Required Application Instructions

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

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

Purpose and Background

The overall goal of NIH Research Career Development programs 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 needs. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The proposed institutional research career development program may complement other, ongoing research training and career development programs at the applicant institution, but the proposed career development experiences must be distinct from those career development programs currently receiving Federal support.

This funding opportunity announcement (FOA) encourages applications from research-intensive institutions (RIIs) that propose to develop a pool of highly trained biomedical scientists who have the necessary knowledge and skills to pursue research and teaching careers in academia, and to enhance science educational offerings at partner institutions which, for the purposes of this FOA, are institutions that have a historical mission or a demonstrated commitment to educating students from diverse backgrounds underrepresented in the biomedical research enterprise of the nation, as described in NOT-OD-15-053.

NIGMS recognizes the growing need for future faculty who can not only conduct research, but who are also effective in the classroom. Teaching is the central mission of partner institutions, yet it can be a challenge to enrich the curriculum with the most contemporary research topics and laboratory experiences when faculty have less time and resources to engage in their respective research areas. A mentored teaching experience for postdoctoral fellows who are actively engaged in research can address this challenge and may also provide an opportunity to expand the repertoire of science courses offered at the partner institution. A separate but contemporary problem is that many new scientists find that the traditional postdoctoral research experience does not provide the best preparation and experience for entering an academic environment in which teaching and other problem-solving skills are essential.

The IRACDA program provides support for a traditional mentored postdoctoral research experience at an RII combined with an opportunity to develop critical academic skills, including teaching, through pedagogy workshops and mentored teaching assignments of postdoctoral fellows at a partner institution.

The mission of the National Institute of General Medical Sciences (NIGMS) is to support research that increases our understanding of life processes and lays the foundation for advances in disease, diagnosis, treatment, and prevention. To ensure the vitality and continued productivity of the research enterprise, NIGMS provides leadership in the areas of (a) training the next generation of scientists in basic and general biological and biomedical sciences, (b) enhancing the diversity of the scientific workforce, and (c) developing research capacities throughout the country. To accomplish these objectives, NIGMS supports a variety of capacity building and training programs with the ultimate goal of developing a diverse pool of well-trained scientists available to address the nation’s research needs.

NIGMS seeks to increase the number of individuals from groups underrepresented in the biomedical workforce by providing training opportunities during multiple training and career stages at varied institutions and educational settings across the country. By increasing the number of students from underrepresented groups pursuing advanced training in the biomedical sciences, NIGMS strives to ensure that the future generation of researchers draws from the entire pool of talented individuals, bringing different aptitudes, perspectives, creativity, and experiences to address complex scientific problems.

Accordingly, the teaching experience is to be conducted at institutions that serve groups underrepresented in biomedical research (see Section III.1 Partner Institutions ) with the expectation that this will further foster the development of the next generation of a diverse pool of scientists who are available to address the nation’s research needs. Training and retaining a diverse workforce ensures that the nation remains a competitive global leader in discovery and innovation in biomedical research.

Goals and Objectives

The primary goals of the IRACDA program are to (1) develop a group of highly trained biomedical scientists who have the necessary knowledge and skills to pursue independent research and teaching careers in academia; and (2) enhance science educational offerings at partner institutions, and promote links between RIIs and partner institutions through research and teaching collaborations. The specific objectives of this initiative are to:

• Develop the research, teaching, and other skills that are needed by postdoctoral scholars in order to conduct high-quality research and pursue an independent research and teaching career in an academic environment;
• Foster the development of research-oriented science curricula, using contemporary teaching strategies, at partner institutions; and
• Promote links between RIIs and partner institutions that can lead to further collaborations in faculty research and student training.

Program Elements

The IRACDA mechanism provides support for the design of a creative and innovative research career development program that combines a traditional mentored research experience at an RII with an opportunity to develop teaching and other academic skills, such as problem solving, communication, time management, and grant writing, as well as opportunities for career development through workshops and mentored assignments at a partner institution. The program promotes effective partnership between an RII and partner institution(s), and encourages innovative solutions to the problems of attracting and training postdoctoral candidates in both research and academic skills and of increasing educational opportunities for students at partner institutions.

The IRACDA Program recognizes that combining research and teaching in a single career development program offers certain challenges. Designing a program that moves a postdoctoral scholar between partners of a consortium offers other challenges. Therefore, the application must provide strong evidence of a solid working relationship among partners of the consortium and must include plans that anticipate and mitigate the challenges. The application should involve all partners in the planning and execution of the various elements of the career development program. The following should be considered and addressed in planning and design of an IRACDA program:

• Geographic location of the participating institutions;
• The academic environment, including the curricular content and quality, and opportunities for developing new courses, or revising/updating existing courses, in the biomedical sciences at the partner institution(s);
• Student demographics, including the number of underrepresented students at the partner institution(s) that go on to complete the Ph.D. degree in biomedical sciences;
• Faculty demographics, including the number of faculty who have externally funded research programs at the partner institution(s) and the status of their existing collaborations with faculty at RIIs;
• Pool of research mentors and postdoctoral scholars at the RII who may be interested in participating in the combined research and academic career development program; and
• Institutional track record of scholars in the traditional postdoctoral research program at the RII in publishing, grant writing, and obtaining research and teaching positions.

Applicant institutions have wide latitude in the design of the program. However, career development activities, which should last two to four years (see below), must include the following three elements that sum to K12 participants dedicated 100% effort to this appointment:

• A mentored research experience that is typical of other competitive postdoctoral opportunities. The research mentor will sponsor and oversee the proposed research development program and will ensure that the candidate receives the proper guidance and mentoring for a future independent research career. The candidate may conduct collaborative research with other experienced researchers, subject to approval of the mentor. Approximately 9 person-months (75% of full-time professional effort) of the effort must be spent on this activity.
• A mentored teaching experience, the practicum of which will take place at a partner institution.
• Other mentored and/or didactic experiences to improve critical academic skills (e.g., problem-solving, communication, time management, and grant writing) and provide career development opportunities that are deemed important for an individual to prosper in an academic environment. Approximately 3 person-months (25% of full-time professional effort) of the effort must be spent on mentored teaching and other mentored and/or didactic experiences, the timing of which may be flexible over the duration of the award.

The Program must have a strong research base, comprised of established scientists who will provide expertise, resources, and mentoring to the IRACDA scholars. The mentored research experience must fall within the scope of the NIGMS mission (http://www.nigms.nih.gov/About/), which is to support research that increases understanding of life processes and lays the foundation for advances in disease diagnosis, treatment and prevention. NIGMS-funded researchers seek to answer important scientific questions in fields such as cell biology, biophysics, genetics, developmental biology, pharmacology, physiology, biological chemistry, bioinformatics, computational biology, selected aspects of the behavioral sciences and specific cross-cutting clinical areas that affect multiple organ systems. Further details on the NIGMS-supported major research and research training areas can be found at: http://www.nigms.nih.gov/About/Overview/).

The applicant institutions have flexibility in program design, including the flexibility in scheduling of research and teaching elements. For example, a plan might involve large blocks of time devoted to research separated by a large block of time devoted to teaching. Alternatively, the workshops, didactics and teaching may represent 3 person-months (25% of full-time professional effort) throughout the calendar or academic year. The program provides support to postdoctoral scholars in their research at RIIs and in teaching assignments at partner institutions.

The scholars may be supported full-time on IRACDA funding for up to three years provided their progress toward an independent academic career is on track and satisfactory. Applicants may, and are indeed encouraged to, propose the use of non-IRACDA funds to provide a four-year career development program, with the first or the last three years of support from IRACDA and the remaining one year's support from the mentor or other source(s).

NIGMS anticipates that most programs will have three-four fellows per cohort for an average size of 9-12 active scholars supported by the IRACDA funding at any one time. Applicants must justify the proposed program size based on the research capacity and pool of research mentors and postdoctoral scholars at the RII who may be interested in participating in the combined research and academic career development program, and the pool of teaching mentors available at the partner institution(s). For renewal applications from programs with an exceptionally large pool of scholars and mentors, as well as an outstanding track record of scholar placement post-training, NIGMS will consider requests for larger cohorts but, because of budget constraints, will provide support for only a maximum of 18 fellows in a given year and for three years per fellow.

Awardees are expected to attend the annual IRACDA Conference. The conference is organized by the grantee institutions on a rotating basis. To defray the cost of organizing the conference, the grantee institution may use grant funds for allowable costs, and other institutional and non-institutional resources; NIGMS may also consider a request for supplementary funds, provided it is reasonable and well justified. Program Directors, as well as IRACDA scholars are expected to attend this meeting. These meetings feature keynote presentations by invited guests who are leaders in the areas of science, education, and public policy and administration. The IRACDA scholars are encouraged to present their career development award-supported research to their peers. The conference also provides an opportunity for the Program Directors, program staff, and IRACDA scholars to exchange ideas about the effective teaching pedagogies, talk about common problems and suggest solutions, and interact with their peers and NIGMS staff.

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)

An IRACDA program involves a consortium of multiple institutions. The lead applicant institution must be an RII, and it must serve as the primary site of the postdoctoral research experience.

The consortium must include one or more partners that are institutions which, for the purposes of this FOA, are defined as public or private nonprofit universities, two-year or four-year colleges or universities, offering associate and/or baccalaureate degrees with a historical mission or a demonstrated commitment to educating students from diverse backgrounds underrepresented in biomedical research as defined in NOT-OD-15-053.

The sponsoring institution must assure support for the proposed program.

The applicant institution must have a strong and high-quality research program in the area(s) proposed under this FOA and must have the requisite faculty and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goals.

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) (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.
  • 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 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.

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.

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

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).

Only one application per institution is allowed and an institution may only hold one IRACDA grant award.

This institutional research career development program (K12) may not be transferred from one institution to another.

Program faculty should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program. Program faculty should also have a record of research training, including successful, former trainees who have established productive careers relevant to the NIH mission. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.

Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the award. Faculty research mentors at the applicant institution must have active, externally funded research projects relevant to the mission of NIGMS, and track records in mentoring and training students and postdoctoral researchers. The mentors do not receive support for their salaries or fringe benefits from the career development award. Mentors may be added as appropriate to the roster of an ongoing funded IRACDA program without prior NIGMS approval.

Teaching mentors from the partner institution(s) must have a strong record of teaching. They are expected to facilitate the postdoctoral fellows adjustment to the academic environment of the partner institution and provide guidance and mentoring on teaching skills as well as teaching-related challenges and opportunities at the partner institution.

Postdoctoral scholars to be supported by the institutional career development program must be at the career level for which the planned program is intended. IRACDA scholars are expected to devote a minimum of 9 person-months (75% of full-time professional effort) to the mentored research and the remaining 3 person-months (25% of full-time professional effort) to the mentored teaching and other mentored and/or didactic experiences, during their appointment on the K12 award

By the time of appointment, each scholar must be a citizen or a non-citizen national of the United States who has been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status). Individuals on temporary or student visas are not eligible.

Details on citizenship requirements are available in the NIH Grants Policy Statement.

Postdoctoral scholars must have received, as of the beginning date of the IRACDA appointment, a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of the training appointment is acceptable. Candidates should be early in their postdoctoral stage, with no more than 2 years since the date of their doctoral degree. Candidates must be committed to research and have the potential to develop as independent researchers.

It is the responsibility of the applicant institution to establish the qualifications of candidates prior to their appointment in the IRACDA Program.

Institutions with an IRACDA program may recruit and select candidates directly into their programs rather than submitting a separate application on behalf of each prospective candidate. The candidates need not be identified at the time the application is submitted.

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the 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 Guide.

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA), with the following additional modifications:

Substitute the term scholars for all references to trainees in the SF424 (R&R) Application Guide, and substitute the term career development for all references to training in the SF424 (R&R) Application Guide.

Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research career development program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of scholars and intended scholar 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 career development program. The composition, 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. Proposed Advisory Committee members should be named in the application only if they have been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. Please name your file Advisory_Committee.pdf .

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

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.

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

• Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff. Also include proposed salary costs for planned scholars.
• Do not complete the section on Participant Support Costs.

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:

Particular attention must be given to the required Training Data Tables.

Substitute the term scholars for all references to trainees in the SF424 (R&R) Application Guide, and substitute the term career development for all references to training in the SF424 (R&R) Application Guide.

Training Program

Program Plan

Program Administration.

Institutions with existing programs must explain what distinguishes this program from the others, how their programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential scholars, and resources are robust enough to support additional programs. When a program administrator position is planned, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate a program for developing investigators must be included in the application.

Proposed Training.

Describe the immediate and long-term objectives of the proposed career development program, including activities that will be used to ensure that the objectives of the program are met. Include information about planned courses, seminars, workshops, or tutorials that will be incorporated into the training program and mentored research experiences and activities. The description should include planned strategies to be used to ensure that the objectives are met. The application must describe the teaching training, how the teaching mentors will be assigned to and interact with the scholars, what courses are accessible to the scholars at the partner institution(s), what courses the partner institution(s) now offers and what it would like to offer, and how the scholars will contribute to the teaching mission of the partner institution(s). In addition to describing how the proposed activities will advance the preparation of the scholars for academic research and teaching careers, benefits to the partner institution may also be described. The application must describe how the partner institution will incorporate new or revised courses into the curriculum and how collaboration between the research intensive institution and partner institution will be enhanced to meet the goals of this FOA stated in Part 2, Section I.

NIGMS strongly encourages the use of individual development plans (IDP) for all scholars supported by the IRACDA program, and each application should describe a plan to implement the IDP for all scholars. The application must describe the plan for professional development of the postdoctoral scholars, including problem solving, communication, time management, and leadership skills, as well as career guidance including instruction and training in grant writing in order to apply successfully for future fellowships and career development and independent research support. All postdoctoral scholars should also be provided with instruction in laboratory and project management.

IRACDA/K12 applicants also are encouraged to review NIH Notice NOT-OD-16-034 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-034.html). This Notice describes upcoming requirements for formal instruction in rigorous experimental design and transparency to enhance reproducibility. Applicants should review the Notice and plan for implementation of this training in the IRACDA/K12 career development program.

For renewal applications, a detailed progress report must be included following the instructions for a postdoctoral NRSA training grant application. The progress report section must include information on: a) goals and objectives stated in the previous application, b) career development activities, including mentored research and teaching, and course work, workshops, seminars and other activities conducted as part of the program, c) recruitment and appointment of scholars, and program's overall accomplishments in preparing scholars for careers as scientists who pursue independent research and teaching careers in academia, d) a list of scholar-authored peer-reviewed publications [must be in compliance with the NIH Public Access Policy rules ( https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-091.html)], e) a summary of the program evaluation outcome, and any changes made to the program as a result of the evaluation or for other reasons. The progress report must also contain a one-page narrative prepared by the Program Coordinator at the partner institution that provides a detailed explanation of how the partner institution has benefited from the IRACDA program in the previous cycle.

The progress report must also include the list of appointed (program-supported) scholars; and their current career status (e.g., faculty position at RII, liberal arts, partner institution; research in industry or government; and administration, etc.). Applicants should use the selected training tables (i.e. Tables 2, 4, 5b, 6b, and 8c) associated with the SF424. If relevant, additional explanation may be provided in the narrative. The application should describe any previously funded IRACDA activities that are now continuing (or will continue) on institutional funds. If none, so indicate.

Institutional Environment and Commitment to the Program.

The sponsoring institution must assure support for the proposed program including assurance that sufficient time will be allowed for the PDs/PIs and other Program Faculty to contribute to the proposed program, and that there will be protected time for scholars (9 person months, equivalent to 75%) selected for the program.

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 Chapter 8 of the SF424 (R&R) Application Guide.

Data Tables

NIGMS encourages the use of selected Training Tables associated with the SF424 (such as 2, 3 4, 5B, 6B, and 8c). In addition, applicants are reminded that ASSIST, NIH's on-line system for the preparation, submission and tracking of grant applications through Grants.gov to NIH, is now available for IRACDA/K12 submissions. More information about ASSIST can be found in the NIH Notice NOT-OD-15-126 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-126.html) and at https://grants.nih.gov/grants/ElectronicReceipt/assist.htm.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a Delayed Onset Study record. DO NOT complete a full study record using the Study Record: PHS Human Subjects and Clinical Trials Information form.

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. .

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

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide..

Applicants are required to follow our Post Submission Application Materials 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/priority score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of the merit of the training program, and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Career Development Program and Environment

• Does the proposed program clearly outline a plan to recruit and develop well-qualified postdoctoral scholars for successful careers as biomedical or clinical researchers?
• Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support?
• Are the content and duration of any proposed didactic, training-related, and research-related activities of the program appropriate?
• Are appropriate timelines indicated for career progression and transition to non-mentored academic careers?
• Does the institutional environment (e.g., research facilities and other relevant resources) in which the program will be conducted contribute to the probability of success?
• Does the proposed career development program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements?
• Is the institutional commitment from the Research Intensive and Partner Institution(s) to the proposed program appropriate?
• If multiple partner institutions are participating, is this adequately justified in terms of the career development and teaching experiences provided?
• Is there sufficient assurance that the required effort on the part of the scholars will be devoted directly to the research training, career development, and related activities?
• When applicable, is there adequate documentation describing the responsibilities of the advisory committee with regard to the provision of input, guidance and oversight of the program?
• Is there evidence of a functional partnership, with commitment and involvement in planning on the part of all partners as well as strengths of the efforts of the partner institution(s), to foster the professional development of the postdoctoral scholars in the biomedical and behavioral sciences?
• In what ways does the proposed program provide substantial benefit to the partner institution(s) and its students?

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

• Do the PD/PI and Research Administrator (if applicable) have the experience to develop, direct and administer the proposed program?
• Does the leadership team bring complementary and integrated expertise to the program?
• Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives?
• Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program?
• Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?
• Does the program coordinator(s) have the experience and stature to effectively coordinate the mentored teaching component of the program at the respective partner institution(s)?
• For applications designating multiple PDs/PIs:
• Is a strong justification provided that the multiple PD/PI leadership approach will benefit the career development program and the scholars?
• Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the career development program and the complementary expertise of the PDs/PIs?

Mentors

• Do the research and teaching mentors have appropriate expertise and experience?
• Is there evidence of a successful past training record of the PD/PI and research mentors, including the success of former scholars in seeking independent support and establishing productive scientific careers?
• Are the quality and extent of the mentors roles in providing guidance and scientific or teaching advice to the scholars acceptable? Are the research mentors currently engaged in relevant research?

Scholars

• Is a recruitment plan proposed with strategies likely to attract high quality scholar candidates with a commitment to research, the potential to develop as independent researchers, and commitment to pursue an academic career?
• Are there well-defined and well-justified recruitment and selection strategies?
• Is there evidence of a sufficiently large, competitive scholar pool to warrant the proposed size of the career development program?
• Are the content, phasing, and proposed duration of the career development plan appropriate for achieving scientific independence of the scholar candidates?
• What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars?
• Does the plan for selection of the scholars include all of the eligibility criteria stated in the FOA?
• Do the Individual Development Plans include both research and academic career related goals and objectives for each participant?

Record of Training and Benefit for Partner Institution(s)

• Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training?
• What are the quality, and effectiveness of this program in developing postdoctoral scholars as scientists who pursue independent research and teaching careers in academia?
• Is there evidence of measurable benefits to partner institution(s), including adoption of scholar-developed new and/or revised/updated courses into the regular departmental curriculum; and increased research collaborations between faculty from RII and the partner institution(s)?

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

For Renewals, the committee will consider the progress made in the last funding period, including on the Recruitment Plan to Enhance Diversity, and Training in the Responsible Conduct of Research. Does the application describe the program’s accomplishments over the past funding period(s)? Are changes proposed that would improve or strengthen the career development experience? Is there evidence of a successful past training record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific research careers?

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. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

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

For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?

Plans and past record 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 NIGMS in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

Applications will be assigned to NIGMS. 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 Council General Medical Sciences. 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.
• Cost-effectiveness of the proposed budget.
• Geographical and program balance

For renewal applications: Past performance of the program in achieving its goals and objectives during the prior project period(s) is weighted heavily in making funding decisions.

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.

Termination of Award

When a grantee institution plans to terminate an award, program and grants management staff at the NIH funding component must be notified in writing as soon as possible.

Change of Institution

The institutional career development program may not be transferred from one institution to another.

Change of Program

Awards are made for a specific program under the guidance and leadership of a particular PD/PI. A change in any of these parameters requires prior approval by the responsible NIGMS program officer. A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program. If the new program does not satisfy this requirement, the award will be terminated.

Change of PD/PI

If change of the PD/PI is necessary, support of the award is not automatic but may be continued with prior written approval by the NIGMS funding component, provided that the following conditions are met. The current PD/PI or the grantee institution must submit a written request for the change, signed by the appropriate institutional business official and the proposed PD/PI, to the responsible program officer at NIGMS that describes the reasons for the change. The Biographical Sketch of the proposed PD/PI, including a complete listing of active research/training and student development grant support, must be provided. The information in the request must establish that the goals of the original peer-reviewed institutional career development program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate research and administrative expertise to lead the program. This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review.

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 scholar appointed for eight weeks or more or reappointed to the training grant. 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.

A final progress report, invention statement, 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. Evaluation results should be included as part of the final Progress Report.

Additional Instructions for K12 Non-Competing Continuation Progress Report

The progress report must provide information on the implementation and outcome of the proposed career development program, any modifications to the program as originally proposed and details about the program outcomes.

A narrative should be included in the annual progress report and should describe the following:

• Overall program impact on partner institution(s) in terms of courses/curriculum, pedagogy, student research and career mentoring, and faculty research collaborations with RIIs.
• Outcomes of the program evaluation.
• Any changes made to the program as a result of the evaluation or for other reasons.
• Summary outcome data on recruitment, appointments and career outcomes of scholars as well as information on program's impact at partner institution(s). If relevant, additional explanation may be provided in the narrative.
• The progress report must also contain a one-page narrative prepared by the Program Coordinator at the partner institution that provides a detailed explanation of how the partner institution has benefited from the IRACDA program in the previous cycle.

The narrative part is limited to up to five pages, and numerical and other data, including scholars publications, may be presented in tabular form (tables and figures are not counted in the five-page limit). Large tables and figures as well as the summary of annual evaluation report should be included in the appendix.

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

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

For programs involving postdoctoral scholars:

• Subsequent participation in a formal research training or career development program in a STEM field
• Subsequent participation in research or employment in a STEM field
• Authorship of scientific publications in a STEM field
• Subsequent independent research grant support from NIH or another source

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: https://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: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Jessica M. Faupel-Badger, M.P.H., Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3900
Email: [email protected]

Helen R. Sunshine, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-2881
Email: [email protected]

Ilene Glassman
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-4648
Email: [email protected]

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

Awards are made under the authorization of 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.