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
National Program for the Career Development Of Physician Scientists in Diabetes Research (Diabetes - Docs) (K12 Clinical Trial Optional)
Activity Code

K12 Physician Scientist Award Program (PSA)

Announcement Type
New
Related Notices
  • September 30, 2021 - Notice of Extension of Application Due Date for RFA-DK-21-019, National Program for the Career Development Of Physician Scientists in Diabetes Research (Diabetes - Docs) (K12 Clinical Trial Optional). See Notice NOT-DK-21-030
  • September 20, 2021 - Notice of Change to Award Information and Application and Submission Instructions for RFA-DK-21-019. See Notice NOT-DK-21-027.
Funding Opportunity Announcement (FOA) Number
RFA-DK-21-019
Companion Funding Opportunity
None
Number of Applications

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

Assistance Listing Number(s)
93.847
Funding Opportunity Purpose

The purpose of the Diabetes-Docs Program is to support the career development of physicians committed to a career in diabetes research. The program is intended to remedy the dearth of pediatric endocrinologists and physicians from other specialties conducting innovative research into the causes and consequences of diabetes. Diabetes-Docs will be a single national program, implemented by one or more PD/PIs, together with an advisory committee composed of basic and clinical investigators who have a strong record of funded research and successful training of physician-scientists. Although there will be one national administrative center awardee, scholars are expected to be appointed and supported at their home institutions around the country. The program will have a focus on Type 1 Diabetes (T1D) research, with the major funding from the Statutory Special Diabetes Program https://www.niddk.nih.gov/about-niddk/research-areas/diabetes/type-1-diabetes-special-statutory-funding-program/about-special-diabetes-program. Starting in the second year, the program will expand to support the career development of physicians whose research focuses on innovative projects in type 2 diabetes. The program is expected to deliver on goals to increase the diversity of physician scientists with independent research careers in the mission of NIDDK https://www.niddk.nih.gov/research-funding/research-programs#diabetes.

This Funding Opportunity Announcement (FOA) allows appointment of Scholars (K12) proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.

Key Dates

Posted Date
August 31, 2021
Open Date (Earliest Submission Date)
November 2, 2021
Letter of Intent Due Date(s)

Not Applicable

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
December 2, 2021 Not Applicable Not Applicable March 2022 May 2022 July 2022

Expiration Date
December 3, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

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


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose and Background Information

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

This FOA encourages applications from organizations that propose creative and innovative institutional research career development programs in the mission area(s) of the NIH.

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.

The Division of Diabetes, Endocrinology, and Metabolic Diseases of NIDDK has previously provided funding opportunities for individual institutional K12 programs for endocrinologists in research on the causes and consequences of type 1 diabetes. In this FOA, the NIDDK seeks to create a single highly collaborative national program, which will provide support for physician-scientist Scholars in diabetes research across the country. While the majority of the career development funding will be for type 1 diabetes research, the opportunity includes an expansion for research in type 2 diabetes. The intention is to provide for geographically distributed career development and a diverse national cohort of up-and-coming research leaders.

Funding Opportunity Description

This FOA will fund a single 5-year K12 award to support the Diabetes-Docs Program, overseen by a single or multiple PD/PI(s) who may be at different institutions. To help applicants in developing their application for this new NIDDK initiative, there will be two informational webinars hosted by NIDDK staff, the first on September 9 from 4:00PM AM to 5:00PM ET, and the second on September 21, 2021 from 11:00AM to 12:00 noon ET. After the webinars, a list of frequently asked questions will be published. Please visit the NIDDK Meetings and Events webpage for more information about the Webinars and to view the FAQ after the webinars.

Diabetes-Docs includes the following program requirements:

  • A strong administrative program with experienced leaders and institutional support.
  • A plan for recruitment of highly qualified, diverse applicants from institutions around the country; especially those from groups under-represented in science.
  • A plan for selection of Scholars who hold strong promise for a successful, combined research and clinical career. It is expected that the program will utilize a rigorous, fair and effective procedure for application and selection of individuals to be funded, including a written application and interviews.
  • A plan for closely monitoring progress of the Scholars and a mechanism to ensure both progress and compliance with program policies. The program should have a transparent and appropriate plan for granting or denying reappointment for each additional year of support.
  • A plan to support effective mentoring at home institutions; for example, programs for mentoring the mentors and development of tools and strategies for mentoring.
  • A plan for an annual retreat with Scholars and new applicants, faculty mentors, and others associated with the program. The retreat will be the venue for applicant interviews, for research presentations, professional development, skills development, mentoring, career counseling and networking. It is expected that retreats will be held in conjunction with the national meetings of relevant societies and organizations, such as American Diabetes Association (ADA), Endocrine Society, etc. Use of the retreat as a venue to encourage applications from women and individuals from groups under-represented in science is expected. The invitation of fellows and residents to the retreat could also encourage the development of the pipeline of diabetes clinical researchers.
  • A plan to include individuals from groups under-represented as mentors and in program administration.
  • A plan to provide guidelines for didactic and research career development activities for local training venues.. All Scholars should obtain, early in their Diabetes-Docs career development, a comprehensive appreciation of the principles of experimental design, statistics and scientific rigor. In addition, Diabetes-Docs must ensure that all Scholars complete responsible conduct of research training, in accordance with the NIH policies, at their home institutions.
  • An advisory committee to the Diabetes-Docs Program which includes pediatric or adult endocrinologists or other specialists engaged in diabetes research and expert in the training of physician-scientists. The advisory committee should have expertise in both basic and clinical research, should include clinician and non-clinician scientific leaders in the field, should contain appropriate gender-balance and include individuals from groups under-represented in science (see, e.g., NIH's Notice of Interest in Diversity), and represent diverse geographic locations areas of expertise. Members of the advisory committee should have a history of research funding and the stature necessary to conduct site visits to scholar's institutions and effectively carry out the Diabetes-Docs oversight function.
  • A plan for negotiation and coordination with participating institutions, departments and chairs to ensure that Scholars obtain appropriate research support, appropriate protected time for research (a minimum of 75% of full-time professional effort) and opportunities for appropriate career advancement given a combined research and clinical career.


Note: This Funding Opportunity Announcement (FOA) allows appointment of Scholars (K12) proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New

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

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The NIDDK intends to commit up to $2 million to fund 1 award in FY 2022. 

Award Budget

Application budgets are limited to $1.3 million direct costs, exclusive of indirect costs on subcontracts, per year, with variable costs across years allowed to accomodate Scholar appointments. Budgets are expected to reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is 5 years.

Other Award Budget Information

Personnel Costs

Individuals designing, directing, and implementing the career development program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap. If mentoring interactions and other activities with scholars are considered a regular part of an individual's academic duties, then mentoring and other interactions with scholars are non-reimbursable from grant funds.

The salaries of administrative and clerical staff should normally be treated as indirect (F&A) costs. Direct charging of these costs may be appropriate only if all of the following conditions are met: (1) Administrative or clerical services are integral to a project or activity; (2) Individuals involved can be specifically identified with the project or activity; (3) Such costs are explicitly included in the budget or have the prior written approval of the Federal awarding agency; and (4) The costs are not also recovered as indirect costs. When specifically identified and justified, these expenses must be itemized in Sections A and B, as appropriate, of the R&R Budget.

For this FOA, NIDDK will provide up to 2.5 person months total (combined) effort for the PD/PI(s) and/or faculty with significant program responsibilities. Funds may be requested for honoraria for Advisory Committee Members who are not also receiving salary support from this grant.

Total for dedicated administrative services may not exceed 0.8 calendar months of effort.

Scholar Costs

Scholars are those individuals who benefit from the proposed activities and experiences involved in the career development program. Scholar costs must be justified as specifically required for the proposed career development program and based on institutional policies for salaries paid to individuals in similar positions, regardless of the source of funds. These expenses must be itemized in the proposed budget.

Scholar Costs

Salary support of up to $100,000 each year, plus the appropriate fringe benefits, may be requested for each K12 scholar. The total salary requested must be based on a full-time, 12-month staff appointment and requires Scholars to devote a minimum of 9 person months (equivalent to 75 percent) of full-time professional effort toward health-related research and career development activities, with the remaining effort being devoted to activities related to the development of a successful career as a physician-scientist. The institution may supplement the NIDDK contribution. Institutional salary supplementation may not require extra duties or responsibilities that would interfere with the purpose of this award.

Scholar Research and Development Support: Up to $50,000 per Scholar may be requested for the following types of expenses: (a) research supplies, small equipment and technical personnel; (b) tuition and fees related to didactic courses or career development workshops; (c) travel to research meetings or training; including required attendance at the annual Diabetes-Docs retreat; (d) statistical and computational services including personnel and computer time. Each Scholar may use up to $3,000 of their supplies allocation (per year of appointment) for tuition, fees, and books related to career development. All expenses must be directly related to the proposed research career development program; they cannot be pooled and used for other programs unrelated or indirectly related to the research activities of individual Scholars.

It is expected that approximately 56 Scholar-slots will be available over 5 years, based on 28 individual Scholars, each typically receiving 2 years of support. The program as a whole should be primarily focused on T1D research, but up to a maximum of 5 Scholars overall may be appointed to pursue T2D research projects.

Other Program Related Expenses

Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget. These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution.

Up to $70,000 per year may be requested to support the Diabetes-Docs annual retreat. The estimated costs that result in the amount requested should be explicitly described.

Items that may NOT be supported with K12 grant funds include:

  • Salaries and fringe benefits for the program mentors.
  • Direct support of the mentors' laboratories beyond those expenses directly attributable to the scholar's project.
  • Salary and support for central institutional administrative personnel (e.g., budget officers, grant assistants, and building maintenance personnel), which are usually paid from institutional overhead charges.
  • Salary and support for administrative activities such as institutional public relations or health and educational services.

Indirect Costs

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

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

Governments

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

Other

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

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

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.
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.

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training program as the Training Program Director/Principal Investigator (Training PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from 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. together with the Advisory Committee, will be responsible for the selection and appointment of scholars to the approved career development program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI has responsibility for the day to day administration of the program and is responsible for appointing members of the Advisory Committee (when applicable), using their recommendations to determine the appropriate allotment of funds.

The PD/PI or PD/PI(s) should be leader(s) in type 1 diabetes research with available effort and experience leading successful career development programs. The Program should include appropriate expertise to provide leadership for the career development of physician-scientists in type 1 diabetes research but may include expertise in type 2 diabetes research.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

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).
Preceptors/Mentors

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.

Scholars

Scholars to be supported by the institutional career development program must be at the career level for which the planned program is intended. Scholars are expected to devote a minimum of 9 person-months (75% of full-time professional effort) during the appointment on the K12 award.

Scholars must be citizens or noncitizen nationals of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship requirements are available in the NIH Grants Policy Statement.

Additional Information Relating to Scholars

Scholars appointed to the K12 career development program must 1) have full-time appointments at the grantee institution, 2) be physician scientists who have completed their adult or pediatric endocrinology fellowship training, or other specialty if justified for diabetes research, 3) are either board-certified or board eligible, and 4) intend to continue in a dual research/clinical career, supported by an individual career-development or research award that they obtain as PD/PI. The Scholars may spend up to three years in the K12 career development program, but are strongly encouraged to apply for either an individual Mentored Clinical Scientist Research Career Development Award (K08) or an individual Mentored Patient-Oriented Research Career Development Award (K23) after 1-2 years of support through the K12 program. Through NIDDK, the physician scientist scholars may receive up to a total of 6 years of combined support through K12/KL2 and K08/K23 grant mechanisms. It is expected that most Scholars will receive 2 years of support on the K12.

At the time of initial K12 appointment, Scholars must have no more than six years of research or research training experience beyond their last doctoral degree. Time spent in clinical training is not considered postdoctoral research training. Scholars must have Early Stage Investigator status through the duration of their term as Scholar. Mid-career and senior faculty are not eligible to be appointed as Scholars.

Individuals who are or were PD/PIs on NIH Small Research Grants (i.e., R03s) or Exploratory/Developmental Research Grants (i.e., R21s) are eligible for K12 support. However, individuals who are or were PDs/PIs on NIH research projects grants (R01), Project Leads of program projects (P01) or Center grants (P50) or the equivalent, are not eligible for appointment under this K12 program. Individuals who have been previously supported by NIH or non-NIH career development awards are not eligible (such as mentored career training awards identical or equivalent to the K01, K08, K23, or K99). Scholars must not concurrently hold any other PHS award that duplicates the provisions of this award.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

John Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7797
Email: NIDDKLetterofIntent@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424 (R&R) Other Project Information

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

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 career development program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of scholars including their levels (i.e., postdoctoral), 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 training 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 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”.

An Advisory Committee is a required component of this career development program. Provide a plan to recruit an Advisory Committee for the overall program whose members have established records of research and research training of physician-scientists, and are diverse with respect to scientific interests, geographic location and prior training affiliations. Please provide a plan to ensure that the Advisory Committee has appropriate representation of women and individuals from groups under-represented in science. See, e.g., NIH's Notice of Interest in Diversity. 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 and co-directors will evaluate all Scholar applicants to the program (evaluation of written applications and conducting interviews), monitor progress of current scholars and provide feedback to the Mentors, Program PD/PI(s), co-directors and scholars as appropriate. Describe whether Advisory Committee members may be required to perform site visits at Scholar institutions. Describe how Advisory Committee members will be supported for attendance and participation in annual retreats. Describe how the duration of service of Advisory Committee members will be negotiated to ensure a minimum of 3 years. If Advisory Committee members will be allowed to be primary mentors or co-mentors to Scholars, describe how any conflict-of-interest in the Scholar selection process will be managed. Proposed Advisory Committee members need not be named in the application, but if they have been already invited to participate at the time the application is submitted, they should be named to avoid conflicts in review.

Plans for administrative support for the committee’s work should be described, including conflict resolution procedures and a process for managing conflict of interest and turnover within the committee itself. Please name your file “Advisory_Committee.pdf”.

The filename provided for each #147;Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

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

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

PHS 398 Cover Page Supplement

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

PHS 398 Training Subaward Budget Attachment(s)

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

Research and Related (R&R) Budget

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

  • Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff. Also include proposed salary costs for planned scholars.
  • Do not complete the section on Participant/Trainee Support Costs.
PHS 398 Research Training Program Plan

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

Training Program

Faculty, Trainees, and Training Program Record

Other Training Program Sections

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

Data Tables 6b and 8c may be used to provide information on past experiences in similar programs with recruiting and outcomes. No other Data Tables should be included. The following additional modifications apply as listed below.

 

Training Program Section

Program Plan

A. Background

Briefly describe the ability of the proposed Program to deliver on diabetes research career development goals based on prior experience. Since the goal of the National program will be to support career development nationally, local Faculty and research training support relevant to mentoring individual Scholars at the PI/PD's site need not be described. However, if desired, include outcomes of prior relevant training programs (Data Tables 6b and 8c may be used to provide information). .

B. Program Plan

a. Program Administration

Describe the strengths, leadership and skills of the Program's administrative team. Relate these strengths to the proposed management of a national career development program. Describe the plan to include career development in type 2 diabetes related projects for the outyears of the award while maintaining an emphasis on type 1 diabetes. Describe the planned strategy, administrative structure, and guidelines to be used to oversee and monitor the program, including the oversight of didactic, career development-related, and research-related components in different locales. If there are multiple PDs/PIs, then the plan for Program Administration is expected to synergize with the “Multiple PD/PI Leadership Plan” section of the application. For all PD/PIs and co-directors, describe the anticipated responsibilities of each individual in the context of the effort they will devote to the program, and plans for dispute resolution.

This National K12 is intended to support Scholars located at research sites across the country. . Describe a plan for communicating with the diabetes research community about the opportunity to support career development of Scholars, and encouraging applications from Scholars across the country. Describe the plan for negotiation and coordination with participating institutions, departments and chairs to ensure that scholars obtain appropriate research support, appropriate protected time for research and opportunities for appropriate career advancement given a combined research and clinical career.

Provide a timeline of applicant recruitment and appointment that includes solicitation of applications, preparation of candidate applications, submission of applications to the program, selection of applicants, and applicant support for the entire Program period.

b. Program Faculty/Mentors

Since the program is national, it is not possible to identify potential mentors at the time of application. The application must include information about the characteristics of those who would be appropriate to serve as local mentors and mentoring committee, paying attention to the eligibility criteria in Section III of this FOA. Describe how the Diabetes-Docs program will evaluate each scholar's mentor choices and advise on suitability and potential changes. Describe how the Diabetes-Docs program will ensure that local mentors provide the required effort to oversee the Scholar. Describe what requirements the Diabetes-Docs program will have for the makeup of a scholar's local mentoring committee. Describe the criteria used to remove mentors and to evaluate their participation.

In the case that a mentor may not be identified or fully engaged by a Scholar prior to the selection process, the PD/PI may want to designate an individual from the National Program administration as a pre-application advisor to the candidates. This advisor may advise potential applicants on any aspect of their application, including aspects of the research and/or career development plan or choice of mentor(s). This individual should not be a voting member of the selection committee.

Describe the plan for communicating detailed information about the goals and expectations of the Diabetes-Docs program to potential local mentors, including requirements for mentoring time.

Selection criteria for mentors. A plan should be described for the Program to evaluate and approve mentors from diverse backgrounds with strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program (type 1 diabetes). Primary mentors should: (1) be recognized as an accomplished investigator, (2) be actively involved in basic or clinical research, (3) have a successful record of providing the type of training required under this award and (4) will dedicate the time and resources required to foster the Scholar's success. The primary mentor should be at the Scholar's institution, should be appropriate for providing guidance for the research career development of the Scholar, should be aware of the goals of Diabetes-Docs, and is expected to provide the guidance appropriate for helping the Scholar transition to individually funded research. If non-local co-mentors are needed, the Program should require that the method and frequency of interactions are described.

Local Mentoring Committee for the Scholar. In addition to a mentor, each Scholar supported by this program should have a local mentoring committee to provide input and guidance, and oversight of the Scholar's progress. The Diabetes-Docs program should have a plan to ensure that the Scholar's local mentoring committee is composed of experts in areas necessary to ensure the success of the Scholar in research, career development and ultimately the creation and management of an independent research lab. Composition, responsibilities, frequency of meetings, and other relevant information should be included in the document submitted by the Scholar-applicant when applying for support from the Diabetes-Docs.

Diabetes-Docs Program Advisor for the Scholar. Diabetes-Docs should appoint at least one Program Advisor from the Diabetes-Docs advisory committee to each selected scholar. The Diabetes-Docs program should define the goals and minimum frequency of interaction (recommended once per year) between Diabetes-Docs program advisor(s) and the scholar.

c. Proposed Career Development Program

Mentoring Program

Provide an overview of the proposed mentoring program to be delivered nationally. Outline the objectives of the program and the programmatic activities that will be used to meet these objectives. Describe the minimum academic and research background needed for Scholars, and plans to accommodate differences in preparation among scholars. Include details about the planned selection process including the application portal and interview. Describe planned courses, mentored research experiences, and activities conducted by the national program itself, which are designed to develop specific technical skills or other skills essential for the proposed research career development. Also describe how the Program will leverage or coordinate with existing career development opportunities and programs at local sites where Scholars will be trained. Describe how the career development program will allow most Scholars to progress to the next step, such as an independent career development award or other research grant, within 2 years of support on the K12.

Projects. Describe examples of the projects that would be appropriate for Scholars to participate in under this K12 Program. Projects should provide opportunities for Scholars to develop technical, collaborative, and leadership skills, while engaging in significant and impactful research in the causes and consequences of type 1 diabetes, and for a subset, type 2 diabetes.  Describe how projects will provide Scholars opportunities to participate as first or last authors on peer-reviewed publications, and to develop their research on the progression to research career independence depending on their career stage.

In the event that a clinical trial may be proposed by a Scholar, provide the plan to ensure and document the Scholar and Mentor(s) expertise, experience, and ability to oversee the organization, management and implementation of the clinical trial, including any feasibility or ancillary study to a clinical trial.

Career Skills. Describe how the Diabetes-Docs program will ensure that all scholars develop skills for high quality oral and written presentations and skills needed to successfully apply for individual grant support. Describe any diabetes-specific plans above and beyond what is described in Section 4 Plan for Instruction in Methods for Enhancing Reproducibility to ensure rigorous career development for highly rigorous research. Describe any potential plans for education of scholars in ancillary skills required for a research career, such as overseeing laboratory research or a clinical research program, project and budget management and personnel management. The PD/PI(s) may choose to incorporate this career development component into the annual retreat agenda (see below). Alternatively, the PD/PI(s) should have a mechanism to ensure that scholars obtain this instruction at their home institutions or elsewhere. Overall, describe oversight mechanisms to ensure the Scholar's timely career development and progression to independence.

Annual retreat. Describe the plans for the annual retreat. Ideally, the annual retreat would be held in conjunction with another major conference in type 1 and type 2 diabetes research, such as the ADA or Endocrine Society annual meetings. This retreat should be used for the PD/PI(s) and Diabetes-Docs advisory committee members to interview applicants, evaluate their written applications to the program and select scholars to be supported. This meeting should also include, at a minimum, opportunities for supported scholars to 1) improve their oral and written presentation skills, 2) sharpen their analytical skills with regard to data gathering, rigor, and interpretation, as well as an understanding of the clinical significance/relevance of their research at a granular level, 3) obtain knowledgeable advice regarding the specific aims of planned future grants and 4) obtain career guidance. Also, describe any plans to use the retreat for "mentoring the mentors" activities.

The annual retreat is also intended to serve as an infrastructure for building a diverse community of physician-scientists who are dedicated to diabetes research as part of their careers. The application should describe any approach or activities anticipated to facilitate the success of Diabetes-Docs applicants who are not selected for salary support by the program. Describe any plans to use the retreat to engage with future Scholar applicants at earlier career stages, such as fellows or even students, to build the pipeline for diabetes research.

d. Program Evaluation

Discuss short- and long-term measures of success, and how outcomes including success in obtaining independent grant support and in diversifying the diabetes research workforce consistent with the NIH's Notice of Interest in Diversity diversity goals will be monitored.

e. Scholar Candidates

Describe how the Program will ensure that Scholars will meet the following requirements and expectations:

Scholars appointed to the K12 career development program must 1) have full-time appointments at the grantee institution, 2) be physician scientists who have completed their adult or pediatric endocrinology fellowship training, or other specialty if justified for diabetes research, 3) are either board-certified or board eligible, and 4) intend to continue in a dual research/clinical career, supported by an individual career-development or research award that they obtain as PD/PI.

At the time of initial K12 appointment, Scholars must have no more than six years of research or research training experience beyond their last doctoral degree. Time spent in clinical training is not considered postdoctoral research training. Scholars must have Early Stage Investigator status through the duration of their term as Scholar. Mid-career and senior faculty are not eligible to be appointed as Scholars.

The Scholars may spend up to three years in the K12 career development program, but are strongly encouraged to apply for either an individual Mentored Clinical Scientist Research Career Development Award (K08) or an individual Mentored Patient-Oriented Research Career Development Award (K23) after 1-2 years of support through the K12 program. Through NIDDK, the physician scientist scholars may receive up to a total of 6 years of combined support through K12/KL2 and K08/K23 grant mechanisms. It is expected that most Scholars will receive 2 years of support on the K12.Individuals who are or were PD/PIs on NIH Small Research Grants (i.e., R03s) or Exploratory/Developmental Research Grants (i.e., R21s) are eligible for K12 support. However, individuals who are or were PDs/PIs on NIH research projects grants (R01), Project Leads sub-projects of program projects (P01) or Center grants (P50) or the equivalent, are not eligible for appointment under this K12 program. Individuals who have been previously supported by NIH or non-NIH career development awards are not eligible (such as mentored career training awards identical or equivalent to the K01, K08, K23, or K99). Scholars must not concurrently hold any other PHS award that duplicates the provisions of this award.

Estimate, and explain the basis of your estimation, the size of the potential national pool of qualified scholar candidates. Describe specific plans to recruit candidates and explain how these plans will be implemented. Describe the specific efforts to be made to recruit Scholars from groups under-represented in diabetes research to the Diabetes-Docs program. A separate, detailed proposal for achieving diversity is required under the Additional Review Criteria section of the application. See, C. Recruitment Plan to Enhance Diversity PHS Guide. Describe the process to be used to select candidates who would be offered support from the program and criteria for Scholar reappointment to the program. Describe the minimum expected qualifications, paying attention to the eligibility criteria in Section III of the this FOA,(e.g. research experience, publications, institutional support, faculty positions, etc.) required for appointment to the Diabetes-Docs Program and if exceptions to these qualifications are possible, the anticipated bases for exceptions. Describe the anticipated components of the application process, including written documents, personal interviews, reference letters, institutional commitment, etc.

Describe the plan for monitoring progress of the Scholars, and the approach to ensuring both progress and compliance with program policies. Describe the process by which continued support of a Scholar by the program will be granted or denied.

For clinical trials, discuss how prospective Scholars (K12) will be directed and supported to properly organize, manage, and implement a proposed clinical trial, or ancillary study

f. Institutional Environment and Commitment to the Program

In addition to letter of support demonstrating the commitment of the applicant organization for the Program as a whole, describe how the program will obtain assurance from all involved institutions 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% effort) selected for the program. Describe the oversight process to ensure adequate institutional commitment for Scholars' protected time.

?????Plan for Instruction in the Responsible Conduct of Research

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

.

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 theSF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

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

Study Record: PHS Human Subjects and Clinical Trials Information

DO NOT USE. Attempts to submit a full, detailed study record will result in a validation error.

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).

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must complete a Delayed Onset Study.

If you check the “Anticipated Clinical Trial” box within your Delayed Onset Study, then the Justification attachment must acknowledge that additional clinical trial information will be provided to the awarding component before any appointee begins independent clinical trial research.

PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, 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.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed career development 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).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of the merit of the career development 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

  • Are the guidelines proposed for oversight of didactic, career-development-related, and research-related activities of the program complete and appropriate?
  • Is the institutional commitment to the proposed program clear and appropriate?
  • Are appropriate oversight mechanisms in place to ensure Scholar career progression throughout the supported period?
  • If multiple sites are participating in leading the administration of the program, is this adequately justified and is it feasible? Is there a plan to manage disputes?
  • Is there a strong, feasible plan to ensure that appointed Scholars will obtain the required protected time and that scholar's mentors will devote the time necessary for superior mentoring of the scholar?
  • Is there a strong, feasible plan to ensure that research projects and career development activities are likely to position most Scholars for success in individual career or research grant applications after two years of K12 support?
  • Is there an appropriate plan to ensure the appropriate balance of Scholars and projects in type 1 vs. type 2 diabetes research?
  • Are the responsibilities of the Advisory Committee described and appropriate for Scholar selection, input, guidance and oversight of the program?
  • Are the requirements for the to-be-determined advisory committee membership, as a whole and individually, appropriate for the needs of the program, with regard to Scholar selection, career development guidance, the conduct of site visits, scientific breadth, and other committee responsibilities?
  • Is the plan for recruitment of the advisory committee appropriate, with respect to the ability to attract members with strong research accomplishments, diversity of research expertise, training track record, stature in the community, geographic representation, gender balance and racial/ethnic diversity?
  • Is a well-thought out annual retreat program proposed that will significantly aid in the development of successful physician-scientist careers of the supported Scholars and all applicants? Is the Annual Retreat likely to increase recruitment of Scholars from groups under-represented in science?

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?
  • 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?
  • With regard to the proposed leadership for the career development program, do the PD/PI(s) have the expertise, experience, and ability to oversee the organization, management and implementation of the proposed clinical trial?
  • If the program will support clinical trial research experience for the Trainees, do the mentor(s) who will supervise the Trainee(s) have the expertise, experience, resources, and ability to provide appropriate guidance and help the Trainee(s) to meet the timelines?

Mentors

  • Since Mentors are expected to be appointed locally after award, is there an appropriate plan to ensure that local mentors have appropriate expertise and experience, as well as track records of past mentoring and training? Is there a plan to ensure that all Mentors meet the eligibility criteria?
  • Is there an appropriate plan to ensure that each Scholar will have a mentorship team that covers all needed aspects of the Scholar's research and career development?
  • Is there an appropriate plan to ensure that the quality and extent of the mentors’ roles in providing guidance and scientific advice to the Scholars are acceptable?
  • Is there an appropriate plan to ensure that the research productivity, research quality and funding of proposed mentors is suitable for the development of successful Scholar research careers?
  • Is there an appropriate plan to ensure that projects proposed by Scholars can be pursued via an independent funding mechanism without competition from the mentor?
  • is there an appropriate plan to ensure that mentors who will supervise Scholars engaging in clinical trials have the expertise, experience, resources, and ability to provide appropriate guidance and help the Scholars to meet the timelines?

Scholars

  • Is a recruitment plan proposed with strategies likely to attract high quality scholars?
  • 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?
  • Is an appropriate set of qualifications expected of applicants for support, and if exceptions to these qualifications are permitted, is the plan for making exceptions clear and appropriate?
  • 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?

Additional Criteria for Scholars

  • Is there a plan to recruit prospective Scholars who have the potential to organize, manage, and implement a clinical trial, feasibility or ancillary study, as appropriate?
  • Are there plans to provide instruction in data management and statistics including those relevant to clinical trials to the prospective Scholars as appropriate?
  • Is a well-defined and justified recruitment plan proposed with strategies likely to attract diverse, high quality scholar candidates from a national pool, not just the PD/PI's institutions?
  • Is there evidence of a sufficiently large, competitive national scholar pool to warrant the proposed size of the career development program?
  • Does the plan for the Scholars' application to the program include both written application and interviews, and is the plan likely to result in clear and well-conceived instructions for Scholar applicants?
  • Does the plan ensure that scholars appointed to the program will have a well-designed research and career development plan, which could be expected to lead to individual funding after 2 years of program support?
  • Is there a thoughtful, feasible timeline of applicant recruitment and appointment that includes solicitation of applications, preparation of candidate applications, submission of applications to the program, selection of applicants, and applicant support?

Training Record

  • 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 careers? Does the program have a rigorous evaluation plan to assess its quality and effectiveness?
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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Career Development in Methods for Enhancing Reproducibility

Does the plan for Instruction in Methods for Enhancing Reproducibility describe how the program will provide career development in scientific reasoning, rigorous research design, relevant experimental methods, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, quantitative approaches, and data analysis and interpretation, appropriate to field of study and the level and prior preparation of the scholars?

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.

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

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the 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 (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) 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.

2. Review and Selection Process

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

As part of the scientific peer review, all applications will receive a written critique.

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.

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.

Awardees must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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 awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. 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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. 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 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

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

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

Other Reporting Requirements
  • The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar appointed or reappointed to the training grant for 8 weeks or more. Recipients must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.
  • Termination Notice: Within 30 days of the end of the total support period, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each scholar appointed for eight weeks or more.

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. Evaluation results should be included as part of the final RPPR.

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.

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

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

Scientific/Research Contact(s)

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

Peer Review Contact(s)

Charlene Repique, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK_
Telephone: 301-594-7791
Email: charlene.repique@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

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.

This FOA is supported under the authority of P.L. 116-260, Consolidated Appropriations Act, 2021; Section 302. Diabetes Programs.


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