Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Opportunity Title
NIDDK Investigator Award to Support Mentoring of Early Career Researchers from Diverse Backgrounds (K26 - Independent Clinical Trial Not Allowed)
Activity Code
K26 Midcareer Investigator Award in Biomedical and Behavioral Research
Announcement Type
New
Related Notices
  • January 12, 2023 - Notice of Pre-Application Webinar for RFA-DK-22-012. See Notice NOT-DK-23-008.
  • NOT-OD-23-012 - Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available

    Funding Opportunity Announcement (FOA) Number
    RFA-DK-22-012
    Companion Funding Opportunity
    None
    Assistance Listing Number(s)
    93.847
    Funding Opportunity Purpose

    The purpose of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Investigator Award to Support Mentoring of Early Career Researchers from Diverse Backgrounds is to provide protected effort and resources to established, NIDDK-funded, mentors to provide high quality mentoring to graduate students and postdoctoral fellows from diverse backgrounds, including those from underrepresented groups (see, e.g., Notice of NIH’s Interest in Diversity). Program Directors/Principals Investigators (PD/PIs) (mentors) must be conducting research that falls within the missions of the NIDDK and such research programs should serve as the framework around which mentoring activities are constructed. PD/PIs/applicants must have a demonstrable track record of mentoring early career researchers from diverse backgrounds, including those from underrepresented groups.

    This Funding Opportunity Announcement (FOA) is designed specifically for candidates proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

    Key Dates

    Posted Date
    December 05, 2022
    Open Date (Earliest Submission Date)
    January 28, 2023
    Letter of Intent Due Date(s)

    January 28, 2023

    Application Due Dates Review and Award Cycles
    New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
    February 28, 2023 Not Applicable Not Applicable July 2023 October 2023 December 2023

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

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

    Expiration Date
    March 01, 2023
    Due Dates for E.O. 12372

    Not Applicable

    Required Application Instructions

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

    Table of Contents

    Part 2. Full Text of Announcement

    Section I. Funding Opportunity Description

    The goal of this Funding Opportunity Announcement (FOA) is to promote diversity in the NIDDK-supported research workforce.

    The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

    The objective of the Midcareer Investigator Award in Biomedical and Behavioral Research (K26) is to support investigators by providing them protected time to devote to their research and to serve as mentors and role models for junior investigators, thus enhancing their career progression to obtaining independent positions and successfully competing for their own research grants. The Midcareer Investigator Award is intended for experienced scientists with objectives to: 1) Provide protected time for intensive, focused, state-of-the-art research by relieving these investigators from time-consuming institutional service; and 2) Increase their mentoring of junior investigators to build up the pool of skilled investigators who can fill the growing need for trained professionals.

    The prospective candidate for the Midcareer Investigator Award should propose a period of research consistent with his/her research and/or clinical experience and with the proposed further development of his/her research skills. The proposed program should be tailored carefully to meet the individual needs of the candidate and must include a description of meritorious past research projects in scientific areas supported by the sponsoring NIH Institute(s)/Center(s). In addition, the candidate should have a demonstrated record of mentoring and should describe mentoring activities that will involve investigators who have little or no research experience. The junior investigators (mentees) will be exposed to comprehensive research training and supervised interaction with the Principal Investigator.

    Background

    Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires highly advanced training, exceptional research skills and competencies, and creativity. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams, as scientists and trainees from diverse backgrounds and life experiences bring different perspectives and individual enterprise to address complex scientific problems. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help advance the NIH mission (see Notice of NIH’s Interest in Diversity).

    The United States has seen an increase in the number of Ph.D. degrees in the biomedical and behavioral sciences earned by scientists from backgrounds historically underrepresented in the biomedical sciences (Gibbs et al., 2016); however, the attrition of scientists from underrepresented groups from academic research reverses some of the gains (Valantine, Lund & Gammie, 2016). Significant racial and ethnic disparities also exist in NIH grant funding, and this disparity is compounded by a lower rate of success for applications submitted by women as compared to men from underrepresented groups (URGs) (Ginther et al. 2011,Hoppe et al. 2019,Erosheva et al. 2020).

    These disparities may result from bias and structural barriers encountered over the entire course of their careers (Ginther et al. 2011). Creative ways to help realize the potential of all investigators, including URG investigators, regardless of career stage, are clearly needed. Supporting dedicated mentors of early-stage investigators (e.g. pre- and postdoctoral researchers), including URG investigators, could result in both immediate and long-term benefit, since scientists who are effectively mentored are more likely to stay in the career and provide effective mentoring to others.

    Effective mentoring is critical for successful career advancement in academic biomedical research, particularly at early career stages where emerging investigators begin to formulate their research focus and develop needed scientific skill sets and insights. In their 2013 review of mentoring programs for underrepresented minorities (URM; a significant subset of URG), Beech et al. noted that URM faculty typically receive less mentoring than non-minority peers and that augmentation of mentoring programs could help overcome challenges faced by URM students, trainees, and faculty. The NIH Advisory Council to the Director (ACD) convened its Working Group on Diversity in Biomedical Workforce in 2012, which highlighted mentoring as an important factor in successfully enhancing the proportion of URM students who will ultimately obtain an independent position in a research university, medical school, or independent research institute, and finally, successfully compete for R01 grants" (https://acd.od.nih.gov/documents/reports/DiversityBiomedicalResearchWorkforceReport.pdf). Furthermore, it is postulated that barriers to effective mentoring may partially explain some of the decreased success rates of NIH grant applications supporting URG researchers (Ginther et al., 2011; Tabak and Collins, 2011). Additionally, the NIDDK's Strategic Plan for Research recognizes that innovative approaches are needed in support of its cross-cutting theme of enhancing the diversity and training of the biomedical research workforce, for example, through the support of mentoring and mentorship programs.

    Despite the established value and need for high quality mentoring, challenges exist for established investigators to engage in mentoring early-stage scientists (including those from URGs), including identification and recruitment of potential candidate mentees from diverse backgrounds and having dedicated time for their direct mentoring.

    Purpose/Objectives

    This K26 award will provide dedicated salary support for NIDDK-funded scientists who have a desire and commitment to provide quality mentoring to early career stage mentees (graduate students and postdoctoral researchers) from diverse backgrounds, including those from URGs in biomedical science. This opportunity would be available to institutions with established, NIDDK-funded PD/PIs conducting basic, translational, clinical, and behavioral research within the missions of NIDDK and these funded projects would serve as the basis for the PD/PI’s mentoring framework. This award is not intended to provide support for a new or existing research project. While PD/PIs from underrepresented groups are encouraged to work with their institutions to apply, eligibility for this program is not limited to individuals from such groups. Mentors are encouraged to use recruiting methods that target prospective mentee candidates from underrepresented groups, such as those groups identified in the Notice of NIH’s Interest in Diversity. Additionally, PD/PIs/mentors should demonstrate 1) a track record of mentoring and commitment to the training of the next generation of the biomedical research workforce, including evidence of prior mentor training focused on the unique challenges faced by URG mentees, 2) a track record of recruiting trainees from diverse backgrounds, including URGs, and 3) a sound plan to increase mentoring success by enhancing recruitment, eliminating selection bias, and meeting the needs of mentees from diverse backgrounds, including URGs.

    In addition to having a track record of recruiting, mentoring, training, and supporting early career scientists conducting research in NIDDK mission areas, including those from underrepresented groups, applicants must also have a history of sustained, federally-funded, research in NIDDK mission areas, equivalent to NIH research project grants (e.g., R01s, R21s, P01s; see: https://grants.nih.gov/grants/glossary.htm#R01EquivalentGrant)). It is expected that the PD/PI’s funded research projects and programs will serve as the basis for additional, hands-on mentoring opportunities for participating mentees.

    This K26 award will also provide funds for training/courses/programs that support the PD/PI’s ongoing mentor training, including training in eliminating selection bias and in meeting the specific needs of mentees from diverse backgrounds, including those who are underrepresented in basic, translational, clinical, and behavioral research within the missions of NIDDK. In addition to supporting mentor training for the PI, this award will also support mentoring activities that directly involve mentees, including, but not limited to the following:

    • Research career, professional and leadership development;
    • Career progression strategies such as job search skills, networking with peers and senior investigators; and developing collaborations with other members of the scientific community;
    • Mentor/mentee travel to research meetings or national mentoring events;
    • Research skill-building and laboratory management;
    • Education and experience in pedagogical skill development and mentoring;
    • Grant writing, appropriate administrative and other support relevant to preparation and submission of research grant applications, and grant management.

    In addition to mentoring that utilizes hands-on research projects as mentoring vehicles, it is highly recommended that PD/PIs provide career development-focused mentoring to additional graduate student and postdoctoral mentees at their home institutions, as well as through participation in broader mentoring networks (e.g. NIDDK Mentoring Programs and the Network of Minority Health Research Investigators (NMRI).

    This K26 program is not intended to provide direct salary support for participating mentees but rather will provide salary support for the PD/PI (mentor). It is expected that there will be an increased effort and commitment to serve as a mentor to participating early career investigators, including those from URGs, to help foster inclusive research environments and a diverse pool of well-trained researchers focused on conducting basic, translational, clinical, and behavioral research within the missions of NIDDK. Funded PD/PIs under this program will serve as the mentor to at least 1 participating mentee at award onset, increasing to and maintaining at least 2 mentees throughout the duration of the award period, though the PD/PI effort for mentoring should be commensurate with the number of mentees and depth and degree of mentoring activities proposed. It is also expected that a NIDDK K26 supported investigator would establish and assume leadership roles at their institutions concerning mentoring efforts and programs focused on early career investigators, including those from underrepresented groups.

    K26 mentees may have and are expected to pursue NIH grant funding and may currently hold or participate in training grants, fellowship awards, career development awards (i.e. T/F/K awards), or small/pilot grants from NIH, other Federal agencies, or private foundations. In addition, the mentees will be strongly encouraged to become members of NIDDK’s Network for Minority Health Research Investigators and attend the annual meetings:https://www.niddk.nih.gov/research-funding/research-programs/diversity-programs/network-minority-health-research-investigators-nmri

    Accordingly, activities and outcomes from this K26 award are expected to add to and intersect with other NIH programs and efforts that support researchers from diverse backgrounds, including those from URGs, such as the Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) K99/R00/UE5, the National Research Mentoring Network (NRMN) U01/U24, UNITE, or other similar programs designed to enhance networking and professional development of early-career researchers from diverse backgrounds, including those from URGs.

    Note: While this Funding Opportunity Announcement (FOA) does not support independent clinical trials or any direct research, it is expected that PD/PIs/mentors will leverage their funded clinical trials, clinical research, and/or basic biomedical research projects, as the framework for providing mentoring experiences, including hands-on research opportunities.

    NIDDK Mission

    The NIDDK’s mission is to conduct and support research, training, health information dissemination, and other programs with respect to diseases and conditions in NIDDK’s research missions; such missions include diabetes and other endocrine and metabolic diseases, nutritional disorders and obesity, digestive, hepatobiliary, pancreas, kidney, urologic and hematologic conditions and diseases. This FOA seeks to facilitate mentoring of early career investigators from diverse backgrounds, including those from groups underrepresented in NIDDK’s mission areas, who are knowledgeable about the above diseases and conditions constituting these missions, and it is expected that mentees will be available to focus on NIDDK research mission(s) later in their careers.

    Applications Not Responsive to this FOA

    Applications from PD/PIs conducting funded research outside of the missions of NIDDK will not be considered responsive to this FOA. Applications that do not reflect a mentor's demonstrated track record of mentoring early career investigators from diverse backgrounds, including those from groups underrepresented in biomedical, clinical, behavioral, and social sciences research will not be considered responsive. Applications that fail to propose mentoring to graduate students and postdoctoral fellows from diverse backgrounds, including those from underrepresented groups will not be considered responsive. Non-responsive applications submitted to this FOA will be withdrawn without review.

    Technical Assistance Webinars

    Potential applicants are encouraged to participate in one of the pre-application Technical Assistance webinars, which will clarify expectations for the FOA so applicants can present their strongest case for support. The webinars will be held at least one month prior to the submission deadline. Additional information will be advertised on a separate notice.

    Note: This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

    NIH defines a clinical trial as "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." (NOT-OD-15-015).

    NIH not only supports trials of safety and efficacy, it also supports mechanistic exploratory studies that meet the definition of a clinical trial and are designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. These studies may focus on basic and/or translational discovery research in healthy human subjects and in human subjects who are affected by the pathophysiology of diseases and disorders. By addressing basic questions and concepts in biology, behavior, and pathophysiology, these studies may provide insight into understanding human diseases and disorders along with potential treatments or preventive strategies. NIH also supports biomarker studies that meet the definition of a clinical trial and that may provide information about physiological function, target engagement of novel therapeutics, and/or the impact of therapeutics on treatment response. NIH thus supports studies that meet the definition of clinical trials (as noted above) but do not seek to establish safety, clinical efficacy, effectiveness, clinical management, and/or implementation of preventive, therapeutic, and services interventions.

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

    Section II. Award Information

    Funding Instrument

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

    Application Types Allowed
    New
    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
    Clinical Trial?

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

    Note: Applicants may propose to gain experience in a clinical trial led by a mentor/co-mentor as part of their research career development.

    Funds Available and Anticipated Number of Awards

    NIDDK intends to commit $1,920,000 in FY 2023 to fund up to twenty awards.

    Award Budget
    Award budgets are composed of salary and other program-related expenses, as described below.
    Award Project Period

    The maximum project period may not exceed 5 years.

    Other Award Budget Information

    Salary

    The NIDDK Investigator Award to Support Mentoring of Early Career Researchers from Diverse Backgrounds (K26) will provide salary for levels of effort between 3-6 person-months (or 25 and 50% full-time professional effort). The actual salary provided by the award is based on a full-time, 12-month staff appointment at the sponsoring institution, the PD/PIs institutional salary, and the level of effort requested, up to the maximum legislated salary rate in effect at the time of award (see: https://grants.nih.gov/grants/policy/salcap_summary.htm).

    In addition, the candidate may derive additional compensation for effort associated with other Federal sources or awards provided the total salary derived from all Federal sources does not exceed the maximum legislated salary rate and the total percent effort does not exceed 100%.

    Other Program-Related Expenses

    NIDDK will contribute up to $10,000 per year for the following expenses: (a) mentor training courses for the PD/PI; (b) PD/PI and mentee travel to research meetings or mentorship training and networking events; (c) registration fees for workshops, courses, or didactic training focused on career development activities for mentees, (d) other relevant opportunities proposed by the applicant/awardee if well justified and approved by NIDDK officials.

    Salary for secretarial and administrative assistants, etc. is not allowed.

    Indirect Costs
    Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.
    NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

    Section III. Eligibility Information

    1. Eligible Applicants

    Eligible Organizations

    Higher Education Institutions

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

    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)

    For-Profit Organizations

    • Small Businesses
    • For-Profit Organizations (Other than Small Businesses)

    Governments

    • State Governments
    • County Governments
    • City or Township Governments
    • Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)

    Federal Governments

    • Eligible Agencies of the Federal Government
    • U.S. Territory or Possession

    Other

    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations
    Foreign Institutions
    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.
    Required Registrations

    Applicant Organizations

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

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

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

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

    All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

    Eligible Individuals (Program Director/Principal Investigator)

    Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Applicants must be currently NIDDK-funded PD/PIs conducting basic, translational, clinical, and behavioral research within the missions of NIDDK. While individuals from diverse backgrounds, including those from underrepresented groups, are encouraged to work with their institutions to apply for support under this program, eligibility for this program is not limited to such individuals. 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. See: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019. Applicants must oversee an established, NIDDK-funded research program, however the PD/PI's academic rank can be at the level of Assistant, Associate, or Full Professor at time of application. Multiple PDs/PIs are not allowed.

    By the time of award, the individual must be a citizen or a non-citizen national of the United States or have 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).

    Applicants must have a demonstrable track record of mentoring early career researchers from diverse backgrounds, including those from underrepresented groups.

    Candidates for the K26 award must have a research or health-professional doctoral degree. Candidates for this award must have demonstrated the necessary expertise to perform high-quality, peer-reviewed, funded research (as PD/PI or co-investigator) in a scientific area supported by the sponsoring NIH Institute(s)/Center(s). Candidates must have demonstrated ability to serve as mentors to more junior researchers. Candidates must have completed their clinical specialty or research training.

    3. Additional Information on Eligibility

    Number of Applications

    Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.

    The NIH will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept:

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

    At the time of award, the candidate must have a full-time appointment at the academic institution.

    After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances. See NOT-OD-18-156 and NIH Grants Policy Statement, Section 12.3.6.4 Temporary Adjustments to the Percent Effort Requirement for more details.

    Institutional Environment

    The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research.

    Section IV. Application and Submission Information

    1. Requesting an Application Package

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

    2. Content and Form of Application Submission

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

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

    Page Limitations

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

    Instructions for Application Submission

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

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    Other Project Information

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

    Project Summary/Abstract

    Include a description of your current research and the research you propose to continue for the duration of this K26 mentoring award. .

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

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

    R&R Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Career Development Award Supplemental Form

    The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:

    Candidate
    Research Plan
    Other Candidate Information
    Mentor, Co-Mentor, Consultant, Collaborators
    Environment & Institutional
    Commitment to the Candidate
    Other Research Plan Sections
    Appendix

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

    Candidate Section

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

    Candidate Information and Goals for Career Development

    Candidate’s Background

    • Provide a summary of the candidate’s experience in research within NIDDK’s scientific mission. Highlight the candidate’s grant awards history and publications, especially projects that involved prior mentees at the graduate student and postdoctoral levels.
    • Include a description of the mentoring career of the candidate, documenting experience and commitment to high quality mentoring of graduate students and postdoctoral fellows (research mentees) from diverse backgrounds, including those from underrepresented groups. Describe mentorship philosophy, including culturally responsive mentoring for individuals from diverse backgrounds. Describe training received related to mentoring
    • Document the ability of the K26 candidate to provide the proposed new mentoring based on prior work. Provide the number of years of mentoring experience, mentoring role (i.e., research advisor, clinical mentor, etc.), the number of researchers mentored, the scientific areas of the individual mentees and the stages in their professional career. In addition, describe the types of research that were conducted by the individuals mentored, and their outcomes; i.e., whether they are still active researchers and progression through the appropriate career stages.
    • Provide an explanation as to how relief from academic or other responsibilities through the protected time provided by this award will contribute to the expansion of the candidate’s mentoring program and increased level of commitment to mentoring. It is important to convey to the reviewers the reasons for needing protected time to engage in increased mentoring of new scientists from diverse backgrounds. It should be clear that this award will permit the candidate to spend more time on mentoring targeted to those from diverse backgrounds, including those from underrepresented groups, and less time on administrative and clinical responsibilities for the institution

    Career Goals and Objectives

    • Provide details of the candidate’s immediate and long-term objectives in providing high quality mentoring to graduate students and postdoctoral fellows from diverse backgrounds, including those from underrepresented groups.
    • Describe the candidate’s career goals and objectives under this award, including enhancing the availability of mentoring for early-stage investigators from diverse backgrounds, including those from underrepresented groups. Also describe any other activities related to such mentoring, such leadership of mentoring committees at the institution, participation in regional or national conferences expressly to promote the better mentoring of student and post-doctoral fellows from diverse backgrounds, including those from underrepresented groups.

    Candidate’s Plan for Career Development/Training Activities During Award Period

    • Describe the professional responsibilities/activities, including other research projects, beyond the effort commitment to the career award. Explain how these responsibilities/activities will be enhanced or at minimum, not impacted by the new dedication of effort and focus on mentoring of student and post-doctoral fellows from diverse backgrounds, including those from underrepresented groups.
    • The candidate should describe any new or enhanced skills and knowledge he/she will acquire during the career award period, and how these skills and experiences will significantly enhance his/her ability to continue his/her mentoring of student and post-doctoral fellows from diverse backgrounds, including those from underrepresented groups.

    Research Plan Section

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

    Research Strategy

    • Not Applicable

    Currently Supported Research

    • List each funded, ongoing research program led by the Candidate. Provide enough information in the areas of Hypotheses and Specific Aims; Background, Significance and Rationale; Preliminary Studies and Results; and Research Design and Methods to permit the peer reviewers to evaluate the quality of the science and the significance of the research.
    • Describe how these funded projects will generate opportunities for mentees to learn rigorous research skills by hands-on engagement with the candidate’s research programs.

    Training in the Responsible Conduct of Research

    • All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See SF424 (R&R) Application Guide for instructions.

    Other Candidate Information Section

    • Describe other ways in which mentoring will be delivered, for example through seminar series, discussion groups, grant writing and evaluation, laboratory management, one-on-one meetings, etc.
    • This required component should include a description of the availability of appropriate graduate student and post-doctoral fellow mentees; their previous training and specialization; plans for recruitment, selection and supervision; the types of educational and research experiences that will be provided; and the capacity in which the candidate for the career award will serve as a mentor.
    • Candidates must also describe a plan for supporting the research of their mentees during the period of the K26 award; including the availability of departmental resources or other sources should there be a gap in funding during the tenure of a mentee.
    • Candidates must indicate the proposed person months committed to the mentoring plan. This commitment may vary depending on the Candidate’s career stage and experience, and based on their individual plans for increasing the number of mentees (mentors must have one mentee at the time of application, and plans to increase the number of mentees to at least 2 during the award period). Proposed effort should be at least 3 calendar months and no more than 6 months, but well justified based on the plans for recruitment and mentoring activities. Plans should be well justified and feasible.
    • If the Candidate proposes to provide mentoring to a mentee located at an institution other than that of the PI, describe how the mentoring plan will be implemented (e.g. frequency/format/content.

    Mentor, Co-Mentor, Consultant, Collaborators Section

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

    Plans and Statements of Mentor and Co-mentor(s)

    Not Applicable

    Letters of Support from Collaborators, Contributors and Consultants

    • Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Unless also listed as senior/key personnel, collaborators and consultants do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration.
    • Advisory committee members (if applicable): Signed statements must be provided by each member of the proposed advisory committee. These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute. Unless also listed as senior/key personnel, these individuals do not need to provide their biographical sketches.

    Environmental and Institutional Commitment to the Candidate

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

    Description of Institutional Environment

    • The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.
    • Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the enhanced mentoring activity through this award.
    • Describe the resources and facilities that will be available to the candidate.

    Institutional Commitment to the Candidate’s Research Career Development

    • The sponsoring institution must provide a statement of commitment to the candidate's continued productivity as an independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award.
    • The letter of commitment from the institution should provide statements concerning the amount of protected time the candidate will receive (3-6 person-months or 25 to 50% full-time professional effort required); the duties from which he/she will be relieved (if clinical duties the institution should describe specific steps that will be taken to cover these duties, such as hiring clinical staff); and the institutional commitment to the candidate’s increased effort mentoring of student and post-doctoral fellows from diverse backgrounds, including those from underrepresented groups.

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information

    When involving NIH-defined human subjects research, clinical research, and/or 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

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

    • For FOAs that do not allow independent clinical trials, do not complete Section 4 Protocol Synopsis information or Section 5 - Other Clinical Trial-related Attachments.

    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.

    PHS Assignment Request Form

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

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

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

    4. Submission Dates and Times

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

    Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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 fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

    See more tips for avoiding common errors.

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

    Post Submission Materials

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

    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 particular announcement, note the following: Reviewers should evaluate the candidate’s potential for continuing an independent research program that will make important contributions to the field, and for increased effort in mentoring of student and post-doctoral fellows from diverse backgrounds, including those from underrepresented groups.

    Overall Impact

    Reviewers should provide their assessment of the likelihood that the proposed career development and mentoring plan will enhance the candidate’s career and increase their capacity for mentoring of student and post-doctoral fellows from diverse backgrounds, including those from underrepresented groups, taking into consideration the criteria below in determining the overall impact score.

    Scored Review Criteria

    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.

    Candidate

    • What is the quality of the evidence that the candidate is engaged in ongoing high quality research, suitable for hands-on participation of graduate student and postdoctoral fellow mentees?
    • How well does the candidate demonstrate a track record of mentoring early career scholars from diverse backgrounds, including those from underrepresented groups?
    • What is the evidence of the candidate's capabilities and commitment to serve as a mentor in the conduct of high-quality research?
    • How well does the application demonstrate the proposed program and protected time will relieve the candidate from non-research, administrative duties and allow additional time to mentoring and acquisition of better capabilities for mentoring of student and post-doctoral fellows from diverse backgrounds, including those from underrepresented groups?
    • How well does the application demonstrate a record of independent peer-reviewed research support likely to continue during the K26 award?

    Plan to Provide Mentoring

    • How likely are the mentoring plans to contribute to the career development of students and post-doctoral fellows from diverse backgrounds?
    • How appropriate and justified is the level of effort proposed for the mentoring and related activities?
    • How clearly outlined and plausible are the plans for the delivery of mentoring (e.g., seminar series, discussion groups, conference attendance, grant writing and evaluation, laboratory management, peer-to-peer mentoring opportunities, and one-on-one meetings)?
    • How well does the application describe research support for mentees during the period of the K26 award, including the availability of departmental resources or other sources of support?
    • If applicable, how appropriate is the plan for remote mentorship? This applies to PD/PIs who plan to facilitate mentorship remotely with mentees who are affiliated with Institutions other than that of the PD/PI.

    Research Plan

    • How likely is it that the research being done by the candidate will provide exceptional opportunities for graduate students and post-doctoral fellows from diverse backgrounds, including those from underrepresented groups, to provide career enhancement?
    • How well does the research plan provide an appropriate vehicle for demonstrating and developing the prospective mentee’s skills and capabilities in research?
    • How adequate are the resources available to conduct the research program? This includes adequacy of plans for continued support of the research during the funding period of the grant.

    Consultant(s), Collaborator(s)

    • If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, is there evidence of the appropriate expertise, experience, and ability on the part of the mentor(s) to guide the applicant during participation in the clinical trial?
    • How well does the information provided clearly document expertise in the proposed area(s) of consulting/collaboration?

    Environment & Institutional Commitment to the Candidate

    • How well do the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate support the proposed mentoring program?
    • How well does the level of the applicant institution’s commitment to the research of the candidate fully support the program and ensure its success?
    • Is the applicant’s description of the size and quality of the pool of graduate students and post-doctoral fellows sufficient to support the program’s goals?
    • How strong is the environment for supporting the continued research productivity of the candidate and the career development of mentees?
    • How strong is the commitment from the sponsoring institution to provide protected time for the candidate to conduct their ongoing research and the new mentoring program?
    • How strong is the level of commitment of the candidate’s institution to the mentoring of student and post-doctoral fellows from diverse backgrounds, including those from underrepresented groups?
    Additional Review Criteria
    As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

    For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

    For this FOA, this is 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

    When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

    For this FOA, this is general not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

    For this FOA, this is general not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

    Biohazards

    Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

    For this FOA, this is generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

    Resubmissions

    Not Applicable

    Revisions

    Not Applicable

    Additional Review Considerations

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

    Resource Sharing Plans

    For this FOA, this is generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

    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 level of experience of the candidate, including any prior instruction or participation in RCR as appropriate for the candidate’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.

    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).

    Authentication of Key Biological and/or Chemical Resources:

    For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

    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), 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 for initial peer review will not be accepted for applications submitted in response to this FOA.

    Applications will be assigned 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 National Diabetes and Digestive and Kidney Diseases Advisory Council.

    The following will be considered in making funding decisions:
    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities

    3. Anticipated Announcement and Award Dates

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

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

    Section VI. Award Administration Information

    1. Award Notices

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

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

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

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

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

    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: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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

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

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

    3. Reporting

    When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. For mentored awards, the Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

    A final RPPR, 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.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

    4. Evaluation

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

    Within ten years of making awards under this program, NIDDK 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, NIDDK will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.

    The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:

    • 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

    Section VII. Agency Contacts

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

    Because of the difference in individual Institute and Center (IC) program requirements for this FOA, prospective applications MUST consult the Table of IC-Specific Information, Requirements, and Staff Contacts, to make sure that their application is responsive to the requirements of one of the participating NIH ICs. Prior consultation with NIH staff is strongly encouraged.
    Application Submission Contacts

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

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

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

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

    Scientific/Research Contact(s)

    Digestive and Liver Diseases, Nutrition and Obesity

    David Saslowsky, Ph.D.
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: 301-594-8876
    Email: David.Saslowsky@nih.gov

    Diabetes, Endocrinology, and Metabolic Diseases

    Lisa M. Spain, Ph.D.
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: 301-451-9871
    Email: SpainL@niddk.nih.gov

    Kidney, Urologic, and Hematology Diseases

    Tracy L. Rankin, Ph.D.
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: 301-594-4748
    Email: rankint@mail.nih.gov

    Office of Minority Health Research Coordination

    Katrina Serrano, Ph.D.
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: 301-480-7855
    Email: katrina.serrano@nih.gov

    Peer Review Contact(s)

    Michele L. Barnard, Ph.D.
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: 301-594-8898
    Email: BarnardM@EXTRA.NIDDK.NIH.GOV

    Financial/Grants Management Contact(s)

    Hubert Walters
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: 301-827-4411
    Email: Hubert.Walters@nih.gov

    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.

    Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of career development awards are encouraged to consider applying for an extramural LRP award.

    Authority and Regulations

    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 and 2 CFR Part 200.

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