Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of General Medical Sciences (NIGMS)

Funding Opportunity Title
Leading Equity and Diversity in the Medical Scientist Training Program (LEAD MSTP)(T32)
Activity Code

T32 Institutional National Research Service Award (NRSA)

Announcement Type
New
Related Notices

November 22, 2022 - Notice of Informational Webinar for PAR-23-030 "Leading Equity and Diversity in the Medical Scientist Training Program (LEAD MSTP) (T32)". See Notice NOT-GM-23-026

NOT-OD-23-012 - Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available

Funding Opportunity Announcement (FOA) Number
PAR-23-030
Companion Funding Opportunity
None
Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.859
Funding Opportunity Purpose

The goal of the Leading Equity and Diversity in the Medical Scientist Training Program (LEAD MSTP) is to develop a diverse pool of highly trained clinician-scientist leaders available to meet the Nation’s biomedical research needs by providing support for dual-degree clinician scientist training at institutions that have historically not been well represented among NIGMS-funded MSTPs. Specifically, this Funding Opportunity Announcement (FOA) provides support to eligible domestic institutions to develop and implement effective, evidence-informed approaches to fully integrate the transitional phases of dual-degree training and mentoring that will lead to the completion of both clinical degrees (e.g., M.D., D.O., D.V.M., D.D.S., Pharm.D., etc.), and research doctorate degrees (Ph.D.) and keep pace with the rapid evolution of the biomedical enterprise.

With the dual qualification of a rigorous scientist and clinician, graduates will be equipped with the skills to develop research programs that accelerate the translation of research advances to the understanding, detection, treatment, and prevention of human disease, and to lead the advancement of biomedical research. Areas of particular importance to NIGMS are optimizing training efficiency, fostering the persistence of alumni in research careers, and enhancing the diversity of the clinician-scientist workforce. NIGMS expects that the proposed research training programs will incorporate didactic, research, mentoring and career development elements to prepare trainees for careers that will have a significant impact on the health-related research needs of the Nation.

This program is limited to dual-degree training programs at (1) Historically Black Colleges and Universities (HBCUs), (2) Tribal Colleges and Universities (TCUs), and (3) institutions within Institutional Development Award (IDeA)-eligible states. When appropriate, NIGMS encourages applications using a partnership model to further and advance the goals of the program (see Section III for detailed eligibility information).

This Funding Opportunity Announcement (FOA) does not allow appointed Trainees to lead an independent clinical trial, but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor.

Key Dates

Posted Date
November 22, 2022
Open Date (Earliest Submission Date)
December 25, 2022
Letter of Intent Due Date(s)

Not Applicable

The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
January 25, 2023 * Not Applicable Not Applicable July 2023 October 2023 December 2023
January 25, 2024 * Not Applicable Not Applicable July 2024 October 2024 December 2024
January 27, 2025 Not Applicable Not Applicable July 2025 October 2025 December 2025

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

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

Expiration Date
January 28, 2025
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose and Background Information

The National Research Service Award (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 following skills:

  • Technical (e.g., appropriate methods, technologies, and quantitative/computational approaches),
  • Operational (e.g., independent knowledge acquisition, rigorous experimental design and interpretation of data, conducting research in the safest manner possible), and
  • Professional (e.g., management, leadership, communication, and teamwork) skills required for careers in the biomedical research workforce.

NIGMS strives to ensure that future generations of researchers will be drawn from the entire pool of individuals, bringing different aptitudes, perspectives, interests, and experiences to address complex scientific problems. NIGMS seeks to enhance the diversity of the biomedical research workforce by supporting individuals from a variety of backgrounds,  including, individuals from underrepresented groups (see Notice of NIH’s Interest in Diversity), at multiple training and career stages in a variety of institutions and educational settings across the country. This funding announcement is focused on broadening the participation of institution types with NIH funded dual degree training programs (i.e., a Ph.D. combined with a clinical degree, such as M.D., D.O., D.V.M., D.D.S., Pharm.D., etc.).  

Applications through this funding announcement are limited to the following (see Section III for detailed eligibility information):

  • Historically Black Colleges and Universities (HBCUs),
  • Tribal Colleges and Universities (TCUs), and
  • Institutions within Institutional Development Award (IDeA)-eligible states.

When appropriate, NIGMS encourages applications using a partnership model to further and advance the goals of the program (see Section III for detailed eligibility information). Institutions that do not fit within these criteria are encouraged to apply to PAR-21-189 “Medical Scientist Training Program (T32)”, or subsequent reissuances. Only one NIGMS funded clinician-scientist award per institution is allowed.

Need for the Program

Since 1975, the long-standing Medical Scientist Training Program (MSTP) has provided support to institutions to train more than 14,000 dual-degree students. The institutions providing NIH-funded dual-degree clinician scientist training are currently not well distributed across the country, limiting access to careers in research for students in many rural, low socio-economic, and under-served regions. Currently, only 6% of awards through NIGMS' MSTP are to institutions in IDeA-eligible states and no MSTP awards are to HBCUs or TCUs. This uneven distribution across regions and institution types limits the impact of the program by reducing access to careers as clinician-scientists for talented students from many parts of the country, including rural and under-served communities.

In the United States, certain racial/ethnic groups as well as low socio-economic status (SES) and rural populations experience health disparities compared to the general population. These disparities include a higher incidence of disease and/or disability, increased mortality rates, lower life expectancies, as well as higher rates of pain and suffering.

HBCUs and TCUs have a longstanding and current commitment to educating students with interests in studying health disparities as well as population/region specific conditions and health challenges. In addition, IDeA eligible institutions in the 23 states plus Puerto Rico are in areas with distinct populations, such as rural, low SES, and medically under-served communities. Because of the unique contexts, many of the students at these institutions also have an interest in scientific research focusing on diseases or conditions that disproportionately affect populations experiencing health disparities. Supporting the research training of individuals at these institutions will increase the impact of the NIGMS funded clinician-scientist program across the country.

Program Objective

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

  • A broad understanding across biomedical disciplines and the skills to independently acquire the knowledge needed to advance their chosen fields.
  • Expertise in a biomedical scientific discipline and the skills to think critically and independently.
  • A strong foundation in scientific reasoning, rigorous research design, experimental methods, quantitative and computational approaches, and data analysis and interpretation.
  • The skills to conduct research in the safest manner possible, and a commitment to approaching and conducting biomedical research and clinical practice responsibly, ethically, and with integrity.
  • Experience initiating, conducting, interpreting, and presenting rigorous and reproducible biomedical research with increasing self-direction.
  • The ability to utilize clinical experience and observations to identify important biomedical research questions and to develop impactful research programs that push forward the boundaries of their areas of study.
  • The capacity to translate scientific research findings into clinical practice.
  • The knowledge, professional skills and experiences required to identify and transition into careers that utilize the dual clinician-scientist degrees.
  • 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 ability and skills to lead changes that promote health equity, reduce health disparities and improve the health of those medically underserved across diseases, disorders, and conditions.
  • The skills to teach and communicate scientific methodologies and findings to a wide variety of audiences (e.g., discipline-specific, across disciplines, and the public).

Diversity at all levels—from the types of science to the regions in which it is conducted, to the backgrounds of the people conducting it— is integral 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 in the biomedical research workforce. This program supports the development of a diverse pool of clinician scientists who will be equipped with the skills to accelerate the translation of research advances to the understanding, detection, treatment, and prevention of human disease, that lead to the advancement of biomedical research.

Program Considerations

This program is intended to enable the community to develop and implement evidence-informed approaches to dual-degree biomedical research training and mentoring to enhance diversity in the clinician-scientist research workforce. Applicants are strongly encouraged to read information on the NIGMS website regarding NRSA Institutional Predoctoral Training Grants Program Description and Guidelines and to contact program staff listed on this FOA before submitting an application to discuss unresolved questions and to verify that the proposed program is in alignment with NIGMS funding priorities.

NIGMS encourages creative and transformational approaches to biomedical research training, including curricular reform, that preserve the best elements of current programs, while enhancing the focus on the needs of the trainees and the development of trainee skills.

NIGMS encourages applicants to offer training across the landscape of medical fields and scientific disciplines related to health, and to provide opportunities for the exploration of clinician-scientist career options. Programs that take advantage of clinical research opportunities within nationwide networks and infrastructures such as the Research Centers in Minority Institutions (RCMI), Native American Research Centers for Health (NARCH), NIH Clinical and Translational Science Award (CTSA), and IDeA Networks for Clinical and Translational Research (IDeA-CTR) program are encouraged to apply.

Funded programs are expected to:

  • Provide high-quality clinical training, mentored research experiences, and additional opportunities that will build a strong cohort of research-oriented individuals.
  • Implement plans to optimize the time required to earn the dual degree.
  • Address the training needs and objectives (i.e., specific and measurable outcomes the program intends to achieve), provide evidence of accomplishing the training objectives in progress reports, make training and career outcomes publicly available, and disseminate successful training practices to the broader training community.
  • Implement evidence-informed training and mentoring activities (i.e., approaches that are grounded in the literature and from evaluations of existing relevant training programs).
  • Ensure that trainees have a solid foundation in methods to enhance data reproducibility through rigor and transparency. Applicants are encouraged to consult the NIGMS clearinghouse for training modules to enhance data reproducibility, and other resources when developing the plans.
  • Promote inclusive, safe, and supportive research and clinical training environments. Specifically, funded programs should have institutional and departmental environments where individuals from all backgrounds are welcomed and feel integrated into and supported by the biomedical community. Additionally, safety in research training should encompass (1) environments free from harassment and intimidation, in which everyone participating is treated in a respectful and supportive manner, (2) laboratory and clinical settings where individuals exercise the highest standards of practice for chemical, biological and physical safety, and (3) practices at the institutional leadership and research community levels that demonstrate core values and behaviors to emphasize safety over competing goals.
  • Enhance trainee retention, i.e., to sustain the scientific interests and participation of trainees from all backgrounds. Activities associated with these efforts should include cohort building, increasing self-efficacy and sense of belonging within research and clinical training environments, and faculty training to promote inclusive mentoring.

Institutional commitment and support for the proposed training program are important elements of the application. This training program may complement and synergize with other ongoing federally-supported predoctoral research training programs at the applicant institution (e.g., in the development of skills that are not discipline-specific); however, the goals must be distinct from related programs at the same institution currently receiving federal support. In cases where an institution has multiple NIGMS institutional training grants, it is expected that these programs will seek to create administrative and training efficiencies to reduce costs and improve trainee services and outcomes. Programs should be fully integrated and should exert a strong, positive influence on the development and execution of the outreach and recruitment of potential trainees, curriculum, training opportunities and mentoring. Training grant funds may not be used solely as a vehicle to provide financial aid for trainees to complete their separate degree programs.

Training grants are usually awarded for five years. The grant offsets the cost of stipends, tuition, and training-related expenses for the appointed trainees. Many dual degree training programs guarantee enrolled students full support for the duration of the dual degree program (through combinations of federal support, institutional funds, other fellowships, and grants). Trainees may be appointed the grant for three or more years of the dual-degree program (note that NRSA support is limited to 6 years for dual-degree training). Training programs may implement institutional policies regarding the payback of non-NRSA institutional sources of funds by students who start training but do not complete one or both degrees. NIGMS does not require nor permit institutions to receive payback of NRSA funds from trainees who are appointed to NIH training grants, but do not complete training.

NIGMS will not accept predoctoral training applications:

  • Proposing combined predoctoral and postdoctoral training.
  • Submitted through the PA-20-142 “Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grant (Parent T32)” and subsequent reissuances.
  • Proposing only short-term research training.

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

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

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Note: Appointed Trainees are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited, but need to reflect the actual needs of the proposed project.

Recipients are expected to be familiar with and comply with applicable cost policies and the NRSA Guidelines (NIH Grants Policy Statement - Institutional Research Training Grants). Funds may be used only for those expenses that are directly related to and necessary for the research training and must be expended in conformance with OMB Cost Principles, the NIH Grants Policy Statement, and the NRSA regulations, policies, guidelines, and conditions set forth in this document.

Award Project Period

Awards may be for project periods up to five years in duration and are renewable.

Other Award Budget Information

Stipends, Tuition, and Fees

Kirschstein-NRSA awards provide stipends as a subsistence allowance to help defray living expenses during the research training experience.

NIH will contribute to the combined cost of tuition and fees at the rate in place at the time of award.

Stipend levels, as well as funding amounts for tuition and fees and the institutional allowance are announced annually in the NIH Guide for Grants and Contracts, and are also posted on the Ruth L. Kirschstein National Research Service Award (NRSA) webpage.

Trainee Travel

Trainee travel to attend scientific meetings and workshops that the institution determines to be necessary for the individual’s research training experience is an allowable trainee expense for predoctoral and postdoctoral trainees.

NIGMS will provide up to $1000 per trainee per year to travel to scientific meetings or training experiences that will enhance their development as a clinician-scientist, build science identity, create a sense of belonging in the scientific community, and build professional networks. For institutions outside the continental United States, $1,250 for travel per trainee per year will be provided. Trainees must be appointed to the training grant at the time of the actual travel for this to be an allowable cost.

Training Related Expenses

NIGMS will provide funds to help defray other research training expenses, such as health insurance, staff salaries, consultant costs, equipment, research supplies, and faculty/staff travel directly related to the research training program. Training related expenses are limited to a maximum of $8,400/trainee/year. Examples of allowable costs include those associated with the following:

  • Skills development training activities (e.g., focusing on quantitative and computational, problem-solving, critical thinking, scientific writing, effective communication, and project management).
  • Seminar speakers, who will serve as role models to the trainees.
  • Training or mentoring interventions designed to increase persistence in research (e.g., those designed to increase science identity, self-efficacy, and a sense of belonging in the scientific community).
  • Salary support for the PD/PI or in a combination of multiple PD(s)/PI(s)/Co-Investigators that typically would not exceed 1.8 person months (i.e., 15% effort on a 12-month basis in total) depending on the size and scope of the program.
  • Salary support for administrative personnel; typically, the total combined salary support for program administrator/program coordinator and/or program assistant/clerical support would not exceed 3.0 person months (i.e., 25% effort on a 12-month basis) depending on the size and scope of the program.
  • Limited program evaluation costs (typically up to $3,000 for the 5-year training grant period) and other program-related expenses may be included within the budget for training-related expenses.
Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, consortium costs in excess of $25,000, and expenditures for equipment), rather than on the basis of a negotiated rate agreement.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Single Institution Programs:

For single institution programs, the applicant institution must be a higher education institution located in the United States and/or its territories with the following characteristics:

  • Is an institution in at least one of the following categories:
    • Historically Black Colleges and Universities (HBCUs), (i.e., institutions described in section 4(b) of Executive Order 14041 (incorporating by reference the institutions listed in 34 C.F.R. 608.2)),
    • Tribal Colleges and Universities (TCUs), (i.e., institutions described in section 5(e) of Executive Order 14049)
    • Institutions in an IDeA state or territory - Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Rhode Island, South Carolina, South Dakota, Vermont, West Virginia, Wyoming, and Puerto Rico
  • Has an accredited clinical degree granting program (e.g., M.D., D.O., D.V.M., D.D.S., Pharm.D., etc.)
  • Awards Ph.D. degrees in the biomedical sciences
  • Does not currently have an NIGMS-funded Medical Scientist Training Program

Partnerships:

NIGMS encourages applications describing partnerships when this may further advance the goals of the program. Partnerships must have the following:

  • The applicant institution must be an HBCU, TCU or institution in an IDeA state or territory (defined above).
  • Each partner must be a higher education institution located in the United States and/or its territories
  • The applicant institution must have an accredited clinical degree granting program (e.g., M.D., D.O., D.V.M., D.D.S., Pharm.D., etc.)
  • One of the institutional partners must award Ph.D. degrees in the biomedical sciences
  • The applicant institution may not have an NIGMS-funded Medical Scientist Training Program

The applicant and partner institution(s) must assure support for the proposed program. Appropriate institutional commitment to the program should be detailed in the Institutional Support Letter in the Letters of Support attachment (see instructions in Section IV).

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are noteligible to apply.

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

Required Registrations

Applicant Organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

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 a scientist capable of providing leadership to the development and implementation of the proposed clinician-scientist training program. Additional PD(s)/PI(s), including individuals with experience in clinical education and training, the science of education, relevant social science disciplines, program evaluation, mentoring, and university administration should be included to achieve the training goals. Any of the PDs/PIs may serve as the contact PD/PI.

Applications with partnerships are encouraged to include a PD/PI from each participating institution.

The contact PD/PI is expected to have a full-time appointment at the applicant institution. If the full-time status of the contact PD/PI changes after the award, the institution must obtain prior program approval to appoint a new PD/PI or request a deviation from the full-time rule.

The PDs/PIs will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program.

The PDs/PIs will be expected to monitor and assess the program and submit all documents and reports as required. The PDs/PIs have responsibility for the day-to-day administration of the program and are responsible for appointing members of the Advisory Committee (when applicable) and using their recommendations to determine the appropriate allotment of funds.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique NIH Institutional Profile Number, IPF) is allowed.

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

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

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

Trainees

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

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

Trainees must be enrolled in a program or programs leading to a combined clinical degree and a Ph.D. (e.g., M.D./Ph.D.; D.O./Ph.D.; D.V.M./PhD.; D.D.S./Ph.D., Pharm.D./Ph.D., etc.). Programs are encouraged to limit appointments to individuals committed to careers that utilize the dual-degree qualifications.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424 (R&R) Other Project Information

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

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 that utilize the dual degree. Indicate the planned duration of appointments, the projected number of trainees and intended trainee outcomes.

Other Attachments: The following 5 attachments must be included or the application will not be reviewed:

1. Application and Admissions Data: The application must include Application and Admissions Data to allow for the evaluation of the ability of participating departments/institutions to recruit training grant eligible individuals. These data are useful in assessing the admissions and recruitment process, the diversity of the pool, and the appropriate number of training positions to be awarded. Provide the numbers and characteristics of training grant eligible (I) applicants, (II) admitted individuals, and (III) matriculants for each of the past 5 academic years as well as the average over those years. Applicants are encouraged to use the Suggested Table Format Table A  and to report on the categories listed in NIH’s Interest in Diversity (listed below). Demographic data should be from voluntary self-reporting.

  • Total: The total number of individuals in the relevant category (e.g., applicants, admitted individuals, or matriculants). In cases of multiple-departmental/multiple-institutional programs, provide aggregate data for all the participating departments/institutions.

  • Number from Underrepresented Racial and Ethnic Minority (URM) Groups: Number of individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in biomedical research on a national basis (i.e., Black or African Americans, Hispanic or Latinos, American Indians or Alaska Natives, Native Hawaiians and other Pacific Islanders; see https://grants.nih.gov/grants/guide/notice-files/not-od-15-089.html)

  • Number with a Disability: If data are available, the number of individuals with disabilities, defined as those with a physical or mental impairment that substantially limits one or more major life activities as described in the Americans with Disabilities Act of 1990, as amended.

  • Number from Disadvantaged Backgrounds: If data are available, the number of individuals from disadvantaged backgrounds (see NIH’s Interest in Diversity).

  • Women: Number of applicants who identify as women.

  • Institutionally Defined Underrepresented Group: Number of individuals from an institutionally defined underrepresented group. If relevant, number of applicants from a racial or ethnic group that can be demonstrated convincingly to be underrepresented by the grantee institution. For more information on racial and ethnic categories and definitions, see the OMB Revisions to the Standards for Classification of Federal Data on Race and Ethnicity. Add columns as needed.

If the training program is interdepartmental with separate admissions for each department, provide the number of training grant eligible (I) applicants, (II) admitted individuals, and (III) matriculants in the relevant departments described in the application for each of the past 5 academic years. Please name the file “Application_Admissions_Data.pdf”.

2. Recruitment Plan to Enhance Diversity (3-page maximum): The applicant must provide a Recruitment Plan to Enhance Diversity. The application should include outreach strategies and activities designed to recruit potential training program candidates who are from diverse backgrounds, including students from underrepresented racial and ethnic groups, individuals with disabilities, and students from disadvantaged backgrounds (see Notice of NIH's Interest in Diversity). Applicants are encouraged to consult the NIGMS webpage for strategies to enhance diversity in training programs when designing their plans. Describe the specific efforts to be undertaken by the training program and how these might coordinate with trainee recruitment efforts of the institution. Centralized institutional efforts alone will not satisfy the requirement to recruit prospective individuals from underrepresented groups. Participating faculty are expected to be actively involved in recruitment efforts. Please name the file “Recruitment_Plan.pdf”.

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

4. Outcomes Data Collection and Storage Plan (2-page maximum): The applicant must provide an Outcomes Data Collection and Storage Plan to track the outcomes for all supported trainees for a minimum of 15 years beyond the trainee’s participation in the program.  Programs are encouraged to make the aggregate outcome data available on the institution's website. If the applicant intends to make the data available, describe how the aggregate data will be de-identified before public posting. The applicant must include a strategy to ensure the secure storage and preservation of program data and outcomes. Describe how the data will be centralized, safeguarded, and retrievable during leadership changes. Please name the file “Data_Collection_Storage_Plan.pdf”.

5. Dissemination Plan (1-page maximum): The application must provide a specific Dissemination Plan to publish or present nationally any findings or materials developed under the auspices of the program. Examples of dissemination may include data or materials from successful training or mentoring interventions via web postings, presentations at scientific meetings, and/or workshops. Please name the file “Dissemination_Plan.pdf”.

The following attachment may be included:

6. Advisory Committee (1-page maximum). An Advisory Committee is not a required component of a training program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the training program. The roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will assess the overall effectiveness of the program. To avoid conflicts in the review process, only pre-existing Advisory Committee members should be named in the application. Potential Advisory Committee members should not be identified or contacted prior to receiving an award. Please name the file “Advisory_Committee.pdf”.

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

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

Follow all instructions provided in the SF424 (R&R) Application. The additional instructions apply:

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

PHS 398 Cover Page Supplement

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

PHS 398 Training Subaward Budget Attachment(s)

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

Training Budget

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

  • Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.

PHS 398 Research Training Program Plan

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

  • Training Program
  • Faculty, Trainees, and Training Record
  • Other Training Program Sections
  • Appendix

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

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

Training Program

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

Program Plan

The "Program Plan" attachment is required and must adhere to the NIH Table of Page Limits, as well as the organization and instructions provided below.

Do not follow the organization and instructions provided in the SF424 (R&R) application guide for the Program Plan attachment; instead, applicants must use the instructions below.  Start each section with the appropriate heading. 

Rationale, Mission, and Objectives

The application should describe how the program will develop a diverse pool of well-trained clinician-scientists with the qualifications to conduct rigorous scientific research and engage in clinical practice. The trained clinician-scientists should have the technical, operational, and professional skills required to conduct research in a safe, ethically responsible and rigorous manner, and to enter careers in the biomedical research workforce that utilize the dual degree as delineated in the Program Objective.  

Programs with partnerships should describe the rationale for the partnership, including the geographic location of the participating institutions and the strategies for overcoming any logistical challenges. Applications should provide an explanation of the need and the methods for ensuring a strong partnership.

The application should describe how the program will enhance the training environment and not simply provide financial support to dual degree trainees. Specifically, the application should describe the following:

  • The justification for the proposed diversity-enhancing research training program. The application should describe the current institutional efforts to promote diversity and to create inclusive research training environments and how this program will enhance, but not duplicate these efforts. The rationale for the program should expand upon the "Training Outcome" data requested below that provides institutional baseline data on previous student outcomes comparing success rates across demographic groups.
  • Current research training environment. The application should describe the research training program including, but not limited to, the relevant background, an overview of the current research training activities of the participating department(s) or unit(s), and areas for improvement in the current research training practices. Applications must demonstrate the presence of a sufficient number of potential trainees in appropriate disciplines (Table 1) and program faculty with the appropriate scientific expertise (Tables 2 and 4) as well as the current research training resources (Table 3).
  • The training mission (i.e., broad statement of purpose of the program), and objectives (i.e., specific measurable outcomes the program intends to achieve). The program-specific mission and objectives should align with the Overarching Objective of this funding announcement while focusing on developing the specific skills required to be a well-trained clinician scientist. Objectives should include, but not be limited to, degree completion rates and appropriate time-to-degree.
  • Administrative Structure. The application should describe the administrative structure, distribution of responsibilities within it, and the leadership succession plan for critical positions (e.g., PD(s)/PI(s)). Applications with partnerships are encouraged to include a PD/PI from each participating institution.

Curriculum and Overall Training Plan

The application should describe the following:

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

Career Development

The application should describe the following:

  • How the pool of potential applicants and trainees will be provided with information about the career outcomes of graduates of the program (e.g., on publicly accessible websites) and about the overall clinician-scientist and biomedical research workforce employment landscape.
  • How trainees in the program will be provided with adequate and appropriate information regarding the variety of careers in the biomedical research workforce that utilize the dual degree.
  • How the proposed program will engage a range of potential employers to ensure the trainees will acquire the appropriate skills, knowledge, and steps needed to attain positions in the sectors of the biomedical research workforce that are of interest to them.
  • How the training program or institution will provide experiential learning opportunities (e.g., internships, shadowing, informational interviews, teaching opportunities) that allow trainees to develop the professional skills and networks necessary to transition into careers in the biomedical research workforce that utilize the dual degree.
  • The programmatic initiatives to allow trainees to identify medical residency programs that will support and develop their research interests.

Program Oversight

The application should include the planned strategy to oversee and monitor the program, and to ensure appropriate, supportive, and timely trainee progression for the duration of the trainees' dual degree training (the application may include the "Evaluation and Assessment Instruments" Appendix to provide blank rubrics or forms). The application should describe the following:

  • How the program ensures the use of evidence-informed training and mentoring practices.
  • The mechanism for matching trainees with the appropriate participating faculty (e.g., laboratory rotations, faculty forums, and interviews).
  • How the program monitors that participating faculty engage in activities that promote trainee career development (including but not limited to the utilization of Individual Development Plans) and fulfill the need of the trainees to obtain their degrees in a timely fashion with the skills, credentials, and experiences to transition into careers in the biomedical research workforce that are consistent with the trainees’ interests and values.
  • A mechanism to monitor mentoring, including oversight of the effectiveness of the trainee/participating faculty match, and a plan for removing faculty displaying unacceptable mentorship qualities from the training program (applicants may use the Appendix labeled “Conflict Resolution Protocols” to provide details of the plan).
  • How the program will ensure that participating faculty employ the highest standards of scientific rigor and impart those standards to their trainees.
  • How the program will ensure that participating faculty reinforce and augment the curricular material on responsible conduct of research, and methods for enhancing reproducibility.
  • If a program coordinator or administrator position is planned to enhance oversight, a description of the person's administrative capabilities that are essential to coordinate the program must be included in the application.

Institutional and Departmental Commitment to the Program

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

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

The application should describe how the Training PDs/PIs will promote the success of the trainees and training program.  NIGMS encourages multiple PDs/PIs, particularly when each brings a unique perspective and skill set that will enhance training as described in the Eligible Individuals section. The application should expand on the information in the biosketch(es) to address how the PD/PI or PD/PI team has:

  • The scientific expertise, as well as the administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program.
  • The time to commit sufficient effort to ensure the program’s success given other professional obligations (the application should indicate the PD(s)/PI(s)’s percent effort in the proposed program).
  • A record of using rigorous and transparent methods in experimental design, data collection, analysis, and reporting.
  • A demonstrated commitment to training the next generation of the biomedical research workforce, leading recruitment efforts to enhance diversity, and fostering inclusive research environments. The PDs/PIs should have received training on how to effectively mentor trainees from all backgrounds, e.g., trainees from groups underrepresented in the biomedical sciences (see Notice of NIH's Interest in Diversity).

Preceptors/Mentors (Participating faculty)

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

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

Application Process, Trainee Positions, Retention, and Support

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

Application Process

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

  • Describe how large the program will be across all cohorts (i.e., the total number of individuals enrolled in the proposed program ranging from the entering cohort to those nearing graduation). For multi-departmental or institutional programs, describe the expected number of individuals in the program from each partner.
  • Provide a strong justification for the number of requested funded slots per year in the context of the training grant eligible pool, the size of the proposed program, the number of participating faculty, and other NIGMS-funded training grants at the institution.
  • Explain the proposed training grant support structure, i.e., how many individuals (e.g., 4 per year), at what stage (e.g., first-year entrants), and for how long (e.g., for 3 years).
  • Define and justify the selection and re-appointment criteria for the training grant supported trainees in the program.
  • Retention and Support

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

    Training Outcomes

    This section is intended to provide outcomes for training grant eligible students for any current clinician-scientist training program at the applicant institution. For programs that do not yet exist, present data for the training eligible pool for the clinical and doctoral programs proposed in the application. The application should provide the information about recent outcomes through narrative descriptions and a summary of the data presented in the required training tables. Although the training tables for new applications only allow for five years of recent outcomes, the application may describe up to 15 years of outcomes in the narrative. The application should describe the following:

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

    Program Evaluation and Dissemination

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

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

    Plan for Instruction in the Responsible Conduct of Research

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

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

    Plan for Instruction in Methods for Enhancing Reproducibility

    Applicants are required to provide a Plan for Instruction in Methods for Enhancing Reproducibility as provided in the SF424 (R&R) Application Guide, along with the following additional instructions:

    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.

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

    Faculty, Trainees, and Training Record

    Participating Faculty Biosketches

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

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

    Letters of Support

    Institutional Support Letter (10-page maximum): The application must include a signed letter on institutional letterhead from a President, Provost, Dean, or similar key institutional leader that describes the activities and resources provided by the institution(s) designed to ensure the success of the planned training program and its trainees. The institutions must have the resources and structures in place to support the trainees in the completion of their dual degree in a timely manner

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

    The institutional commitment to the following areas should be described (as applicable):

    • Developing and promoting a culture in which the highest standards of safety, scientific rigor, reproducibility, and responsible conduct are advanced.
    • Ensuring sufficient start-up funding to permit early stage faculty to participate in training, and bridge funding to ensure that training may continue if a mentor experiences a hiatus in funds.
    • Supporting core facilities and technology resources, and describing how they can be used to enhance training.
    • Providing adequate staff, facilities, and educational resources to the planned program.
    • Supporting the PDs/PIs and other key staff associated with the planned training program.
    • Fostering and rewarding excellence in training (e.g., through institutional polices such as tenure and promotion).
    • Supporting the remediation or removal of Participating Faculty from the program who are poorly performing mentors.
    • Promoting diversity and inclusion at all levels of the research training environment (trainees, staff, faculty, and leadership).
    • Ensuring a positive, supportive and inclusive research and training environment for individuals from all backgrounds.
    • Ensuring the research facilities and laboratory practices promote the safety of trainees.
    • Guaranteeing the research facilities are accessible to trainees with disabilities.
    • Ensuring that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices and to appropriately respond to allegations of such discriminatory practices, including providing any required notifications to NIH (e.g., requesting a change of PD/PI status; see NOT-OD-19-029).
    • Providing trainees access to student support services, such as healthcare, counseling services, and housing.
    • Ensuring that trainees will continue to be supported when they transition from the training grant to other sources of support.
    • Providing resources and expertise for evaluating the training outcomes of the program.
    • For institutions that have multiple NIGMS-funded predoctoral training grants, the letter should also explain what distinguishes the proposed program from existing ones at the same training level, how the programs will synergize and share resources when appropriate, and how the training faculty, pool of potential trainees, and resources are sufficiently robust to support the proposed program in addition to existing ones.

    For programs proposing partnerships, the institutional support letter must be signed by a President, Provost, or Dean from both institutions. In addition to the items above, the letter should describe:

    • Each institution's respective role in administering the program, including the coordination, integration, synergy, and mutual reinforcement of the training program, and
    • How the resources within each institution will be leveraged to enhance the competitiveness of dual degree graduates.

    Other Letters of Support: Additional letters of support are permitted; however, these letters may not contain any information required in the Institutional Support Letter.

    Combine all Letters of Support into a single PDF file.

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

    Appendix:

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

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

    The following are required Appendix materials:

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

    The following are allowable Appendix materials:

    • Elective Activities (2 pages maximum per activity): The application may include summary content from up to four additional elective courses, workshops, and/or training activities (e.g., streamlined syllabi with topics, timelines, activities, credits, etc.). 
    • Evaluation and Assessment Instruments: The application may include blank surveys, rubrics, and/or forms used to (a) document and monitor trainee progress and (b) determine whether the training and research environment is effective, inclusive, safe, and supportive. Do not include any data or examples of data.
    • Conflict Resolution Protocols (3 pages maximum): The application may include detailed protocols for addressing problems with trainee and faculty matches, removal of faculty from the training program with unacceptable training/mentoring skills and for conflict resolutions for multi PD(s)/PI(s) and mentor/mentee relationships.

    PHS Assignment Request Form

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

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

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

    4. Submission Dates and Times

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

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

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

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

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

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

    7. Other Submission Requirements and Information

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

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

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

    Important reminders:

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

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

    See more tips for avoiding common errors.

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

    Applicants Requesting $500,000 or more for direct costs (less consortium F&A) in any year

    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.

    Post Submission Materials

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

    Section V. Application Review Information

    1. Criteria

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

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

    Overall Impact

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

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed integrated training program will produce a diverse pool of well-trained clinician-scientists with the technical, operational, and professional skills necessary to conduct rigorous and reproducible research, and transition into careers in the biomedical research workforce that utilize the dual degree, in consideration of the following review criteria and additional review criteria (as applicable for the program proposed). Specifically, do the courses, structured training activities, mentoring, and research experiences equip the trainees with:

    • A broad understanding across biomedical disciplines and the skills to independently acquire the knowledge needed to advance their chosen fields.
    • Expertise in a biomedical scientific discipline and the skills to think critically and independently.
    • A strong foundation in scientific reasoning, rigorous research design, experimental methods, quantitative and computational approaches, and data analysis and interpretation.
    • The skills to conduct research in the safest manner possible, and a commitment to approaching and conducting biomedical research and clinical practice responsibly, ethically, and with integrity.
    • Experience initiating, conducting, interpreting, and presenting rigorous and reproducible biomedical research with increasing self-direction.
    • The ability to utilize clinical experience and observations to identify important biomedical research questions and to develop impactful research programs that push forward the boundaries of their areas of study.
    • The capacity to translate scientific research findings into clinical practice.
    • The knowledge, professional skills and experiences required to identify and transition into careers that utilize the dual clinician-scientist degrees.
    • 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 ability and skills to lead changes that promote health equity, reduce health disparities and improve the health of those medically underserved across diseases, disorders, and conditions.
    • The skills to teach and communicate scientific methodologies and findings to a wide variety of audiences (e.g., discipline-specific, across disciplines, and the public)
    Scored Review Criteria

    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 EnvironmentRationale, Mission, and Objectives

    • Does the application provide a compelling rationale for the proposed research training program?
    • Does the proposed program demonstrate the presence of a sufficient pool of potential trainees in appropriate disciplines (Table 1), program faculty with the appropriate scientific expertise (Tables 2 and 4), and resources to achieve the training objectives (Table 3)?
    • Are the mission and objectives for the training program specific and measurable and in alignment with the goal of the program?
    • Is the administrative structure appropriate for achieving the objectives? Is there a sound leadership succession plan for critical positions (e.g., PD/PI)?

    Curriculum and Overall Training Plan

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

    Career Development

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

    Program Oversight, Participating Faculty Selection, and Mentor Training

    • Does the application describe an effective strategy and administrative structure to oversee and monitor the program to ensure appropriate, supportive, and timely trainee progression for the duration of the trainees' dual degree training?
    • Does the application describe effective mechanisms to ensure the use of evidence-informed teaching and mentoring practices that promote the development of trainees from all backgrounds?
    • Is there a clear mechanism for matching the trainees with appropriate program faculty (e.g., laboratory rotations, faculty forums and interviews)?
    • Is there an effective mechanism to monitor mentoring, including oversight of the effectiveness of the trainee/participating faculty match, and a plan for removing participating faculty displaying unacceptable mentorship qualities from the training program?
    • Is there an effective plan to ensure that the participating faculty engage in activities that promote trainee career development and fulfill the need of the trainees to obtain their degrees in a timely fashion with the skills, credentials and experiences to transition into clinician-scientist careers in the biomedical research workforce that are consistent with the trainees' interests, and values?
    • Will the program ensure that program faculty reinforce and augment the curricular material on rigor and transparency and the responsible conduct of research?
    • If a program coordinator or administrator position is planned, will the person's administrative capabilities contribute to the success of the program?

    Institutional and Departmental Commitment to the Program

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

     

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

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

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

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

    Preceptors/Mentors (Participating Faculty)

    • Is selection of the program faculty based on a commitment to training and mentoring, and not simply research productivity?
    • Does the applicant have plans to recruit potential program faculty from various backgrounds, for example, individuals from groups underrepresented in the biomedical sciences, women, as well as faculty at different career stages (i.e., junior and senior faculty) 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?
    • Do the participating faculty describe a compelling commitment to rigorous and unbiased experimental design, methodology, analysis, interpretation, and reporting of results as well as ethically sound and responsible scientific research?
    • Do the participating faculty have plans to promote the use of highest standards of practice to ensure the safety of all individuals in the research environment?
    • Is there evidence that the participating faculty cooperate, interact, and collaborate?
    • Do the participating faculty provide opportunities for trainees to initiate, conduct, interpret, and present rigorous and reproducible biomedical research with increasing self-direction?
    • Do the participating faculty have plans for ensuring their trainees develop skills in approaches to experimental design, as well as methods of data collection, analysis, interpretation, and reporting?
    • Do the participating faculty demonstrate a commitment to effective mentoring, and promoting inclusive, safe, and supportive scientific and training environments?
    • Are the participating faculty willing to engage in activities to promote the trainees’ career goals and to support trainees participating in activities required to identify and transition into careers in the biomedical research workforce that are consistent with the trainees' skills, interests, and values?
    • Do the participating faculty have a commitment to fulfilling the need of the trainees to obtain their dual degrees in a timely fashion with the skills, credentials, and experiences to transition into careers that utilize the dual degree?

     

    Application Process, Trainee Positions, Retention, and Support

    Application Process

    • Will the candidate review process allow a broad group of research-oriented individuals the ability to participate in the dual-degree training program? Does the process consider metrics beyond undergraduate institution prestige, grade point averages, and standardized test scores?
    • Is the recruitment process responsive to application and matriculation data?
    • If the program trainees are drawn from multiple departments/institutions, is the review process consistent across all relevant departments/institutions?
    • Is the training program’s approach to recruiting and admitting students effective?

    Funded Positions

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

    Retention and Support

    • Is there an adequate, evidence-informed retention plan to ensure the well-being and success of all trainees throughout their dual degree training (see the “Trainee Retention Plan” attachment)?
    • Is there a sufficient research grant base and/or other resources at the institution(s) to support trainees during their Ph.D. training?
    • Will the institution ensure support of the dual-degree trainees during their clinical training?

    Training Record

    Training Outcomes for Training Grant Eligible Pool

    • Does the application provide evidence the training grant eligible pool conducted rigorous research that advanced scientific knowledge and/or technologies with increasing self-direction (e.g., peer-reviewed publications listed in Table 5A, and other accomplishments appropriate to the field)?
    • Does the rate of degree attainment and time-to-degree for the training grant eligible pool indicate that these students completed their degrees at a high rate in a timely fashion (Training Table 8A)?
    • Are completion rates, time-to-degree, and scholarly outcomes for the training grant eligible pool comparable across demographic groups?
    • Are the trainees training grant eligible pool transitioning to careers that utilize the dual degree (Table 8A)?

    Program Evaluation

    • Is there a well thought out evaluation or assessment plan to determine whether the overall program is effective in meeting its training mission and objectives, and whether the training and scientific research climates are inclusive and supportive of trainee development (narrative and "Evaluation and Assessment Instruments" Appendix)?
    • Is there evidence that the program has been and/or will be responsive to outcomes, critiques, and evaluations?
    • Does the training program have an appropriate plan to track trainee outcomes and make the data publicly available (e.g., on the institution's website)?
    Additional Review Criteria
    As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

    Training in Methods for Enhancing Reproducibility

    • Does the Instruction in Methods for Enhancing Reproducibility plan describe:
      • how trainees will be instructed in principles important for enhancing research reproducibility including;
      • at a minimum, evaluation of foundational research underlying a project, rigorous experimental design and data analysis;
      • consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources;
      • data and material sharing, record keeping, and transparency in reporting?
    • Are the rigor and transparency components sufficiently well integrated into the overall curriculum?
    • Are they taught at multiple stages of trainee development and in a variety of formats and contexts?
    • Does the teaching synergize with elements of the curriculum designed to enhance trainees' abilities to conduct responsible research?
    • Is there evidence that all participating faculty reiterate and augment key elements of methods for enhancing reproducibility when trainees are performing mentored research their laboratories?

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

    Recruitment Plan to Enhance Diversity

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

    Training in the Responsible Conduct of Research

    All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components:

    1) Format- Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable)

    2) Subject Matter– Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, and research ethics?

    3) Faculty Participation- Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application?

    4) Duration of Instruction- Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction?

    5) Frequency of Instruction– Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

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

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

    Protections for Human Subjects

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

    Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

    Vertebrate Animals

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

    Biohazards

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

    Resubmissions

    Not applicable

    Renewals

    Not applicable

    Revisions

    Not applicable

    Additional Review Considerations

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

    Select Agent Research

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

    Budget and Period of Support

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

    2. Review and Selection Process

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

    As part of the scientific peer review, all applications:

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

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

    The following will be considered in making funding decisions:

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities
    • Geographic and institutional distribution
    • Contributions to portfolio breadth as outlined in the NIGMS Strategic Plan
    3. Anticipated Announcement and Award Dates

    After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

    Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

    Section VI. Award Administration Information

    1. Award Notices

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

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

    Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

    2. Administrative and National Policy Requirements

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

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

    Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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

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

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

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

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

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

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

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable

    3. Reporting

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

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

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

    Other Reporting Requirements

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

    • A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.
    • Termination Notice: Within 30 days of the end of the total support period, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each trainee appointed for eight weeks or more. Trainees with service payback requirements must notify the NIH of any change in address and submit Annual Payback Activities Certification Forms (PHS Form 6031-1) until the payback service obligation is satisfied.

    A final RPPR, the expenditure data portion of the Federal Financial Report, and Termination Notices for all Trainees, are required for closeout of an award as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

    4. Evaluation

    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, gauge its effectiveness in enhancing diversity, 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 of programs
    • Demographics of trainees
    • Trainee dual degree completion rates
    • Time-to-degree
    • Scientific accomplishments of trainees
    • Graduate research training areas represented
    • Residency fields chosen by trainees
    • Trainee career outcomes
    • Persistence of graduates in biomedical research careers

    Section VII. Agency Contacts

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

    Application Submission Contacts

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

    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application processes and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

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

    Scientific/Research Contacts

    Mercedes Rubio, Ph.D.
    National Institutes of General Medical Sciences (NIGMS)
    Email: rubiome@mail.nih.gov

    Peer Review Contact(s)

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

    Financial/Grants Management Contacts

    Jun Moy
    National Institute of General Medical Sciences (NIGMS)
    Email: moyj@nigms.nih.gov

    Section VIII. Other Information

    Section VIII. Other Information header text

    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.

    Authority and Regulations

    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.

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