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

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

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

Purpose and Background Information

The NRSA program has been the primary means of supporting predoctoral and postdoctoral research training programs since enactment of the NRSA legislation in 1974. 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) and professional (e.g., management, leadership, communication, education, 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 that keep pace with the rapid evolution of a research environment that is increasingly complex, interdisciplinary, quantitative, and collaborative. As the biomedical enterprise has become larger and more complex, there is the need for greater diversity in the biomedical workforce, in the approaches taken to investigate clinically relevant research questions, and in the variety of careers that dual-degree recipients will fill. There is also a need to improve reproducibility of biomedical research results through scientific rigor and transparency. This FOA will support the scientific community’s efforts to develop and implement evidence-based, integrated approaches to clinical and research training and mentoring that will effectively prepare future generations of outstanding physician-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 physician-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 approaches to biomedical graduate training 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.), and then disseminates the results of those experiments to the community.

The Overarching Objective of the Institutional Research Training Grant (T32) Medical Scientist Training Program (MSTP) is to develop a diverse pool of highly trained physician-scientists who have the following:

• 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;
• 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 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;
• 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 productive careers in the biomedical research workforce that utilize the dual-degree training.

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.

The NIGMS will accept predoctoral training grant applications supporting integrated medical and graduate research training through the Medical Scientist Training Program Funding Opportunity Announcement (graduate research training in basic biomedical sciences is supported by PAR-17-341). Applicants are strongly encouraged to read information about NIGMS Institutional Predoctoral Training Grants and the MSTP program found on the NIGMS website and to contact program staff before submitting an application. All NIGMS MSTP T32 applications submitted for and after the May 25, 2019 receipt date must follow the guidelines in this FOA.

Applicants 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 approaches, and technologies. Programs should identify training needs and objectives (i.e., specific and measurable outcomes the program intends to achieve) and develop plans to implement evidence-based training activities that are grounded in the literature and from evaluations of existing relevant graduate training programs. Programs must ensure that trainees have a solid foundation in methods to enhance data reproducibility through rigor and transparency. Programs are expected to implement robust plans to enhance diversity and to promote inclusive, safe and supportive research environments (i.e., institutional and departmental environments where trainees from all backgrounds feel integrated into and supported by the biomedical community). Programs are expected to limit appointments to individuals committed to research careers that utilize the dual-degree qualifications. Funded programs should integrate clinical and research training of research-active physician-scientists. Importantly, programs should implement plans to optimize time-to-degree and enhance trainee retention in the program and in research careers (i.e., to sustain the scientific interests and participation of trainees from all backgrounds). Funded programs are expected to provide, in progress reports and in competing continuation applications, evidence of accomplishing the training objectives. Additionally, funded programs should make training and career outcomes publicly available and share successful training practices with members of the larger training community.

Institutional commitment and support for the proposed training program are important elements of the application. Such support may include stipend supplementation, trainee travel or research support, support for seminars and other program activities, salary support for the training grant program directors and administrators, recruitment costs, etc. The dual-degree training program may complement and synergize with other ongoing federally-supported predoctoral research or clinical 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). In cases where an institution has multiple NIGMS predoctoral training grants, programs are encouraged to create administrative and training efficiencies to reduce costs, limit redundancies, and improve trainee services and outcomes, as applicable. Training grant funds may not be used solely as a vehicle to provide stipends for trainees to conduct research.

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 M.D.-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 physician-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 physician-scientist career options.

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-18-404 and subsequent reissuances, but note that NIGMS does not participate in that FOA). 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 students who are appointed to NIH training grants, but do not complete training.

For applicants who currently have an NIGMS MSTP grant, NIGMS recommends that applicants plan to submit an application 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, 2021, applicants are advised to submit an application under this FOA no later than May 25, 2020. 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.

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

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 is detailed in the Institutional Support Letter attachment instructions in Section IV.2.

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) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research 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 investigator with an active research program in basic, translational, or clinical science, capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. Additional PDs/PIs, including physician-scientists or individuals with experience in science education, social sciences, 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 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.

Applicant organizations may submit only one application. NIGMS will support only one MSTP training program per institution (normally identified by having a unique DUNS number or NIH IPF number). Likewise, applicant institutions may not submit applications to NIGMS for a training program to both the January 25, 2019 application due date for the Parent T32 announcement and the May 25, 2019 due date for this announcement.

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 (NIH's Interest in Diversity), women, and faculty at different career stages (i.e., junior as well as senior 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 NIH awarding unit.

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.).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the 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.

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

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

Instructions for Application Submission

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

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

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

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

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 that require the dual-degree. Indicate the intended trainee outcomes.

Other Attachments. 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 evaluate the overall effectiveness of the program. Advisory Committee members should not be identified or contacted prior to receiving an award. Please name your file "Advisory_Committee.pdf".

Recruitment Plan to Enhance Diversity (3 pages maximum). The applicant must provide the recruitment plan to enhance diversity. Include outreach strategies and activities designed to recruit trainees from diverse backgrounds, including students from underrepresented racial and ethnic groups, first-generation college students, students from low socioeconomic backgrounds, and individuals with disabilities (see 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 medical school(s), graduate school(s), and/or the institution(s). Centralized institutional efforts alone will not satisfy the requirement to recruit individuals from underrepresented groups. Training grant 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 pages maximum). The applicant must provide a Trainee Retention Plan. The trainee retention plan must describe efforts to sustain the scientific interests as well as the academic and research progress of trainees from all backgrounds within a program (i.e., retention). Applicants are encouraged to consult the NIH extramural diversity website to identify promising retention practices and to use evidence-based 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 medical school(s), graduate school(s), and/or 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.

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.

Biographical sketch. The personal statement should describe a commitment to scientific rigor, training, mentoring, as well as to promoting inclusive 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 additional modifications:

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

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

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

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

Particular attention must be given to the required Training Data Tables for new applications for predoctoral programs (Tables: 1, 2, 3, 4, 5A, 6A, 8A Part III). In the Program Plan, applicants should summarize key data from the tables that highlight the characteristics of the applicant pool, participating faculty, institutional support, student outcomes, and other factors that contribute to the overall training environment of the program.

Training Program

Program Plan

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

Rationale, Mission, Objectives, and Overall Training Plan

The application should describe how the program will develop a diverse pool of physician-scientist leaders with the qualifications to conduct rigorous scientific research and engage in clinical practice. The physician-scientists should have the technical, operational, and professional skills required to transition into productive careers in the biomedical research workforce that require the dual degree. The application should describe how the program will enhance the training environment for T32 trainees and other graduate and/or medical students at the institution and not simply provide financial support to dual-degree trainees. Specifically, applicants should describe the following:

• The rationale and need for the proposed dual-degree training program, the relevant background history, and the research training activities of the participating medical and research institutions, department(s) or unit(s). Demonstrate the presence of a sufficient number of potential trainees (Table 1) and participating faculty with the appropriate scientific, medical, and/or other relevant expertise (Tables 2 and 4) as well as the resources to achieve the training objectives (Table 3).
• The ways, when applicable, that the training plan will share resources and synergize with other training programs at the same institution (i.e., training programs listed in Table 3). See the "Program Considerations" section above.
• The training mission (i.e., broad statement of purpose of the program) and objectives (i.e., specific measurable outcomes the program intends to achieve). Objectives should include, but not be limited to, dual-degree completion rates and appropriate time-to-degree. Longer-term trainee career placement objectives should also be included.
• 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 (applicants may use the "Required Training Activities" and "Elective Activities" appendices to provide syllabi).
• How the training activities will integrate medical and research training.
• How the training plan employs evidence-based approaches to trainee learning, mentorship, inclusion, and professional development.
• Any innovations in training, education, mentoring or career development currently in use or that will be tested during the grant period;
• Representative examples of training programs for individual trainees. Examples may include degree requirements, didactic courses during medical and graduate training, laboratory and clinical experiences, qualifying examinations and licensing board exams, 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.
• Academic and research preparation that trainees need to succeed in the training program and plans to accommodate differences in preparation among trainees.
• 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, physician-scientist career.
• For multi-disciplinary, multi-institutional, 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.

Career Development

The application should describe the following:

• How applicants and trainees will be provided with information about the career outcomes of graduates of the program (including on publicly accessible websites) and about the overall physician-scientist and biomedical research workforce employment landscape;
• How trainees in the program will be provided with adequate and appropriate information regarding the variety of physician-scientist careers in the biomedical research workforce for which their training would be useful;
• How trainees will learn the 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) that allow trainees to develop the professional skills and networks necessary to transition into careers in the biomedical research workforce that require 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 describe the planned strategy and administrative structure to oversee and monitor the program and to ensure appropriate and timely trainee progress towards the dual-degree (applicants may use 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-based teaching, training, and mentoring practices that promote the development of trainees from all backgrounds, including trainees from underrepresented groups in the biomedical sciences (see NIH's Interest in Diversity). Applications should describe the following:

• How the program will ensure that faculty employ the highest standards of scientific rigor and impart those standards to their trainees;
• How the program will ensure that faculty reinforce and augment the curricular material on responsible conduct of research and methods for enhancing reproducibility;
• The mechanism for matching trainees with a network of appropriate clinical and research faculty (e.g., rotations, faculty forums, and interviews);
• How the program will ensure that faculty engage in activities that promote trainee career development (including but not limited to the utilization of Individual Development Plans) and fulfill the needs of the trainees to obtain their dual-degrees in a timely fashion with the skills, credentials, knowledge and experiences to transition into productive careers in the biomedical research workforce that are consistent with the trainees' interests and values; and
• Mechanisms to train faculty mentors and 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 include the appendix labeled "Conflict Resolution Protocols" to provide details of the plan).

Institutional and Departmental Commitment to the Program

The application should describe how the level of institutional and departmental commitment to research and training excellence will promote the success of the trainees and training program. A letter providing assurances of the institutional commitment should be provided in the Letters of Support section of the application. Detailed instructions on the types of support are found below in the Letters of Support section of the FOA.

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

The application should describe how the Training 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 and/or medical expertise as well as the administrative and training experience to provide strong leadership, direction, management, and administration of the proposed dual-degree training program;
• The time to commit sufficient effort to ensure the program's success given other professional obligations (applicants should indicate the program director's effort in person-months in the proposed program);
• A record of physician-scientist research using rigorous and transparent methods in experimental design, data collection, analysis, and reporting; and
• A demonstrated commitment to training the next generation of physician-scientists leaders across 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 diverse backgrounds.

Preceptors/Mentors (Participating Faculty)

The application should describe how the participating faculty will promote the success of the trainees and training program. Describe how the program has or will build a diverse team of participating faculty (e.g., physician-scientists, individuals from underrepresented backgrounds, women, and faculty at different career stages) to help trainees gain access to potential role models within the training program and to enhance the excellence of the training environment. Summarize and expand on the material presented in the Training Tables and biosketches. The application should address how the participating faculty:

• Have sufficient time to commit to training given their other professional obligations;
• Receive training in effective, evidence-based mentoring and teaching practices;
• 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 promoting inclusive, safe and supportive scientific and training environments; and
• Are evaluated as mentors and teachers.

Trainee Positions, Recruitment, Retention

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

• Provide a strong justification for the number of requested trainee positions. Describe the characteristics of the applicant pool, applicants eligible for support, and the percentage of training eligible students supported though the training program (Table 6A). Describe the strategies to provide financial support to the trainees when they are not appointed to the training grant (e.g., funds from fellowships, research grants, institutional endowments).
• Expand upon the recruitment plan to enhance diversity (provided in Other Attachments) and explain how it will identify and recruit a diverse pool of potential candidates from a wide variety of institution types and backgrounds (with a focus on identifying effective recruitment strategies for individuals from groups that are underrepresented in the biomedical sciences, NIH's Interest in Diversity). Program candidates should have the potential to strongly benefit from, and with proper training and support, succeed in the program. Information on dimensions of diversity not included in the training tables (e.g., trainees from disadvantaged backgrounds) can be incorporated into the narrative.
• Describe the plans for a holistic candidate review process (i.e., a process that considers metrics beyond undergraduate institution, GPA, and standardized test scores) that will select a diverse group of promising trainees who have taken advantage of the research opportunities available to them and are committed to contributing to the biomedical research enterprise.
• Define and justify the selection and re-appointment criteria for trainees in the training program (appointment procedure protocols should be provided in the "Trainee Selection and Appointment Procedures" appendix).
• Expand upon the trainee retention plan (provided in the Other Attachments) and describe how it will promote the well-being and success of all trainees throughout their graduate training.

Training Outcomes

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

• The rate of dual-degree attainment and time-to-degree for recent graduates (Training Table 8A Part III). In the narrative, clearly explain how time-to-degree was calculated, including the training start and endpoints;
• Evidence that recent graduates conducted rigorous research that advanced scientific knowledge and/or technologies, with increasing self-direction (including peer-reviewed publications in Training Table 5A, and other measures of scientific accomplishment appropriate to the field);
• Aggregate data on the diversity of the trainees, including demographic data (see NIH's Interest in Diversity; data may be provided in Training Table 6A and the narrative);
• A description or analysis for how the dual-degree attainment and time-to-degree data for recent graduates from underrepresented groups (NIH's Interest in Diversity) compare to the data for recent graduates from well-represented groups;
• The success of recent graduates transitioning to physician-scientist careers in the biomedical research workforce (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; and
• For long-term programs, describe the extent to which former trainees are leaders in the biomedical research workforce. It should be noted that the success of former trainees will not compensate for programs that are currently underperforming.

Program Evaluation

The application should describe the following:

• An evaluation or assessment process to determine whether the overall program is effective in meeting its training mission and objectives, and whether the scientific research and medical practice climates are inclusive, safe and supportive of trainee development (applicants should use the "Evaluation and Assessment Instruments" appendix to provide blank survey instruments, rubrics or forms);
• The plans for being responsive to internal and external outcomes analyses, critiques, surveys, and evaluations; and
• The plan to track trainee and career outcomes, and the mechanisms to make this career data publicly available on the institution's website.

Plan for Instruction in the Responsible Conduct of Research

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

Describe how the Responsible Conduct of Research (RCR) components are 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' ability 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 using the following instructions:

A "Plan for Instruction in Methods for Enhancing Reproducibility" attachment is required (not to exceed three pages). Applicants are encouraged to consult the NIGMS clearinghouse for training modules to enhance data reproducibility and other resources when developing the plans. The plan must describe how trainees will be instructed in principles important for enhancing research reproducibility including, at a minimum, critical evaluation of foundational research underlying a project, rigorous experimental design and data interpretation, 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. Describe how instruction strategies are sufficiently well integrated into the overall curriculum, that is, how they are taught at multiple stages of trainee development and in a variety of formats and contexts. Describe how all participating faculty will reiterate and augment key elements of methods for enhancing scientific rigor and reproducibility when trainees are performing research in their laboratories.

Faculty, Trainees, And Training Record Section

Participating Faculty Biosketches

Program faculty should provide a personal statement in their biosketches 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;
• Supporting trainees participating in activities required to identify and transition into careers in the biomedical research workforce that use the dual-degree and are consistent with the trainees' skills, interests, and values; and
• Fulfilling the need of the trainees to complete their training in a timely fashion with the skills, credentials and experiences to transition into careers in the biomedical research workforce.

Letters of Support. Combine all Letters of Support into a single PDF file.

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 will ensure the success of the planned training program and its trainees. As applicable, the letter should address how the institution: promotes a culture in which the highest standards of scientific rigor, reproducibility and responsible conduct are advanced; provides opportunities for early stage faculty and those with a hiatus in research support to participate in training; supports core facilities and technology resources that can be used to enhance training; provides adequate staff, facilities, and educational resources to the planned program; supports the PDs/PIs and other key staff associated with the planned training program; ensures that faculty have protected time available to devote to mentoring, training and research; fosters and rewards excellence in training and mentoring (for example, through institutional policies); provides support for remediation or removal of Participating Faculty who are poorly performing mentors; promotes diversity and inclusion at all levels of the research training environment (trainees, staff, faculty, and leadership); ensures that the research and clinical facilities as well as the laboratory and clinical practices promote the safety of trainees; ensures that the research and clinical facilities are accessible to trainees with disabilities; promotes a positive, supportive and inclusive research, clinical and training environment for individuals from all backgrounds; ensures 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-15-152 and NOT-OD-18-172); ensures that trainees will continue to be supported when they transition from the training grant to other funding sources; and provides resources and expertise for evaluating the training outcomes of the program. For institutions that have multiple graduate training programs, the letter should also explain 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 both the proposed and existing programs. If multiple institutions participate in a single MSTP application, plans for recruitment of trainees and faculty and integration of other program functions across the institutions should be described. All information related to institutional support, as defined above, must be included within the 10-page limit of this letter.

If this letter is not included, the application will be considered incomplete and will not be reviewed.

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

Data Tables: The application must include the required Training Data Tables for new applications for predoctoral programs (Tables: 1, 2, 3, 4, 5A, 6A, 8A Part III). Applications that do not contain these tables, or 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 not meant to substitute for clear descriptions in the body of the application. Do not include items other than the allowable materials described below, as doing so will result in administrative withdrawal of the application for noncompliance. A summary sheet listing all the items included in the Appendix may be included in the first Appendix attachment.

The following is required Appendix material:

• Required Training Activities. To adequately assess the content of the didactic portion of the training program, applicants must provide syllabi/outlines of all required training activities (e.g., syllabi for courses, mentor training materials, professional development workshops, career exploration opportunities, skills development activities).
• Responsible Conduct of Research Syllabi. In addition to the Plan for Instruction in the Responsible Conduct of Research (described above), the application must provide syllabi/outlines of materials relating to Responsible Conduct of Research and descriptions of when in the trainees' career path the material is taught.
• Trainee Selection and Appointment Procedures (3 pages maximum). Applicants must outline the criteria for trainee selection from the training grant eligible pool and the process for trainee appointment. Materials may include, but not be limited to appointment protocols and/or blank applications.

The following are allowable Appendix materials:

• Elective Activities. Applicants may provide details for up to four additional elective courses and/or training activities (e.g., syllabi or summaries for courses, mentor training materials, outlines of professional development workshops, career exploration opportunities, or skills development activities).
• Evaluation and Assessment Instruments. Applicants may provide blank surveys, rubrics, and/or forms used to (a) document and monitor trainee progress and (b) determine whether the program and its environment is effective, inclusive, safe, and supportive.
• Conflict Resolution Protocols (3 pages maximum). Applicants may provide detailed protocols for addressing problems with trainee and faculty matches, removal of faculty from the training program with unacceptable training/mentoring skills, as well as conflict resolutions for multi PD/PIs and mentor/mentee relationships.

Applications that exceed the number of allowed appendices or the page limitation of any of the allowed materials will be considered noncompliant and will not be reviewed.

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.

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Applicants 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.

Add any other Submission Requirements and Information here, include heading (use Heading 4 Style) and description. Do not include information about the CONTENT and FORM of the application, which should instead be placed above in Section IV.2. Content and Form.

Add modifications only if your FOA will deviate from the Policy by adding bullets describing the modification.

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

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed integrated training program will produce a diverse pool of highly skilled physician-scientist leaders trained in both rigorous scientific research and clinical practice. The trained physician-scientists should have 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 transition into careers in the biomedical research workforce that utilize the dual-degree and to become leaders in advancing the research to meet the health needs of the Nation.

Specifically, do the medical and graduate school courses, structured training activities, mentoring, career development, clinical, 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 research and clinical disciplines and the skills to independently acquire the knowledge needed to advance their chosen field;
• The ability to think critically and independently, and to identify important biomedical research questions and approaches;
• A foundation in scientific reasoning, rigorous research design, experimental methods, quantitative and computational approaches, as well as data analysis and interpretation;
• A commitment to conducting biomedical research and clinical practice responsibly and ethically;
• 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 diverse backgrounds to promote an inclusive, supportive, efficient and productive scientific research environment;
• 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 productive careers in the biomedical research workforce that use dual-degree training?

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

Training Program and Environment

Rationale, Mission, Objectives, and Overall Training Plan

• Does the application provide a compelling rationale and demonstrate a need for the proposed dual-degree training program? Specifically, does the proposed program demonstrate the presence of a sufficient number of potential trainees (Table 1), participating faculty with the appropriate scientific and/or medical expertise (Tables 2 and 4), and resources to achieve the training objectives (Table 3)?
• If applicable, is the proposed program planning to share resources and synergize with other training programs at the institution (listed in Table 3, and reinforced in the Letters of Support section)?
• Are the mission and objectives for the training program specific and measurable and in alignment with the long-term goal of producing a diverse pool of physician-scientists with the dual qualifications of rigorous scientific research and clinical practice with the skills necessary to transition into careers in the biomedical research workforce that utilize the dual-degree?
• Will the courses, structured training activities, mentoring, and research experiences achieve the stated mission and objectives of the training program (provided in the "Required Training Activities" appendix?
• Does the training program plan provide a compelling explanation of how the courses, structured training activities, mentoring, and research experiences integrate medical and research training?
• Does the training program plan employ modern, evidence-based approaches to training, mentorship, inclusion, and professional development?
• Are any innovative approaches to training, education, mentoring or career development currently in use or are there plans to test any innovative approaches?
• Does the application provide examples of how each trainee's progress will be guided throughout the medical and research training and how the trainee's performance and skills development will be monitored and evaluated?
• Are adequate plans described for reducing unnecessary redundancies in coursework and other requirements between the M.D. and Ph.D. training phases?
• Are there plans to accommodate differences in preparation among trainees?
• Does the proposed program enhance the clinical and research training environment and not simply provide financial assistance for the trainees?
• Is the dual-degree training program structure across the participating medical and research components mirrored by a student-focused mentoring network that promotes trainee progress towards the dual-degree with attention to time-to-graduation and preparation for a research-oriented, physician-scientist career?
• For multi-disciplinary, multi-institutional and/or multi-departmental programs, is it clear how the individual components of the program are integrated and coordinated and how each will relate to an individual trainee's experience?

Career Development

• Will the applicants and trainees be provided with information about the career outcomes of graduates of the program and about the overall physician-scientist and biomedical research workforce employment landscape?
• Will the trainees be provided with adequate and appropriate information regarding the wide variety of physician-scientist careers in the biomedical research workforce for which their dual training may be useful?
• Will the trainees learn the 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 careers that utilize the dual-degree?
• If applicable, will the training program be integrated with other research training initiatives at the institution(s)?
• Does the application describe initiatives that allow 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 trainee progress towards the dual-degree?
• Is selection of the participating faculty based on a commitment to training and mentoring, in addition to research quality and/or clinical expertise?
• Will the participating faculty be trained to ensure the use of evidence-based teaching and mentoring practices that promote the development of trainees from all backgrounds?
• Do the potential mentors have a record of employing the highest standards of rigor, transparency and responsible conduct in their research and/or clinical practice, and plans to impart those standards to their trainees?
• Will the program ensure that its faculty reinforces and supplements the curricular material on responsible conduct of research, and methods for enhancing research rigor and reproducibility?
• Is there a clear mechanism for matching the trainees with a network of appropriate clinical and research mentors that include physician-scientists?
• Will the trainees be exposed to a broad range of scientific areas as thesis research options and to possible career paths that utilize both research and clinical training?
• Is there a plan to ensure that faculty engage in activities that promote trainee career development (including but not limited to the utilization of Individual Development Plans) to help trainees obtain their dual-degree in a timely fashion with the skills, knowledge, credentials, and experiences necessary for careers that are consistent with the trainees' interests and values?
• Is there a 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?

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 clear institutional commitment to develop and promote a culture in which the highest standards of scientific rigor, reproducibility and responsible conduct of research are advanced?
• Does the institution provide opportunities for early stage faculty and those with a hiatus in research support to participate in training?
• Are the core facilities and technology resources necessary for the success of the program well-supported?
• Is there adequate support of the PDs/PIs and other key staff, facilities, and educational resources associated with the training program?
• Do faculty have sufficient protected time available to devote to training activities?
• Is there evidence that the institution fosters and rewards excellence in training and mentoring (for example, through institutional policies)?Is there evidence of institutional support for remediating or removing participating faculty from the program that display poor mentoring?
• Are diversity and inclusion promoted at all levels of the research and clinical training environment (trainees, staff, faculty, and leadership)?
• Is there evidence that the research and clinical practices and facilities ensure trainee safety?
• Are appropriate policies and procedures in place to protect trainees from harassment and other prohibited practices?
• Are the research and clinical facilities accessible to trainees with disabilities?
• Is there a commitment to ensure that trainees will continue to be supported when they transition from the training grant to other funding sources?
• Are there resources and expertise for evaluating program training outcomes?
• Does the program plan describe proposed changes to the graduate program(s), department(s) and/or the institution(s) to better support training program goals?

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

• Do the PDs/PIs have the scientific and/or medical, administrative, and training expertise to provide strong leadership, direction, management, and administration of the proposed dual-degree training program?
• Do the PDs/PIs have the time to commit sufficient effort to ensure the program's success, given their other professional obligations?
• Is at least one member of the PD/PI team a physician-scientist with a demonstrated record of using rigorous and transparent methods in experimental design, data collection, analysis, and reporting in research?
• Have the PDs/PIs received training on how to effectively mentor trainees, including those from underrepresented groups, and promote inclusive, safe and supportive research and clinical training environments?
• Do the PDs/PIs have a demonstrated commitment to training the next generation of physician-scientists leaders across the biomedical research enterprise, leading recruitment efforts to enhance diversity and fostering inclusive research environments?
• For applications designating multiple PDs/PIs: 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 research mentors have a record of rigorous and unbiased experimental design, methodology, analysis, interpretation and reporting of results?
• Do the research mentors have a record of conducting ethically sound and responsible research?
• Do the selected participating faculty come from diverse backgrounds, for example, physician-scientists, 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 and/or co-mentoring of dual-degree trainees)?
• 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 participating faculty receive training in effective mentoring?
• Do the participating faculty demonstrate a commitment to effective mentoring and promoting inclusive and supportive scientific and training environments?
• Do the participating faculty have a commitment to fulfilling the need of the trainees to obtain their dual-degrees in a timely fashion with the necessary tools for careers in the biomedical research workforce?

Trainee Positions, Recruitment and Retention

• Does the application provide a strong justification for the number of requested trainee positions given the pools of potential trainees (Tables 1, 6A) and participating faculty with the appropriate funding and scientific expertise (Tables 2, 3, 4, and participating faculty Biosketches)?
• Does the pool of candidates who apply to the program derive from a wide variety of institution types and backgrounds (e.g., from groups underrepresented in the biomedical workforce) (Tables 6A)? Is the recruitment plan likely to identify and attract a diverse group of candidates who will apply to the program ("Recruitment Plan to Enhance Diversity" attachment)?
• Is a holistic candidate review process proposed (i.e., a process that considers metrics beyond undergraduate institution, GPA, and standardized test scores) that will allow a broad group of trainees the ability to participate in the training program and identifies students that are likely to pursue a research-active physician-scientist career?
• Are there well-defined and justified selection and re-appointment criteria for trainees in the training program (protocols for appointments are provided in the "Trainee Selection and Appointment Procedures" appendix)?
• Is there an adequate, evidence-based retention plan to promote the well-being and success of all trainees throughout their graduate training (see the "Trainee Retention Plan" attachment)?

Training Record

Training Outcomes

• Does the program provide evidence that dual-degree trainees conducted rigorous research that advanced scientific knowledge and/or technologies (e.g., peer-reviewed publications listed in Table 5A, and other accomplishments appropriate to the field)?
• Are the current rate of dual-degree attainment and time-to-degree for trainees in the program reasonable?
• Are completion rates and time-to-degree for trainees from underrepresented groups (NIH's Interest in Diversity) comparable to those from well-represented groups?
• Are the trainees transitioning to research-oriented residency programs and ultimately into physician-scientist careers in the biomedical research workforce that utilize the dual-degree and are relevant to the biomedical workforce needs of the Nation (outcomes data in text and Training Table 8A)?
• For long-term programs, is there evidence that former trainees are leaders in the biomedical research workforce? The success of former trainees may not compensate for programs that are currently underperforming with regards to training goals and objectives.
• For longer-term programs, is there evidence that graduates had sustained success in research-related careers that utilize their dual degrees?

Program Evaluation

• Is there a well thought out evaluation or assessment process to determine whether the overall program is effective in meeting its training mission and short-, intermediate-, and long-term objectives, and whether the training, scientific and clinical climates are inclusive, safe and supportive of trainee development?
• Is there evidence that the program has been and/or will be responsive to internal and external critiques and evaluations?
• Does the training program have a plan to track trainee outcomes and make the data publicly available 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.

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.

Renewals

Not Applicable

Revisions

Not Applicable

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

Recruitment Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used to recruit a diverse pool of applicants that includes individuals from groups underrepresented in biomedical research (NIH's Interest in Diversity). The overall plan will be rated as ACCEPTABLE only if the recruitment strategies for all of the relevant groups identified in the NIH Interest in Diversity are viewed by the review panel as acceptable; otherwise the plan will be rated as UNACCEPTABLE. 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 dual-degree 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 Do the plan and syllabus provided in the appendix include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? 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/residency, and faculty levels) and at a frequency of no less than once every four years? Because M.D.-Ph.D. training is an integrated program of greater than four years, plans must include training in both the early and later stages of the program.

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 in their laboratories?

The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

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, critical evaluation of foundational research underlying a project, rigorous experimental design, 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 in their laboratories?

The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

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 training program.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NIGMS Office of Scientific Review 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. Site visits may be employed as part of this process; however, applicants should not assume that site visits are automatic.

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 law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

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

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

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

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

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. When submitting RPPRs, funded programs are expected to provide evidence of accomplishing the training objectives. 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.

A final RPPR, the expenditure data portion of the Federal Financial Report, and Termination Notices for all Trainees, are required for closeout of an award as described in the NIH Grants Policy Statement.

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

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

Within ten years of making awards under this program, NIH will assess the program’s overall outcomes and consider whether there is a continuing need for the program. Upon the completion of this evaluation, NIH will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.

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 and sizes of programs
• Demographics of trainees
• Trainee dual-degree completion rates
• Time-to-dual-degree
• Scientific accomplishments of trainees
• Graduate research training areas represented
• Residency fields chosen by trainees
• Trainee career outcomes
• Persistence of graduates in biomedical research career paths

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

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

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

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

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

Telephone: 301-945-7573

Joseph Gindhart, Ph.D.
National Institutes of General Medical Sciences (NIGMS)
Email: gindhartjg@mail.nih.gov

Andrea Keane-Myers, Ph.D.
National Institutes of General Medical Sciences (NIGMS)
Email: andrea.keane-myers@nih.gov

Stephanie Constant, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: stephanie.constant@nih.gov

Ms. Christine Leake
National Institute of General Medical Sciences (NIGMS)
Email: Christy.Leake@nih.gov

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

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