Part 1. Overview Information

Key Dates

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

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

It is critical that applicants follow the Training (T) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose and Background Information

The purpose of this notice of funding opportunity (NOFO) is to invite applications for an Emergency Medicine Research Career Development Program in Neurological Sciences (EMRCDP-NS). The EMRCDP-NS will support a national effort for mentored career development and training of junior emergency medicine (EM) faculty at institutions nationwide that support EM research. The goal of this program is to increase the cadre of EM investigators trained to lead and conduct research into neurological disorders, making use of their EM training and clinical experience. This research career development program should promote high quality, novel, creative research and innovative investigation by this cohort of individuals who possess unique clinical and research skills. As a result of training in this program, highly skilled EM physician-scientists should be prepared to develop a successful, independent, well-funded research program, which they will combine with their clinical career to advance the understanding and treatment of neurological disorders commonly treated in the Emergency Department (ED) setting. This NOFO will fund the administration and infrastructure of one, national EMRCDP-NS for 5 years. It uses the K12 Career Development mechanism, to be overseen by one or more PD/PIs and a national cohort of renowned basic and clinical investigators, to support the career development of EM-researchers at institutions around the country.

The involvement of EM physicians in cutting edge scientific research is critical, due to their unique access to, and experience with, patients entering the ED setting with a wide variety of neurological disorders. Research into, for example, seizures, head trauma, acute cognitive dysfunction, acute stroke, sensory loss, loss of consciousness, spinal cord injury, meningitis, addiction and many other neurological disorders can benefit greatly from the leadership and involvement of EM physicians. Moreover, treatments and cures for diseases across the age range, from pediatrics to neurological disorders associated with aging, will be more quickly discovered with the involvement of EM physicians. However, the cohort of EM physicians conducting NIH-funded research is small relative to the need. The dearth of EM clinician-scientists largely reflects the relative youth of emergency medicine as a field positioned to lead research programs. Moreover, junior EM faculty are often not equipped to make use of individual NIH research career development mechanisms, which require a level of research experience and skills that most EM residencies and fellowships don’t provide. Even with additional fellowship training, it is often difficult for an EM physician to have sufficient research training to obtain individual support from NIH career development awards, which are used to prepare clinician-scientists to launch an independently funded research program. The purpose of the EMRCDP-NS program is to support an immersive period of mentored research and career development following residency or fellowship, to provide a venue for networking, collaboration and support of junior EM researchers, and to facilitate the transition of EM physicians from mentored to independent research positions. Scholars must start support by the EMRCDP-NS in either their first or second faculty year.EM physicians may apply to the EMRCDP-NS program within the first two years of their first independent faculty position subsequent to completion of residency or fellowship. The selected scholars may receive up to 3 years of financial support, during which the EMRCDP-NS will provide them with the mentorship, career development guidance, research experience, and protected time for research necessary to initiate a vigorous, sustainable research program. In addition, the EMRCDP-NS will create a support and mentoring network whereby scholars will have the opportunity to interact with both junior and senior EM researchers, as well as clinician-scientists from other subspecialties. A successful outcome of the program will be that all EMRCDP-NS scholars obtain subsequent, individual major awards, such as an NIH K or R01-equivalent, to continue to grow their research project and career. The primary metric by which this program will be evaluated will be the transition of supported scholars to subsequent funding equivalent to an NIH K or R01 award. Because of the critical mentorship and community building component incorporated into the annual meeting and program activities, a secondary metric by which the EMRCDP-NS program will be evaluated will be the number of candidates to the program who do not receive scholar support but nonetheless go on to obtain NIH research funding to continue towards a robust dual career as clinician-scientists.

The EMRCDP-NS Program

The EMRCDP-NS K12 award provides five years of funding to the applicant organization to support a national research career development program. Although this K12 award is housed at the contact PD/PI's institution, it is not intended to support scholars solely at that institution. The PD/PIs will solicit applications to the EMRCDP-NS program from eligible candidates at institutions from across the country, and selected scholars will proceed with their career development and research plan at their home institution, with a local mentor. The institution that houses this K12 is just one of these institutions from which a scholar might be selected. The leadership of the EMRCDP-NS consists of one or more PD/PIs and a committee of advisors (the National Advisory Committee, or NAC) selected by the PD/PIs to help guide the program. The PD/PIs may also choose to appoint program co-directors to help accomplish the goals of the program. The PD/PIs, together with the NAC and, if applicable, co-directors, will define the specifics of the application process, advise potential applicants, review candidate applications, provide feedback to the candidates on their applications, select candidates for appointment, monitor progress of each scholar, and ensure that program policies and requirements are followed. It is also expected that program leaders (i.e. PD/PIs or NAC members) will serve as secondary mentors for each scholar, working with the scholar, primary mentor and Chair to ensure success of the scholar’s development into an independently funded research investigator.

Annual EMRCDP-NS Meeting

The PD/PI(s) will organize an annual meeting for applicants, scholars, the NAC, and appropriate additional faculty. This meeting will serve as the venue for candidate interviews and selection, and also provide a forum for mentoring, career development activities, monitoring of scholar progress, and development of scientific networks among scholars, applicants and other researchers as well as other related purposes. As the primary goal of the EMRCDP-NS is to prepare scholars to transition to competitive, individual funding (such as an NIH K award), this meeting should include organized sessions to help scholars formulate and refine their projects, write a strong specific aims page intended to be used for their next grant submission, and otherwise help with creation of a clear, well-organized grant application. It is expected that, each year, all scholars will orally present their research projects to the entire cohort of attendees and will receive feedback to hone both their communication skills and project approach. This meeting should also include junior EM researchers not affiliated with the EMRCDP-NS program to broaden the scope of career development, mentorship and networking within the EM research community.

Although not required, there are many benefits to organizing this meeting at a small venue as a stand-alone event where participants will be immersed in the activities and social structure of this meeting without distraction. Funding provided by this award is designed to support a stand-alone meeting, which is strongly recommended.

Preceptors/Mentors

Although the identity of future mentors will not be known at the time of application, the mentors of successful scholar applicants to the EMRCDP-NS should fulfill some general requirements. Primary mentors must be tenure-track faculty (or equivalent) who have an established record of research productivity, competitive grant support and successful training of clinician scientists. A primary mentor should have a strong research program in a neuroscientific area directly relevant to the NINDS, NIDA or NIA mission. Just as in any mentored award, scholars should have a team of mentors when needed to cover the variety of expertise needed, such as technical, analytical and subject matter expertise. Mentors should have research expertise and experience relevant to the proposed research project and must be committed to providing strong mentorship to the scholar throughout the duration of the award and efforts to obtain subsequent funding. The primary mentor need not be an EM clinician or even a clinician-scientist. However, in such cases, all scholars should have a secondary mentor who is an accomplished EM researcher who has experience navigating a dual career as EM clinician and researcher. Members of the NAC may serve as secondary mentors that provide career guidance to scholars when an appropriate, local EM-researcher is not available.

Linkages of scholars to other departments, potentially through choice of mentors, should be encouraged, as they enhance career development and facilitate collaborative efforts. It is particularly encouraged that scholars develop interactions with neurologists, neurosurgeons, neuropathologists, neuroradiologists and/or other non-EM clinicians, as this can foster multidisciplinary research and the development of novel ideas and approaches. In addition, working with Ph.D. scientists can expand the scholar’s knowledge of specialized fields and technologies, as well as providing the perspective of a full-time research scientist. Although mentors must demonstrate a strong commitment to the EMRCDP-NS program and scholars, they cannot receive salary, fringe benefits or research support for this role on the K12 grant.

Candidates should be strongly encouraged to include researchers from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, persons with disabilities, and women as mentors, as this provides a diverse perspective on their research approach and scientific thinking. Scholars should be encouraged to create a mentoring team that fulfills a wide variety of useful purposes, with thought as to the roles, commitment, and availability of each mentor.

Program Scholars

Scholars funded by the EMRCDP-NS K12 must be conducting research that falls within the NINDS, NIDA or NIA mission. All types of research, including basic, clinical and translational, are equally appropriate. Regardless of research type, it should be directly relevant to diseases or disorders of the nervous system and be potentially applicable to clinical practice. It is expected that this research will integrate with the scholar’s clinical activities and that their clinical and research activities will inform each other. The program should strive to support individuals whose research might have a significant impact on patients who enter the ED environment with neurological diseases or disorders.

As part of the recruitment effort, the EMRCDP-NS program should make every effort to broadly advertise the program. The program must actively recruit prospective individuals from diverse backgrounds, including individuals from groups underrepresented in Emergency Medicine.. The candidate selection process must include a written application (the format of an NIH K award is recommended) and interviews by the PD/PI and multiple members of the NAC. It is expected that, unless impossible due to an individual’s circumstance or in the interest of the health and safety of all involved, all applicant interviews will take place in-person at the annual meeting.

The EMRCDP-NS K12 will have funds committed to support up to three new scholars per year, in each of 5 years (15 different individuals for 3 years each). For each scholar, a five-year career development program consists of two phases.

Phase I

In Phase I, the scholar receives up to three years of financial support directly from the K12 award. During this phase, the scholar will embark on a focused career development program that will include research, skills development and educational activities, under the auspices of a mentor who has a strong record of research productivity and training. In conjunction with the mentor, the scholar will develop a research and career development plan suitable to launch an independent research career to investigate a clinically significant research topic. This plan, and scholar progress, will be reviewed annually by the EMRCDP-NS PD/PI and NAC. Provided they make appropriate progress during the first year, as judged by the PD/PI and NAC, scholars are renewed for a second year of EMRCDP-NS support. With appropriate progress made in year 2, scholars may be supported for a 3^rd year. It is strongly encouraged that scholars  apply for an NIH individual mentored K award no later than halfway through the 3^rd year of K12 support. This will accomplish two purposes. First, it will encourage scholars, together with their mentors, to create a focused research and training plan that will result in the progress needed to submit a competitive NIH K application on a specific timeline. Second, it will help scholars obtain individual funding before or shortly after phase I funding expires. Scholars are also encouraged to seek funding from non-NIH sources during and after phase I of the program.

During each year of Phase I, in addition to conducting research and pursuing their research career development at their home institution, scholars will submit an annual progress report to the EMRCDP-NS PD/PI, will attend the EMRCDP-NS annual meeting, and will present their research in a public forum at the meeting. Scholars may engage in brief research activities at another institution if they are directly related to the purpose of the award. For research activities outside of their home institution that last longer than one month, scholars must obtain prior written approval from the K12 PD/PI. In addition, periods of leave from the program for greater than three months, for either professional or personal reasons, require prior written approval from the K12 PD/PI and the NINDS Director of Training and Workforce Development.

Phase II

In Phase II of the EMRCDP-NS program, the scholar begins to transition to independence. The scholar is expected to remain associated with the EMRCDP-NS program, but must be supported by funds not derived from the K12. As such, scholar selection should consider 1) the likelihood that the candidate will be competitive for individual funding by the end of the third year of the program and 2) the strength of the commitment by the applicant’s chair to support the candidate’s research success subsequent to EMRCDP-NS support. It is intended that the scholar will secure funds from an individual, mentored career development award, such as an NIH K08, K23 or equivalent. However, some scholars may be ready to obtain support under a large independent research grant, such as an NIH R01 or equivalent, or an independent career development award such as an NINDS K02. To this end, it is important that the scholar receive strong guidance and support from their local mentor, the EMRCDP-NS PD/PI, the NAC and the Chair of the scholar's department, to provide the best possible opportunity for success. Because scholars might not receive competitive funding by the end of phase I, it is critical that the scholar’s Chair is committed to continuing to support the scholar towards their goal of successfully developing a funded research program (see below).

Scholars should continue to attend the annual EMRCDP-NS meeting and are encouraged to provide progress updates to, and present their research findings at, the EMRCDP-NS meetings during each year of the phase II period. This attendance at EMRCDP-NS meetings during phase II will help them with their own careers, will serve to facilitate their role as mentors to those who come behind them, and will serve to strengthen the network of EM researchers, ranging from those in the career development phase of their careers to more established faculty.

Phase I and II effort expectations

The EMRCDP-NS program requires that scholars commit 75% of full-time professional effort to research when funded by the K12 program (phase I). In phase II of the EMRCDP-NS program (years 4-5, when K12 funds are not used to support the scholars), candidates should be expected to devote a minimum of 50% of full-time professional effort, and ideally up to 75% of full-time professional effort, to research, towards the goal of achieving individual K or R01 funding. In the event that the candidate is making good progress during Phase I, makes appropriate efforts to obtain individual funding for the start of Phase II, but fails to do so by the end of phase I, an ability to continue to devote at least 50% effort to research is critical to the scholar’s continued progress towards success. Thus, it is expected that the Chair of the scholar’s home department will commit, in the initial application to the EMRCDP-NS program, to continuing to provide at least 50% protected time to the scholar during the entire Phase II period, even in the absence of external research funding. Because protected time for research is critical for a candidate’s success, the EMRCDP-NS is expected to obtain a description of the home department’s 5-year financial and non-financial commitment to the candidate’s research success in the candidate’s initial application to the program. This commitment would include discussion of resources available, ability of the scholar to continue to attend the EMRCDP-NS annual meeting for 5 years and the commitment of protected time both during Phase I and for research during the two years after conclusion of K12 support.

Institutional Environment and Commitment to the Program

The Chair of the scholar's home department plays a critical role in the success of the EMRCDP-NS. The program will directly support relatively few scholars, with the goal that all of those supported will go on to successful, dual careers as clinical EM physicians and productive, well-funded researchers. In order to launch such a career, scholars need a period of outstanding training and mentoring as well as adequate protected time to successfully conduct high quality research and obtain independent funding. Consequently, a successful application to the EMRCDP-NS program must require that Chairs commit to provide the protected time for research as described above. This is critical to ensure that scholars have the time to devote to obtaining strong research funding to continue their research program. In addition, Chairs should make every effort to provide appropriate resources and support, in whatever form needed, to ensure success of the scholar, and should describe these resources and support in the scholar’s application to the program.

It is expected that the EMRCDP-NS program will make at least one in-person site visit to each scholar's home department to discuss with the scholar, mentor(s), Chair and others involved in the scholar's activities, the scholar's progress, needs and any other relevant issues. It is recommended that this first site visit occur within 6-8 months of initial funding. All individuals associated with selected scholars must be willing to participate in this site visit, and commit to it in the application to the program. In addition, the leadership of the EMRCDP-NS may choose to schedule additional, regularly scheduled site visits, either virtual or in-person, as deemed appropriate to the success of the individual scholars or program.

Special Note: The PD/PI is strongly encouraged to work closely with the NINDS Director of Training and Workforce Development to maximize the success of the program in achieving the goals of this NOFO. Potential applicants should contact the NINDS Director of Training and Workforce Development with any questions about this program, program planning or application for this award. 

Applications Not Responsive to this NOFO

Applications that propose research training and career development activities that do not fall within the NINDS, NIDA or NIA mission will be considered nonresponsive. For this reason, potential applicants are strongly encouraged to contact the NINDS Director of Training and Workforce Development with any questions about this program, program planning or application for this award.

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

Section II. Award Information

Other Award Budget Information

Scholars are those individuals who benefit from the proposed activities and experiences of, and have salaries partially funded by, the career development program. It is intended that three or more new scholars per year will be funded by this program, with each scholar supported for up to 3 years. This NOFO will provide $115,000 per year towards each scholar’s salary plus associated fringe benefits. In addition, up to $40,000 per scholar per year may be requested to support scholar research and career development. Allowable costs include research supplies, equipment necessary for the scholar's research project, technical personnel to assist the scholar in the research project, statistical services (including personnel) for the scholar's research project, and scholar travel to the EMRCDP-NS meeting, other scientific meetings and workshops. Each scholar may use up to $9,000 (from the $120,000) over a 3-year period for tuition, fees, and books related to their research career development. Scholar costs must be justified as specifically required for the proposed career development program and must be itemized in the proposed budget. Scholar support should be budgeted evenly over the 5-year duration of the award, so that funds are requested for 9 scholar-slots per year for 5 years (which will support 15 scholars for 3 years each or 45 scholar-slots). 8% IDC should be requested in the direct cost budget for subcontract costs associated with funding each scholar at an institution other than the institution holding the K12 award.

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

Section III. Eligibility Information

1. Eligible Applicants

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)

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.

Eligible institutions must be affiliated with a medical school with an Emergency Medicine Department that supports both clinical practice and funded research activities.

The applicant institution must have a strong and high quality research program in the area(s) proposed under this NOFO and must have the requisite faculty, staff, potential trainees and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goals.

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.

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training program as the Training Program Director/Principal Investigator (Training PD/PI) is invited to work with their organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.  See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

The PD/PI(s) of the EMRCDP-NS should possess the scientific expertise, demonstrated leadership capabilities, stature and administrative capabilities required to implement, coordinate and supervise a national, multidisciplinary research career development program for EM clinicians. The PD/PI(s), together with the NAC and, if applicable, co-directors, will be responsible for the selection and appointment of scholars to the EMRCDP-NS, and for the overall direction, management, administration, and evaluation of the program. The PD/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI(s) have responsibility for the day-to-day administration of the program and is responsible for appointing members of the NAC and using their recommendations to determine the appropriate allocation of funds. The PD/PI(s) are also responsible for informing all scholars, mentors and chairs of the goals of the program, and ensuring that policies designed to achieve these goals are followed. Any co-PD/PIs and co-directors should also have the qualifications necessary to guide an institutional training program for emergency medicine. It is highly recommended, although not required, that the program be led by a multi-PD/PI leadership arrangement, with individual PD/PIs responsible for critical roles required to achieve the comprehensive goals of the program. If the program does employ multiple PIs, applicants are strongly encouraged to recruit leadership team members from a variety of backgrounds,  who represent a wide range of perspectives, and who, as a group, must have expertise that reflects the range of interests of the discipline as a whole. In addition, if a multi-PI leadership team is used, it is recommended that at least one member of this team have expertise with the pediatric EM patient population.

Any PD/PI who has overseen an NIH institutional training program in the past (e.g., T32, K12, etc.) should have a strong outcome record from that program, which would include trainees and scholars achieving individual NIH funding, subsequent placement into positions that provide strong research support and the launching of a research program that includes rigorous experimental approaches to address a significant scientific question.

2. Cost Sharing

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

3. Additional Information on Eligibility

Only one application per institution is allowed.

EMRCDP-NS National Advisory Committee (NAC)

The NAC, chaired by the PD/PI, is a select group of scientists who have established records of research and research training of clinician-scientists. The committee should be composed of approximately 12-15 members. Applicants are encouraged to recruit members from diverse backgrounds and with diverse perspectives, including those from groups underrepresented in Emergency Medicine. This committee must be diverse in nature with respect to the scientific interests, technical expertise, geographic location and prior training affiliations of individual members. The NAC membership must also be constructed so that it can expertly evaluate research proposals across a wide variety of neurobiological topics, which may range from pediatrics to older adults (at least one  NAC member must have specific expertise related to the pediatric EM population, and at least one NAC member must have expertise related to older EM patients). Whereas it is appropriate that most members of the NAC be EM-researchers, the NAC must also include leading physician-scientists from other disciplines (e.g., neurology, neurosurgery, psychiatry, etc.) and ideally, a nationally renowned PhD scientist with an established record of successful research and training of clinician-scientists. NAC membership must include individuals with specific expertise in issues related to complex clinical trial methodology and ethics as it relates to clinical research and clinical trials. The NAC should contain  at least one member with expertise in issues related to health equity, and it is recommended, but not required, that at least one member of the NAC specializes in a non-neurobiological research area.

The NAC evaluates all applicants to the program (this will include the evaluation of written applications and conducting interviews at the EMRCDP-NS meeting), constitutes the selection committee chaired by the PD/PI, monitors progress of current scholars and provides feedback to all applicants to the program to facilitate their success as clinician-scientists. NAC members will be asked to perform site visits at scholar institutions and should have the appropriate stature within the community to discuss and enforce program principles and policies with scholars, local mentors and chairs. NAC members are expected to attend and participate in all annual meetings of the EMRCDP-NS program and should have the expertise to provide centralized mentorship as representatives of the EMRCDP-NS program. The duration of service of individual NAC members to the EMRCDP-NS program will be negotiated between individual members and the PD/PI and should generally be a minimum of 3 years. NAC members may be primary or secondary mentors to individuals but must avoid any conflict-of-interest in the scholar selection process.

The PD/PI may wish to recruit an additional group of junior NAC members who have recently completed training and gone on to R01 or equivalent funding, to serve as near peer mentors and add directly to the networking community for EMRCDP-NS applicants and scholars. These junior NAC members should not be involved in site visits, applicant selection or other activities that require a more established stature in the field.

All individuals serving as primary mentors to scholars should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program. Mentors should also have a successful record of research training, evidenced by former trainees who have established productive careers relevant to the NIH mission. All mentors must understand and agree to the goals and policies of the EMRCDP-NS program. Including a diversity of perspectives on a mentoring team will broaden the thinking and experience of the scholar. Thus, researchers from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, persons with disabilities, and women are encouraged to participate as local mentors wherever practical and appropriate. Leaders of the EMRCDP-NS program should help scholars identify and recruit a diverse group of mentors where appropriate and possible.

Scholars

Scholars to be supported by the institutional career development program must be at the career level for which the planned program is intended. Scholars must devote a minimum of 9 person-months (75% of full-time professional effort) to their K12 research and research career development during the appointment to the K12 award.

Scholars to be supported by the EMRCDP-NS must be clinically practicing EM physicians. Eligible candidates for application to the program include those within their first two years in a faculty position subsequent to their residency or fellowship training. It is intended that scholar support from this program will begin during the first or second year of their first faculty appointment subsequent to completion of clinical training.

An individual who has served as a PD/PI on an NIH research grant (R01, R03, R21, P01, etc.), an individual career development award (K01, K02, K08, K23, K99, etc.), other non-training NIH grant (e.g. U-type or P-type grant, etc.), a subproject of a program project (P01) or contract (N01), or has been supported by a KL2 or other institutional NIH career development award may not be considered for support as a scholar by the EMRCDP-NS.

Scholars must be citizens or noncitizen nationals of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship requirements are available in the NIH Grants Policy Statement.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the Training (T) Instructions in the SF424 (R&R) Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Stephen Korn, Ph.D.
Email: [email protected]

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 NOFO.

Substitute the term “scholars” for all references to “trainees” in the SF424 (R&R) Application Guide, and substitute the term “career development” for all references to “training” in the SF424 (R&R) Application Guide.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424 (R&R) Other Project Information

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

Substitute the term “scholars” for all references to “trainees” in the SF424 (R&R) Application Guide, and substitute the term “career development” for all references to “training” in the SF424 (R&R) Application Guide.

Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research career development program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of scholars including their levels (1st or 2nd year faculty) and intended scholar outcomes.

The National Advisory Committee (NAC). The proposed NAC members should be selected in advance and listed in the application, as the appropriateness of the committee will be evaluated by the peer review process.

The composition, including name, scientific expertise, track record in training clinician- and/or Ph.D.-scientists, current affiliation and prior training affiliations (e.g., their residency/fellowship training institution(s)), as well as their roles and responsibilities and other relevant information, should be included. Describe how the NAC will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment, selection and retention of candidates, mentorship and the evaluation of the overall effectiveness of the program. There should be an adequate number of NAC members with the expertise to evaluate complex issues associated with clinical trial applications, such as safety and ethical considerations. If any members of the NAC are to have special roles (e.g., serve as part of an executive committee or as co-directors), this should be explained. A biosketch for each NAC member should be included in the application.

The application should describe the rationale for selection of the NAC members, both individually and collectively.

Please name your file “Advisory_Committee.pdf”.

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.

PHS 398 Cover Page Supplement

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

PHS 398 Training Subaward Budget Attachment(s)

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

Research and Related (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 Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff. Also include proposed salary costs for planned scholars.
• Do not complete the section on Participant/Trainee Support Costs.

PHS 398 Research Training Program Plan

The PHS 398 Research Training Program Plan Form is comprised of the following sections:

• Training Program
• Faculty, Trainees, and Training Record
• Other Training Program Sections
• Appendix- Note that the Appendix should only be used in circumstances covered in the NIH policy on appendix materials or if the NOFO specifically instructs applicants to do so.

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

Data Tables are not required for this K12.

Substitute the term “scholars” for all references to “trainees” in the SF424 (R&R) Application Guide, and substitute the term “career development” for all references to “training” in the SF424 (R&R) Application Guide.

Career Development Program

Program Plan

Program Leadership/Administration:

Institutions with existing institutional programs for EM clinician-scientists must explain what distinguishes this program from the others and how their programs will synergize with one another, if applicable. When a program administrator position is planned, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate a program for developing investigators must be included in the application.

Describe the strengths, leadership and administrative skills, scientific expertise and training experience of the EMRCDP-NS PD/PI(s). Particular attention should be paid to the qualifications of the PD/PI(s) to lead and oversee this national training program and include a discussion of prior leadership of institutional training programs and leadership activities at a national level. Include a discussion of active research, current oversight of trainees and the planned strategy and administrative structure to be used to oversee and monitor the program.

If the PD/PI, or any of the PD/PIs in a multi-PI leadership plan, is currently, or has been PD/PI of an institutional training program (e.g., NIH T32, K12, etc.) for clinician-scientists, the outcome of that program should be clearly described. This description should include a list of the trainees/scholars supported, the positions taken by scholars subsequent to that support and the record of each of the supported trainees/scholars in obtaining competitive individual funding and leading a research program.

If the EMRCDP-NS program will have co-directors, these individuals should be identified with their roles and qualifications to carry out these roles discussed. All proposed participating individuals, including co-directors and NAC members, should provide a letter documenting their willingness to serve in their proposed capacity, as well as a brief description of their expectation for their role in the program.

The letters should be included in the “Letters of Support” section.

Program Faculty:

Describe the expertise and experience expected of local mentors. Because the identity of individual mentors cannot be known in advance, describe the plan for evaluating mentors and ensuring proper, successful mentorship of scholars, including any approaches to intervention if scholars are not getting adequate mentorship and guidance from their mentors. Describe the plan for secondary mentorship of scholars by PD/PIs and/or NAC members and how this mentorship will complement, not compete with, mentorship by the scholar’s local mentors.

Proposed Education to be provided by the EMRCDP-NS:

Describe the immediate and long-term objectives of the program, and describe training and/or career development activities that will be used by the national K12 to ensure that the objectives of the program are met. Include information about planned activities that will be incorporated into the overall EMRCDP-NS program, and what activities will be expected of the local institution. Describe how the EMRCDP-NS will provide scholars with:

• strong oral and written presentation skills, including help with grant writing, which will allow them to apply successfully for future career development and research support;
• thorough training in experimental and analytical rigor with respect to experimental design, statistical methodology, data analysis and interpretation and unconscious scientific bias (e.g., publication, cognitive, biases that result from poor experimental methodology, etc.);
• training in ethical scientific conduct and successful scientific practices;
• laboratory, project and time-management skills;
• mentorship and personnel management skills;
• education in building and maintaining fruitful collaborations, and the ethical and practical considerations associated with working in large teams.

Site visits and monitoring of progress:

Describe plans for the EMRCDP-NS program to make at least one site visit to each scholar's home department to discuss the scholar’s progress, needs and any other relevant issues with the scholar, mentor(s), Chair and others involved in the scholar's activities. This description should include plans for how site visitors will be assigned, timing of site visits for maximum efficacy, an anticipated agenda for the site visits, etc. If additional meetings, either in person or virtual, are planned to evaluate scholar progress, describe the goals and planned frequency of these meetings, as well as how these meetings will be implemented.

Annual Meeting:

Describe the goals, with an anticipated general agenda, for the annual meeting. This description should include an anticipated meeting duration, categories of individuals to be invited to the meeting, goals to be achieved by the annual meeting and types of activities that will be included to reach the goals of the meeting and overall program. Describe not only potential meeting activities that provide education and training (such as described above) but also those designed to achieve community building objectives.

Scholar Candidates:

The K12 application must describe the approach to recruitment of outstanding scholar applicants to the program, including any plans to disseminate publicity intended to attract applications from outstanding candidates in diverse neurobiological research areas from institutions around the country. The application should also describe specific efforts to recruit women and individuals from any group underrepresented in Emergency Medicine research as prospective candidates to the K12 program. The application should describe specific efforts that will be made by the EMRCDP-NS to ensure the success of all scholars once in the program. Explain why the planned approach is expected to be successful in achieving this goal.

The scholar selection process must require a written research and career development plan, a mentorship plan provided by the proposed primary mentor and a letter of institutional commitment from the applicant’s Department Chair. It is recommended, but not required, that the written document have the format of an NIH career development (K) award application. If the NIH K award format is not used, the application should describe the format of the application and the rationale for deviating from the K application format. Define the process by which candidates will apply to the program, in terms of application timing, funding decisions and start of research support.

The scholar selection process must also include interviews of the applicants by multiple members of program leadership and the NAC. All information gleaned from the written document and the interviews may be used in selecting scholars via a rigorous review process. The interview, review and selection process must take place at the annual meeting.

The application should include a description of how the EMRCDP-NS will inform scholars, mentors and Chairs of their responsibilities, a plan for monitoring scholar progress, and a mechanism to ensure both progress and compliance with program policies.

Institutional Environment and Commitment to the Program

The sponsoring institution, and any institution at which a PD/PI belongs, must assure support for the proposed program which includesassurance that sufficient time will be allowed for the PDs/PIs to contribute to the proposed program.

The institution at which scholar-applicants are employed must include in the application a written assurance that, if funded by the EMRCDP-NS, scholars will be provided with the protected time for research that is dictated by participation in the program. Specifically, the application must include a letter from the Chair of the scholar’s department committing to 75% protected time for research (with an explanation of how protected time was calculated) for the duration of EMRCDP-NS funding period plus a commitment to provide a minimum of 50% protected time for research for at least 2 years following EMRCDP-NS support to allow scholars to obtain subsequent funding.

The application should describe plans for monitoring and ensuring appropriate commitments of the scholar's institution to the scholar, including appropriate research support, protected time for research, and opportunities for advancement given a combined research and clinical career.

​​​​​Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in the SF424 (R&R) Application Guide.

Program Faculty.

For any Scholar proposing a research project that includes a a clinical trial, or gain research experience in a clinical trial, the scholar’s mentor must provide documentation of their  expertise, experience, and ability to provide guidance in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help the scholar to meet the study timelines. In addition, mentor’s overseeing a scholar’s clinical trial must document their experience with any potential ethical considerations associated with the planned clinical trial.

Scholar Candidates.

If the event that a clinical trial may be proposed, discuss the ability of the EMRCDP-NS leadership to oversee and evaluate the scholar’s effort to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study, as well as any safety and/or ethical issues that may be associated with the clinical trial.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to theSF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

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

Study Record: PHS Human Subjects and Clinical Trials Information

DO NOT USE. Attempts to submit a full, detailed study record will result in a validation error.

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).

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must complete a Delayed Onset Study.

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 form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive 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

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.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed.

Reviewers will consider each of the review criteria below in the determination of the merit of the training program and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Career Development Program and Environment

• Is there a thorough, detailed plan for the operation of a national career development program that will be successful in its goals?
• Does the proposed program clearly outline a plan to recruit and develop well-qualified junior emergency medicine investigators and conduct a comprehensive career development program that would be expected to help all scholars transition successfully to careers as clinician-scientists?
• Does the program describe a rigorous scholar selection plan, designed to select outstanding applicants from a national pool of candidates in an unbiased manner?
• Is there a plan to ensure that all scholars obtain a thorough understanding of how to conduct rigorous scientific investigations with respect to experimental design, statistical methodology, sources of unconscious scientific bias, and data analysis and interpretation?
• Is there a plan to ensure that all scholars obtain a thorough education in ethics as it relates to scientific activities, professional skills such as oral and written presentations and grant writing, mentorship skills, laboratory and personnel management and other requirements for a highly successful research career?
• Is there sufficient assurance that the required effort of the PD/PI, mentors and scholars will be devoted to their respective activities within the program?
• Does the program describe a well-conceived plan for an annual meeting that will serve to foster career development, success in research, and community building among emergency medicine scholars and other junior emergency medicine investigators?
• Is there a clear plan for successful monitoring of scholar progress, including through site visits, as well as monitoring of mentorship and chair support, and a plan for effective intervention when necessary?
• Is there an affirmative plan for recruiting prospective individuals from diverse backgrounds and with a wide variety of perspectives?

Advisory Committee (NAC)

• Is the constitution of the NAC appropriate, at both the individual level and group level, with regard to range of scientific expertise, prior training records, stature in the community, and diversity of backgrounds  who are likely to contribute different perspectives to the program and scholars?
• Is there representation on the NAC by successful EM clinician-scientists with specialized expertise in pediatric, adult and older patient populations?
• Are the members of the NAC appropriately diverse with respect to geographic distribution and prior training affiliations?
• Are the NAC members well qualified to serve as secondary mentors with the goal of helping scholars achieve success as independently funded researchers?
• Do most members of the NAC have the necessary status within the community to enforce the policies of the EMRCDP-NS?
• Is there a sufficient number of NAC members who have the expertise to evaluate applications that propose clinical trials, including safety and ethical considerations associated with an array of clinical trial types?
• Is there expertise on the proposed NAC that can guide the program, and specific scholar research areas, on issues related to health equity?
• Is there evidence that each member of the NAC has agreed to devote the time necessary to ensure success of the program as designed?
• Is there adequate documentation describing the responsibilities of the NAC with regard to the provision of input, guidance and oversight of the program?
• If a cohort of junior NAC members is proposed, are the selected individuals appropriate and is the role of this cohort in the program well-described?

Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

• Do the PD/PIs, co-directors and Research Administrator (if applicable) have the experience to develop, direct and administer the proposed program?
• Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure achievement of program objectives?
• If research proposed by applicants to the program involves the conduct of clinical trials, does at least one of the PD/PIs have the knowledge and experience to adequately evaluate the research plan as well as patient safety and ethical assurances?
• Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) of all PD/PIs appropriate for successful operation of the proposed career development program?
• Are the PD/PI(s) currently engaged in research relevant to the scientific area of the proposed program??
• If any of the PD/PIs currently or formerly have overseen institutional NIH training programs (e.g. T32, K12, etc.), is the outcome from those programs clearly described? Do those outcomes indicate that the PD/PI is highly qualified to run a national training program with an expectation of nearly 100% transition of scholars to individual NIH funding?
• For applications designating multiple PDs/PIs:
  • Is the proposed multiple PD/PI leadership approach likely to benefit the career development program and the scholars?
  • Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the career development program and the complementary expertise of the PDs/PIs?

Mentors

• Is there a plan to ensure that local mentors have the qualifications described in this NOFO as necessary?
• Are there plans for ongoing evaluation of mentors chosen by the scholars? Will this evaluation process ensure high quality mentorship and successful research career development of the scholars? Is there an approach to intervention if needed, and does the application provide confidence that the EMRCDP-NS PD/PI and NAC have a plan to, and will be able to, ensure appropriate and successful mentorship of the scholars?

Scholars

• Does the application propose thoughtful plans to identify, recruit, and select candidates who have a commitment to research relevant to the broad mission of the participating institutes and the potential to develop as independent researchers?
• Are there well-conceived plans for the EMRCDP-NS to contribute significantly to the scientific and professional development of the scholars?
• Does the plan for selection of the scholars include all of the eligibility criteria stated in this announcement?
• Does the plan for selection address the need to recruit from a national pool of candidates to enable selection of  outstanding applicants from any eligible institution in the country?
• Does the selection plan adequately address the need for fairness and breadth with respect to background, departmental affiliations and research areas  in selection of scholars?
• Is there an appropriate and adequate plan to affirmatively recruit prospective scholars from diverse backgrounds with a wide variety of perspectives ?

Training Record

• Is there evidence of a successful past training record of the PD/PIs and NAC members, including the success of former scholars in seeking independent support and establishing productive scientific careers?
• Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training?

Protections for Human Subjects

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Career Development in Methods for Enhancing Reproducibility

Does the plan for Instruction in Methods for Enhancing Reproducibility describe how the program will provide career development in scientific reasoning, rigorous research design, relevant experimental methods, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, quantitative approaches, and data analysis and interpretation, appropriate to field of study and the level and prior preparation of the scholars?

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

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

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 individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

All applications for support under this NOFO must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the career development program, the level of scholar experience, and the particular circumstances of the scholars, the reviewers will evaluate the adequacy of the proposed RCR career development in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter – Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all career development faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction – Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?

Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

Select Agent Research

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

Budget and Period of Support

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

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

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

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

Applications will be assigned 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 appropriate national Advisory Council or Board.

• 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.

Section VI. Award Administration Information

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’s business official.

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

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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 NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment; see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

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

Not Applicable.

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

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

When multiple years are involved, recipients 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.

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

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.

The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar appointed or reappointed to the training grant for 8 weeks or more. Recipients must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.

• Termination Notice: Within 30 days of the end of the total support period, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each scholar appointed for eight weeks or more. Scholars with service payback requirements must notify the NIH of any change in address and submit Annual Payback Activities Certification Forms (PHS Form 6031-1) until the payback service obligation is satisfied.

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

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

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

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

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

Stephen Korn, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

Lindsey Nicole Friend
National Institute on Drug Abuse (NIDA)
Phone: 301-402-1428
E-mail: [email protected]

NIA Training Office
National Institute on Aging (NIA)
Email: [email protected]

Ernest Lyons, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email:[email protected]

Shellie Wilburn, M.B.A.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: [email protected]

Pamela G Fleming
National Institute on Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: [email protected]

E.C. Melvin
National Institute on Aging (NIA)
Phone: (301) 594-3912
E-mail: [email protected]

Section VIII. Other Information

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

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 and 2 CFR Part 200.