Part 1. Overview Information

NIGMS will support creative educational activities designed to equip a diverse cohort of participants with the technical, operational, and professional skills required for careers in the biomedical research workforce. Funded programs are expected to have robust evaluation, outreach, dissemination, and sustainability plans.

Key Dates

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers. The over-arching goals of the NIH R25 program are to: (1) complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs; (2) encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research; (3) help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences; and (4) foster a better understanding of biomedical, behavioral and clinical research and its implications.

The over-arching goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs.

The goal of the Innovative Programs to Enhance Research Training (IPERT) initiative is to enable the scientific community to develop and implement innovative educational activities to equip diverse cohorts of participants with technical, operational or professional skills required for careers in the biomedical research workforce, by effectively integrating the required core elements described below:

• Courses for Skills Development: For example, support for short courses designed to develop technical (e.g., appropriate methods, technologies, and quantitative/computational approaches), operational (e.g., independent knowledge acquisition, rigorous experimental design, and interpretation of data) and/or professional (e.g., management, leadership, communication, and teamwork) skills necessary to conduct rigorous and reproducible research, and to transition successfully into careers in the biomedical research workforce. These courses could be in-person or provided electronically. Dissemination of educational materials and outreach activities to benefit individuals from a variety of backgrounds are required components of the program.
• Mentoring Activities: For example, activities designed to provide career information, advice, and support to research-oriented undergraduates, graduate students, postdoctoral fellows, or independent faculty in biomedical fields. The activities should provide participants with a perspective on the biomedical research training pathway and tools for overcoming challenges, navigating career transition points, and successfully transitioning into careers in the biomedical research workforce.

Background

The recent NIGMS Strategic Plans emphasize that (1) research training is a responsibility shared by the NIH, academic institutions, faculty, and trainees; (2) research training must focus on student development, rather than simply the selection of talent; (3) breadth and flexibility enable research training to keep pace with the opportunities and demands of contemporary science and provide the foundation for a variety of scientific career paths; and (4) diversity is an indispensable component of research training excellence and must be advanced across the entire research enterprise.

Through this funding announcement, NIGMS intends to encourage innovative biomedical research education activities designed 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 and to reinforce the principles of the responsible conduct of research. This FOA is intended to enable the scientific community to develop and implement innovative activities that will provide high-quality skills development, mentoring, and outreach to equip diverse cohorts of participants with technical, operational or professional skills required for careers in the biomedical research workforce.

Program Considerations

The IPERT activities must be open to the broader biomedical community and not be restricted to individuals from a single department, program or institution. NIGMS encourages applications that are intended for individuals in a variety of biomedical fields; however, if a scientific area is described, it must be within the NIGMS mission.

The activities may focus on individuals at a particular research career stage or at a range of career stages. NIGMS will support programs designed for research-oriented individuals from the undergraduate to independent faculty stages. Programs designed for pre-college participants should utilize the Science Education Partnership Awards (SEPA) funding opportunities rather than the IPERT.

Applications will not be accepted from for-profit institutions or for courses that are or would become part of the standard/required curriculum of an academic degree program.

Applicants interested in obtaining support for scientific meetings, conferences, seminars, or similar activities should apply to the NIH Support for Conferences and Scientific Meetings (R13) . Note that NIGMS only funds R13 grants in limited circumstances, as described on the Support for Scientific Meetings (R13) page of the NIGMS website.

Renewal applications or applications describing programs previously supported by NIGMS or other NIH Institutes and Centers through the R25 and other activity codes (e.g., T36, R13) must strongly justify the need for the program and/or for continued funding from NIGMS, including new elements that build on the initial award activities. An application that simply proposes to continue previously supported activities will not be considered for funding. All applications must include a sustainability plan to describe how the program will be maintained once IPERT funding for it ends.

Potential applicants are strongly advised to communicate with the Scientific/Research staff listed in this funding announcement prior to writing an application to determine whether the IPERT is the appropriate program for the proposed efforts to enhance research training.

Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. R25 programs may augment institutional research training programs (e.g., T32, T90) but cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs.

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

Section II. Award Information

Other Award Budget Information

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

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)

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving federal support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.

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. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant organizations

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

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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.

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 SF424 (R&R) Application Guide.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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)

Program Faculty

Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as preceptors/mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continuing their involvement throughout the total period of this award.

Participants

NIGMS will support programs designed for research-oriented individuals across the training pathway, including undergraduates, graduate students, postdoctoral fellows, and independent faculty in biomedical fields. The activities may include individuals at a particular research career stage or at a range of career stages.

Unless strongly justified on the basis of exceptional relevance to NIH, research education programs should be used primarily for the education of U.S. citizens and permanent residents.

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 instructions in the Research (R) 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 will not be reviewed.

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

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

Facilities & Other Resources. Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.

Other Attachments.

An Advisory Committee Plan (1-page maximum) is not a required component of a career development program; however, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the 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. Name the file Advisory_Committee.pdf .

Outcomes Data Collection and Storage Plan (2-page maximum). The applicant must provide a plan to track outcomes. Programs are encouraged to make the aggregate outcome data available on the grantee'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. Please name the file Data_Collection_Storage_Plan.pdf . If this attachment is not included, the application will be considered incomplete and will not be reviewed.

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 Guide with the following additional instructions:

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

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

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

• Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.

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

Research Strategy

The Research Strategy section must be used to upload the Research Education Program described below. The Research Education Plan must include the following components :

• Proposed Research Education Program
• Program Director/Principal Investigator
• Program Faculty
• Program Participants
• Diversity Recruitment Plan
• Plan for Instruction in Methods for Enhancing Reproducibility
• Plan for Instruction in the Responsible Conduct of Research
• Evaluation Plan
• Sustainability Plan
• Dissemination Plan

Research Education Program Plan

Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support.

Applicants should describe the following:

• Specific Aims. Applicants should provide a succinct summary of the (a) measurable and obtainable objectives; (b) the evidence-based activities designed to accomplish the objectives; (c) the participants or beneficiaries of the activities; and (d) how the proposed IPERT will contribute to the NIGMS goals for training a diverse biomedical research workforce to address the nation’s needs.
• Rationale for the proposed program. Describe the gap in biomedical research training the program is intended to address. The application should include existing baseline data to provide a strong justification for the program. For renewals, or for programs previously funded by NIH, provide a detailed description of how the proposed program is new, innovative, and differs from the original program.
• The specific, obtainable, and measurable short-term and long-term objectives of the proposed program. The objectives should align with the overarching goal of the IPERT described above. Applicants are encouraged to develop the Research Education Program Plan in consultation with the evaluation team (see Evaluation Plan section below) to ensure the activities are designed to meet the objectives and that the milestones for success are measurable.
• Scientific focus (if applicable). When a scientific focus is proposed, how the program aligns with the NIGMS mission.
• Innovative activities designed to develop the technical, operational, and professional skills of the participants. Provide details on planned courses, seminars, or workshops (applicants may include the Required Research Education Activities appendix, described in the Appendix instructions below, to provide material for required training activities). Applicants should describe how the activities employ evidence-based approaches to teaching and learning.
• The mentoring activities. The application should describe the plans for mentoring participants and describe how the plans address the program objectives. The application should describe how the mentors are trained in using evidence-based mentoring practices that promote the development of individuals from all backgrounds, including those from underrepresented groups in the biomedical sciences (NIH's Interest in Diversity).
• Outreach. Describe the activities designed to ensure a diverse group of individuals will benefit from the research education resources or materials developed under the auspices of the proposed IPERT program.
• Learning Environment. How the activities employ evidence-based methods that promote learning environments that are supportive, safe and inclusive.
• Synergies. How the skills development, mentoring, and outreach activities synergize and are designed to accomplish the objectives.

Program Director/Principal Investigator. Describe arrangements for administration of the program. Provide evidence that the Program Director/Principal Investigator is actively engaged in research and/or teaching in an area related to the mission of NIH, and can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple PDs/PIs, describe the complementary and integrated expertise of the PDs/PIs, their leadership approach, and governance appropriate for the planned project.

Program Faculty. The application should describe how the program faculty will promote the success of the participants. Describe how the program will build a diverse team of participating faculty (e.g., individuals from underrepresented backgrounds (NIH's Interest in Diversity), women, and faculty at different career stages) to help participants gain access to potential role models and to enhance the excellence of the research education environment. Applicants should summarize and expand on the material presented in the biosketches while addressing how the program faculty:

• Have sufficient time to commit to training given their other professional obligations;
• Will receive training in effective, evidence-based mentoring and teaching practices; and
• Demonstrate a commitment to effective mentoring and to promoting inclusive, safe, and supportive scientific and research education environments.

Program Participants. Applications must describe the intended participants, and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels for which the proposed program is planned. Expand upon the Recruitment Plan to Enhance Diversity (see below) and explain how the program will identify and recruit a diverse pool of potential candidates from a wide variety of institution types and backgrounds, e.g., see NIH's Interest in Diversity. When relevant, describe the plans for a holistic candidate review process (i.e., a process that considers metrics beyond the institution, GPA, and standardized test scores) that will select a diverse group of promising participants who are committed to contributing to the biomedical research enterprise (appointment procedure protocols may be provided in the "Participant Appointment Procedures" appendix).

Recruitment Plan to Enhance Diversity. The plan should include outreach strategies and activities designed to recruit potential candidates who are from diverse backgrounds, including underrepresented racial and ethnic groups, students from low socio-economic backgrounds, and individuals with disabilities (see NIH's Interest in Diversity). Applicants are encouraged to consult the NIGMS webpage for strategies to enhance diversity in training programs when designing their plans. Describe the specific efforts to be undertaken by the program and how these might coordinate with recruitment efforts of the institution(s). Centralized institutional efforts alone will not satisfy the requirement to recruit individuals from diverse backgrounds.

Plan for Instruction in Methods for Enhancing Reproducibility. Applicants must provide a Plan for Instruction in Methods for Enhancing Reproducibility through rigor and transparency. The plan should describe how participants will be instructed in principles important for enhancing research reproducibility, for example, critical evaluation of foundational research underlying a project, rigorous experimental design and data interpretation, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, data and material sharing, record keeping, and transparency in reporting. The plan should be appropriate and reasonable for the nature and duration of the proposed activities. Applicants are encouraged to consult the NIGMS clearinghouse for training modules to enhance data reproducibility and other resources when developing the plans. Describe how the methods for enhancing reproducibility strategies are integrated into proposed activities. If a plan for the instruction in methods for enhancing reproducibility is not included, the application will be considered incomplete and will not be reviewed

Plan for Instruction in the Responsible Conduct of Research. Applicants must provide a plan in the Responsible Conduct of Research (RCR) for example, conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, and research ethics. The plan should be appropriate and reasonable for the nature and duration of the proposed activities. Explain how the teaching of RCR synergizes with elements of the activities designed to enhance the participants ability to conduct rigorous and reproducible research. Applications lacking a responsible conduct of research plan will not be reviewed.

Evaluation Plan. NIGMS funded research education programs must conduct ongoing evaluations to monitor the success of the activities. The application may include the "Evaluation and Assessment Instruments" appendix to provide blank survey instruments, rubrics or forms. The evaluation plan should describe the following:

• The methods, metrics, and timeline to determine whether the program is effective in meeting its objectives with respect to the participants' development;
• Characteristics of the data to be collected. The data should be centered not only on psychosocial factors (e.g., self-perceived gains, belonging, science identity, self-efficacy, career satisfaction), but also on outcomes (e.g., pursuit of a science degree, degree attainment, success in career transitioning, grant submissions, publications);
• If possible, a comparator group (e.g., individuals with similar demographics and aptitude metrics who are at a similar training level and will not participate in program activities). If applicants are not able to identify a comparator group, provide the framework for determining whether the program activities were effective and did not simply recruit talented individuals already on a successful trajectory;
• The mechanism for determining whether the skill development and mentoring activities are conducted in environments that are inclusive, safe, and supportive of the participants' development;
• The plans for being responsive to internal and external outcomes analyses, critiques, surveys and evaluations. Programs are expected to obtain feedback from the participants about the effectiveness of the activities using confidential methods; and
• How the program will effectively track outcomes while ensuring the data collection and storage methods will be safeguarded and preserved by briefly expanding upon the "Outcomes Data Collection and Storage Plan" attachment.

Sustainability Plan. NIGMS intends to fund innovative programs and to use IPERT awards to catalyze advances in biomedical research education in a wide variety of areas; therefore, applicants should not assume renewals of their programs will be possible and must include a sustainability plan describing how successful IPERT activities and elements will be continued beyond the duration of the award. Sustainability plans may include, but are not limited to, innovative business models or strategies to secure external sources of government, private sector, or professional society funding.

Dissemination Plan. A specific plan must be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the research education program. Examples include, but are not limited to, sharing material via internet educational portals, conducting webinars, running workshops, or presenting at scientific meetings. Publication of the program’s activities and outcomes in peer-reviewed journals is highly encouraged. See also the expectations for sharing resources developed with the support of an IPERT award in the instructions for Resource Sharing Plans below.

Letters of Support

A letter of institutional commitment must be attached as part of Letters of Support. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. Applications lacking a letter of institutional commitment will not be reviewed.

Resource Sharing Plans

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

When relevant, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application.There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

• Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.
• The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Appendix

Only limited Appendix materials are allowed. Follow the instructions for the Appendix as described in the SF424 (R&R) Application Guide.

The following are allowable Appendix materials:

• Required Research Education Activities. To adequately assess the content of the didactic portion of the research education program, the application may include syllabi/outlines of all required training activities (e.g., syllabi for courses, mentor training materials, professional development workshops, career exploration opportunities, skills development activities).
• Participant Selection and Appointment Procedures (3 pages maximum). Materials may include, but not be limited to, appointment protocols and/or blank applications.
• Evaluation and Assessment Instruments. The application may include blank surveys, rubrics, and/or forms used to (a) document and monitor participant progress and (b) determine whether the research education environment is effective, inclusive, safe, and supportive.
• Conflict Resolution Protocols (3-page maximum). The application may include detailed protocols for addressing (1) mentor/mentee matches, (2) faculty with unacceptable training/mentoring skills and (3) multi PD(s)/PI(s).

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

Generally, not applicable.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Generally, not applicable.

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 .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and NIGMS. 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.

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.

For this FOA: The goal of this R25 program is to support innovative, high-quality skills development, mentoring, and outreach educational activities to equip a diverse cohort of participants with the technical, operational, and professional skills required for careers in the biomedical research workforce.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to strongly advance research education by fulfilling the goal of this R25 Education Program, in consideration of the following review criteria and additional review criteria, as applicable for the project proposed. Reviewers will consider each of the review criteria below in the determination of scientific merit, 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.

Significance

Does the proposed program address a key audience and an important aspect or important need in research education? Is there convincing evidence in the application that the proposed program will significantly advance the stated goal of the program?

Investigator(s)

Is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Taking into consideration the nature of the proposed research education program, does the applicant make a strong case for this program effectively reaching an audience in need of the program’s offerings? Is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience?

For this FOA: If previously supported activities are proposed, are there new elements that are likely to result in outcomes that increase the reach and/or impact of the activities?

Approach

Does the proposed program clearly state its goals and objectives, including the educational level of the audience to be reached, the content to be conveyed, and the intended outcome? Is there evidence that the program is based on a sound rationale, as well as sound educational concepts and principles? Is the plan for evaluation sound and likely to provide information on the effectiveness of the program? If the proposed program will recruit participants, are the planned recruitment, retention, and follow-up (if applicable) activities adequate to ensure a highly qualified participant pool?

For this FOA: Are the proposed strategies for meeting the goals and objectives well-conceived? If the application proposes to continue previously supported activities, is documentation of the success of those previous activities provided? Is the proposed plan for sustainability of identified activities feasible and likely to result in lasting changes beyond the duration of the award? Is the proposed plan for dissemination of the education program sound and likely to provide useful information to the broader scientific community?

Environment

Will the scientific and educational environment of the proposed program contribute to its intended goals? Is there a plan to take advantage of this environment to enhance the educational value of the program? Is there tangible evidence of institutional commitment? Is there evidence that the faculty have sufficient institutional support to create a sound educational environment for the participants? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, and institutions?

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 a well-conceived approach to instructing participants in principles important for enhancing research reproducibility and transparency in reporting? Are the components sufficiently well integrated into the overall program?

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

Revisions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period, and the success of the program in recruiting individuals from diverse populations (e.g., populations underrepresented in biomedical, behavioral and clinical research).

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. The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of the proposed research education program and the level of participant experience, the reviewers will evaluate the adequacy of the proposed RCR training. Are the components sufficiently well integrated into the overall program? The review panel’s evaluation will be included in the summary statement. Plans will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan.

If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the proposed software dissemination plan.

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 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.

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 submitted in response to this FOA. 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.
• Portfolio balance.

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 grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.6. 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, 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.

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.

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 https://www.hhs.gov/civil-rights/for-individuals/section-1557/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 https://www.hhs.gov/civil-rights/for-individuals/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.

3. Reporting

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.

Programs that involve participants should report on education in the responsible conduct of research and complete a Trainee Diversity Report, in accordance with the RPPR Instruction Guide. 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.

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.

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.

Other Reporting Requirements

• The institution must submit a completed Statement of Appointment (PHS Form 2271) for each participant appointed full time for eight weeks or more or the equivalent. 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.
• Participant Termination Notice: Within 30 days of the end of the total support period for each participant, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each participant appointed full time for eight weeks or more, or the equivalent.

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

4. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH or its Institutes and Centers will periodically evaluate their R25 research education programs, employing the measures identified below. In assessing the effectiveness of its research education investments, NIGMS may request information from databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be contacted after the completion of a research education experience for periodic updates on participants subsequent educational or employment history and professional activities.

Upon the completion of a program evaluation, NIGMS will determine whether to (a) continue a program as currently configured, (b) continue a program with modifications, or (c) discontinue a program.

Evaluation of this research education program will use, but not be limited to, the following metrics:

• Institution types represented
• Geographical distribution of programs
• Scientific focus areas
• Course content areas
• Aggregate number and demographic characteristics of individuals reached
• Career outcomes of participants
• Scientific productivity and impact of participants
• Grant applications submitted by and awarded to participants
• Educational levels of participants
• Dissemination products
• Evidence of sustainability

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

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

SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg

Edgardo Falc n Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Michael Sesma, Ph.D.
National Institutes of General Medical Sciences (NIGMS)
Email:[email protected]

Stephanie Constant, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Justin Rosenzweig
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Section VIII. Other Information

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 Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.