, the committee will consider the progress made in the last funding period, and the success of the program in attracting and retaining individuals from diverse populations, including populations underrepresented in biomedical, behavioral and clinical research on a national basis. The committee will also consider outcomes resulting from previous funding periods.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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 individuals from underrepresented groups. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Training in the Responsible Conduct of Research

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

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

As part of the scientific peer review, all applications:

• 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.

Keep the appeals sentence for RFAs only; otherwise delete for all PA, PAR, PAS.

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. Following initial peer review, recommended applications will receive a second level of review by the NINDS National Advisory Council. The following will be considered in making funding decisions:

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

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.

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.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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 law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. 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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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.

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 Training Diversity Report, in accordance with the RPPR Instruction Guide.

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.

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:

For Research Experience Involving the Following Groups:

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

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

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

Stephen Korn, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496- 4188
Email: korns@ninds.nih.gov

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

Tijuanna DeCoster, Ph.D.
National Institute of Neurological Diseases and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@ninds.nih.gov

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

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