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.

The NRSA program has been the primary means of supporting predoctoral and postdoctoral research training programs since enactment of the NRSA legislation in 1974. Each program should provide high-quality research training, mentored research experiences, and additional training opportunities that equip trainees with the technical (e.g., appropriate methods, technologies, and quantitative/computational approaches), operational (e.g., independent knowledge acquisition, rigorous experimental design and interpretation of data, conducting research in the safest manner possible) and professional (e.g., management, leadership, communication, and teamwork) skills required for careers in the biomedical research workforce.

Through this funding announcement, NIGMS encourages changes in integrated medical and graduate research training to keep pace with the rapid evolution of the biomedical research enterprise that is increasingly complex, interdisciplinary, quantitative, and collaborative. Other changes in the biomedical research enterprise include greater diversity in the backgrounds of people participating in biomedical research, the approaches utilized to investigate clinically relevant research questions, and the range of the careers that dual-degree recipients are pursuing. Additionally, there is an increasing recognition of the need to enhance reproducibility of biomedical research results through scientific rigor and transparency, and to promote a culture where the highest standards of practice are used to ensure the safety of all individuals in the research environment. This FOA is intended to encourage and enable the scientific community to develop and implement evidence-informed approaches to biomedical research training and mentoring that will effectively train future generations of rigorous biomedical clinician scientists to become leaders in biomedical research and clinical medicine.

Each funded program should provide high-quality clinical training and mentored research experiences, and additional opportunities that equip trainees with the technical, operational, and professional skills required for careers as clinician-scientists in the biomedical research workforce. The intention is not to layer additional activities onto existing structures; instead, this FOA is designed to allow for creative and transformational approaches to biomedical graduate training, including curricular reform, that preserve the best elements of current programs, while enhancing the focus on the development of trainee skills. NIGMS encourages continuous experimentation that tests and evaluates new approaches to dual-degree training (Ph.D. combined with clinical degrees, e.g., M.D., D.O., D.V.M., D.D.S., Pharm.D.), and then disseminates the results of those experiments to the community.

The Overarching Objective of this Medical Scientist Training Program is to develop a diverse pool of well-trained clinician scientists, who have the following technical, operational, and professional skills:

• The skills necessary to integrate research and clinical activities in support of a productive research career;
• The ability to utilize clinical experience and observations to identify important biomedical research questions and develop impactful research programs;
• A broad understanding across biomedical disciplines and the skills to independently acquire the knowledge needed to advance their chosen fields;
• Expertise in a biomedical scientific discipline and the skills to think critically and independently, and to identify important biomedical research questions and approaches that push forward the boundaries of their areas of study and that enable the translation of basic research findings into clinical practice;
• A strong foundation in scientific reasoning, rigorous research design, experimental methods, quantitative and computational approaches, and data analysis and interpretation;
• The skills to conduct research in the safest manner possible, and a commitment to approaching and conducting biomedical research and clinical practice responsibly, ethically, and with integrity;
• Experience initiating, conducting, interpreting, and presenting rigorous and reproducible biomedical research with increasing self-direction;
• The ability to work effectively in teams with colleagues from a variety of cultural and scientific backgrounds, and to promote inclusive and supportive scientific research environments;
• The skills to teach and communicate scientific research methodologies and findings to a wide variety of audiences (e.g., discipline-specific, across disciplines, and the public); and
• The knowledge, professional skills and experiences required to identify and transition into careers in the biomedical research workforce (i.e., careers that utilize the dual degree).

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 contributes to excellence in research training environments and strengthens the research enterprise. This FOA is intended to support outstanding research training programs that will enhance diversity at all levels (e.g., see NIH's Interest in Diversity).

Under this FOA, NIAID will support the medical school portion of training for students enrolled in an NIH Graduate Partnership Program, which is designed to bring Ph.D. graduate students to the NIH Intramural Research Program for dissertation research. These students must be accepted by an NIGMS-funded Medical Scientist Training Program (MSTP T32).

NIGMS will accept predoctoral training grant applications supporting integrated medical and graduate research training through this MSTP FOA and subsequent reissuances (graduate research training in basic biomedical sciences is supported through PAR-20-213 and subsequent reissuances). Applicants are strongly encouraged to read information about NIGMS Institutional Predoctoral Training Grants and the MSTP found on the NIGMS website and to contact program staff before submitting an application. NIGMS will not accept applications for predoctoral training submitted through the Parent T32 FOA, PA-20-142 and subsequent reissuances.

Programs are expected to develop institutional training programs that integrate clinical and research training and expose trainees to a diversity of scientific approaches, systems for study, research methods, and technologies. Funded programs should implement plans to optimize the time required to earn the dual degree. Programs are expected to limit appointments to individuals committed to research careers that utilize the dual-degree qualifications.

NIGMS encourages programs to devise and test alternative entry pathways in addition to or instead of the direct application and admission to the first year of a dual-degree training program, thus providing opportunities to recruit students from clinician-only or from Ph.D.-only programs. NIGMS encourages institutions to offer MSTP trainees the opportunity to earn the Ph.D. in a broad range of biomedical, physical, social and behavioral sciences, and engineering to meet the needs for clinician-scientist researchers in all areas of the biomedical workforce. Programs that provide interdisciplinary research training, incorporate training in data science, or take advantage of clinical research opportunities within nationwide networks and infrastructures such as the NIH Clinical and Translational Science Award program are encouraged to apply. NIGMS encourages applicants to offer training across the landscape of medical fields and scientific disciplines related to health, and to provide opportunities for the exploration of clinician-scientist career options.

Applicants are expected to identify training needs and objectives (i.e., specific and measurable outcomes the program intends to achieve) and 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). Funded training programs must ensure that trainees have a solid foundation in methods to enhance data reproducibility through rigor and transparency. Applicants are encouraged to consult the NIGMS clearinghouse for training modules to enhance data reproducibility, and other resources when developing the plans.

Funded programs are expected to implement robust plans to enhance diversity and to promote inclusive, safe, and supportive research environments. Specifically, funded programs should have institutional and departmental environments where individuals from all backgrounds are welcomed and feel integrated into and supported by the biomedical community. Programs are also expected to implement plans to enhance trainee retention, i.e., to sustain the scientific interests and participation of trainees from all backgrounds. Additionally, safety in research training should encompass (1) environments free from harassment and intimidation, in which everyone participating is treated in a respectful and supportive manner, (2) laboratory and clinical settings where individuals exercise the highest standards of practice for chemical, biological and physical safety, and (3) practices at the institutional leadership and research community levels that demonstrate core values and behaviors to emphasize safety over competing goals.

Funded programs are expected to provide evidence of accomplishing the training objectives in progress reports and when applying for renewal, to make training and career outcomes publicly available, and are strongly encouraged to disseminate successful training practices to the broader training community.

Institutional commitment and support for the proposed training program are important elements of the application. The research training program may complement and synergize with other ongoing federally-supported predoctoral research training programs at the applicant institution (e.g., in the development of skills needed for careers in the biomedical research workforce that are not discipline-specific); however, the scientific training goals must be distinct from related programs at the same institution currently receiving federal support. In cases where an institution has multiple NIGMS predoctoral training grants, it is expected that these programs will seek to create administrative and training efficiencies to reduce costs and improve trainee services and outcomes. The training grant should be well integrated within one or more graduate department(s)/program(s) and should exert a strong, positive influence on the development and execution of the outreach and recruitment of potential trainees, graduate curriculum, training opportunities and mentoring. Training grant funds may not be used solely as a vehicle to provide stipends for trainees to conduct research.

NIGMS does not accept applications for predoctoral T32 programs proposing only short-term research training. Programs proposing short-term research training should apply to the Kirschstein-NRSA Short-Term Institutional Research Training Grant Program (T35) exclusively reserved for predoctoral, short-term research training (see PA-20-162 and subsequent reissuances). NIGMS will not accept applications proposing combined predoctoral and postdoctoral training under this FOA.

Training grants are usually awarded for five years. 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. NIGMS typically provides full-time support for approximately 25% of the trainees in the training program during any given year. Individuals may receive up to six years of aggregate Kirschstein-NRSA support at the predoctoral level for dual-degree training, including any combination of support from institutional training grants (e.g., T32) and an individual fellowship award. NIGMS encourages training grant support to be concentrated earlier in graduate school for students to receive maximum benefit from training grant activities, but there may be situations in which other modes of training support are acceptable. Many dual-degree training programs guarantee enrolled students full support throughout the training period (through combinations of MSTP support, institutional funds, other fellowships, and grants). Training programs may implement institutional policies regarding the payback of non-NRSA institutional sources of funds by students who start training but do not complete one or both degrees. NIGMS does not require (nor permit institutions to receive) payback of NRSA funds from trainees who are appointed to NIH training grants, but do not complete training.

For applicants that currently have an NIGMS institutional predoctoral MSTP, NIGMS recommends that applicants plan to apply under this FOA at least one- to one-and-a-half years before the current grant is scheduled to terminate. For example, if the current grant is scheduled to terminate on June 30, 2023, applicants are advised to submit an application to this FOA no later than May 25, 2022. Please consult the NIGMS website for more information on Predoctoral Training Grant Application Deadlines.

This 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)
• Predominantly Black Institutions (PBI)
• After Tribally Controlled Colleges and Universities (TCCUs)
• American Indian/Alaska Native Serving, Non-Tribal Institutions (AI/AN)
• 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

NIGMS encourages multiple institutions to participate in a single MSTP application, where this may further advance the goals of the program. A single contact institution would receive and administer the award.

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program should be detailed in the Institutional Support Letter in the Letters of Support attachment. See the application instructions for the required Letters of Support instructions in Section IV.

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.

As described in the instructions for the Training Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) in Section IV.2 below, NIGMS encourages multiple PDs/PIs, particularly when each brings a unique perspective and skill set that will enhance training. At least one of the training PDs/PIs should be an established investigator in the biomedical sciences and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. Additional PD(s)/PI(s), including individuals with experience in the science of education, relevant social science disciplines, program evaluation, mentoring, and university administration may be included to achieve the training goals. Any of the PDs/PIs may serve as the contact PD/PI. The contact PD/PI is expected to have a full-time appointment at the applicant institution unless extremely well-justified. If the full-time status of the contact PD/PI changes after the award, the institution must obtain prior program approval to appoint a new PD/PI or request a deviation from the full-time rule. The PDs/PIs 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 PDs/PIs will be expected to monitor and assess the program and submit all documents and reports as required. The PDs/PIs have responsibility for the day-to-day administration of the program and are responsible for appointing members of the Advisory Committee (when applicable) and using their recommendations to determine the appropriate allotment of funds.

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

NIGMS will accept only one application per institution, typically defined by a unique entity identifier, such as DUNS and an NIH Institution Profile File (IPF) number.

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 faculty should be active researchers in the biomedical sciences as demonstrated by recent publications and research support. When building a training team, programs should include faculty who are committed to training, mentoring, and providing supportive and inclusive research environments. Programs are encouraged to build a diverse team of preceptors/mentors that includes, for example, faculty from underrepresented groups (see Notice of NIH's Interest in Diversity) and faculty at different career stages (i.e., early-career as well as established faculty).

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.

MSTP predoctoral trainees must be enrolled in a program leading to a combined health professional degree and a Ph.D. (e.g., M.D./Ph.D.).

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.

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 modifications:

Are Human Subjects Involved: Check "No" unless the training program itself requires the trainees to take a workshop or course that will involve human subjects.

Are Vertebrate Animals Used: Check "No" unless the training program itself requires the trainees to take a workshop or course that will involve vertebrate animals.

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.

Other Attachments.

Advisory Committee (1-page maximum). 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 program. The 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 assess the overall effectiveness of the program. To avoid conflicts in the review process, only pre-existing Advisory Committee members should be named in the application. Potential Advisory Committee members should not be identified or contacted prior to receiving an award. Please name the file Advisory_Committee.pdf .

Application and Admissions Data: The application must provide baseline data on the characteristics of the trainee pool. The data must reflect the training grant eligible individuals who further the goals of the proposed research training program. The data serve as a basis for review of planned activities, including recruitment. The number of training grant eligible candidates will be used to determine the appropriate budget and number of funded positions. NIGMS will use the data provided in a manner consistent with applicable law.

• Trainee Characteristics. All applicants must provide the numbers and average for the past five academic years of training grant eligible candidates who applied to, were admitted to, and matriculated into the training program or departments described in the application. NIGMS encourages the use of Suggested Formats A to aid in the structuring of the data. Applicants are encouraged to use categories reflected in the Notice of NIH’s Interest in Diversity or the NIH Trainee Diversity Report (such as race, ethnicity, gender, disability and disadvantaged background) as these data will be collected as part of annual progress reports for funded programs. Additional trainee candidate pool characteristics that are relevant to the goals of the training program may also be included. Applicants should use appropriate methods for data privacy, confidentiality, and security practices related to student data systems and reporting (for example, cell sizes for sensitive data).
• Multi-Component Program Data. If the training program is multi-departmental or multi-organizational in structure with separate recruitment, admissions and matriculation procedures, applicants should provide the numbers and average for the past five academic years of training grant eligible candidates who applied to, were admitted to, and matriculated into the relevant departments or organizations described in the application. Applicants are encouraged to use the Suggested Formats B, in addition to Suggested Formats A, to aid in the structuring of the data.

Please name the file Application_Admissions_Data.pdf .

Recruitment Plan to Enhance Diversity (3-page maximum). The applicant must provide a Recruitment Plan to Enhance Diversity. The application should 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). Applicants are encouraged to consult the NIGMS webpage for strategies to enhance diversity in training programs when designing their plans. 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 a Trainee Retention Plan. The Trainee 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.

Outcomes Data Collection and Storage Plan (2-page maximum). The applicant must provide an Outcomes Data Collection and Storage Plan to 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 Plan to 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.

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 with the following modifications.

Biographical sketch. The personal statement should describe a commitment to scientific rigor, training, mentoring, as well as to promoting inclusive, safe, and supportive scientific environments.

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

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

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

• Include all allowable categories of funds requested to support trainees in the program.
• As per the instructions, request actual amounts for tuition/fees and provide justification. The amounts may be adjusted at the time of award.

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 modifications:

Attention must be given to the required Training Data Tables for New or Renewal applications. Guidance for preparing the Training Data Tables is found on the NIGMS website. Table 6A is not required for NIGMS Predoctoral Training Grant applications, and applicants must not include it. In the Program Plan, applicants should also summarize key data from the tables that highlight the characteristics of the applicant pool, program faculty, institutional support, student outcomes, and other factors that contribute to the overall training environment of the program.

Training Program

Follow all training instructions provided in the SF424 (R&R) application guide except where instructed to do otherwise below.

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 SF424 (R&R) application guide for the Program Plan attachment; instead applicants must use the instructions below. Start each section with the appropriate heading.

Rationale, Mission, and Objectives

The application should describe how the MSTP will develop a diverse pool of well-trained clinician-scientists with the qualifications to conduct rigorous scientific research and engage in clinical practice. The MSTP trained clinician-scientists should have the technical, operational, and professional skills required to conduct research in a safe, ethically responsible and rigorous manner, and to enter careers in the biomedical research workforce that utilize the dual degree as delineated in the Program Objective. The application should describe how the program will enhance the training environment and not simply provide financial support to dual degree trainees. Specifically, applicants should describe the following:

• The justification for the proposed research training program including, but not limited to, the relevant background, an overview of the current research training activities of the participating department(s) or unit(s), and areas for improvement in the current research training practices. Applicants must demonstrate the presence of a sufficient number of potential trainees in appropriate disciplines (Table 1) and program faculty with the appropriate scientific expertise (Tables 2 and 4) as well as the current research training resources (Table 3); 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). The program-specific mission and objectives should align with the Overarching Objective of this funding announcement while focusing on developing the specific skills required to be a well-trained scientist in the proposed scientific discipline. Objectives should include, but not be limited to, degree completion rates and appropriate time-to-degree.

Curriculum and Overall Training Plan

The application should describe the following:

• How the courses, structured activities, and research experiences will accomplish the specific training mission and objectives. Explain how these training activities are designed to develop the technical, operational, and professional skills of trainees. The application must include the "Required Training Activities" appendix to provide material to assess the required training elements and may use the "Elective Activities" appendix to provide up to four additional activities;
• How the training program plans to integrate medical and research training;
• Proposed changes to current research training practices to keep pace with the rapidly evolving biomedical research enterprise (e.g., curricular reforms, incorporation of additional quantitative and computational skills development, etc.);
• The mechanism for ensuring that the trainees are learning the highest standards of practice in biomedical research (e.g., record keeping and safety);
• How the Participating Faculty will teach laboratory safety throughout the didactic and mentored portions of the program;
• How the training activities will employ evidence-informed approaches to trainee learning, mentorship, inclusion, and professional development;
• The activities that will build a strong cohort of research-oriented individuals while enhancing the science identity, self-efficacy, and a sense of belonging among the cohort members;
• Representative examples of training programs for individual trainees. Examples may include degree requirements, didactic medical and graduate courses, laboratory and clinical experiences, qualifying and licensing board examinations, and other training activities, such as seminars, journal clubs, etc. Describe how each trainee's program will be guided throughout the medical and research training, and how the trainee's performance will be monitored and evaluated. Discuss the anticipated time required to complete the training program up to degree attainment;
• How training efficiencies are created between the medical and graduate curricula to avoid unproductive redundancies in coursework and other requirements and to reduce time to degree;
• The trainees academic and research background needed to pursue the proposed training and plans to accommodate differences in preparation among trainees;
• How the training activities will be available to other trainees in the program(s), department(s) or institution(s) from which the supported trainees are drawn;
• How the dual training program structure across the participating medical and research components are mirrored by a trainee-focused mentoring network that promotes trainee progress towards the dual-degree and preparation for a research-oriented, clinician-scientist career;
• For multi-institutional, multi-disciplinary and/or multi-departmental programs, indicate how the individual components of the program are integrated and coordinated, and how they will relate to an individual trainee's experience; and
• The ways, when applicable, that the training plan is distinct from, but will share resources and synergize with, other NIGMS-funded predoctoral training programs at the same institution (i.e., NIGMS predoctoral training programs listed in Table 3). See the "Program Considerations" section above.

Career Development

The application should describe the following:

• How the pool of potential applicants and trainees will be provided with information about the career outcomes of graduates of the program (e.g., on publicly accessible websites) and about the overall clinician-scientist and biomedical research workforce employment landscape;
• How trainees in the program will be provided with adequate and appropriate information regarding the variety of careers in the biomedical research workforce that utilize the dual degree;
• 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., 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 that utilize the dual degree; and
• The programmatic initiatives to allow trainees to identify medical residency programs that will support and develop their research interests.

Program Oversight, Participating Faculty Selection, and Mentor Training

The application should include the planned strategy and administrative structure to oversee and monitor the program, and to ensure appropriate and timely trainee progress for the duration of the trainees' dual degree training (the application may include the "Evaluation and Assessment Instruments" Appendix to provide blank rubrics or forms). The application should describe how the participating faculty are trained to ensure the use of evidence-informed teaching, training and mentoring practices that promote the development of trainees from all backgrounds e.g., trainees from groups underrepresented in the biomedical sciences (see Notice of NIH's Interest in Diversity). The application should describe the following:

• How the program will ensure that participating faculty employ the highest standards of scientific rigor and impart those standards to their trainees;
• How the program will ensure that participating faculty reinforce and augment the curricular material on responsible conduct of research, and methods for enhancing reproducibility;
• The mechanism for matching trainees with the appropriate participating faculty (e.g., laboratory rotations, faculty forums, and interviews);
• How the program will ensure that 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 their degrees in a timely fashion with the skills, credentials, and experiences to transition into careers in the biomedical research workforce that are consistent with the trainees interests and values;
• 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 may use the Appendix labeled Conflict Resolution Protocols to provide details of the plan); and
• If a program coordinator or administrator position is planned to enhance oversight, a description of the person's administrative capabilities that are essential to coordinate the program must be included in the application.

Institutional and Departmental Commitment to the Program

A letter providing assurances of the institutional commitment to the program must be included in the "Letters of Support" section of the application. Applicants may use this section to expand upon the Facilities & Other Resources section and the Letters of Support section, as necessary, to provide additional information regarding the institutional and departmental commitment to the program. Do not repeat information contained elsewhere in the application.

Training Program Director(s)/Principal Investigator(s) (PDs/PIs)

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. NIGMS encourages multiple PDs/PIs, 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, 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 (the application should indicate the PD(s)/PI(s)’s percent effort in the proposed program);
• A record of using rigorous and transparent methods in experimental design, data collection, analysis, and reporting;
• A demonstrated commitment to training the next generation of the biomedical research workforce, leading recruitment efforts to enhance diversity, and fostering inclusive research environments. As with all participating faculty, the PDs/PIs should have received training on how to effectively mentor trainees from all backgrounds, e.g., trainees from groups underrepresented in the biomedical sciences (see Notice of NIH's Interest in Diversity); and
• The administrative structure and leadership succession plan for critical positions (e.g., PD(s)/PI(s)).

Preceptors/Mentors (Participating faculty)

The application should describe how the participating faculty will promote the success of the trainees and training program, as well as conducting responsible and rigorous research. Describe how the program has or will assemble a diverse team of participating faculty (e.g., individuals from underrepresented backgrounds (see Notice of NIH's Interest in Diversity) and at different career stages) to provide potential role models within the training program and to enhance the excellence of the training environment. The application should summarize and expand on the material presented in the Training Tables and Biosketches and address how the participating faculty:

• Have sufficient time to commit to training given their other professional obligations;
• Receive training in effective, evidence-informed teaching and mentoring practices;
• Promote the use of highest standards of practice to ensure the safety of all individuals in the research environment;
• Cooperate, interact, and collaborate (which can include joint sponsorship of trainee research);
• Promote the development of trainee skills in approaches to rigorous experimental design, methods of data collection, data analysis and interpretation, and reporting;
• Provide opportunities for trainees to initiate, conduct, interpret, and present rigorous, reproducible and responsible biomedical research with increasing self-direction;
• Demonstrate a commitment to effective mentoring, and to promoting inclusive, safe and supportive scientific and training environments; and
• Are evaluated as teachers and mentors.

Application Process, Trainee Positions, Retention, and Support

Through the narrative and summaries of the information presented in the required Training Tables and the required attachments (i.e., Application and Admissions Data for all applications) the following areas relevant to trainees should be addressed.

Application Process

• Describe the admissions data provided in the required "Application and Admissions Data" attachment in "Other Attachments", including the characteristics of training grant eligible (I) applicants, (II) admitted individuals, and (III) matriculants for each of the past 5 academic years. Applicants are encouraged to report on the numbers and averages for the categories listed in NIH s Interest in Diversity. If the program is an interdepartmental training program with separate admissions, describe the data in the required attachment regarding the number and averages of training grant eligible (I) applicants, (II) admitted individuals, and (III) matriculants in the relevant departments for each of the past 5 academic years. Application and admissions data should inform the recruitment plans in the training grant application;
• Expand upon the "Recruitment Plan to Enhance Diversity" (provided in "Other Attachments"). Explain how the program will identify and recruit a diverse pool of potential candidates from a wide variety of institutions and backgrounds (with a focus on identifying effective recruitment strategies for individuals from nationally underrepresented groups in the biomedical sciences, see Notice of NIH's Interest in Diversity) who have the potential to strongly benefit from, and with proper training and support succeed in the program;
• Describe plans for a candidate review process 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 in the training program. The process should consider metrics beyond undergraduate institution, GPA, and standardized test scores. If the program trainees are drawn from multiple departments, describe how the PD(s)/PI(s) will ensure that the review process is consistent across all relevant departments; and
• If the training program does not conduct its own recruitment and admissions for dual degree students entering the university and instead appoints students who were admitted by university departments or other graduate programs, provide a strong rationale for taking this approach.

Trainee Positions

• Describe how large the program will be across all cohorts (i.e., the total number of individuals enrolled in the proposed program ranging from the entering cohort to those nearing graduation). For interdepartmental programs, describe the expected number of individuals in the program from each scientific discipline;
• Provide 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, the number of participating faculty, and other NIGMS-funded training grants at the institution. For Renewal Applications - Describe the characteristics of the previously awarded training positions (Table 7) as part of the justification for the requested positions;
• Explain the proposed training grant support structure, i.e., how many individuals (e.g., 4 per year), at what stage (e.g., first-year entrants), and for how long (e.g., for 1 year); and
• Define and justify the selection and re-appointment criteria for the training grant supported trainees in the program.

Retention and Support

• Applicants may use this section to expand upon the Trainee Retention Plan (provided in the "Other Attachments") and to provide evidence of the program's commitment to ensuring the well-being and success of all trainees throughout their graduate training; and
• Describe the ability for participating department(s) and/or the institution(s) to support trainees for the duration of their graduate careers.

Training Outcomes

This section is intended to provide outcomes for the program described in the application (or for new programs, to provide outcomes for training grant eligible students for the proposed program). The application should provide the information below about recent outcomes through narrative descriptions and a summary of the data presented in the required training tables. Although the training tables for new applications only allow for five years of recent outcomes, the application may describe up to 15 years of outcomes in the narrative. The application should describe the following:

• Evidence that recent program graduates conducted rigorous research that advanced scientific knowledge and/or technologies, with increasing self-direction (e.g., peer-reviewed publications in Training Table 5A, or other measures of scientific accomplishment appropriate to the field);
• The rate of dual degree attainment and time-to-degree for recent graduates (Training Table 8A). Verify in the text that the time-to-degree was calculated as directed in the table instructions;
• A description or analysis of how the dual degree attainment, time-to-degree data, and evidence of scholarly productivity (e.g., peer-reviewed publications, or other measures of scientific accomplishment appropriate to the field) for recent program graduates from underrepresented groups (see Notice of NIH's Interest in Diversity) compares to the data for recent program graduates from well-represented groups; and
• The success of recent graduates transitioning to clinician-scientist careers (Training Table 8A), including the types of postgraduate work and residency fields of program alumni. Applicants should include information on the number and percentage of graduates continuing research during their residencies.

Program Evaluation and Dissemination

NIGMS funded training programs must conduct ongoing evaluations to monitor the success of the training and mentoring activities. The application should describe:

• The evaluation or assessment process to determine whether the overall program is effective in meeting its training mission and objectives, and whether the scientific research climate is inclusive, safe, and supportive of trainee development (the application may include the "Evaluation and Assessment Instruments" Appendix to provide blank survey instruments, rubrics, or forms);
• Plans for being responsive to outcomes analyses, critiques, surveys and evaluations;
• Past activities to track and post the career outcomes of trainees (applicants should expand upon, but not duplicate the information in the Outcomes Data Collection and Storage Plan ); and
• Past activities designed to share the outcomes of the training or mentoring interventions with the broader community (applicants should expand upon, but not duplicate the information in the Dissemination Plan ).

Plan for Instruction in the Responsible Conduct of Research

Applicants 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, along with the following additional instructions:

Describe how the Responsible Conduct of Research (RCR) components are well integrated into the overall curriculum, i.e., how they are 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 and reproducible research. Describe how all participating faculty will reiterate and augment key elements of responsible conduct when trainees are performing mentored research in their laboratories.

Plan for Instruction in Methods for Enhancing Reproducibility

Applicants are required to provide a Plan for Instruction in Methods for Enhancing Reproducibility as provided in the SF424 (R&R) Application Guide.

Applicants are encouraged to consult the NIGMS clearinghouse for training modules to enhance data reproducibility and other resources when developing the plans.

Progress Report (only for Renewal applications)

For applications describing programs that were previously funded under PAR-19-036 follow the instructions provided in the SF424 (R&R) Application Guide with the following exceptions:

For the "Program Overview" section, follow the page limit indicated in the SF424 (R&R) application guide, but follow the instructions below instead:

• Indicate the period covered since the last competitive review;
• Include information to demonstrate that the program successfully trained a diverse pool of individuals who have the technical, operational, and professional skills to transition into careers in the biomedical research workforce;
• Describe successes and challenges with regards to implementing the programmatic elements described in the previous application, including but not limited to the following areas:

o Incorporating evidence-informed training and mentoring practices into the program;

o Teaching of rigor and transparency, and the responsible and safe conduct of research throughout the training experience;

o The challenges and successes for enhancing diversity and inclusion;

o Overseeing all aspects of the program (e.g., of the mentor/mentee matches, the participating faculty, and trainee progress); and

o Preparing trainees for a career that utilize the dual degree (including but not limited to the use of Individual Development Plans, IDPs);

• Provide justifications for failing to implement previously proposed programmatic elements;
• Provide evidence that the specific and measurable objectives described in the previous application were achieved and if not, provide a justification for failing to achieve the objectives;
• Describe how the funds provided under "Training Related Expenses" were used to benefit the program;
• Provide the methods and results of the evaluations of the program activities. Indicate whether the training activities were effective in contributing to the program objectives;
• Provide evidence that the scientific research climate is inclusive, safe, and supportive of trainee development;
• Expand upon the "Training Outcomes" to highlight successes and areas for improvement;
• Describe how the program responded to outcomes analyses, critiques, surveys and evaluations. Describe the barriers to success and indicate changes to the program designed to address these barriers;
• Describe how the program makes training and career outcomes publicly available;
• Indicate whether the PD(s)/PI(s) disseminated nationally any findings or materials developed under the auspices of the program to the broader training community;
• Indicate the broader impact of the program (e.g., on the curriculum, training environment, or institutional practices); and
• Highlight how the training program has evolved in response to changes in relevant scientific and technical knowledge, educational practices, and evaluation of the training program.

Faculty, Trainees, and Training Record

Participating Faculty Biosketches

Participating faculty should provide a personal statement that describes the appropriateness of their research background for the proposed training program, and their commitment to the following:

• Training, mentoring, and promoting inclusive, safe and supportive research environments;
• Maintaining a record of, and providing training in rigorous and unbiased experimental design, methodology, analysis, interpretation, and reporting of results;
• Promoting the use of highest standards of practice to ensure the safety of all individuals in the research environment;
• Supporting trainees participating 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 complete their degrees in a timely fashion with the skills, credentials, and experiences to transition into careers in the biomedical research workforce.

Letters of Support

Institutional Support Letter (10-page maximum). The application must include a signed letter on institutional letterhead from a President, Provost, Dean, or similar key institutional leader that describes the activities and resources provided by the institution that are designed to ensure the success of the planned training program and its trainees. If this letter is not included, the application will be considered incomplete and will not be reviewed. The institutional commitment to the following areas should be described (as applicable):

• Developing and promoting a culture in which the highest standards of safety, scientific rigor, reproducibility, and responsible conduct are advanced;
• Ensuring sufficient start-up funding to permit early stage faculty to participate in training, and bridge funding to ensure that training may continue if a mentor experiences a hiatus in funds;
• 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;
• Fostering and rewarding excellence in training (e.g., through institutional polices such as tenure and promotion);
• Supporting the remediation or removal of Participating Faculty from the program who are poorly performing mentors;
• Promoting diversity and inclusion at all levels of the research training environment (trainees, staff, faculty, and leadership);
• Ensuring a positive, supportive and inclusive research and training environment for individuals from all backgrounds;
• Ensuring the research facilities and laboratory practices promote the safety of trainees;
• Guaranteeing the research facilities are accessible to trainees with disabilities;
• 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 (e.g., requesting a change of PD/PI status; see NOT-OD-19-029);
• Providing trainees access to student support services, such as healthcare, counseling services, and housing;
• Ensuring that trainees will continue to be supported when they transition from the training grant to other sources of support;
• Providing resources and expertise for evaluating the training outcomes of the program; and
• For institutions that have multiple NIGMS-funded predoctoral training grants, the letter should 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.

Other Letters of Support. Additional letters of support (e.g., from partner institutions or organizations) are permitted; however, these letters may not contain any information required in the Institutional Support Letter.

Combine all Letters of Support into a single PDF file.

Data Tables: The application must include the required Training Data Tables. For New applications: Tables 1, 2, 3, 4, 5A, and 8A Part III. For Renewals: Tables 1, 2, 3, 4, 5A, 7, and 8A. Applications that do not contain the required tables, or that submit any additional tables in this attachment, will be considered noncompliant and will not be reviewed.

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.

The Appendix is meant to provide additional details to the following topics but is not meant to substitute for clear descriptions in the body of the application. Do not include items other than the required and allowable materials described below, as doing so will result in administrative withdrawal of the application prior to review. Name the file according to the headings below. A summary sheet listing all the items included in the Appendix may be included in the first Appendix attachment.

The following are required Appendix materials:

• Required Training Activities (2 pages maximum per activity). To adequately assess the content of the didactic portion of the training program, the application must include brief descriptions of all required courses, workshops, and training activities (e.g., streamlined syllabi with topics, timelines, activities, credits, etc.).
• Responsible Conduct of Research Syllabi (2 pages maximum). In addition to the Plan for Instruction in the Responsible Conduct of Research, the application must provide syllabi/outlines of materials relating to Responsible Conduct of Research and descriptions of when in the trainees career paths the material is taught.

The following are allowable Appendix materials:

• Elective Activities (2 pages maximum per activity). The application may include summary content from up to four additional elective courses, workshops, and/or training activities (e.g., streamlined syllabi with topics, timelines, activities, credits, etc.).
• Evaluation and Assessment Instruments. The application may include blank surveys, rubrics, and/or forms used to (a) document and monitor trainee progress and (b) determine whether the training and research environment is effective, inclusive, safe, and supportive.
• Conflict Resolution Protocols (3 pages maximum). The application may include detailed protocols for addressing problems with trainee and faculty matches, removal of faculty from the training program with unacceptable training/mentoring skills and for conflict resolutions for multi PD(s)/PI(s) and mentor/mentee relationships.

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.

NIGMS does not permit automatic carryover of training grant funds from one budget period to the next.

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 and NIGMS. Applications that are incomplete or non-compliant will not be reviewed.

Applicants requesting $500,000 or more in direct costs in any year are not required to contact a Scientific/ Research Contact prior to submitting an application. The Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide is not applicable to this FOA.

Applicants are required to follow the instructions for post-submission materials, as described 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 integrated training program will produce a diverse pool of well-trained clinician-scientists with the technical (e.g., appropriate methods, technologies, and quantitative/computational approaches), operational (e.g., independent knowledge acquisition, rigorous experimental design, and interpretation of data), and professional (e.g., management, leadership, communication, and teamwork) skills necessary to conduct rigorous and reproducible research, and transition into careers in the biomedical research workforce that utilize the dual degree, in consideration of the following review criteria and additional review criteria (as applicable for the program proposed).

Specifically, do the courses, structured training activities, mentoring, and research experiences equip the trainees with:

• The skills necessary to integrate research and clinical activities in support of a productive research career that combines both qualifications;
• The ability to utilize clinical experience and observations to inform research projects and use research findings to inform clinical practice;
• A broad understanding across biomedical and clinical disciplines;
• Expertise in a basic biomedical scientific discipline and the skills to independently acquire the knowledge needed to advance their chosen fields;
• The ability to think critically and independently, and to identify important biomedical research questions and approaches that push forward the boundaries of their areas of study;
• A strong foundation in scientific reasoning, rigorous research design, experimental methods, quantitative and computational approaches, and data analysis and interpretation;
• The skills to conduct research in the safest manner possible, and a commitment to approaching biomedical research responsibly, ethically, and with integrity;
• Experience initiating, conducting, interpreting, and presenting rigorous and reproducible biomedical research with increasing self-direction;
• The ability to work effectively in teams with colleagues from a variety of cultural and scientific backgrounds, and to promote inclusive and supportive scientific research environments;
• The skills to teach and communicate scientific research methodologies and findings to a wide variety of audiences (e.g., discipline-specific, across disciplines, and the public); and

The knowledge, professional skills and experiences required to identify and transition into careers that utilize the dual degree.

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 eachAn application does not need to be strong in all categories to be judged likely to have major scientific impact.

Training Program and Environment

Rationale, Mission, and Objectives

• Does the application provide a compelling rationale for the proposed research training program?
• Does the proposed program demonstrate the presence of a sufficient pool of potential trainees in appropriate disciplines (Table 1), program faculty with the appropriate scientific expertise (Tables 2 and 4), and resources to achieve the training objectives (Table 3)?
• Are the mission and objectives for the training program specific and measurable and in alignment with the goal of the Medical Science Training Program?

Curriculum and Overall Training Plan

• Will the courses, structured training activities, mentoring, and research experiences achieve the stated mission and objectives of the training program?
• Does the application propose changes in the program’s research training and mentoring practices to effectively address the rapidly evolving biomedical research enterprise and current understanding of evidence-informed training and mentoring approaches?
• Is the mechanism for ensuring that the trainees are learning the highest standards of practice in biomedical research (e.g., record keeping and safety) robust?
• Will the Participating Faculty teach laboratory safety throughout the didactic and mentored portions of the program?
• Does the training program plan provide a compelling explanation of how the courses, structured training activities, mentoring, and clinical and research experiences are well integrated and employ modern, evidence-informed approaches that are likely to enhance the success of the trainees?
• Are the activities likely to build a strong cohort of research-oriented individuals while enhancing the science identity, self-efficacy, and a sense of belonging among the cohort members?
• Do the required and elective training elements (e.g., syllabi, course descriptions) provide compelling evidence that the trainees will gain the requisite skills for the discipline in a timely fashion and that there are mechanisms to ensure that the trainees will be guided, monitored, and evaluated?
• Are there adequate plans for reducing unnecessary redundancies in coursework and other requirements between the clinical and Ph.D. training phases to ensure an efficient time to earning the dual degrees?
• Are there plans to accommodate differences in preparation among trainees?
• Is it clear how the proposed program will enhance the research training environment and not simply provide financial assistance for the trainees?
• Is it clear how the training activities will be available to other students in the program(s), department(s), or institution(s) from which the trainees are drawn?
• For multi-institutional, multi-disciplinary 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?
• If applicable, is the proposed program distinct from, but planning to share resources and synergize with other NIGMS-funded predoctoral training programs at the institution (listed in Training Table 3, and reinforced in the Institutional Support Letter)?

Career Development

• Will the applicants and trainees be provided with information about the career outcomes of graduates of the program and about the overall clinician-scientist biomedical research workforce employment landscape?
• Will the trainees be provided with adequate and appropriate information regarding the wide variety of clinician-scientist careers in the biomedical 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 the sectors of the biomedical research workforce that are of interest to them?
• Will the training program or institution provide experiential learning opportunities (e.g. internships, shadowing, informational interviews) that allow trainees to develop the professional skills and networks necessary to transition into clinician-scientist careers in the biomedical research workforce?
• Will the planned activities help trainees to identify medical residency programs that will support and develop their interest in research?

Program Oversight, Participating Faculty Selection, and Mentor Training

• Does the application describe an effective strategy and administrative structure to oversee and monitor the program to ensure appropriate and timely progress for the duration of the trainees' dual degree training?
• Is selection of the program faculty based on a commitment to training and mentoring, and not simply research productivity?
• Will the participating faculty be trained to ensure the use of evidence-informed teaching and mentoring practices that promote the development of trainees from all backgrounds?
• Do the participating faculty have a record of employing the highest standards of rigor and transparency in their research, and plans to impart those standards to their trainees?
• Will the program ensure that program faculty reinforce and augment the curricular material on responsible conduct of research, and methods for enhancing reproducibility?
• Is there a clear mechanism for matching the trainees with appropriate program faculty (e.g., laboratory rotations, faculty forums and interviews)?
• 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 their degrees in a timely fashion with the skills, credentials and experiences to transition into clinician-scientist careers in the biomedical research workforce that are consistent with the trainees' interests, and values?
• 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?
• If a program coordinator or administrator position is planned, will the person's administrative capabilities contribute to the success of the program?

Institutional and Departmental Commitment to the Program

• Will the institutional and departmental commitment to research and training excellence promote the success of the trainees and training program?
• Is there a clear institutional commitment to develop and promote a culture in which the highest standards of safety, scientific rigor, reproducibility, and responsible conduct of research are advanced?
• Does the institution provide sufficient start-up funding to permit early stage faculty to participate in training, and bridge funding to ensure that training may continue if a mentor experiences a hiatus in funds?
• Are the core facilities and technology resources necessary for the success of the program well supported?
• Is there adequate support of the PD(s)/PI(s) and other key staff, facilities, and educational resources associated with the training program?
• Do participating faculty have sufficient protected time available to devote to the training and mentoring activities?
• Is there evidence that the institution rewards excellence in training and mentoring through institutional policies?
• Does the institution support the remediation or removal of Participating Faculty from the program who are poorly performing mentors?
• Are diversity and inclusion efforts promoted at all levels of the research training environment (trainees, staff, faculty, and leadership)?
• Does the institution promote a positive, supportive, safe and inclusive research and training environment for individuals from all backgrounds?
• Is there evidence that the research facilities and laboratory practices ensure the safety of trainees?
• Is a process in place to address access issues for trainees with identified disabilities?
• Are appropriate policies and procedures in place to protect trainees from harassment and other prohibited practices?
• Is there evidence of an institutional commitment to providing the trainees access to student support services, such as health care, counseling services, and housing?
• Is there a commitment to ensure that trainees will continue to be supported when they transition from the training grant to other sources of support?
• Are the resources and expertise for evaluating the training outcomes of the program appropriate?
• Does the program plan describe the changes the graduate program(s), department(s) and/or the institution(s) will make to better support the goals of the training program?

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

• Do the PD(s)/PI(s) have the scientific expertise, and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program?
• Do the PD(s)/PI(s) have the time to commit sufficient effort to ensure the program's success, given their other professional obligations?
• Does at least one member of the PD/PI team have a demonstrated record of using rigorous and transparent methods in experimental design, data collection, analysis, and reporting in the proposed scientific field?
• Have the PD(s)/PI(s) received training on how to effectively mentor trainees, including those from underrepresented groups, and promote inclusive, safe, and supportive research training environments?
• Do the PD(s)/PI(s) have a demonstrated commitment to training the next generation of the biomedical research workforce, leading recruitment efforts to enhance diversity, and fostering inclusive research environments?
• Are there a strong administrative structure and leadership succession plan for critical positions (e.g., PD/PI)?

For applications designating multiple PD(s)/PI(s):

• Will the multiple PD/PI leadership approach benefit the trainees and enhance the ability of the program to achieve its training goals?
• Is there a clear leadership plan including the designated roles and responsibilities, governance, conflict resolution procedures, and organizational structure (see Multiple PD/PI Leadership Plan section)?

Preceptors/Mentors (Participating Faculty)

• Do the participating faculty describe a compelling commitment to rigorous and unbiased experimental design, methodology, analysis, interpretation, and reporting of results?
• Do the participating faculty describe a compelling commitment to ethically sound and responsible scientific research?
• Do the participating faculty have plans to promote the use of highest standards of practice to ensure the safety of all individuals in the research environment?
• Do the selected program faculty come from various backgrounds, for example, individuals from groups underrepresented in the biomedical sciences, women, as well as faculty at different career stages (i.e., junior and senior faculty)? If not, are there plans to recruit faculty to enhance the diversity?
• Do the participating faculty have the time to commit sufficient effort to ensure trainee development and success, given their other professional obligations?
• Is there evidence that the participating faculty cooperate, interact, and collaborate (which can include joint sponsorship of trainee research)?
• Do the participating faculty provide opportunities for trainees to initiate, conduct, interpret, and present rigorous and reproducible biomedical research with increasing self-direction?
• Do the participating faculty have plans for ensuring their trainees develop skills in approaches to experimental design, as well as methods of data collection, analysis, interpretation, and reporting?
• Do the participating faculty demonstrate a commitment to effective mentoring, and promoting inclusive, safe, and supportive scientific and training environments?
• Are the participating faculty willing to engage in activities to promote the trainees career goals and to support trainees participating in activities required to identify and transition into careers in the biomedical research workforce that are consistent with the trainees' skills, interests, and values?
• Do the participating faculty have a commitment to fulfilling the need of the trainees to obtain their Ph.D. degrees in a timely fashion with the skills, credentials, and experiences to transition into careers in the biomedical research workforce?

Application Process, Trainee Positions, Retention, and Support

Application Process

• Is a candidate review process proposed 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 in the training program? Does the process consider metrics beyond undergraduate institution, GPA, and standardized test scores?
• If the program trainees are drawn from multiple departments, is the review process consistent across all relevant departments?
• Is the training program’s approach to recruiting and admitting students effective?

Funded Positions

• Does the application provide a strong justification for the number of requested funded trainee positions given the pool of potential trainees, the size of the proposed program, the number of participating faculty, and other NIGMS funded training programs?
• Are there well-defined and justified selection and re-appointment criteria for trainees in the training program?
• Are trainees being appointed at the appropriate stage in order to most strongly benefit from the training program?

Retention and Support

• Is there an adequate, evidence-informed retention plan to ensure the well-being and success of all trainees throughout their dual degree training (see the "Trainee Retention Plan" attachment)?
• Does the institution have the resources to support trainees for the duration of their dual degree training?

Training Record

Training Outcomes for Trainees (renewals) or Training Grant Eligible Pool (new applications)

• Does the application provide evidence the trainees (or training grant eligible pool) conducted rigorous research that advanced scientific knowledge and/or technologies with increasing self-direction (e.g., peer-reviewed publications listed in Table 5A, and other accomplishments appropriate to the field)?
• Does the rate of degree attainment and time-to-degree for the trainees (or training grant eligible pool) indicate that these students completed their degrees at a high rate in a timely fashion (Training Table 8A)?
• Are completion rates, time-to-degree, and scholarly outcomes for the trainees (or training grant eligible pool) from underrepresented groups (see Notice of NIH's Interest in Diversity) comparable to those from well-represented groups?
• Are the trainees (or individuals in the training grant eligible pool) transitioning to clinician-scientist careers (Table 8A)?

Program Evaluation

• Is there a well thought out evaluation or assessment plan to determine whether the overall program is effective in meeting its training mission and objectives, and whether the training and scientific research climates are inclusive and supportive of trainee development (narrative and "Evaluation and Assessment Instruments" Appendix)?
• Is there evidence that the program has been and/or will be responsive to outcomes, critiques and evaluations?
• Does the training program have an appropriate plan to track trainee outcomes and make the data publicly available (e.g., on the institution's website)?

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.

Training in Methods for Enhancing Reproducibility

Does the Instruction in Methods for Enhancing Reproducibility plan describe how trainees will be instructed in principles important for enhancing research reproducibility including, at a minimum, evaluation of foundational research underlying a project, rigorous experimental design and data analysis, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, data and material sharing, record keeping, and transparency in reporting? Are the rigor and transparency 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 synergize with elements of the curriculum designed to enhance trainees' abilities to conduct responsible research? Is there evidence that all participating faculty reiterate and augment key elements of methods for enhancing reproducibility when trainees are performing mentored research their laboratories? The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

Recruitment Plan to Enhance Diversity

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, and 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 participating faculty reiterate and augment key elements of responsible conduct when trainees are performing mentored research their laboratories?

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

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.

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. Undue weight should not be given for simply responding to previous comments; instead the content of the responses and how the application project will be improved by any proposed changes should be considered.

Renewals

For Renewals, the committee will consider the progress made in the last funding period, including on the Training in Methods for Enhancing Reproducibility Plan, Recruitment Plan to Enhance Diversity, and Training in the Responsible Conduct of Research Plan.

• Did the training grant team successfully implement the proposed programmatic elements?
• Is the program achieving its training objectives?
• Is there evidence that the training environment is inclusive, safe, and supportive?
• Has the program evaluated the quality and effectiveness of the 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?
• Does the program continue to evolve to reflect changes in the research area in which the training occurs and current evidence-informed training and mentoring approaches?
• Is the program having a broader impact (e.g., are students beyond the trainees directly supported by the program being positively impacted by the program's presence, are training practices and outcomes being shared with the broader biomedical training community)?

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.

Select Agent Research

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

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NIGMS 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. Following initial peer review, recommended applications will receive a second level of review by the National Advisory General Medical Sciences 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.
• Geographic distribution of the NIGMS training grant portfolio.

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 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 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.

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.
• 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 traineest themselves. Trainees 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.

Within 10 years of making awards under this program, NIGMS will assess the program's overall outcomes.

The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:

• Institution types represented
• Geographical distribution of programs
• Demographics of trainees
• Trainee dual degree completion rates
• Time-to-degree
• Scientific accomplishments of trainees
• Graduate research training areas represented
• Residency fields chosen by trainees
• Trainee career outcomes
• Persistence of graduates in biomedical research careers

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: 301-480-7075

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

Miles Fabian

National Institutes of General Medical Sciences (NIGMS)

Email: [email protected]

Andrea Keane-Myers, Ph.D.

National Institutes of General Medical Sciences (NIGMS)

Email: [email protected]

Roya Kalantari, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-594-5945
Email: [email protected]

National Institute of General Medical Sciences

Email: [email protected]

Christine Leake

National Institute of General Medical Sciences (NIGMS)

Email: [email protected]

Regina Kitsoulis
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2946
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.