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 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 may be delayed or not accepted for review.

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 overall goal of the NIH Ruth L. Kirschstein National Research Service Award (NRSA) program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. In order to accomplish this goal, NRSA training programs are designed to train individuals to conduct research and to prepare for research careers. More information about NRSA programs may be found at the Ruth L. Kirschstein National Research Service Award (NRSA) website.

Purpose and Background Information

The NRSA program has been the primary means of supporting predoctoral and postdoctoral research training programs since enactment of the NRSA legislation in 1974. Research training activities can be in basic biomedical or clinical sciences, in behavioral or social sciences, in health services research, or in any other discipline relevant to the NIH mission.

Institutional NRSA programs allow the Training Program Director/Principal Investigator (Training PD/PI) to select the trainees and develop a program of coursework, research experiences, and technical and/or professional skills development appropriate for the selected trainees. Each program should provide high-quality research training and offer opportunities in addition to conducting mentored research. The grant offsets the cost of stipends, tuition and fees, and training related expenses, including health insurance, for the appointed trainees in accordance with agency-approved support levels.

The purpose of the Institutional Translational Research Training Program is to support comprehensive training within an environment rich in translational research in which trainees will conduct basic, disease-related studies with an understanding of the requirements for translating discoveries into viable therapies. These programs should prepare advanced graduate students, postdoctoral fellows and/or fellowship-stage clinicians to become successful scientists equipped to pursue neuroscience research that is informed by translational considerations and principles.

The explosion of novel experimental techniques and technological advances has made it increasingly possible to correct and modify the biological events associated with disease. Translation of basic discoveries to clinical application ( bench to bedside ) requires a close collaboration between basic scientists and clinical investigators. Equally important, however, is an understanding of the overall process and specific practices required for designing projects with the potential for advancement through the translational pathway from basic discovery to clinical application. NINDS supports a number of programs intended for researchers to advance their translational projects towards human clinical trials (PAR-18-762, PAR-18-761, PAR-18-763). Whereas opportunities and funding for translational neuroscience research are growing, there is a dearth of training of scientists who understand what is required to do translationally-relevant basic research. This initiative will address the need for earlier and better preparation for scientists to conduct and lead translationally-relevant research projects.

This FOA is specifically for institutional translational research training.

NINDS is committed to supporting T32 programs that address basic, clinical, translational or a combination of approaches in any area of research across the NINDS mission. Applications for all types of innovative programs are encouraged and will be accepted under the NINDS Institutional Research Training Program (PAR-19-211).

NIA is likewise committed to supporting T32 programs that address basic, clinical, translational or a combination of approaches in any area of neuroscience research across the NIA mission. Applications for all types of innovative programs are encouraged and will be accepted by NIA under the NIH Parent T32 funding opportunity (PA-18-403).

It is critical that applicants contact the individuals listed under Agency Contacts (Section VII) for preapplication guidance and to confirm the mission relevance of their application with the Scientific Research Contacts for the participating Institutes prior to application submission.

The proposed institutional research training program may complement other ongoing research training and career development programs at the applicant institution, but the proposed program must be clearly distinct from related programs currently receiving Federal support.

Overall Program

Training programs responsive to this funding opportunity should be designed to increase the depth and breadth of trainee expertise within a thematic area. Programs should consist of an integrated set of activities that will both unify a cohort of trainees and expand their expertise beyond what would occur in the absence of the program. For training grants supported under this funding opportunity, a well-developed program 1) has a programmatic purpose and a scientific theme, 2) provides activities created to address that purpose that go beyond the standard activities (e.g. journal club, departmental seminars) associated with research career development and 3) will have programmatic activities that bring together faculty and trainees with a broad spectrum of expertise, the integration of which has the potential to stimulate innovative ideas and solutions to scientific problems. The fundamental benefit of an institutional, T32-funded training program is to create a rich, theme-driven environment that stimulates innovation, drives trainee focus on the highest standards of scientific rigor, and provides multiple opportunities for practice in scientific communication. Thus, in most cases, the creation of a T32-funded training program should benefit trainees who are not directly supported financially by the grant as well as those who are.

Programs should create novel and/or expanded research training experiences and activities; they are not intended to simply support trainees to conduct research. Education in career skills (e.g. grant-writing, oral presentation) although a critical component of all programs, is not sufficient to constitute a T32-funded training program. Moreover, the activities that constitute the program should be specifically designed to achieve the stated thematic purpose of the training program, and not simply be cobbled together from existing activities that the institution or department offers.

Training PDs/PIs are encouraged to develop institutional training programs that will expose trainees to a diversity of scientific approaches, systems for study and tools and technologies. The training provided should enhance the trainees ability to conceptualize and think through research problems with increasing independence. Moreover, programs should foster a culture in which trainees draw from a broad knowledge obtained from both neuroscience and other disciplines to address their research questions.

Programs may support predoctoral students, PhD postdoctoral fellows, fellowship-stage clinicians, or any combination of trainees from these three groups. For institutions that also have MSTP programs and intend to support MD/PhD students with this funding opportunity, the PD/PI should ensure that the majority of trainees supported by the program are those seeking a PhD rather than an MD/PhD.

Training grants that will support both predoctoral students and postdoctoral fellows should have a single program in which both groups of trainees participate and interact. The program may include shared and different activities, but they must occur in the context of an integrated program in which both predocs and postdocs benefit from the interaction, programmatic activities and collaborative possibilities that the program creates.

Institutional research training grants must be used to support a program of full-time research training. Within the full-time training period, research trainees who are also training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training goals. The program may not be used to support medical training leading to the MD, DDS, or other clinical, health-professional training. Similarly, trainees may not accept NRSA support for clinical training that is part of residency training leading to clinical certification in a medical or dental specialty or subspecialty. It is permissible and encouraged, however, for clinicians to engage in NRSA-supported, full-time postdoctoral research training even when that experience is creditable toward certification by a clinical specialty or subspecialty board.

Short-term training is not allowed under this PAR.

Translational Training

Programs supported under this funding opportunity are expected to equip trainees with research expertise and an understanding of the principles and practices involved in translating basic research discoveries to clinical applications. Moreover, programs should help expand the community of basic and clinical researchers working in teams to address research problems with an eye toward development of viable therapies. To these ends, programs should be housed in an environment that supports ongoing neuroscience research projects across the basic-clinical spectrum that are informed by, and conducted with reference to, translational principles, and should

• provide cross-disciplinary training designed to facilitate an understanding of translationally relevant issues related to basic mechanistic studies, and an understanding of fundamental biological mechanisms that contribute to diseases/disorders being studied in the clinical arena
• provide training in how to advance from fundamental biological mechanisms that contribute to diseases/disorders toward therapies and diagnostics;
• provide exposure to team research in which basic scientists are actively engaged in collaborative research projects with clinical investigators engaged in early stage therapeutic trials;
• integrate faculty who are actively engaged in translational research and have experience advancing therapies/devices to the clinic and demonstrated successful collaborations/interaction with industry;
• provide formal education in translational processes and practices necessary to advance from fundamental biological mechanisms that contribute to neurological diseases and disorders, toward therapies and diagnostics. This training should bring awareness to trainees of the issues involved in translating discoveries into therapies in the context of their own research. Topics may include

o preclinical activities (e.g. proof of concept studies, safety and toxicity studies, device design considerations, regulatory approval, manufacturing principles that lead to FDA approval for IND or IDE),

o first-in-human clinical trial design to test target engagement and/or proof of concept,

o intellectual property, technology transfer and entrepreneurship,

o securing funding and establishing collaborations with industry.

Programmatic activities to achieve this training may include clinical exposure and opportunities for formal engagement with clinical faculty, patients and end product beneficiaries; cross-discipline training; internships with pharmaceutical or biotech companies; boot camps, symposia, workshops or annual retreats that provide education in aspects of the translational process (e.g. regulatory issues, technologies, etc.) and that allow for interactions with experts in translational processes; training to develop skills for communicating with stakeholders (e.g. elevator pitches for lay audiences, shark tank pitches for investors, bi-directional communication with advocacy groups).

Programs should ensure that each trainee has an advisory committee composed of faculty with expertise across the bench-to-bedside research progression, and with expertise in the translational process.

Experimental Design and Statistical Methodology

Experimental Design: Programs are expected to provide formal educational activities that reinforce the principles of rigorous experimental design to ensure that trainees understand the practices required for robust hypothesis testing and the application of these principles and practices to their individual research.

Statistical Methodology: Programs should ensure that each trainee is equipped with a solid understanding of statistical methodology relevant to neuroscience research. Ideally, trainees will develop a depth and breadth of statistical understanding that will enable them to adapt and appropriately apply statistical approaches as their experimental repertoire changes. Programs must ensure that all trainees have a solid understanding of the value and proper use of statistics, including an understanding of the many types of scientific failures that can occur due to inappropriate application of statistical tests. An introductory course in statistics is not sufficient to achieve these goals.

Statistical Training and Support

It is critical that trainees understand that statistical considerations are vital not only for analysis of data but for designing experiments and experimental approaches. To help trainees develop an understanding of the many contexts in which statistical considerations come into play, programs may wish to incorporate the expertise of a statistician into the training program. Funds may be available for up to 1.2 person months effort to support a faculty-level statistician to play an integral role in the training program. Ideally this support will provide the opportunity for all trainees participating in the program to consult with the statistician when considering experimental approaches, designing experiments, determining appropriate sample size for their studies, analyzing collected data, etc. It is envisioned that the supported statistician will contribute to educating the trainees on statistical issues in scientific inquiry, such as, for example, a rigorous understanding of p values, Bayesian vs frequentist methods, the problems encountered with multiplicities, "p-hacking", the differences in acceptable statistical treatment of exploratory and hypothesis-testing studies, etc. Finally, it is anticipated that the supported statistician will actively participate in the "Program-wide Meetings" to lend strong statistical expertise to the discussions (see below for details).

Whereas the statistician may contribute to courses required for the program, funding will not be provided simply to support a statistician to teach a course.

Program-wide Meetings: Experimental Design and Statistics

As part of all NINDS and NIA training programs, it is expected that the trainees and program faculty will meet regularly as a group to discuss and evaluate the experimental and statistical approaches used in their own work and in literature relevant to the thematic area of the program.

Scientific Rigor

Trainees should have a thorough understanding of the principles and practices of rigorous scientific research. Programs are also strongly encouraged to provide education in human decision-making tendencies and cognitive biases, and how they can lead to erroneous interpretation of data (c.f. Kahneman, D. 2011 Thinking, Fast and Slow. New York. Farrar, Straus and Giroux).

Professional Skills

Programs should provide students with training in professional skills such as written and oral presentation for a wide variety of audiences. Programs are strongly encouraged to include group activities such as elevator pitches, data blitzes and/or shark tank presentations, etc. Not only are these helpful for honing organizational and presentation skills, but they help trainees to articulate the significance of their work to both lay (i.e. investors, advocacy groups and the general public) and scientifically literate audiences. Further, programs should provide training in the skills necessary for grant applications, such as grant writing, understanding the grant submission and review process and understanding and responding to critiques.

Understanding Career Opportunities

The career outcomes of individuals supported by NRSA training programs will likely include both research-intensive careers in academia and industry, and research-related careers in various sectors, e.g., academic institutions, government agencies, for-profit businesses, and private foundations. Trainees should have access to career development advising and exposure to a range of career opportunities. Through these activities, trainees should become familiar with various potential career directions that make strong use of the knowledge and skills gained during research training and the steps required to transition successfully to the next stage of their chosen career.

Oversight of Trainee Mentoring and Progression

In addition to outstanding scientific training, strong mentorship and career guidance are critical for advancement and success in science. Consequently, T32 programs responsive to this FOA are expected to have a formal oversight plan to ensure that trainees receive outstanding mentorship and progress through their training in a timely manner. The oversight process should ensure that trainees receive 1) appropriate professional guidance and projects with the potential to generate a publication record that will allow them to progress to subsequent research opportunities, 2) written and oral presentation skills that will facilitate their ability to publish their results as first author, submit competitive grant applications, speak at national meetings and interview for future positions, 3) an understanding of the research enterprise that will enable them to successfully navigate a research career and 4) an understanding of the many career opportunities available to them as scientists and what is required to compete for these different opportunities.

Enhancing Workforce Diversity

The research enterprise will be strongest when it involves individuals from a wide variety of backgrounds, who have a wide variety of perspectives. Within the framework of the NRSA program’s longstanding commitment to excellence and the focus of programs in particular areas of research, T32-funded programs play a critical role in training individuals from groups that are underrepresented biomedical sciences. Training programs are expected to implement robust plans to enhance diversity and to promote inclusive research environments (i.e. institutional and departmental environments in which trainees from all backgrounds feel integrated into and supported by the biomedical community). Whereas institutional efforts are critical to creation of inclusive environments, training programs must also strive to create environments that effectively promote diversity and inclusion.

Exposure to a Diversity of Role Models

To enhance diversity, it is essential that trainees have exposure and access to appropriate role models. This includes women, individuals from different backgrounds and with different perspectives, senior faculty who have the benefit of long experience, and junior faculty who have more recent experience in transitioning from training to independent positions. Programs should actively strive to achieve diverse representation in program leadership, participating faculty and mentors, and invited speakers.

Training Program Evaluation

It is expected that T32 programs funded under this PAR will undergo regular internal and external evaluation to promote innovation and evolution, as well as to bring attention to deficiencies that those close to the program may not perceive.

Expectations for Training Program Outcomes

Trainees should leave the T32 training program with the appropriate accomplishment and skills to move on to the next step on an independent research pathway. Outcomes expected of training programs include strong trainee publications (including first author publications), and other accomplishments appropriate to their training.

Although a major goal of these training programs is to develop highly skilled and creative researchers, NINDS and NIA understand that students and postdocs have many career choices. In any program, it would be expected that there will be some trainees who go on to do research, and there will likely be many who will go into research-related and non-research positions that make use of their training. However, outstanding scientific and professional training provided by NINDS and NIA T32 training programs will be invaluable to both the trainee and the community, regardless of a trainee's career choice.

This Funding Opportunity Announcement (FOA) does not allow appointed Trainees to lead an independent clinical trial, but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor. NIH strongly supports training towards a career in clinically relevant research and so gaining experience in clinical trials under the guidance of a mentor or co-mentor is encouraged.

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 from 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)

Governments

• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations

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.

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

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

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

Applicant Organizations

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

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

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

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

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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (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 responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the day to day administration of the program and is responsible for appointing members of the Advisory Committee (when applicable), and considering their recommendations for determination of the appropriate allotment of funds.

For programs that propose to have multiple PDs/PIs, at least one 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. Additional PDs/PIs may be included to achieve the training goals. Any of the PDs/PIs may serve as the contact PD/PI. Applicants are encouraged to clearly delineate the roles of the different PD/PIs.

In keeping with the effort to enhance the involvement of individuals from diverse backgrounds and perspectives in training, and in providing role models that bring diversity to a training environment, it is strongly encouraged that institutions include women and/or individuals from diverse backgrounds when forming the leadership team of the program.

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 programmatically 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).

The selected program faculty should be active researchers as demonstrated by recent publications and research support in the proposed research training program area. Program faculty should also have a record of research training, including successful, former trainees who have established productive careers relevant to the NINDS mission. When building a training team, programs should recruit faculty who are committed to training, mentoring, and providing supportive and inclusive research environments. Additionally, consideration should be given to recruiting program faculty from underrepresented backgrounds (NOT-OD-18-210), women, and faculty at different career stages (i.e. junior as well as senior faculty). It is the PD/PI's responsibility to ensure that every faculty member participating in the training program provides outstanding mentorship and guidance and agrees to fully participate in programmatic activities, as appropriate.

Whereas including outstanding junior faculty with limited training records as primary mentors is strongly encouraged, programs should ensure that there is a strong oversight mechanism, and potentially regular mentorship of junior faculty, so that each trainee, regardless of chosen mentor, receives outstanding mentorship and guidance.

When choosing faculty to participate in T32-funded training programs, PD/PIs should ensure that each faculty member included in a mentorship role is committed to following the strictest principles of experimental design, appropriate statistical analysis, and scientific rigor, in their research.

Add information as needed to describe the eligibility criteria and responsibilities of program mentors.

Keep heading and text below for K12 only, otherwise delete. For K12, be sure to include details about the pool of proposed scholars, their qualification, recruitment strategies, and sources of applicant pool, etc.

The individual to be trained must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship, training period, and aggregate duration of support are available in the NIH Grants Policy Statement.

All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the awarding unit, or when trainees are appointed to approved, short-term training positions.

Predoctoral trainees must be enrolled in a program leading to a PhD or in an equivalent research doctoral degree program.

Postdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Comparable doctoral degrees include, but are not limited to, the following: D.M.D., DC, DO, DVM., OD, DPM, ScD, EngD, DrPH, DNSc, DPT, PharmD, ND (Doctor of Naturopathy), DSW, PsyD, as well as a doctoral degree in nursing research. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of the training appointment is acceptable. Individuals in postgraduate clinical training, who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs, are also eligible.

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

It is critical that applicants follow the Training (T) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions 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.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-4188
Email: [email protected]
Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9666
Email: [email protected]

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.

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

Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research training program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of trainees including their levels (i.e., predoctoral, postdoctoral,clinician fellow ), and intended trainee outcomes.

Other Attachments.

Advisory Committee: An Advisory Committee is not a required component of a training program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the training [career development] program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. If an Advisory Committee is intended, applications should include a letter from each member confirming his/her participation. 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.

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

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

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

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

• Programs seeking funds to support up to 1.2 person months effort for a faculty-level statistician to be integrated into the training program should include a request in the Training Budget. Provide a justification for these funds that includes the name and qualifications of the individual to be supported, and a description of his or her role, contribution and responsibilities in providing statistical training and support for trainees in the program.

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 FOA specifically instructs applicants to do so.

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

Particular attention must be given to the required Training Data Tables. Reviewers rely heavily on these tables during the peer review process. Applicants are encouraged to carefully construct and review the tables, not only for completeness but for formatting.

Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the applicant pool, faculty mentor research accomplishments and training records, the educational and career outcomes of participants, and other factors that contribute to the overall environment of the program. Applicants should carefully ensure that summaries accurately reflect the data in the tables, as reviewers pay careful attention to both.

Training Program

Program Plan

Program Administration

Describe the planned strategy and administrative structure to be used to oversee and monitor the program, to provide oversight that will ensure outstanding mentorship and guidance to each trainee, and to ensure appropriate and timely trainee progress for the duration of the training program.

The application should describe how the Training Program Director(s)/Principal Investigator(s) (PDs/PIs) will promote the success of the trainees and training program. If there are multiple PDs/PIs, the plan for Program Administration is expected to synergize with the "Multiple PD/PI Leadership Plan" section of the application. Applicants should provide a clear leadership plan, including designated roles and responsibilities for each of the PDs/PIs and how their respective expertise and experience will benefit the trainees and enhance the ability of the program to achieve its training goals. The application should expand on the information in the biosketch(es) to address how the PD/PI or PD/PI team has:

• the scientific expertise as well as the administrative and training experience to provide strong leadership, direction, management and administration of the proposed research training program; and
• the time to commit sufficient effort to ensure the program's success given other professional obligations (applicants should indicate the person months to be devoted to the proposed program for each PD/PI and describe the institutional commitment to the PD/PI devoting the necessary time to directing the program);

The application should also describe any pro-active effort the program leadership, and if relevant other program-affiliated faculty, will take to build or expand on an inclusive environment that values a wide variety of perspectives and welcomes input from, and participation of, individuals from different backgrounds and different perspectives. The application should describe measures that are in place, or will be implemented, to ensure that trainees have access to a variety of role models and individuals with different perspectives.

Program Faculty and Mentoring Oversight

The application must include information about the program faculty who will serve as preceptors/mentors and, if relevant, distinguish between faculty members who will serve as primary mentors and those who have other roles in the training program. It should expand on the information in the biosketches (see "Participating Faculty Biosketches") to address the following:

• the complementary expertise and experiences of the program faculty as they relate specifically to the programmatic structure and goals of the proposed program, as well as how the faculty interact and collaborate;
• how the composition of the faculty will ensure that trainees have access to individuals with expertise across the basic-clinical spectrum and in the processes and practices necessary to translate basic discoveries to clinical applications;
• expectations for faculty participation in programmatic activities beyond training within their labs; what mechanisms are in place to ensure faculty participation in programmatic activities?
• how the program will ensure the involvement of participating mentors in equipping trainees to approach their research with a quantitative mindset, and with attention to rigorous experimental design, use of appropriate statistical methodology and an understanding of appropriate, statistically rigorous, interpretation of results;
• the plans and specific approach to building a diverse team of program faculty (including individuals from underrepresented backgrounds (NOT-OD-18-210), women and faculty at different career stages) so that trainees will have access to a wide variety of role models within the training program;
• the commitment of preceptors/mentors to effective mentoring and promoting inclusive and supportive scientific and training environments;
• a plan to ensure that preceptors who lack a strong research training record will provide strong and effective mentoring;
• a plan for mentoring oversight, including oversight of the effectiveness of the trainee/program faculty match.
• the plan for evaluation of participating faculty for their contribution to the following: high quality mentorship, attention to robust experimental design and statistical and experimental rigor, promoting the values of quantitative literacy expected by the T32-funded program, and creating an inclusive environment that welcomes varied perspectives of both trainees and faculty. The evaluation plan should describe the approach to, and timeline for making changes to the cohort of participating faculty based on their commitment to achieving the goals of the program.

Proposed Training

The application should describe how the program will develop a diverse pool of outstanding neuroscientists who have the technical, operational and professional skills required to conduct research in an ethically responsible and rigorous manner, and to enter careers in the biomedical research workforce as delineated in the Program Objectives. The application should describe how the program will enhance the breadth and depth of training obtained by trainees, and more broadly, enhance the training environment.

Rationale

The application should explain the rationale and need for the proposed research training program, the relevant background history and the research training activities of the participating department(s) or unit(s). Demonstrate the presence of a sufficient number of potential trainees in appropriate disciplines and program faculty with the appropriate scientific expertise as well as the resources to achieve the training objectives. When applicable, describe the ways in which the training plan is distinct from other funded T32 programs at the same institution. For renewal applications, highlight how the training program has evolved in response to changes in relevant scientific and technical knowledge, educational practices, and to evaluation of the training program.

Program Purpose and Goals

Provide an overview of the proposed program. Describe the programmatic theme and scientific area. Outline the objectives of the program and the programmatic activities that will be used to meet these objectives. Include information about planned courses, mentored research experiences and any structured activities designed to develop specific technical skills or other skills essential for the proposed research training. Describe how the program will ensure that trainees are exposed to a diversity of scientific approaches, systems for study and tools and technologies relevant to neuroscience research. Describe how the programmatic activities will unify a cohort of trainees and expand their expertise beyond what would occur in the absence of the program. For programs proposing to train a combination of predoctoral and postdoctoral trainees, describe the activities in which each group of trainees will participate, and how they will interact and benefit from the interaction, programmatic activities and collaborative possibilities that the program creates. For multi-disciplinary and/or multi-departmental programs, indicate how the individual disciplinary and/or departmental components of the program are integrated and coordinated and how they will relate to an individual trainee's experience.

Translational Training

Applications must include a detailed training plan that describes how trainees will be equipped with translational research expertise and an understanding of the principles and practices involved in translating basic research to health relevant therapies, technologies and devices.

Describe opportunities that trainees will have to lead research projects across the basic-clinical spectrum that will be informed by, and conducted with reference to, translational principles. Describe opportunities for cross disciplinary training that will facilitate an understanding of clinically relevant issues related to basic mechanistic studies, and an understanding of fundamental biological mechanisms that contribute to diseases/disorders being studied in the clinical arena. Describe the programmatic activities that will ensure that trainees receive the following: exposure to team research in which basic scientists are actively engaged in collaborative research projects with clinicians; opportunities to work with faculty who are actively engaged in translational research and have experience advancing therapies/devices to the clinic and demonstrated successful collaborations/interaction with industry; opportunities to interact with mentors and experts in translational processes.

Applications must include a plan for formal education in translational processes and practices necessary to advance basic discoveries and clinical research to clinical trials, and their application in the context of each trainee's individual research. Include a description of the topics to be covered, the programmatic activities that will be designed to achieve this training and the timeframe for instruction. Topics may include, but are not limited to, preclinical activities (e.g. proof of concept studies, device design considerations, regulatory approval, manufacturing principles), clinical practices, commercialization, securing funding and establishing collaborations with industry. Programmatic activities to achieve this training may include clinical exposure and opportunities for formal engagement with clinical faculty, patients and end product beneficiaries; cross-discipline training; internships with pharmaceutical or biotech companies; boot camps, symposia, workshops or annual retreats that provide education in aspects of the translational process (e.g. regulatory issues, technologies, etc.) and that allow for interactions with experts in translational processes; training to develop skills for communicating with stakeholders (e.g. elevator pitches for lay audiences, shark tank pitches for investors).

Describe how the program will ensure that each trainee has an advisory committee of faculty with expertise across the bench-to-bedside research progression, and with expertise in the translational process. Describe how committees will be composed, the nature and time frame for interacting with and advising the trainees and the role that the committee members will play in each trainee's training and in their development as a scientist equipped to conduct research with an eye to the translational processes and practices relevant to their individual project.

Experimental Design and Statistical Methodology

Experimental Design: Describe the formal programmatic activities designed to reinforce the principles of experimental design to ensure that trainees understand the practices required for robust hypothesis testing. Describe the principles that will be covered and the format and timeframe for instruction. Topics should include, but are not limited to, education in the design of well-controlled experiments; the difference between hypothesis-generating and hypothesis-testing experimentation, and the differences in design and analytical rigor required for each; scientifically appropriate determination of sample size; the appropriate use of statistics in experimental design and data analysis; and criteria for inclusion and exclusion of data for analysis. Describe plans to expose trainees to the analytical approaches used in common experimental systems (e.g. electrophysiology, imaging, behavior, genetics etc.) such that they will be able to evaluate scientific data presented in the literature, seminars and other contexts. Describe the program’s approach to ensuring that each trainee will develop a practical appreciation of these principles and their application to their individual research.

Statistical Methodology: Applications must include a detailed description of the plan for ensuring that each trainee is equipped with a thorough understanding of statistical methodology relevant to neuroscience research. Describe how trainees will be educated in the different types of statistical tests appropriate for different experimental paradigms, the appropriate application of statistics in analyzing data, interpreting results and forming conclusions, and the practical application of statistics to data in their own experimental systems. Describe the program's approach to instilling trainees with the depth and breadth of statistical understanding to enable them to adapt and appropriately apply statistical approaches as their experimental repertoire changes. While trainees may take, or have taken, an introductory statistics course, this is not sufficient to achieve the goals of this FOA.

Statistical Training and Support

Applications should describe how statistical support will be provided to the trainees, and if funds are requested for incorporation of a faculty-level statistician into the program, a detailed description of the role, contribution and responsibilities of that individual with respect to the program.

Program-wide Meetings: Experimental Design and Statistics

Describe plans for ensuring that trainees and program faculty meet regularly as a group to discuss and evaluate the experimental and statistical approaches used in their own work and in literature relevant to the thematic area of the program. Plans should include a description of the format and timeframe for these meetings.

Scientific Rigor

Describe the programmatic activities designed to ensure that trainees gain a thorough understanding of the principles of scientific rigor. Describe the principles that will be covered and the format and timeframe for instruction. Topics should include, but are not limited to, unbiased experimental approaches, methods, analyses, and data interpretation; transparent reporting of results; and acceptable and unacceptable approaches to image manipulation and figure preparation. Education in the role of human decision-making tendencies and cognitive biases in data interpretation is strongly encouraged. Additional topics may include proper data storage, data labelling, data organization and archiving, and when applicable, preparation of computer code for public sharing so that it can be interpreted by others in the scientific community.

Professional Skills

Describe the activities intended to provide trainees with outstanding oral and written presentation skills for both lay and scientifically-literate audiences, and the typical frequency of public oral presentations by trainees. Describe policies and expectations related to trainee submission of individual funding applications (e.g. fellowships, foundation awards, etc.). Describe required and optional programmatic activities intended to develop skills needed to apply successfully for individual fellowship or other types of grant support.

Understanding Career Opportunities

Describe the opportunities for trainees to learn about the many potential career paths available to them so that they may pursue a career of their choice that draws upon their Ph.D. training. Such opportunities may include, for example, access to formal career advising, internship/externships, or exposure to individuals with different kinds of jobs in the workforce. Describe the oversight mechanism that will ensure that all trainees, in the context of meeting the program's expectations for research excellence and productivity, can pursue their desired career.

Training Outcomes

The application should provide the information below about recent trainee outcomes through narrative descriptions and a summary of the data presented in the training tables. Although the training tables for new applications only allow for five years of recent graduate outcomes, applicants may describe up to 15 years of outcomes in the narrative.

Describe the following:

• evidence that the productivity (quality and number of publications, authorship placement) of trainees is appropriate for an outstanding training program, and the ability to continue toward successful independent scientific careers;
• the rate of Ph.D. degree attainment and time-to-degree for recent graduates of predoctoral training programs;
• the record of the program (or, for new applications, the existing training environment that houses the program) at producing trainees who transition to excellent next research positions, as well as other positions that make use of their training;
• the record of recent trainees (or, for new applications, other past trainees in similar training) in achieving productive scientific careers as evidenced by successful competition for research and other research-related positions in industry, academia, government or other research venues; grants; receipt of honors; high-impact publications; promotion to scientific leadership positions; and/or other such measures of success.

Training Program Evaluation

The application should describe an evaluation process to determine the effectiveness of the program, and whether the scientific research climate is inclusive and supportive of trainee development. The overall evaluation plan should include the metrics to be evaluated (e.g. program activities completed, degree completion (if applicable), publications, fellowships/honors, subsequent positions, etc.) as well as plans to obtain feedback from current and former trainees to provide suggestions for program improvement. The evaluation should address not only the cumulative record of the program, but the individual training records each participating mentor. Describe plans to have the program evaluated by internal and external faculty.

Trainee Candidates

Through the narrative and summaries of the information presented in the Training Tables and the attachments, the following areas relevant to trainees should be addressed:

• Describe the characteristics of the applicant pool, applicants eligible for support, new entrants into the program, and new entrants eligible for support.
• Describe the ability for participating department(s) and/or the institution(s) to support trainees for the duration of their training.
• Describe the plans for a holistic candidate review process that will select a diverse group of trainees who have taken advantage of the research opportunities available to them and are committed to contributing to the biomedical research enterprise.
• Define and justify the selection and re-appointment criteria for trainees in the training program.
• Explain how the program's support for courses, seminars, workshops and other activities may benefit other students or postdoctorates at the institution.
• Describe the trainees' academic and research background needed to pursue the proposed training and plans to accommodate differences in preparation among trainees.
• Describe the record of training individuals from diverse backgrounds, including those from population groups that have been shown to be underrepresented in the biomedical, behavioral or clinical research workforce, such as underrepresented racial and ethnic groups and those with disabilities (see NOT-OD-18-210).
• For those institutions that also have MSTP programs and intend to support MD/PhD students with this funding opportunity, the PD/PI should explain the process by which MD/PhD students will be selected for support (including the anticipated number of MSTP students supported) and how he/she will ensure that the majority of trainees supported by the program are those seeking a PhD rather than an MD/PhD.

For renewal applications, highlight how the training program has evolved in response to changes in relevant scientific and technical knowledge, educational practices, and to evaluation of the training program.

Institutional Environment and Commitment to the Program.

The application should describe how the level of institutional and departmental commitment to research and training excellence will promote the success of the trainees and training program. A letter providing assurances of the institutional commitment should be provided in the Letters of Support section of the application.

Program Diversity

Describe efforts to promote an inclusive research environment (i.e. institutional and departmental environments in which trainees from all backgrounds are integrated into, and supported by, the institution). Describe efforts to ensure that trainees have access to an appropriate diversity of role models, both within the institution and through activities such as invited seminars. The pool of role models should include women, individuals from different backgrounds, senior faculty who have the benefit of long experience, and junior faculty who have more recent experience in transitioning from training to independent positions.

Describe the representation of diverse trainees in the proposed programmatic area over the last five years. This should include information about the total trainee population, the training grant eligible population, and for renewal applications, inclusion of diverse individuals in the training program.

Participating Faculty Biosketches

Program faculty must provide a personal statement that describes the appropriateness of their research background for the proposed training program, and their approach to and/or record of the following:

• training, mentoring and promoting inclusive and supportive scientific research environments;
• training in sound experimental design, statistical methodology and the application of quantitative approaches in their research;
• supporting trainees' participation in activities required to identify and transition into careers in the biomedical research workforce that are consistent with the trainees' skills, interests, and values; and
• fulfilling the need of the trainees to progress to the next career stage in a timely manner with the skills, credentials and experiences to transition into careers in the biomedical research workforce.

Letters of Support

Institutional Support Letter

The application must include a signed letter on institutional letterhead from a President, Provost, Dean or key institutional leader that describes the activities and resources provided by the institution that will ensure the success of the planned training program and its trainees (not to exceed 10 pages).

The letter should include a description of the financial and non-financial resources that are directly committed or available to the proposed T32 program, including the specific resources that are intended to directly aid in accomplishing the programmatic mission of the training program to be supported by this T32.

The institutional commitment and/or approach to the following areas should also be described in the letter: developing and promoting a culture in which the highest standards of scientific rigor and responsible conduct are advanced; ensuring that all faculty, including early stage faculty, are recognized for their participation and effort in training and mentoring; ensuring availability of funding so that graduate students are able to complete their doctoral training if their mentor experiences a hiatus in funds or leaves the institution; supporting the PDs/PIs and other key staff associated with the planned training program; ensuring that faculty with a role in the proposed program have time available to devote to their responsibilities to the program; considering activities integral to excellent research training (such as teaching and mentorship) in tenure and promotion decisions; promoting diversity and inclusion at all levels of the research training environment (trainees, staff, faculty, and leadership); ensuring accessibility of research facilities to trainees with disabilities; creating a positive, supportive and inclusive research and training environment for individuals from all backgrounds; ensuring that the institution has an appropriately diverse faculty (including women, individuals from different backgrounds and with different perspectives, senior faculty and junior faculty) to serve as role models; and providing resources and expertise for evaluating the training outcomes of the program.

The institutional support letter should include a separate paragraph describing the institutional commitment to providing an environment free of discriminatory harassment and other discriminatory practices. The letter should explicitly address the areas laid out in NOT-OD-19-029.

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.

In addition, describe how the Responsible Conduct of Research (RCR) components are sufficiently well integrated into the overall curriculum, i.e., how they taught at multiple stages of trainee development and in a variety of formats and contexts. Explain how the teaching of RCR synergizes with elements of the curriculum designed to enhance trainees' abilities to conduct rigorous scientific research. Describe how all program faculty will reiterate and augment key elements of responsible conduct when trainees are performing mentored research their laboratories.

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.

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.

If you check the Anticipated Clinical Trial box within your Delayed Onset Study, then the Justification attachment must acknowledge that additional clinical trial information will be provided to the awarding component before any appointee begins independent clinical trial research.

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The National Research Service Award (NRSA) policies apply to this program. An NRSA appointment may not be held concurrently with another Federally sponsored fellowship, traineeship, or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement. Note, however, that pre-award costs are not allowable charges for stipends or tuition/fees on institutional training grants because these costs may not be charged to the grant until a trainee has actually been appointed and the appropriate paperwork submitted to the NIH awarding component. Any additional costs associated with the decision to allow research elective credit for short-term research training are not allowable charges on an institutional training grant.

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

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

Only the review criteria described below will be considered in the review process.

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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.

Training Program and Environment

Rationale, Program Purpose and Goals

• Are the research facilities and research environment conducive to preparing trainees for successful careers as biomedical research scientists?
• Does the proposed program demonstrate the presence of a sufficient number of potential trainees in appropriate disciplines and program faculty with appropriate scientific expertise?
• Is there a clear programmatic theme and area of scientific focus?
• Are the design of the program, the planned coursework, mentored research experiences and structured activities likely to achieve the training objectives of the program and to expose trainees to a diversity of scientific approaches, systems for study and tools and technologies relevant to neuroscience research?
• Is there evidence that the proposed programmatic activities will unify a cohort of trainees and expand their expertise beyond what would occur in the absence of the program?
• Will the proposed program enhance the research training environment and not simply provide financial assistance for the trainees?
• For multidisciplinary and/or multi-departmental programs, is it clear how the individual disciplinary and/or departmental components of the program are integrated and coordinated and how each will relate to an individual trainee's experience?
• Is it clear how the proposed training program is distinguished from other externally funded training programs at the institution?

Translational Training

• Will the proposed program of translational training activities equip trainees with translational research expertise and an understanding of the principles and practices involved in translating basic research to health relevant therapies?
• Will the research environment and training program provide opportunities for trainees to lead projects across the basic-clinical spectrum that will be informed by, and conducted with reference to translational principles?
• Does the translational training plan include opportunities for trainees to engage in cross-disciplinary training that will facilitate an understanding of clinically relevant issues related to basic mechanistic studies, and an understanding of the fundamental biological mechanisms that contribute to diseases/disorders being studied in the clinical arena?
• Do the program include activities that will ensure that trainees a) are exposed to team research in which basic scientists are actively engaged in collaborative research projects with clinicians, b) have opportunities to work with faculty who are actively engaged in translational research and have experience advancing therapies/devices to the clinic and who have demonstrated successful collaborations/interaction with industry, and c) have opportunities to interact with mentors and experts in translational processes?
• Does the program describe a well-designed plan, for formal education in translational processes and practices necessary to advance basic discoveries and clinical research to clinical trials, and their application in the context of the trainees' individual research?

Experimental Design and Statistical Methodology

• Does the program describe formal programmatic activities that will reinforce the principles of sound experimental design and the appropriate use of statistics, such that they will foster an understanding of the critical need for the rigorous application of the concepts covered, and their incorporation into the trainees' individual research?
• If funds are requested for a statistician, has the application provided a plan for participation of the statistician in the program as described above?

Program-wide Meetings

• Is there a detailed plan to ensure that trainees and program faculty meet regularly as a group to discuss and evaluate the experimental and statistical approaches used in their own work and in literature relevant to the thematic area of the program?

Scientific Rigor

• Does the program include formal activities that will ensure that trainees gain a thorough understanding of the principles of scientific rigor, and apply them to their individual research, as well as written and oral research communications?

Professional Skills and Career Opportunities

• Does the program provide appropriate training in career skills such as written and oral presentation for both lay and scientifically-literate audiences, and grant writing?
• Does the program encourage trainees to submit individual grant applications when feasible and appropriate?
• Are students in the program provided with adequate and appropriate information regarding the wide variety of careers for which their training may be useful?

Institutional and Departmental Commitment

• Will the institutional and departmental commitment to research and training excellence promote the success of the trainees and training program?
• Is it clear that there is a commitment to promote a culture in which the highest standards of scientific rigor, reproducibility and responsible conduct of research are advanced?
• Is it clear that there will be adequate funds available to ensure that graduate students are able to complete their doctoral training if their mentor experiences a hiatus in research support or leaves the institution?
• Are the core facilities and technology resources necessary for the success of the program well supported?
• Is there adequate support of the PDs/PIs and other key staff, facilities, and educational resources associated with the training program?
• Do faculty have sufficient protected time available to devote to the training activities?
• Do institutional policies for tenure and promotion decisions reward excellence in training and mentoring?
• Are diversity and inclusion promoted at all levels of the research training environment (trainees, staff, faculty, and leadership)?
• Is there a commitment to ensuring that the institution has an appropriately diverse faculty including women, individuals from different backgrounds and with different perspectives, as well as both senior and junior faculty?
• Do institutional policies reflect a commitment to providing an environment free from discrimination and harassment, sexual or otherwise
• Are the research facilities accessible to trainees with disabilities?
• Are there resources and the expertise for evaluating the training outcomes of the program?

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

• Does the PD/PI have the scientific background, expertise, and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program?
• Does the PD/PI plan to commit sufficient effort to ensure the program s success?
• Do the PDs/PIs have a demonstrated commitment to providing outstanding training to the next generation of the biomedical research workforce, leading recruitment efforts to enhance diversity, and fostering inclusive research environments?
• Is there a planned strategy and administrative structure to oversee and monitor the program and to ensure appropriate and timely progress for the duration of each trainee's time in the program?
• For applications designating multiple PDs/PIs:
• Is a strong justification provided that the multiple PD/PI leadership approach will benefit the training program and the trainees?
• 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 training program and the complementary expertise of the PDs/PIs?

Preceptors/Mentors and Mentoring Oversight

• Are sufficient numbers of experienced preceptors/mentors with appropriate expertise and funding available to support the number and level of trainees proposed in the application?
• Do the preceptors/mentors have strong records as researchers, including recent publications and successful competition for research support in areas directly related to the proposed research training program?
• Do the preceptors/mentors as a group possess complimentary experience and expertise related to the goals and structure of the proposed program?
• Do the established preceptors/mentors have a successful record of training individuals at the level(s) proposed in the program who go on to excellent positions after an appropriate time in training?
• Does the application describe the expectations for preceptor/mentor participation in programmatic activities beyond training within their own labs?
• Does the program provide a plan for ensuring the involvement of participating preceptors/mentors in equipping trainees to approach their research with a quantitative mindset and with an understanding of the principles of sound experimental design and the appropriate use of statistics?
• Are appropriate plans in place to ensure that preceptors lacking sufficient research training experience are likely to provide strong and successful mentoring?
• Is there an appropriate diversity of program faculty, including women, individuals from underrepresented backgrounds (NOT-OD-18-210), and faculty at different career stages, so that trainees will have access to appropriate role models within the training program?
• Does the program provide evidence of the commitment of preceptors/mentors to effective mentoring and promoting inclusive and supportive scientific and training environments?
• Is there a plan for mentoring oversight, including oversight of the effectiveness of the trainee/program faculty match?
• Is there a plan for evaluation of participating faculty for their contribution to high quality mentorship, attention to robust experimental design and statistical and experimental rigor, promoting the values of quantitative literacy expected by the T32-funded program, and creating an inclusive environment that welcomes varied perspectives of both trainees and faculty?
• Does the application describe an approach to and timeline for making changes to the cohort of participating faculty based on their commitment to achieving the goals of the program?

Trainees

• Is the recruitment plan likely to identify and attract a broad and diverse group of candidates who will bring a range of perspectives, and include individuals underrepresented in the biomedical workforce (NOT-OD-18-210)?
• Is there a competitive applicant pool of sufficient size and quality, at each of the proposed levels (predoctoral, postdoctoral, fellowship-stage clinician), to ensure a successful training program?
• Are there well-defined and justified selection and re-appointment criteria?
• Is there a holistic candidate review process proposed (i.e., a process that considers metrics beyond undergraduate institution, GPA, and standardized test scores) that will allow a broad group of trainees, who have taken advantage of the research opportunities available to them and are committed to contributing to the biomedical research enterprise, the ability to participate the training program?
• Does the institution have the resources to support students for the duration of their graduate careers?
• Is there a plan monitor the progress of every trainee to ensure the highest possible level of success for each trainee? Note that for an individual trainee, the highest level of success might include choosing to actively pursue a non-research career opportunity, either after program completion or by exiting prior to program completion?

Training Record

• Was the trainee productivity (quality and number of publications; authorship placement) of trainees who obtained PhD degrees appropriate for 1) an outstanding training program and 2) the ability to continue toward successful independent scientific careers?
• How successful is the program (or, for new applications, the existing neuroscience training environment that houses the program) at producing students who obtain a PhD and transition to excellent next research positions, as well as other positions that make use of their training?
• How successful are the trainees (or, for new applications, other past students/postdoctorates in similar training) in achieving productive scientific careers as evidenced by successful competition for research science positions in industry, academia, government or other research venues; grants; receipt of honors, awards, or patents; high-impact publications; promotion to scientific leadership positions; and/or other such measures of success?
• Does the program have an appropriate record of training individuals from diverse backgrounds, including those from population groups that have been shown to be underrepresented in the biomedical, behavioral, or clinical research workforce, such as underrepresented racial and ethnic groups and those with disabilities?

Training Program Evaluation

• Does the program propose a rigorous evaluation plan to assess the quality and effectiveness of the training and an approach to making appropriate and timely changes in response to the evaluation? Does the plan include involvement of both internal and external faculty? Does the program have a strategy to address the training outcomes of the overall program and the training records of the individual mentors? Is an effective mechanism in place for obtaining feedback from current and former trainees?

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

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

Inclusion of Women, Minorities, and Children

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.

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, including on the Recruitment Plan to Enhance Diversity, and Training in the Responsible Conduct of Research. Does the application describe the program s accomplishments over the past funding period(s)? Is the program achieving its training objectives? Has the program evaluated the quality and effectiveness of the training experience (and when applicable, short-term training experience), and is there evidence that the evaluation outcomes and feedback from trainees have been acted upon? Are changes proposed that are likely to improve or strengthen the research training experience during the next project period (may not be applicable to short-term training)? Does the program continue to evolve and reflect changes in the research area in which the training occurs?

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 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 FOA 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 training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training 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 training 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?

Are the RCR components sufficiently well integrated into the overall curriculum? Are they taught at multiple stages of trainee development and in a variety of formats and contexts? Does the teaching of RCR synergize with elements of the curriculum designed to enhance trainees' abilities to conduct rigorous and reproducible research? Is there evidence that all program faculty reiterate and augment key elements of responsible conduct when trainees are performing mentored research their laboratories?

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

As part of the scientific peer review, all applications:

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Neurological Disorders and Stroke (NANDS) Council. The following will be considered in making funding decisions:

• 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 https://www.hhs.gov/civil-rights/for-individuals/section-1557/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 https://www.hhs.gov/civil-rights/for-individuals/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.

Institutional NRSA training grants must be administered in accordance with the current NRSA section of the NIH Grants Policy Statement - Institutional Research Training Grants.

The taxability of stipends is described in the NIH Grants Policy Statement. Policies regarding the Ruth L. Kirschstein-NRSA payback obligation are explained in the NIH Grants Policy Statement.

As specified in the NIH Revitalization Act of 1993, Kirschstein-NRSA recipients incur a service payback obligation for the first 12 months of postdoctoral support. Policies regarding the Ruth L. Kirschstein-NRSA payback obligation are explained in the NIH Grants Policy Statement; and more details are in the Frequently Asked Questions. Officials at the grantee institution have the responsibility of explaining the terms of the payback requirements to all prospective trainees before appointment to the training grant. Additionally, all trainees recruited into the training program should be provided with information related to the career options that might be available when they complete the program. The suitability of such career options as methods to satisfy the NRSA service payback obligation should be discussed.

Awards made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required, as described in the NIH Grants Policy Statement.

Not Applicable

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.

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.

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 trainee appointed or reappointed to the training grant for 8 weeks or more. Grantees 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.
• Additionally, a completed Payback Agreement Form (PHS Form 6031) must be submitted for each postdoctoral trainee in his or her first 12 months of support.
• A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.
• 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 trainee appointed for eight weeks or more. Trainees 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, the expenditure data portion of the Federal Financial Report, and Termination Notices for all Trainees, are required for closeout of an award as described in the NIH Grants Policy Statement.

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.

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.

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

eRA Commons Help Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

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

Stephen Korn, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-4188
Email: [email protected]

Brad Wise, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: [email protected]

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: [email protected]

Chief, Scientific Review Branch
National Institute on Aging (NIA)
Telephone: 301-496-9666
Email: [email protected]

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

Richard Proper
National Institute on Aging (NIA)
Telephone: 301-402-7735
Email: [email protected]

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 Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66.