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 FOA-specific instructions noted in Section IV. When the FOA-specific instructions deviate from those in the Application Guide, follow the FOA-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

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

Purpose and Background Information

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

Through this funding announcement, NIGMS intends to encourage changes in biomedical graduate training to keep pace with the rapid evolution of the research enterprise that is increasingly complex, interdisciplinary, and collaborative. As the scientific enterprise has expanded, there is greater variation in the backgrounds of people participating, approaches taken to investigate research questions, and the range of the careers in the biomedical research workforce that Ph.D. recipients are pursuing. There is also an increasing recognition of the need to enhance reproducibility of biomedical research results through scientific rigor and transparency. This FOA is intended to enable the scientific community to develop and implement evidence-based approaches to biomedical research training and mentoring that will effectively train future generations of outstanding biomedical scientists.

Each funded program should provide high-quality research training, mentored research experiences, and additional opportunities that equip trainees with the technical, operational and professional skills required for careers in the biomedical research workforce. The intention is not to layer additional activities onto existing structures; instead, this FOA is designed to allow for creative approaches to biomedical graduate training that preserve the best elements of current programs, while enhancing the focus on the development of trainee skills.

The Overarching Objective of the NIGMS Predoctoral Institutional Research Training Grant (T32) program is to develop a diverse pool of well-trained scientists who have the following:

• A broad understanding across biomedical disciplines and the skills to independently acquire the knowledge needed to advance their chosen field;
• The ability to think critically, independently and to identify important biomedical research questions and approaches that push forward the boundaries of their areas of study;
• A strong foundation in scientific reasoning, rigorous research design, experimental methods, quantitative approaches, as well as data analysis and interpretation;
• A commitment to approaching and conducting biomedical research responsibly and with integrity;
• Experience initiating, conducting, interpreting, and presenting rigorous and reproducible biomedical research with increasing self-direction;
• The ability to work effectively in teams with colleagues from a variety of cultural and scientific backgrounds, and to promote inclusive and supportive scientific research environments;
• The skills to teach and communicate scientific research methodologies and findings to a wide variety of audiences (e.g., discipline-specific, across disciplines, and the public); and
• The knowledge, professional skills and experiences required to identify and transition into careers in the biomedical research workforce (i.e., the breadth of careers that sustain biomedical research in areas that are relevant to the NIH mission).

Because diversity at all levels is integral to research and training excellence, this FOA is intended to support outstanding research training environments that focus on all trainees and enhance diversity in the biomedical enterprise by paying particular attention to groups underrepresented in the biomedical sciences, NOT-OD-15-053.

NIGMS will accept predoctoral training grant applications in a broad range of basic biomedical sciences (integrated medical and graduate research training through the Medical Scientist Training Program is not supported on this FOA). NIGMS also will accept applications for cross-disciplinary training programs that do not fit within the defined areas, but that support research training in areas of biomedical science that are within the NIGMS mission. Applicants are strongly encouraged to read information about NIGMS Institutional Predoctoral Training Grants found on the NIGMS website and to contact program staff before submitting an application. Except for Medical Scientist Training Program (MSTP) applications, all NIGMS predoctoral T32 applications submitted after the January 2018 receipt date must follow the guidelines in this FOA.

Applicants are expected to identify training needs and objectives (i.e., specific measurable outcomes the program intends to achieve), and develop plans to implement evidence-based training activities that are grounded in the literature and from evaluations of existing relevant graduate programs. Funded training programs must ensure that trainees have a solid foundation in methods to enhance data reproducibility through rigor and transparency. Applicants are encouraged to consult the NIGMS clearinghouse for training modules to enhance data reproducibility, and other resources when developing the plans. Funded programs are expected to implement robust plans to enhance diversity and to promote inclusive research environments (i.e., institutional and departmental environments where trainees from all backgrounds feel integrated into and supported by the biomedical community). Additionally, funded programs should implement plans to enhance trainee retention (i.e., to sustain the scientific interests and participation of trainees from all backgrounds). Funded programs are expected to provide evidence of accomplishing the training objectives in progress reports and upon renewal, to make training and career outcomes publicly available, and are strongly encouraged to disseminate successful training practices to the broader training community.

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

NIGMS does not accept applications for predoctoral T32 programs proposing only short-term research training. Programs proposing short-term research training should apply to the Kirschstein-NRSA Short-Term Institutional Research Training Grant Program (T35) exclusively reserved for predoctoral, short-term research training (see PA-16-151 and subsequent reissuances). NIGMS will not accept applications proposing combined predoctoral and postdoctoral training under this FOA.

Training grants are usually awarded for 5 years. The grant offsets the cost of stipends, tuition and fees, and training related expenses, including health insurance, for the appointed trainees in accordance with the approved NIH support levels. Students are typically provided full-time support for 1-2 years of graduate studies. Use of training grant support in the first three years of graduate research training is strongly encouraged to provide maximum flexibility in the participation in courses, laboratory rotations, and professional development activities.

For applicants that currently have an NIGMS institutional predoctoral training program in a specific area, NIGMS recommends that applicants plan to submit an application under this FOA at least one- to one-and-a-half years before the current grant is scheduled to terminate. For example, if the current grant is scheduled to terminate on June 30, 2020, applicants are advised to submit an application under this FOA no later than May 25, 2019. Please consult the NIGMS website for more information on Predoctoral Training Grant Application Deadlines.

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

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

Governments

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

Other

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

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program is detailed in the Institutional Support Letter attachment instructions in Section IV.1.

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

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

Applicant Organizations

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

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training program as the Training Program Director/Principal Investigator (Training PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

As described in the instructions for the Training Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) in Section IV.2 below, NIGMS encourages multiple PDs/PIs, particularly when each brings a unique perspective and skill set that will enhance training. At least one of the training PDs/PIs should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. Additional PDs/PIs, including individuals with experience in the science of education, relevant social science disciplines, program evaluation, mentoring, and university administration may be included to achieve the training goals. Any of the PDs/PIs may serve as the contact PD/PI. The PDs/PIs will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PDs/PIs will be expected to monitor and assess the program and submit all documents and reports as required. The PDs/PIs have responsibility for the day-to-day administration of the program and are responsible for appointing members of the Advisory Committee (when applicable), and using their recommendations to determine the appropriate allotment of funds.

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

Applicant organizations may submit more than one application, provided that each application is programmatically distinct. NIGMS accepts predoctoral training grant applications in broad areas of basic biomedical sciences. As described above, NIGMS will support only one training program in each training area per institution (normally identified by having a unique DUNS number or NIH IPF number). Likewise, applicant institutions may not submit applications to NIGMS for a training program in a particular program area to both the January 25, 2018 application due date for the Parent T32 announcement and the May 25, 2018 due date for this announcement.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

The selected program faculty should be active researchers as demonstrated by recent publications and research support in the proposed research training program area. When building a training team, programs should recruit faculty who are committed to training, mentoring, and providing supportive and inclusive research environments. Additionally, consideration should be given to recruiting program faculty from underrepresented backgrounds (NOT-OD-15-053), women, and faculty at different career stages (i.e. junior as well as senior faculty).

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

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

Predoctoral trainees must be enrolled in a program leading to a PhD.

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

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

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

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

Instructions for Application Submission

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

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

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

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

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

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

Project Summary/Abstract.

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

Other Attachments.

An Advisory Committee is not a required component of a training program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the training program. The roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Advisory committee members should not be identified or contacted prior to receiving an award. Please name your file "Advisory_Committee.pdf".

Recruitment Plan to Enhance Diversity (3 pages maximum). The applicant must provide the recruitment plan to enhance diversity. Include outreach strategies and activities designed to recruit trainees from underrepresented groups (see NOT-OD-15-053), specifically underrepresented racial and ethnic groups and individuals with disabilities. Applicants are encouraged to consult the NIGMS webpage for strategies to enhance diversity in training programs when designing their plans. Describe the specific efforts to be undertaken by the training program and how these might coordinate with trainee recruitment efforts of the medical school(s), graduate school(s), and/or the institution(s). Centralized institutional efforts alone will not satisfy the requirement to recruit individuals from underrepresented groups. Training grant program faculty are expected to be actively involved in recruitment efforts. Please name the file "Recruitment_Plan.pdf".

Trainee Retention Plan (3 pages maximum). The trainee retention plan should describe efforts to sustain the scientific interests of trainees from all backgrounds within a program (i.e., retention). Applicants are encouraged to consult the extramural diversity website to identify promising retention practices, and use evidence-based practices for retention with the recognition that the variety of trainee backgrounds and experiences may necessitate the need to tailor retention approaches. Describe the specific efforts to be undertaken by the training program and how these might coordinate with trainee retention efforts of the medical school(s), graduate school(s), and/or the institution(s). Centralized institutional efforts alone will not satisfy the requirement to retain trainees, and training grant faculty are expected to be actively involved in trainee retention efforts. Please name the file "Retention_Plan.pdf".

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

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

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

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

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

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

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

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

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

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

Attention must be given to the required Training Data Tables for new applications (Tables: 1, 2, 3, 4, 5A, 6A, 8A). In the Program Plan, applicants should 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 Section

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

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

Program Plan

Rationale, Mission, Objectives, and Overall Training Plan

The application should describe how the program will develop a diverse pool of well-trained scientists who have the technical, operational and professional skills required to conduct research in an ethically responsible and rigorous manner, and to enter careers in the biomedical research workforce as delineated in the Program Objective. The application should describe how the program will enhance the training environment and not simply provide financial support to graduate trainees. Specifically, applicants should describe the following:

• The rationale and need for the proposed research training program, the relevant background history, and the research training activities of the participating department(s) or unit(s). Demonstrate the presence of a sufficient number of potential trainees in appropriate disciplines (Table 1A) and program faculty with the appropriate scientific expertise (Tables 2 and 4) as well as the resources to achieve the training objectives (Training Table 3).
• The ways, when applicable, that the training plan are 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 Training Table 3). See the "Program Considerations" section above.
• The training mission (i.e., broad statement of purpose of the program), and objectives (i.e., specific measurable outcomes the program intends to achieve). Objectives should include, but should not be limited to, Ph.D. completion rates and appropriate time-to-degree. The program-specific mission and objectives should align with the Overarching Objective of this funding announcement described above.
• How the courses, structured activities, and research experiences will accomplish the specific training mission and objectives. Explain how these training activities are designed to develop the technical, operational and professional skills of trainees (applicants may use the "Courses, Electives and Training Activities" appendix to provide syllabi).
• How the training activities will employ evidence-based approaches to trainee learning, mentorship, inclusion, and professional development.
• Representative examples of training programs for individual trainees. Examples may include degree requirements, didactic courses, laboratory experiences, qualifying examinations, and other training activities, such as seminars, journal clubs, etc. Describe how each trainee's program will be guided, 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.
• 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.
• For multi-disciplinary and/or multi-departmental programs, indicate how the individual disciplinary and/or departmental components of the program are integrated and coordinated and how they will relate to an individual trainee's experience.

Career Development

The application should describe the following:

• How applicants and trainees will be provided with information about the career outcomes of graduates of the program (including on publicly accessible websites) and about the overall 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 for which their training would be useful;
• How trainees will learn the skills, knowledge, and steps needed to attain positions in the sectors of the biomedical research workforce that are of interest to them; and
• How the training program or institution will provide experiential learning opportunities (e.g., internships, shadowing, informational interviews) that allow trainees to develop the professional skills and networks necessary to transition into careers in the biomedical research workforce. Applications for a Biotechnology Training Grant Program are required to include and report annually on industrial internship experiences.

Program Oversight, Program Faculty Selection, and Mentor Training

The application should describe the planned strategy and administrative structure to oversee and monitor the program, and to ensure appropriate and timely trainee progress for the duration of the trainees' graduate careers (applicants may use the "Evaluation and Assessment Instruments" Appendix to provide blank rubrics or forms). The application should describe how the program faculty are trained to ensure the use of evidence-based teaching, training and mentoring practices that promote the development of trainees from all backgrounds, with particular attention to trainees from underrepresented backgrounds in the biomedical sciences (NOT-OD-15-053). Applications should describe the following:

• How the program will ensure that program faculty employ the highest standards of scientific rigor and impart those standards to their trainees;
• How the program will ensure that program faculty reinforce and augment the curricular material on responsible conduct of research, and methods for enhancing reproducibility;
• The mechanism for matching trainees with the appropriate program faculty (e.g., laboratory rotations, faculty forums and interviews);
• How the program will ensure that program faculty engage in activities that promote trainee career development and fulfill the need of the trainees to obtain their Ph.D. degrees in a timely fashion with the skills, credentials and experiences to transition into careers in the biomedical research workforce that are consistent with the trainees' interests, and values; and
• A mechanism to monitor mentoring, including oversight of the effectiveness of the trainee/program 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).

Institutional and Departmental Commitment to the Program

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

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

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

• The scientific expertise as well as the administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program;
• The time to commit sufficient effort to ensure the program's success given other professional obligations (applicants should indicate the program director's percent effort in the proposed program);
• A record of using rigorous and transparent methods in experimental design, data collection, analysis and reporting; and
• 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, with particular attention to trainees from groups underrepresented in the biomedical sciences (NOT-OD-15-053).

Preceptors/Mentors (Program Faculty)

The application should describe how the program 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 build a diverse team of program faculty (including individuals from underrepresented backgrounds (NOT-OD-15-053), women, and faculty at different career stages) so that trainees will have access to role models within the training program. Summarize and expand on the material presented in the Training Tables and biosketches. The application should address how the program faculty:

• Have sufficient time to commit to training given their other professional obligations;
• Cooperate, interact, and collaborate (which can include joint sponsorship of trainee research);
• Promote the development of trainee skills in approaches to 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; and
• Demonstrate a commitment to effective mentoring, and promoting inclusive and supportive scientific and training environments.

Trainee Positions, Recruitment, Retention

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

• Provide a strong justification for the number of requested trainee positions in the context of other NIGMS-funded training grants at the institutions. Describe the characteristics of the applicant pool, applicants eligible for support, new entrants into the program, and new entrants eligible for support (Table 6A). Describe the ability for participating department(s) and/or the institution(s) to support trainees for the duration of their graduate careers.
• Expand upon the recruitment plan to enhance diversity (provided in Other Attachments) and explain how it will identify and recruit a diverse group of candidates from a wide variety of institution types and backgrounds (with a focus on identifying effective recruitment strategies for individuals from nationally underrepresented groups in the biomedical sciences, NOT-OD-15-053) with the potential to strongly benefit from, and with proper training and support, succeed in the program. Information on dimensions of diversity not included in the training tables (e.g., trainees from disadvantaged backgrounds) can be incorporated into the narrative.
• Describe the plans for a holistic candidate review process (i.e., a process that considers metrics beyond undergraduate institution, GPA, and standardized test scores) that will select a diverse group of trainees who have taken advantage of the research opportunities available to them and are committed to contributing to the biomedical research enterprise.
• Define and justify the selection and re-appointment criteria for trainees in the training program (appointment procedure protocols should be provided in the "Trainee Appointment Procedures" Appendix).
• Expand upon the trainee retention plan (provided in the Other Attachments) and describe how it will ensure the well-being and success of all trainees throughout their graduate training.

Training Outcomes

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

• Evidence that recent graduates conducted rigorous research that advanced scientific knowledge and/or technologies, with increasing self-direction (including peer-reviewed publications in Training Table 5A, and other measures of scientific accomplishment appropriate to the field);
• The rate of Ph.D. degree attainment and time-to-degree for recent graduates (Training Table 8A);
• The record of recruiting students from nationally underrepresented groups and sustaining interest in the program (NOT-OD-15-053; data in Training Table 6A and narrative);
• A description or analysis for how the Ph.D. degree attainment and time-to-degree data for recent graduates from underrepresented groups (NOT-OD-15-053) compare to the data for recent graduates from well-represented groups; and
• The success of recent graduates transitioning to careers in the biomedical research workforce (Training Table 8A).

Program Evaluation

The application should describe the following:

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

Plan for Instruction in the Responsible Conduct of Research

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

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

Plan for Instruction in Methods for Enhancing Reproducibility

Individuals are required to provide a Plan for Instruction in Methods for Enhancing Reproducibility using the following additional instructions:

A "Plan for Instruction in Methods for Enhancing Reproducibility" attachment is required (not to exceed three pages). The plan must describe how trainees will be instructed in principles important for enhancing research reproducibility including, at a minimum, evaluation of foundational research underlying a project (i.e., scientific premise), rigorous experimental design and data interpretation, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, data and material sharing, record keeping, and transparency in reporting. Describe how instruction strategies are sufficiently well integrated into the overall curriculum, that is, how they are taught at multiple stages of trainee development and in a variety of formats and contexts. Describe how all program faculty will reiterate and augment key elements of methods for enhancing reproducibility when trainees are performing research in their laboratories.

Faculty, Trainees, And Training Record Section

Participating Faculty Biosketches

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

• Training, mentoring, and promoting inclusive and supportive scientific research environments;
• Maintaining a record of, and training in rigorous and unbiased experimental design, methodology, analysis, interpretation and reporting of results;
• Supporting trainees participating in activities required to identify and transition into careers in the biomedical research workforce that are consistent with the trainees' skills, interests, and values; and
• Fulfilling the need of the trainees to obtain their Ph.D. degrees in a timely fashion with the skills, credentials and experiences to transition into careers in the biomedical research workforce.

Letters of Support

Institutional Support Letter. The application must include a signed letter on institutional letterhead from a President, Provost, Dean or key institutional leader that describes the activities and resources provided by the institution that will ensure the success of the planned training program and its trainees (not to exceed 10 pages). Institutional commitment to the following areas should be described in the letter: developing and promoting a culture in which the highest standards of scientific rigor, reproducibility and responsible conduct are advanced; ensuring sufficient 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; ensuring faculty have protected time available to devote to mentoring, training and research; considering activities integral to excellent graduate training (such as teaching and mentorship) in tenure and promotion decisions; promoting diversity and inclusion at all levels of the research training environment (trainees, staff, faculty, and leadership); ensuring the research facilities and laboratory practices promote the safety of trainees; ensuring the research facilities are accessible to trainees with disabilities; ensuring a positive, supportive and inclusive research and training environment for individuals from all backgrounds; ensuring that trainees will continue to be supported when they transition from the training grant to other sources of support; and 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.

Appendix

Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide with the following additional instructions. The Appendix is meant to provide additional details to the following topics, but not meant to substitute for clear descriptions in the body of the application. Do not use the Appendix to circumvent page limits. Do not include items other than the allowable materials described below, as doing so will result in administrative withdrawal of the application. Name the file according to the headings below. A summary sheet listing all the items included in the Appendix may be included in the first Appendix attachment.

The following is required Appendix material:

• Responsible Conduct of Research Syllabus. In addition to the Plan for Instruction in the Responsible Conduct of Research, the application must provide a syllabus for the course in the responsible conduct of research.

The following are allowable Appendix materials:

• Courses, Electives and Training Activities. This section is intended to allow applicants to provide details for up to four additional courses, and training activities (e.g., syllabi for courses, mentor training materials, professional development workshops, career exploration opportunities, skills development activities).
• Evaluation and Assessment Instruments. This section is intended to allow applicants to provide 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, and supportive.
• Trainee Appointment Procedures (3 pages maximum). This section is intended to allow applicants to provide appointment protocols or blank applications for trainees in the program.
• Conflict Resolution Protocols (3 pages maximum). This section is intended to allow applicants to provide detailed protocols for addressing problems with trainee and faculty matches, removal of faculty from the training program with unacceptable training/mentoring skills from as well as conflict resolutions for multi PD/PIs and mentor/mentee relationships.

Generally, not applicable for training grants. When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for in the SR424 (R&R) Application Guide

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will produce a diverse pool of well-trained scientists with the technical (e.g., appropriate methods, technologies, and quantitative/computational approaches), operational (e.g., independent knowledge acquisition, rigorous experimental design, and interpretation of data), and professional (e.g. management, leadership, communication, and teamwork) skills necessary to conduct rigorous and reproducible research, and transition into careers in the biomedical research workforce, in consideration of the following review criteria and additional review criteria (as applicable for the project 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 field;
• The ability to think critically, independently and to identify important biomedical research questions and approaches that push forward the boundaries of their areas of study;
• A strong foundation in scientific reasoning, rigorous research design, experimental methods, quantitative approaches, as well as data analysis and interpretation;
• A commitment to approaching and conducting biomedical research responsibly and with integrity;
• Experience initiating, conducting, interpreting, and presenting rigorous and reproducible biomedical research with increasing self-direction;
• The ability to work effectively in teams with colleagues from diverse backgrounds and disciplinary backgrounds, and to promote an inclusive and supportive scientific research environment;
• The skills to teach and communicate scientific research methodologies and findings to a wide variety of audiences (e.g., discipline-specific, across disciplines, and the public); and
• The knowledge, professional skills and experiences required to identify and transition into careers in the biomedical research workforce (i.e., the breadth of careers that sustain biomedical research in areas that are relevant to the NIH mission)?

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

Training Program and Environment

Rationale, Mission, Objectives, and Overall Training Plan

• Does the application provide a compelling rationale and demonstrate a need for the proposed research training program? Specifically, does the proposed program demonstrate the presence of a sufficient number of potential trainees in appropriate disciplines (Table 1A), program faculty with the appropriate scientific expertise (Tables 2 and 4), and resources to achieve the training objectives (Table 3)?
• 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 in the Letters of Support section)?
• Are the mission and objectives for the training program specific and measurable and in alignment with the goal of producing a diverse pool of well-trained scientists with the technical, operational, and professional skills necessary to transition into careers in the biomedical research workforce?
• Will the courses, structured training activities, mentoring, and research experiences achieve the stated mission and objectives of the training program (applicants may use the "Courses, Electives and Training Activities" appendix to provide syllabi)?
• Does the training program plan explain how the courses, structured training activities, mentoring, and research experiences employ modern, evidence-based approaches to training, mentorship, inclusion and professional development?
• Does the application provide examples of how each trainee's progress will be guided and how the trainee's performance and skills development will be monitored and evaluated?
• 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-disciplinary and/or multi-departmental programs, is it clear how the individual disciplinary and/or departmental components of the program are integrated and coordinated and how each will relate to an individual trainee's experience?

Career Development

• Will the applicants and trainees be provided with information about the career outcomes of graduates of the program and about the overall biomedical research workforce employment landscape?
• Will the trainees be provided with adequate and appropriate information regarding the wide variety of careers in the biomedical research workforce for which their training may be useful?
• Will the trainees learn the skills, knowledge, and steps needed to attain positions in the sectors of the biomedical research workforce that are of interest to them?
• Will the training program or institution provide experiential learning opportunities (e.g. internships, shadowing, informational interviews) that allow trainees to develop the professional skills and networks necessary to transition into careers in the biomedical research workforce? For applications for a Biotechnology Training Grant, are there plans to include industrial internship experiences in the research training program?

Program Oversight, Program Faculty Selection, and Mentor Training

• Does the application describe an effective strategy and administrative structure to oversee and monitor the program to ensure appropriate and timely trainee progress for the duration of the trainees' graduate careers (applicants may use the "Evaluation and Assessment Instruments" appendix to provide blank rubrics or forms)?
• Is selection of the program faculty based on a commitment to training and mentoring, and not simply research productivity?
• Will the program faculty be trained to ensure the use of evidence-based teaching and mentoring practices that promote the development of trainees from all backgrounds, with attention to trainees from underrepresented groups (NOT-OD-15-053)?
• Do the potential mentors have a record of employing the highest standards of rigor and transparency in their research, and plans to impart those standards to their trainees?
• Will the program ensure that program faculty reinforce and augment the curricular material on responsible conduct of research, and methods for enhancing reproducibility?
• Is there a clear mechanism for matching the trainees with appropriate program faculty (e.g., laboratory rotations, faculty forums and interviews)?
• Is there a plan to ensure that 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 Ph.D. 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?
• Is there a mechanism to monitor mentoring, including oversight of the effectiveness of the trainee/program faculty match, and a plan for removing program faculty displaying unacceptable mentorship qualities from the training program (applicants may use an Appendix labeled "Conflict Resolution Protocols" to provide details of the plan)?

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 it clear that there is a commitment to promote a culture in which the highest standards of scientific rigor, reproducibility and responsible conduct of research are advanced?
• Are there adequate start-up funds to permit early stage faculty to participate in training, and bridge funds to ensure that training may continue if a program faculty member experiences a hiatus in research support?
• Are the core facilities and technology resources necessary for the success of the program well supported?
• Is there adequate support of the PDs/PIs and other key staff, facilities, and educational resources associated with the training program?
• Do faculty have sufficient protected time available to devote to the training activities?
• Do institutional policies for tenure and promotion decisions reward excellence in training and mentoring?
• Are diversity and inclusion promoted at all levels of the research training environment (trainees, staff, faculty, and leadership)?
• Is there evidence that the research facilities and laboratory practices ensure the safety of trainees?
• Are the research facilities accessible to trainees with disabilities?
• Is there a commitment to ensure that trainees will continue to be supported when they transition from the training grant to other sources of support?
• Are there resources and the expertise for evaluating the training outcomes of the program?
• 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) (PDs/PIs)

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

For applications designating multiple PDs/PIs:

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

Preceptors/Mentors (Program Faculty)

• Do mentors have a record of rigorous and unbiased experimental design, methodology, analysis, interpretation and reporting of results?
• Do the mentors have a record of conducting ethically sound and responsible scientific research?
• Do the selected program faculty come from various backgrounds, including from groups underrepresented in the biomedical sciences, women, as well as faculty at different career stages (i.e., junior and senior faculty)? If the faculty team is lacking in diversity, are there plans to enhance the diversity?
• Do the program faculty have the time to commit sufficient effort to ensure trainee development and success, given their other professional obligations?
• Is there evidence that the program faculty cooperate, interact, and collaborate (which can include joint sponsorship of trainee research)?
• Do the program faculty provide opportunities for trainees to initiate, conduct, interpret, and present rigorous and reproducible biomedical research with increasing self-direction?
• Do the program 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 program faculty demonstrate a commitment to effective mentoring, and promoting inclusive and supportive scientific and training environments?
• Are the program faculty willing to engage in conversations with trainees about their career goals and options 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 program faculty have a commitment to fulfilling the need of the trainees to obtain their Ph.D. degrees in a timely fashion with the skills, credentials, and experiences to transition into careers in the biomedical research workforce?

Trainee Positions, Recruitment and Retention

• Does the application provide a strong justification for the number of requested trainee positions given the pools of potential trainees in appropriate disciplines (Table 1A, 6A) and program faculty with the appropriate funding and scientific expertise (Tables 2, 3, 4, and Participating Faculty Biosketches)?
• Does the institution have the resources to support trainees for the duration of their graduate careers (Letters of Support, Institutional Support Letter)?
• Is the recruitment plan likely to identify and attract a broad and diverse group of candidates from a wide variety of institution types and backgrounds (including from groups underrepresented in the biomedical workforce, NOT-OD-15-053) with the potential to strongly benefit from, and with proper training and support, succeed in the training program (Tables 6A and the "Recruitment Plan to Enhance Diversity" attachment)?
• Is there a holistic candidate review process proposed (i.e., a process that considers metrics beyond undergraduate institution, GPA, and standardized test scores) that will allow a broad group of trainees, who have taken advantage of the research opportunities available to them and are committed to contributing to the biomedical research enterprise, the ability to participate the training progam?
• Are there well-defined and justified selection and re-appointment criteria for trainees in the training program (protocols for appointments may be provided in the "Trainee Appointment Procedures" appendix)?
• Is there an adequate, evidence-based retention plan to ensure the well-being and success of all trainees throughout their graduate training (see the "Trainee Retention Plan" attachment)?

Training Record

Training Outcomes

• Does the program provide evidence that trainees 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 application contain information about the current rate of Ph.D. degree attainment and time-to-degree for trainees (Training Table 8A)?
• Are completion rates and time-to-degree for trainees from underrepresented groups (NOT-OD-15-053) comparable to those from well-represented groups?
• Are the trainees transitioning to careers in the biomedical research workforce (i.e., the breadth of careers involved in the conduct and support of biomedical research in areas that are relevant to the NIH mission; Training Table 8A)?

Program Evaluation

• Is there a well thought out evaluation or assessment process to determine whether the overall program is effective in meeting its training mission and 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 internal and external critiques and evaluations?
• Does the training program have a plan to track trainee outcomes and make the data publicly available on the institution's website?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

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

Recruitment Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of individuals from underrepresented groups. Specifically, racial and ethnic groups underrepresented in the biomedical research workforce, and individuals with disabilities should each be addressed. The overall plan will be rated as ACCEPTABLE only if the recruitment strategies for both groups are viewed by the review panel as acceptable, otherwise the plan will be rated as UNACCEPTABLE. The consensus of the review committee will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable); 2) Subject Matter Do the plan and syllabus provided in the appendix include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, and research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

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

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

Training in Methods for Enhancing Reproducibility

Does the Instruction in Methods for Enhancing Reproducibility plan describe how trainees will be instructed in principles important for enhancing research reproducibility including, at a minimum, evaluation of foundational research underlying a project (i.e., scientific premise), rigorous experimental design, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, data and material sharing, record keeping, and transparency in reporting? Are the rigor and transparency components sufficiently well integrated into the overall curriculum? Are they taught at multiple stages of trainee development and in a variety of formats and contexts? Does the teaching synergize with elements of the curriculum designed to enhance trainees' abilities to conduct responsible research? Is there evidence that all program 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.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NIGMS Office of Scientific Review in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons. Site visits may be employed as part of this process; however, applicants should not assume that site visits are automatic.

As part of the scientific peer review, all applications:

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Advisory General Medical Sciences Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Geographic distribution of the NIGMS training grant portfolio.

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

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

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

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

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

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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

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

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

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

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

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

Not Applicable

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

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

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

• The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant for 8 weeks or more. Grantees must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
• A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.
• Termination Notice: Within 30 days of the end of the total support period, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each trainee appointed for eight weeks or more.

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

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

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

The overall evaluation of the NIGMS Predoctoral Institutional Research Training Grant Program will be based on metrics that will include, but are not limited to, the following:

• Scientific training areas represented
• Institution types represented
• Geographical distribution of programs
• Demographics of trainees
• Trainee Ph.D. completion rates
• Time-to-degree
• Scientific accomplishments of trainees
• Trainee career outcomes

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

For general information, contact Dr. Alison Gammie or Dr. Shiva Singh. For specific information about an area of training contact the relevant NIGMS Program Director.
National Institutes of General Medical Sciences
Telephone: 301-594-3900
Email: alison.gammie@nih.gov
Email: singhs@nigms.nih.gov

Stephanie Constant, Ph.D.
National Institute of General Medical Sciences
Phone: 301-594-3663
Email: stephanie.constant@nih.gov

Lisa Moeller
National Institute of General Medical Sciences
Telephone: 301-594-3914
Email: moellerL@mail.nih.gov

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

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