Part 1. Overview Information

Key Dates

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 2. Full Text of Announcement

Section I. Funding Opportunity Description

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.

Program Objective

The objective of the Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Postdoctoral Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program is to equip trainees with the knowledge, skills and abilities (KSAs) to advance diagnostics, therapeutics, clinical interventions, and behavioral modifications that improve health.

The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH), is transforming the translational science process so that new treatments and cures for disease can be delivered to patients faster. NCATS strives to develop innovations to reduce, remove or bypass costly and time-consuming bottlenecks in the translational research pipeline in an effort to speed the delivery of new drugs, diagnostics and medical devices to patients. Translation is the process of turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public from diagnostics and therapeutics to medical procedures and behavioral changes. Translational science is the field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process. NCATS studies translation on a system-wide level as a scientific and operational problem. The NCATS approach is not to focus on specific diseases, but on what is common among them and the translational science process. NCATS does this by developing new approaches, technologies, resources and models; demonstrating their usefulness; and disseminating the data, analysis and methodologies to the community.

The NCATS Clinical and Translational Science Awards (CTSA) Program is designed to develop innovative solutions that will improve the efficiency, quality and impact of the process for turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public. Sustaining a vibrant clinical and translational research enterprise requires a 21st century workforce that can advance clinical and translational science (CTS) that will, in turn, increase the efficiency and efficacy of translation, with the ultimate goal of getting more treatments to more patients more quickly.

Clinical and translational scientists will possess both deep scientific domain expertise and systems understanding, and their research is expected to be designed to produce discoveries that are simultaneously important for their discipline(s) and contribute to other disciplines, thus intentionally advancing the translational process as a whole. These characteristics will be required to successfully prepare trainees to transition into the many and varied productive career paths available to clinical and translational scientists within the translational science spectrum. Proposed training programs are expected to help trainees develop the following characteristics independent of their particular area(s) of expertise (Reference: Gilliland CT, et al. The Fundamental Characteristics of a Translational Scientist. ACS Pharmacol Transl Sci. 2019;2(3):213-216. doi:10.1021/acsptsci.9b00022):

• Domain Expert: Possesses deep disciplinary knowledge and expertise within one or more of the domains of the translational science spectrum ranging from basic to clinical to public health research and domains in between.
• Boundary Crosser: Breaks down disciplinary silos and collaborates with others across research areas and professions to collectively advance the development of a medical intervention.
• Team Player: Practices a team science approach by leveraging the strengths and expertise and valuing the contributions of all players on the translational science team.
• Process Innovator: Seeks to better understand the scientific and operational principles underlying the translational process and innovates to overcome bottlenecks and accelerate that process.
• Skilled Communicator: Communicates clearly with all stakeholders in the translational process across diverse social, cultural, economic, and scientific backgrounds, including patients and community members.
• Systems Thinker: Evaluates the complex external forces, interactions, and relationships impacting the development of medical interventions, including patient needs and preferences, regulatory requirements, current standards of care, and market and business demands.
• Rigorous Researcher: Conducts research at the highest levels of rigor and transparency within their field of expertise, possesses strong statistical analysis skills, and designs research projects to maximize reproducibility.

Program Considerations

Applicants are expected to identify training needs and objectives (i.e., specific and measurable outcomes the program intends to achieve). Applicants are expected to develop plans to implement evidence-informed training and mentoring activities (i.e., approaches that are grounded in the literature and from evaluations of existing relevant training programs). The plans are to describe how the participating faculty and preceptors are trained to use evidence-informed mentoring practices that promote the development of trainees from all backgrounds and enhance diversity at all levels (e.g., see the Notice of NIH’s Interest in Diversity). The evidence-informed plans are to consider mentor training assessments that move beyond the faculty s/preceptor’s participation satisfaction to self-reporting of perceived skills gained, self-reported changes in mentoring behaviors or self-reporting of effectiveness. The plan is expected to include a built-in planned strategy to assess and monitor how well the faculty mentor/preceptor promotes a safe, inclusive, and supportive research training environment. To the extent possible, the development plan is to include information on how trainees in mentoring dyads/teams are to corroborate mentor’s self-report of changes in mentoring behaviors.

Funded programs are expected to implement the following:

Core Knowledge Expectations in Clinical and Translational Science Research: Ensure that by the end of the training period, trainees would have achieved sufficient breadth in clinical and translational science research areas, which include: 1) pre-clinical research, 2) clinical research, 3) clinical implementation, and/or 4) public health. Trainees are expected to acquire knowledge in broad areas of research including, but not limited to: clinical research, regulatory science, biostatistics, epidemiology, health disparities, telehealth and telemedicine, dissemination and implementation science research, bioinformatics, community engagement and cultural diversity, training in translational team science, responsible conduct of research and rigorous research design, entrepreneurship, scientific communication, and leadership. It is expected that customized curricula will be personalized for trainees to achieve domain-specific KSAs depending on the trainee’s desired career role or focused area of research.

Clinical and Translational Science Research is a Team-Based Endeavor: Ensure that trainees have mastered core competencies in their own discipline, while gaining knowledge of other disciplines and knowledge of the operational principles underlying at least two sectors of the translational science ecosystem. These competencies and knowledge will confer the trainee’s ability and capacity to effectively communicate, collaborate, and break down barriers across multidisciplinary teams and the translational process. Clinical and translational science research is a team-based endeavor that requires input from many different disciplines, sectors, and points of view to be successful. Programs should support partnerships that give trainees experience outside of their particular discipline, both within the academic domain and with stakeholders and sectors outside it, such as patients, non-profit organizations, regulatory agencies, and industry.

Building on Institutional Strengths in Clinical and Translational Science Research: Each NRSA (T32) Training program is to be innovative in its research training and career development program efforts so to impart to trainees the KSAs required for high quality clinical and translational science research. To achieve this, programs are encouraged to build on the local strengths and demonstrated translational innovations of their companion CTSA Program hub (i.e., health disparities, telehealth and telemedicine, rural health, community engagement, bioinformatics, dissemination and implementation, entrepreneurship, drug discovery, etc.) to effectively curate and foster the clinical and translational science researcher. In this spirit, programs should identify training strengths, needs and objectives (i.e., specific and measurable outcomes the program intends to achieve) that will lead to the creation of a community of clinical and translational science research trainees that extends beyond the training program and across multiple schools (i.e., nursing, dental, engineering) and departments at the institution. Building on institutional strengths can include approaches on how to expose trainees to a larger cadre of mentors with diverse clinical expertise, experiences, resources, and backgrounds relevant to clinical and translational science and who can help the trainee transition to the next career phase.

Understanding Career Opportunities: The career outcomes of individuals supported by the NRSA Postdoctoral Institutional Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program include both research-intensive careers in academia and industry and research-related careers in various sectors including academia, government, industry, and nonprofit. Training programs should make available structured, career development advising and learning opportunities (e.g., workshops, discussions, grant-writing, Individual Development Plans). Opportunities for trainees to gain direct experience with parts of the translational ecosystem outside academia are also important, such as research externships in industry, regulatory agencies, nonprofit patient-advocacy groups, or with other CTSA Program hubs and/or training programs with strengths different from their home hub. Through such opportunities, trainees are expected to obtain a working knowledge of various potential career paths that would make strong use of the clinical and translational science knowledge and skills gained during research training and the steps required to transition successfully to the next stage of their chosen career.

Diversity Contributes to Excellence: Within the framework of the NRSA’s T32 Program’s commitment to excellence and projected need for investigators in particular areas of research, attention must be given to diversity at all levels from the kinds of science to the regions in which it is conducted to the backgrounds of the people conducting it. Diversity contributes to excellence in research training environments, is needed to address complex translational problems, and strengthens the clinical and translational science research enterprise. Programs are expected to demonstrate a commitment to promoting inclusive, safe and supportive scientific and training environments. Programs are expected to collectively expand the pool of clinical and translational science-trained professionals and ensure the translational science workforce is broadly representative across racial, ethnic, sex, gender, age, socioeconomic, geographic and disability status. This FOA is intended to support outstanding research training programs that will enhance diversity at all levels (e.g., see the Notice of NIH’s Interest in Diversity).

Leadership and Management: In addition to the above referenced Fundamental Characteristics of a Translational Scientist, leadership is another essential characteristic of clinical and translational science scientists. Leadership and management training should be infused into the research-focused career development program activities of the institutional research training (T32) program in Clinical and Translational Science Awards (CTSA) Program so that scholars can develop professional and leadership skills (e.g., emotional intelligence, implicit bias, imposter phenomenon, conflict resolution, job offers negotiation, laboratory management, balancing competing priorities) to be effective leaders in clinical and translational science.

Awards for T32 institutional NRSA research training grants may be for project periods up to five years in duration. The grant offsets the cost of stipends, tuition and fees, and training related expenses, including health insurance, for the appointed trainees in accordance with the approved NIH support levels. Postdoctoral trainees are typically provided full-time support for 2 years.

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.

Applications Not Responsive to this FOA

The following applications will be considered as not responsive. Nonresponsive applications will not be reviewed.

• Applications proposing combined predoctoral and postdoctoral training under this FOA.
• Applications that propose short-term research experiences.
• Applications proposing Predoctoral training.

Resubmission of T32 Predoctoral applications that are not linked to a funded UM1.

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

Section II. Award Information

Other Award Budget Information

Section III. Eligibility Information

1. Eligible Applicants

NCATS solicits the submission of one set of companion applications. With this solicitation for the T32 application, a separate, companion FOA solicits applications for a required UM1 (PAR-21-293: Clinical and Translational Science Award). The UM1 and initial T32 applications must be submitted concurrently; a T32 application without the required companion UM1 application will not be reviewed. The T32 application will only be awarded if the UM1 application is awarded. Resubmission of a T32 without the required UM1 will be allowed only if the UM1 application is awarded.

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)

Local Governments

• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• U.S. Territory or Possession

Federal Governments

• U.S. Territory or Possession

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.

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), using their recommendations to determine the appropriate allotment of funds.

In order to ensure that the PD/PI has adequate time to devote to the training program, a UM1 PD(s)/PI(s) may not be a PD(s)/PI(s) on the T32 postdoctoral award.

2. Cost Sharing

3. Additional Information on Eligibility

Applicant organizations may NOT submit more than one application.

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

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

Only one T32 application will be awarded if the UM1 application is awarded. If the UM1 is awarded and the initial T32 is not, the T32 application may be resubmitted. If the UM1 (A0) application is not awarded, then the T32 (A0) will not be awarded.

The following will be considered ineligible. Ineligible applications will not be reviewed.

• New applications that are not submitted concurrently with the required UM1 (PAR-21-293 Clinical and Translational Science Award (UM1 Clinical Trial Optional) or are submitted prior to the UM1 being awarded.
• Resubmission of T32 Postdoctoral applications that are not linked to a funded UM1.

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

Program faculty should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program. Program faculty should also have a record of research training, including successful, former trainees who have established productive careers relevant to the NIH mission. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.

Program faculty should have experience in working in multidisciplinary teams. Preceptors/mentors should have commitment to promoting inclusive, safe, and supportive scientific and training environments. Programs are encouraged to build a diverse team of preceptors/mentors that includes, for example, faculty from underrepresented groups, women, and faculty at different career stages (i.e., junior as well as senior faculty). See the Notice of NIH's Interest in Diversity.

Trainees

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.

.

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.

Within the full-time training period, research trainees who are also training as clinicians (stage of residency or fellowship) 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. At time of appointment, trainees with clinical degrees, must have completed residency if they have chosen not to subspecialize.

Trainees with PhDs should be early in their postdoctoral stage, with no more than 2 years since the date of their terminal degree. These institutional research training grants typically provide 2 years of full-time support to postdoctoral trainees to ensure they are prepared to apply clinical and translational science research principles to their area of study.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the 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.

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

Descriptive Title of Applicants Project: Use the format CTSA Postdoctoral T32 at Name of Institution".

SF424(R&R) Project/Performance Site Locations

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

SF424 (R&R) Other Project Information

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

Project Summary/Abstract. Provide an overview of the entire program. Include the mission, objectives, rationale and design of the research training program. Highlight key activities in the training plan that promote skills development and successful transitions into careers in the biomedical research workforce. Indicate the planned duration of appointments, the projected number of trainees and intended trainee outcomes.

An Internal Advisory Committee (3-page maximum). A plan must be provided for the appointment of an Internal Advisory Committee. The Internal Advisory Committee will be a group of scientists from the sponsoring department and other departments or institutions, as appropriate, with research interests relevant to clinical and translational science. The two major functions of the committee are to evaluate: 1) applications from potential trainee candidates, and 2) the overall conduct of the Program. Specifically, the committee makes recommendations concerning trainee appointments, evaluates ongoing research activities annually (including the interaction and integrated nature of the trainees' research experience), and makes recommendations regarding their continuation. The committee may use institutional or outside consultants, if needed.

Other Attachments

In the plan provided, describe the composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information. Describe how the Internal Advisory Committee will evaluate the overall effectiveness of the program. Proposed Internal Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. If this attachment is not included, the application will be considered incomplete and will not be reviewed. Please name your file Internal_Advisory_Committee.pdf .

Mentor/Trainee Assessment Plan (3-page maximum): The assessment plan is to describe how the program will monitor mentoring relationships. The plan must describe the approaches and tools that will be used to corroborate the mentors self-rated quality of mentoring with those perceived by their mentees. The plan must include a plan on how the Program leadership will monitor, address and intervene in instances of major discrepancies. A plan for removing faculty displaying unacceptable mentorship qualities from the training program must be described. The application may include blank surveys, rubrics, and/or forms used to (a) document and monitor the mentoring relationship progress and (b) determine whether the training and research environment is effective, inclusive, safe, and supportive. If this attachment is not included, the application will be considered incomplete and will not be reviewed. Please name your file Mentoring_Assessment.pdf .

Trainee Selection and Appointment Process (3 page maximum).Define and justify the selection and appointment criteria for postdoctoral trainees. The applicant must provide information about the process used by the participating departments/interdepartmental programs to recruit training grant eligible individuals. Please name the file Trainee_Selection_Process.pdf . If this attachment is not included, the application will be considered incomplete and will not be reviewed.

Recruitment Plan to Enhance Diversity(3-page maximum). The applicant must provide aRecruitment Plan to Enhance Diversity. The application must include outreach strategies and activities designed to recruit potential training program candidates who are from diverse backgrounds, including students from underrepresented racial and ethnic groups, individuals with disabilities, and students from disadvantaged backgrounds (see Notice of NIH's Interest in Diversity). Describe the specific efforts to be undertaken by the training program and how these might coordinate with trainee recruitment efforts of the institution. Centralized institutional efforts alone will not satisfy the requirement to recruit individuals from underrepresented groups. Participating faculty are expected to be actively involved in recruitment efforts. Please name the file Recruitment_Plan.pdf . If this attachment is not included, the application will be considered incomplete and will not be reviewed.

Trainee Retention Plan (3-page maximum). The applicant must provide aTrainee Retention Plan. TheTrainee Retention Plan must describe efforts to sustain the scientific interests as well as monitor the academic and research progress of trainees from all backgrounds within a program (i.e., retention). Applicants are encouraged to consult the NIH’s extramural diversity website to identify promising retention practices and to use evidence-informed practices for retention with the recognition that the variety of trainee backgrounds and experiences may necessitate the need to tailor retention approaches. Describe the specific efforts to be undertaken by the training program and how these might coordinate with trainee retention efforts of the institution(s). Centralized institutional efforts alone will not satisfy the requirement to implement robust and successful mechanisms to retain all trainees (e.g., participating faculty are expected to be actively involved in trainee retention efforts). Please name the file Retention_Plan.pdf . If this attachment is not included, the application will be considered incomplete and will not be reviewed.

Sustainability Plan (1-page maximum). The application must provide a plan for supporting trainees whose appointments will be on-going at the end of the project period. If this attachment is not included, the application will be considered incomplete and will not be reviewed. Please name your file Sustainability_Plan.pdf .

Outcomes Data Collection and Storage Plan (2-page maximum). The applicant must provide an Outcomes Data Collection and Storage Planto track the outcomes for all supported trainees for a minimum of 15 years beyond the trainee’s participation in the program. Programs are encouraged to make the aggregate outcome data available on the institution's website. If the applicant intends to make the data available, describe how the aggregate data will be de-identified before public posting. The applicant must include a strategy to ensure the secure storage and preservation of program data and outcomes. Describe how the data will be centralized, safeguarded, and retrievable during leadership changes. Please name the file Data_Collection_Storage_Plan.pdf . If this attachment is not included, the application will be considered incomplete and will not be reviewed.

Dissemination Plan (1-page maximum). The application must provide a specific Dissemination Planto publish or present nationally any findings or materials developed under the auspices of the program. Examples of dissemination may include data or materials from successful training or mentoring interventions via web postings, presentations at scientific meetings, and/or workshops. Please name the file Dissemination_Plan.pdf . If this attachment is not included, the application will be considered incomplete and will not be reviewed.

Coordination and Interaction Plan (3-page maximum). The application must provide a specific plan describing the partnership between the UM1, the required K12 (PAR-21-336) and any optional components. The application must describe the overarching goals of each component and the coordination, integration, synergy, and mutual reinforcement of resources between the components. Include a description of the roles of any shared partners and/or collaborators. Please name the file Coordination_Interaction_Plan.pdf . If this attachment is not included, the application will be considered incomplete and will not be reviewed.

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

SF424(R&R) Senior/Key Person Profile Expanded

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

Biographical sketch. Where applicable, personal statements should highlight prior experience with training and mentoring, promoting an inclusive and supportive scientific environment, and providing instruction in scientific rigor.

PHS 398 Cover Page Supplement

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

PHS 398 Training Subaward Budget Attachment(s)

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

Training Budget

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

• Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
• As per the instructions, request actual amounts for tuition/fees and provide justification. The amounts may be adjusted at the time of award.

PHS 398 Research Training Program Plan

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

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

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

Not Applicable.

Particular attention must be given to the required Training Data Tables. Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the applicant pool, faculty mentors, the educational and career outcomes of participants, and other factors that contribute to the overall environment of the program.

Training Program

Program Plan

The "Program Plan" attachment is required and must adhere to the NIH Table of Page Limits, as well as the organization and instructions provided below. Do not follow the organization and instructions provided in the in the SF424 (R&R) application guide for the Program Plan attachment; instead applicants must use the instructions below. Start each section with the appropriate heading.

Mission and Objectives

• The justification for the proposed research training program including, but not limited to, the relevant background and an overview of the current research training activities of the participating department(s) or unit(s); and

• The training mission (i.e., broad statement of purpose of the program), and objectives (i.e., specific measurable outcomes the program intends to achieve) that align with the overarching goals of the CTSA research training program described above and lead to the creation of a community of clinical and translational science research trainees.

Program Administration

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. Multiple PDs/PIs are encouraged, particularly when each brings a unique perspective and skill set that will enhance training, as described in the Eligible Individuals section. 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, including a record of rigorous research, as well as the administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program.
• The time to commit sufficient effort to ensure the program's success, given other professional obligations (applicants should indicate the program director's percent effort in the proposed program).
• The planned strategy and administrative structure to oversee and monitor the program and ensure appropriate and timely trainee progress, along with evidence-informed mentor training and mentoring practices.

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. In addition to the information specified in the Application Guide, describe:

• How the program faculty have time to commit to training given their other professional obligations;
• How the program faculty composition will ensure that trainees will gain the KSAs to advance clinical and translational science research areas into diagnostics, therapeutics, clinical interventions, and behavioral modifications that improve health;
• How the program has a demographically diverse team of program faculty, including faculty at a range of career stages and from a variety of scientific backgrounds;
• How the program will provide mentoring oversight, including oversight of the effectiveness of the trainee/program faculty match;
• How the program faculty are trained to ensure the use of training and mentoring practices that promote the development of trainees from all backgrounds;
• How the program faculty will provide supportive mentoring;
• How the program faculty will be evaluated as teachers and mentors;
• In programs where trainees will have multiple mentors, how the faculty will effectively coordinate training and mentorship responsibilities.

Proposed Training

In addition to the information specified in the Application Guide, describe:

• How trainees will be instructed on data science principles that are relevant to their areas of research. Examples include statistics, computational science, bioinformatics, data sharing and access, data management, data security, and data privacy in human subject research.
• Program activities intended to develop the working knowledge needed for trainees to select among and prepare for the next step in the varied research career options available in the clinical and translational science research workforce. For example, programs should provide all trainees with instruction and training in oral and written presentations and in skills needed to apply for individual fellowship or other grant support.
• How the proposed program will engage a range of potential employers to ensure the trainees will acquire the appropriate skills, knowledge, and steps needed to attain positions in the sectors of the biomedical research workforce that are of interest to them.
• How the training program or institution will provide experiential learning opportunities (e.g., industry internships, shadowing, informational interviews, teaching opportunities) that allow trainees to develop the professional skills and networks necessary to transition into careers in the biomedical research workforce.
• How the training program provides leadership training.

Training Program Evaluation

In addition to the information specified in the Application Guide, describe:

• How the program will identify tools to assess program performance including evaluation of the curriculum, mentors, research training opportunities, and trainees.
• How the program will be evaluated to determine its quality and effectiveness. This plan should include evaluation metrics as well as plans to obtain feedback to help identify weaknesses and to provide suggestions for improvements. The specified evaluation metrics should be tied to the goals of the training research program and is to track the career progress of trainees. How the proposed evaluation will assess the extent to which trainees find the training program to be inclusive and supportive of trainee development.
• How the proposed evaluation will assess the trainee’s perception of a training program that encourages diversity at all levels.
• How the proposed evaluation will assess the trainee’s perceptions of effective mentoring and of an inclusive, safe, and supportive scientific and training environment.
• A mechanism to monitor mentoring, including oversight of the effectiveness of the trainee/participating faculty match, and a plan for removing faculty displaying unacceptable mentorship qualities from the training program (applicants are to use the Mentor/Trainee Assessment Plan to provide details of the plan).
• How the proposed evaluation will assess trainee’s key training milestones and achievements such as, but not limited to, program completion; first authored manuscripts, applications and successes of fellowship or career development awards; successful competition for positions in industry, academia, government or other research venues, etc.

Trainee Candidates

In addition to the information specified in the Application Guide, and through the narrative and summaries of the information presented in the Training Data Tables and the attachments, the application should describe:

• A strong justification for the number of requested funded slots per year in the context of the training grant eligible pool, the size of the proposed program, and the number of participating faculty. For interdepartmental programs, describe the number of appointed individuals in the program from each scientific discipline.
• Expand upon the recruitment plan to enhance diversity and explain how it will identify and recruit a diverse group of candidates from a wide variety of institution types and backgrounds as described in NIH's Notice of Interest in Diversity.
• The proposed training grant support structure, i.e., how many individuals (e.g., 4 per year), at what stage (e.g., first year postdoctoral), and for how long (e.g., for 2 years). Note: The CTSA postdoctoral T32 Programs should support individuals early in their postdoctoral stage (no more than 2 years since the date of their terminal degree).

Institutional Environment and Commitment to Training

A letter providing assurances of the institutional commitment must be provided in the Letters of Support section of the application. Detailed instructions on the types of support are found below in the Letters of Support section of the FOA. The application must describe how the level of institutional and departmental commitment to research and training excellence will promote the success of the trainees and training program. For institutions that have multiple NIH-funded training grants, the letter must also explain what distinguishes the proposed program from existing ones at the same training level, how the programs will synergize and share resources when appropriate, and how the training faculty, pool of potential trainees, and resources are sufficiently robust to support the proposed program in addition to existing ones.

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. This includes the following: Describe how the Responsible Conduct of Research (RCR) components are well integrated into the overall training plan, including instruction at multiple stages of trainee careers and in a variety of formats and contexts. Where applicable, explain how instruction in RCR synergizes with elements of the curriculum designed to enhance trainees abilities to conduct rigorous and reproducible research. Describe how all participating faculty will reiterate and augment key elements of responsible conduct when trainees are performing mentored research projects.

Plan for Instruction in Methods for Enhancing Reproducibility

Individuals are required to comply with the instructions for the Plan for Instruction in Methods for Enhancing Reproducibility as provided in the SF424 (R&R) Application Guide, which include a description of how the program will provide training in scientific reasoning, rigorous research design, relevant experimental methods, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, quantitative approaches, and data analysis and interpretation, as appropriate to the field of study and the level and prior preparation of the trainees.

Individuals are required to comply with the instructions for the Plan for Instruction in Methods for Enhancing Reproducibility as provided in the SF424 (R&R) Application Guide, which include a description of how the program will provide training in scientific reasoning, rigorous research design, relevant experimental methods, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, quantitative approaches, and data analysis and interpretation, as appropriate to the field of study and the level and prior preparation of the trainees.

Faculty, Trainees, and Training Record Section

Participating Faculty Biosketches

Program faculty are encouraged to provide a personal statement that describes their prior experience with:

• Training, mentoring, and promoting an inclusive and supportive scientific environment.
• Providing training in rigorous and unbiased experimental design, methodology, analysis, interpretation, and reporting of results.
• Aiding and supporting trainees in identifying and transitioning into careers in the biomedical research workforce that are consistent with trainees' skills, interests, and values.

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). Institutional commitment to the following areas should be described in the letter:

• Developing and promoting a culture in which the highest standards of scientific rigor, reproducibility and responsible conduct are advanced.
• Ensuring sufficient resources and support will be available to the training faculty and trainees, for example, to permit early-stage faculty to participate in training and trainees to continue in training if their mentors experience a hiatus in research funding.
• Supporting core facilities and technology resources and describing how they can be used to enhance training.
• Providing adequate staff, facilities, and educational resources to the planned program.
• Supporting the PDs/PIs and other key staff associated with the planned training program; ensuring faculty have protected time available to devote to mentoring, training and research; considering activities integral to excellent 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 the research facilities and laboratory practices promote the safety of trainees; ensuring the research facilities are accessible to trainees with disabilities; ensuring a positive, supportive and inclusive research and training environment for individuals from all backgrounds.
• Ensuring that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices and to appropriately respond to allegations of such discriminatory practices, including providing any required notifications to NIH (NOT-OD-19-056) or OCR (e.g., see NOT-OD-15-152).
• Providing the types and levels of support necessary for trainees to successfully complete the research training program.
• Supporting evaluation of the training program and procedures for responding to evaluation findings.

All information related to institutional support, as defined above, must be included within the 10-page limit of this letter.

Appendix:

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Post Submission Materials

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

Section V. Application Review Information

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

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

Overall Impact

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

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

Training Program and Environment

• Program Administration

  Career Development
• Does the application provide a compelling rationale for the proposed research training program?
• Does the proposed program clearly outline obtainable and measurable objectives that align with the overarching goals of the CTSA research training program ?
• Does the program structure ensure that trainees will receive training in knowledge, skills and abilities relevant to clinical and translational science research?
• Are the research facilities and research environment conducive to preparing trainees for successful careers as clinical and translational scientists?
• Is the proposed training program likely to ensure trainees will be well exposed to Clinical and Translational Science (CTS) concepts and prepared for broad, research-related careers in translational science?
• Does this training program have customized curricula that are personalized and nurture domain-specific knowledge, skills and abilities depending on the trainee’s desired career role or focused area of research?
• Does the application describe an effective strategy and administrative structure to oversee and monitor the program to ensure appropriate and timely trainee progress?
• Is it clear how the proposed training program is distinguished from other externally funded training programs at the institution?
• Does the program provide appropriate multidisciplinary research training opportunities?
• 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?
• 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?
• Will the trainees be provided with adequate and appropriate information regarding the wide variety of careers in the translational science research workforce for which their training may be useful?
• Will the program engage with potential employers to ensure that the trainees acquire the appropriate skills, knowledge, and steps needed to attain positions in translational science research workforce sectors that are of interest to them?
• Will the training program or institution provide experiential learning opportunities (e.g., industry internship, shadowing, informational interviews, grant writing) that allow trainees to develop the professional skills and networks necessary to transition into careers in translational science?
• Will the training program provide training in leadership and management (e.g., emotional intelligence, implicit bias, imposter phenomenon, conflict resolution, job offers negotiation, communication skills, self-advocacy, laboratory management, budgeting, hiring, stress management and wellness, balancing competing priorities)?

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

• Does the PD/PI, and where relevant, multiple PDs/PIs, have the scientific expertise, including a record of rigorous research, administrative, and training experience to provide strong leadership, direction, management, and administration of the proposed research training program?
• Does the PD/PI, and where relevant, multiple PD/PIs, plan to commit sufficient effort to ensure the program’s success?
• Are 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?
• Are the PD(s)/PI(s) currently funded and engaged in clinical and translational science?
• Does the leadership demonstrate a commitment to developing the next generation of clinical and translational scientists, leading recruitment efforts to enhance diversity, and fostering inclusive research environments? The PD(s)/PI(s) should have received training on how to effectively mentor individuals from all backgrounds, e.g., from groups underrepresented in the biomedical sciences (NIH's Interest in Diversity).
  

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

Program Faculty and Mentoring Oversight

• Does the program faculty have the experience to train the trainees in the knowledge, skills, and abilities to advance clinical and translational science research areas into diagnostics, therapeutics, clinical interventions, and behavioral modifications that improve health?
• Is selection of the program faculty based on a commitment to training and mentoring?
• Do faculty have sufficient protected time available to devote to the training activities?
• Do faculty have experience working as part of multidisciplinary teams?
• Does the application describe an effective strategy and administrative structure to oversee and monitor the program to ensure appropriate and timely trainee progress for the duration of the trainees' graduate careers?
• For clinically oriented trainees, do these trainees have mentors who are clinicians?
• Will the participating faculty be trained to ensure the use of evidence-informed mentoring practices that promote the development of trainees from all backgrounds?
• Does the evidence-informed mentor training assessment move beyond the faculty s/preceptor’s participation satisfaction to self-reporting of perceived skills gained, self-reported changes in mentoring behaviors or self-reporting of effectiveness?
• Is there a way for trainees in the mentoring teams to corroborate mentor’s self-report of changes in mentoring behaviors?
• Is there a plan to ensure that the participating faculty engage in activities that promote trainee career development (including but not limited to the utilization of Individual Development Plans), and fulfill the need of the trainees to obtain the skills, credentials and experiences to transition into independence and careers in the translational science?
• Is there an effective mechanism to monitor mentoring, including oversight of the effectiveness of the trainee/participating faculty match, and a plan for removing participating faculty displaying unacceptable mentorship qualities from the training program?
• Is there evidence that the program faculty and preceptors are demographically diverse in composition, including faculty at a range of career stages and from a variety of scientific backgrounds?
• Is there a plan for how multiple mentors will effectively coordinate their training and mentoring responsibilities?
• Is there evidence that mentor training efforts extend beyond those involved in the training grant and impact the institution?
• Does the program include mentors with expertise in areas pertinent to clinical and translational science such as pre-clinical research, clinical research, clinical implementation, and public health in order to form the intellectual and technical base for the mentoring of trainees?
• 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 demonstrate a commitment to effective mentoring and promoting inclusive and supportive scientific and career development environments?
• Do the preceptors/mentors have a commitment to training and mentoring? For example, have they received training on how to effectively mentor individuals from all backgrounds, e.g., from groups underrepresented in the biomedical sciences (NIH's Interest in Diversity)?

• If the program will support clinical trial research experience for the Trainees, do the mentor(s) who will supervise the Trainee(s) have the expertise, experience, resources, and ability to provide appropriate guidance and help the Trainee(s) to meet the timelines?

Institutional Environment and Commitment to the Program

• Will the institutional and departmental commitment to research and training excellence promote the success of the CTS trainees and training program that includes, but not limited to, recognition and acknowledgement of all team members and a team science approach?
• Is the level of institutional commitment to the training program, including administrative and research training support, sufficient to ensure the success of the program?
• Is there adequate support of the PDs/PIs and other key staff, facilities, and educational resources associated with the training program?
• Is there evidence that a CTS trainee community is being created and nurtured in ways that permeates the broader learning community beyond the CTSA Program Hub?
• 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 demographically diverse faculty including women, individuals from different backgrounds and with different perspectives, as well as both senior and junior faculty?
• Are there resources and the expertise for evaluating the training outcomes of the program?

Trainees

• Is a recruitment plan proposed with strategies likely to attract well-qualified and demographically diverse trainees for the training program?
• Is there a competitive applicant pool of sufficient size and quality to ensure a successful training program?
• Does the application provide a strong justification for the number of trainee positions requested?
• Are there well-defined and justified selection criteria as well as retention strategies?
• Is the recruitment plan likely to identify and attract a broad and demographically diverse group of candidates who will bring a range of perspectives, and include individuals underrepresented in the biomedical workforce (NOT-OD-20-031)?

Training Record

• 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?
• Does the program have an effective mechanism in place for obtaining feedback from current and former trainees?
• Does the program evaluate that demographically diversity and inclusion is promoted at all levels of the translational science research training environment (trainees, staff, faculty, and leadership)?
• Does the program evaluation indicate positive, supportive and inclusive research and training environment for individuals from all backgrounds?
• Does the program evaluation provide evidence that the PI and team will be attentive and responsive to the evaluation findings?

Protections for Human Subjects

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Training in Methods for Enhancing Reproducibility

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

Renewals

Not Applicable

Revisions

Not Applicable.

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

Recruitment Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of prospective individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

All applications for support under this 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?

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

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board.

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.

Section VI. Award Administration Information

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

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

Recipients must comply with any funding restrictions described in Section IV.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, Recipients, and Activities, including of note, but not limited to:

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

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

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

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides 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/fact-sheet-guidance/index.html and https://www.lep.gov. 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 https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 recipient 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.

Inventions and Copyrights 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, recipients will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.

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

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

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

• 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition 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.

NCATS intends to conduct an overall evaluation of the program and it will be based on metrics that will include, but are not limited to, the following:

For programs involving postdoctorates and early career investigators:

• Subsequent participation in a formal research training or career development program in a Clinical and Translational Science
  field
• Subsequent participation in research or employment in a Clinical and Translational Science field
• Authorship of scientific publications in a Clinical and Translational Science field
• Subsequent independent research grant support from NIH or another source

Section VII. Agency Contacts

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

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

Finding Help Online: 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 processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

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

Jennie Conroy, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8165
Email: jennie.conroy@nih.gov

Carol Kim, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Phone: 301-402-1744
E-mail: carol.kim@nih.gov

Katie Matthews
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-827-7060
Email: CTSATrainingFOAsQuestions@mail.nih.gov

Section VIII. Other Information

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.

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.