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
Institutional Network Award for Promoting Kidney, Urologic, and Hematologic Research Training (U2C - Clinical Trial Not Allowed)
Activity Code

U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements

Announcement Type
Reissue of PAR-23-248
Related Notices
Funding Opportunity Number (FON)
PAR-26-115
Companion Notice of Funding Opportunity
None
Assistance Listing Number(s)
93.847
Notice of Funding Opportunity Purpose

Responding to the needs of the scientific community to bolster a vibrant and sustainable research workforce, the Division of Kidney, Urologic, and Hematologic Diseases (KUH) at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has incorporated additional flexibilities for institutional training programs serving the mission interests of non-malignant kidney, urologic, and hematologic diseases, encompassing both adult and pediatric conditions. The purpose of this notice of funding opportunity is to invite applications for Institutional Network Awards (U2C-TL1) to recruit, train, and retain the next generation of researchers and provide them with the coordinated support, resources, and networks they need to succeed and lead. To maximize integration and promote a highly connected trainee community, institutions are invited to submit a single, unified U2C-TL1 application.  Representation across all kidney, urologic, and hematologic disciplines is not expected or requiredIf feasible, applications may include multiple departments within and across institutions. It is expected that each U2C-TL1 award will actively participate in the Kidney, Urology and Hematology Research-Training Network (KUHR-TN), a nationwide coalition of individual U2C-TL1 awards.

Funding Opportunity Goal(s)

To promote extramural basic and clinical biomedical research that improves the understanding of the mechanisms underlying disease and leads to improved preventions, diagnosis, and treatment of diabetes, digestive, and kidney diseases. Programmatic areas within the National Institute of Diabetes and Digestive and Kidney Diseases include diabetes, digestive, endocrine, hematologic, liver, metabolic, nephrologic, nutrition, obesity, and urologic diseases.

Key Dates

Posted Date
Open Date (Earliest Submission Date)
April 25, 2026
The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
May 25, 2026 * May 25, 2026 * Not Applicable November 2026 January 2027 April 2027
May 25, 2027 * May 25, 2027 * Not Applicable November 2027 January 2028 April 2028
May 25, 2028 * May 25, 2028 * Not Applicable November 2028 January 2029 April 2029

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

Applicants 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
May 26, 2028
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

The Kidney, Urologic, and Hematologic research communities are facing daunting workforce issues. As such, there is a critical need to recruit, train, and retain trainees engaged in research in KUH mission areas, including non-malignant kidney, urologic, and/or hematologic research, encompassing both adult and pediatric conditions, and provide them with the coordinated support, resources, and networks they need to succeed and lead.

Solutions to the difficult and complicated scientific questions facing the kidney, urologic, and hematologic communities demand well-trained basic, translational, and clinical researchers who can employ their skills in a team-based setting and apply rigorous experimental approaches utilizing novel techniques. To develop and grow this workforce, effective training programs must encompass critical thinking, scientific literacy, problem-solving, communication, collaboration, teamwork, adaptability, resilience, and mentoring.

Purpose
The purpose of this Notice of Funding Opportunity (NOFO) is to cultivate a highly integrated cohort of people and resources to propel training in KUH mission areas through Institutional Network Awards (U2C-TL1).

When feasible, each Institutional Network Award (U2C-TL1) is encouraged to leverage all available resources and partner institutions to maximize recruitment, training, and retention by:

  • Collaborating across relevant departments within a given institution, and/or with other partner institutions as needed, to recruit trainees with interest in KUH mission areas and offer them robust educational experiences, broad professional development perspectives, and a supportive mentoring environment. We expect that not  every U2C-TL1 award will include all kidney, urology and hematology disciplines, or cover both adult and pediatric conditions.
  • Promoting a highly integrated community of trainees engaged in research in KUH mission areas.  This fosters the goal of forming a trainee cohort and promoting a more robust local peer-to-peer network.

The U2C cooperative component will provide administrative, networking, professional development, and resources for the Institutional Network Award activities, while the TL1 training component (equivalent to a T32) will allow the institution(s) to recruit and fund at least five (5) highly competitive pre- and/or post-doctoral trainees engaged in KUH research. Each U2C-TL1 Award is expected to have a:

  1. Administrative Core (U2C): Establish governance, manage resources, and ensure program goals are met.
  2. Networking and Professional Development Core (U2C): Foster local peer- and near-peer networking, develop tailored and structured educational experiences to prepare trainees for the next step in their scientific careers, and provide a robust mentoring environment. Activities supported by this Core are expected to be site- and context-specific and address trainee needs, and programmatic goals best accomplished locally.
  3. TL1 Training Core (TL1): Recruit at least five (5) highly talented trainees from broad scientific backgrounds into the KUH workforce. Provide them with the necessary skills to succeed and lead.

Additional Information:

  • The U2C and TL1 components, which are linked at the time of application, will be separated at the time of award. Each of the U2C and TL1 components will maintain their own, separate budgets and have a distinct Principal Investigator(s)/Program Director(s), (PI(s)/PD(s)). Applicants are expected to submit only one application per institution (normally identified by having a unique UEInumber or NIH IPF number) per receipt date.
  • In addition to the networking and professional development activities offered through individual U2C-TL1 programs, the plan is that the trainees will also be able to take advantage of resources available through the planned KUH-FAMILY Coordinating Center. Once established, the KUH-FAMILY Coordinating Center will aim to create and sustain an active, national, peer-to-peer network and community of individuals engaged in research in KUH mission areas across career stages.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed
New
Renewal
Resubmission

The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

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

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

The total costs of the U2C (Administrative Core plus Networking and Professional Development Core) should not exceed 40% of the total cost of the TL1 (NRSA Training Core). In other words, the total costs of the U2C divided by the total costs of the TL1 should not exceed 0.40.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions - Includes all types

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

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)

Local 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 Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organization) 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 allowed. 

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

  • 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 Grants.gov registration; 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.

Eligible Individuals (Program Director/Principal Investigator)

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. 

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 How to Apply - Application Guide.

The PD(s)/PI(s) should be an active investigator in a scientific area relevant to the mission of KUH and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD(s)/PI(s) will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PD(s)/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required.

Multiple PD(s)/PI(s) are allowed, particularly when each brings a unique perspective and skill set that will enhance the training program. At least one of the multiple PD(s)/PI(s) should be an investigator with an active research program in basic, translational, or clinical science aligned with the mission of KUH, capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. Additional PD(s)/PI(s), including individuals with experience in areas such as science education, program evaluation, mentoring, and career development and advancement for early-career scientists, may be included to achieve the overall goal to recruit, train, and retain trainees engaged in KUH research and provide them with the coordinated support, resources, and networks they need to succeed and lead.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Additional Information on Eligibility for the Training Core (TL1)

Preceptors/Mentors
Program faculty should be active researchers in the biomedical sciences as demonstrated by recent publications and research support in the area of the proposed research training program. Programs are encouraged to recruit prospective preceptors/mentors from faculty at different career stages (for example, early stage investigators as well as senior faculty). All program faculty should have a mentoring philosophy appropriately tailored to the needs of potential trainees that ensures trainees will receive the tailored mentorship needed to develop skills and advance their career.  Program faculty should also have sufficient time to commit to training given their other professional obligations.
Trainees
The applicant organization will select the trainees to be supported by the research training program and is responsible for establishing trainee eligibility and selection criteria that are consistent with applicable law. The individual to be trained must be a citizen or a noncitizen national of the United States or have been lawfully admitted for permanent residence at the time of appointment. Additional details on citizenship, training period, and aggregate duration of support are available in the NIH Grants Policy Statement. All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the awarding unit.

Predoctoral traineesPredoctoral trainees must be enrolled in a program leading to a PhD or in an equivalent research doctoral degree program. Health-professional students who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs, are also eligible.

Postdoctoral traineesPostdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Comparable doctoral degrees include, but are not limited to, the following: D.M.D., DC, DO, DVM., OD, DPM, ScD, EngD, DrPH, DNSc, DPT, PharmD, ND (Doctor of Naturopathy), DSW, PsyD, as well as a doctoral degree in nursing research. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of the training appointment is acceptable. Individuals in postgraduate clinical training, who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs, are also eligible.

Additional information:

  • No individual trainee may receive more than five years of aggregate NRSA support at the pre-doctoral level or 3 years of support at the post-doctoral level, including any combination of support from institutional training and individual fellowship awards.
  • Individuals currently supported by other Federal funds are not eligible for trainee support.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts) and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Component Component Type for Submission Page Limit Required/Optional Minimum Maximum
Overall Overall 6 Required 1 1
Administrative Core Admin Core 6 Required 1 1
Networking and Professional Development Core Core 6 Required 1 1
Training Core NRSA Training 12 Required 1 1

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

The application should consist of the following components:

  • Overall: required
  • Administrative Core: required
  • Networking and Professional Development Core: required
  • Training Core: required

Overall Component

When preparing the application, use Component Type ‘Overall’.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: Describe the specific aims of the program as an institutional resource to recruit, train, and retain the next generation of researchers and provide them with the coordinated support, resources, and networks they need to succeed and lead. 

Research Strategy: This section should address the overall vision and mission of the program, the institutional commitment and accomplishments of supporting innovative training, and the institutional approach to fostering a trainee cohort across multiple career stages.

Vision and Mission:

  • Summarize the overall strategic vision for developing a research workforce equipped with the skills and knowledge to engage in scientific research in different sectors.
  • If applicable, describe the vision for developing innovative strategies to recruit trainees from a variety of scientific backgrounds and at different career stages.
  • Describe the vision and strategic goals for local peer-networking and peer-to-peer mentoring within the program.
  • Describe the vision for integrating multiple departments and/or partnering organizations engaged in KUH-mission research into a single institutional program, if applicable. Strategic goals may include increased resource and facility sharing, dissemination of scientific and professional development expertise.

Institutional Track Record of Innovative Training: 
Describe the institution’s commitment and accomplishments over the last five years in promoting innovative training. Highlight the accomplishments of recent trainees that have benefited from such training. Describe institutional programs and incentives for promoting trainee networking and professional development across the participating departments, if applicable.

Letters of Support: Letters of Support should describe the institutional support for the program and commitment to supporting the goals of the Institutional Network Award. Letters should be submitted from the chairs of all participating departments committing to sharing of resources and facilities to provide supported trainees an exceptional training experience.

Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s): 

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

  • A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Not applicable. Do not complete.

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 How to Apply- Application Guide must be followed.

Not applicable. Do not complete.

PHS Assignment Request Form (Overall)

All instructions in the How to Apply- Application Guide must be followed.

Administrative Core

When preparing your application, use Component Type ‘Admin Core.’

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted. 

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application. If a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component (there is no need to include the same Biographical sketch multiple times in the application).
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

  • The PD(s)/PI(s) are expected to commit sufficient effort to ensure the program’s success.
  • Requests for salary support should follow budgetary guidelines.
  • Total salary support combined for PD(s)/PI(s) across all U2C cores and the TL1 core (including Core Director(s), Associate Directors or other senior participating faculty) should not exceed six calendar months per year. There is no cap on other personnel effort as long as there is strong justification for their involvement and the total cost of the award adheres to the restrictions outlined above.
  • Applicants are encouraged to include a Project manager tasked with running the logistical operations of the program.
  • Additionally, applicants must include a budget for contact U2C-TL1 PD(s)/PI(s) and Core PD(s)/PI(s) to travel to the annual KUHR-TN meeting.

PHS 398 Research Plan (Administrative Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: The specific aims should reflect the integrated approach to establish governance, manage resources, and ensure program goals are met.

Research Strategy:

The application should describe:

  • The organizational and governance structure of the U2C-TL1 and provide an organizational chart. This section should describe the proposed relationship of the applicant institution and any participating partner institutions, including: what each partner will contribute; how each partner will have input and participate in decision- making; and how the partners will maintain ongoing communication. It is critical that the inclusion of any partner institutions be well justified, that they each contribute essential elements or unique strengths to the overall program, and that there is a strong plan on how the partners work closely and directly together.
  • Plans to develop milestones and collect data to define and evaluate success of the U2C-TL1, including metrics to evaluate preceptors.
  • How quality of the program will be planned, monitored, and how corrective interventions will be implemented when needed.

Letters of Support: All Letters of Support should be included in the Overall component.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

  • Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

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 How to Apply- Application Guide must be followed.

 

Networking and Professional Development Core

When preparing your application, use Component Type ‘Core.’

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Networking and Professional Development Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Networking and Professional Development Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Networking and Professional Development Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Networking and Professional Development Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Networking and Professional Development Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application. If a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component (there is no need to include the same Biographical sketch multiple times in the application).
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Networking and Professional Development Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Networking and Professional Development Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the aims of the Networking and Professional Development Core towards fostering local peer- and near-peer networking, developing tailored and structured educational experiences to prepare trainees for the next step in their scientific careers and providing a robust mentoring environment. Activities supported by the Networking and Professional Development Core are expected to be site- and context-specific and address trainee needs, and programmatic goals best accomplished locally.

Research Strategy:

The application should describe:

Local trainee peer network

  • The overall approach for developing a local peer network that is trainee-led and designed for trainee interactions and exchange of ideas. The network can utilize several approaches for enhancing trainee communication both in-person and virtual. If virtual networking approaches are proposed, applicants should identify systems and tools that are appropriate for the trainee demographic.
  • How the local peer network would be initiated and monitored and plans for sustaining the network over the proposed project period.

Trainee professional development (while some examples are listed below, it is not expected that all of these examples will be incorporated; applicants should propose strategies commensurate with the proposed budget)

  • Didactic courses and informal forums to improve trainees’ ability to develop a focused scientific question and a competitive grant application.
  • Program curricula available to trainees to enhance their skills in making effective presentations, both written and oral, enhancing overall communication skills, and developing an effective professional network.
  • Graduate-level courses or workshops in specific technologies/approaches/frameworks, research methodologies, data science, statistics, computational science, bioinformatics, data sharing and access, data management, and other emerging areas of science.
  • Formal approach for training in team and interdisciplinary science, business management and/or entrepreneurship courses.
  • Leadership training to prepare trainees to manage their own research teams in the future and other innovative approaches to training the next generation of scientists. 


Preceptor/Mentor professional development (while some examples are listed below, it is not expected that all of these examples will be incorporated; applicants should propose strategies commensurate with the proposed budget)

  • Approach to identify and train preceptors in effective mentoring. The approach can include formal didactic training and informal experiential training.
  • Continuing education approaches for existing preceptors and how trainee evaluations of their training experience are utilized to improve mentoring.
  • Approach for providing support for improving less effective mentors and rewarding effective mentors.

In addition to the local activities, national networking and professional development resources will be available through the KUH-FAMILY Coordinating Center, once launched, to all TL1-appointed trainees and their mentors. It is expected that the local resources will serve as the foundation for achieving the main goal of the KUH-FAMILY Coordinating Center to create and sustain an active, national, peer-to-peer network and community of individuals engaged in research in KUH mission areas across career stages.

Letters of Support: All Letters of Support should be included in the Overall component.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

  • Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Networking and Professional Development Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

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 How to Apply- Application Guide must be followed.

 

Training Core

When preparing your application, use Component Type ‘NSRA Training.’

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Training Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Training Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Training Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Training Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Training Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application. If a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component (there is no need to include the same Biographical sketch multiple times in the application).
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
  • The Project Lead cannot be the PD(s)/PI(s) of the U2C application but should work closely with the U2C leadership to leverage training opportunities and share faculty expertise. 
  • The Project Lead will assume the PD(s)/PI(s) role of the TL1 award following successful review and funding of the U2C application; absent U2C funding, a TL1 award will not be made.
  • Do not include proposed mentors and training faculty members (other than senior/key persons) in this section. Biographical Sketches for mentors and participating faculty will be included in the PHS 398 Research Training Program Plan Form, Participating Faculty Biosketches attachment.

Budget (Training Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

  • The NRSA Training Core is a required component of the application and will be supported only if the U2C is successful. 
  • The Training Core must support a minimum of 5 trainees (can be a combination of pre- and post-doctoral trainees) and the amount budgeted must comply with the NRSA stipend levels and allowable costs.
  • Awarded slots in excess of the minimum five slots will depend on the scientific and technical merit of the proposed program as determined by scientific peer review and the relevance of the proposed program to NIDDK/KUH programmatic priorities.

PHS 398 Research Plan (Training Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

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

  • Training Program
  • Faculty, Trainees, and Training Record
  • Other Training Program
  • Appendix - Note that the Appendix should only be used in circumstances covered in the NIH policy on appendix materials or if the NOFO specifically instructs applicants to do so.

Follow all instructions provided in the How to Apply - Application Guide:

Particular attention must be given to the required Training Data Tables. Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the prospective candidate pool, faculty mentors, the educational and career outcomes of past participants, and other factors that contribute to the overall environment of the program.

For New Predoctoral Training, submit tables: 1, 2, 3, 4, 5A, 8A.

For New Postdoctoral Training, submit tables: 1, 2, 3, 4, 5B, 8C.

For New Mixed Pre and Postdoctoral Training, submit Tables: 1, 2, 3, 4, 5A, 5B, 8A, 8C.

 Training Program
In addition to the information specified in the Application Guide, describe the following for each section of the Program Plan attachment:
 

Background: 
Provide a rationale for the proposed program and the choice of career stage of trainees requested. Do not include a lengthy historical background of training at the institution but instead focus on current training challenges and how the institution is best positioned to recruit, train, and retain the next generation of researchers and provide them with the coordinated support, resources, and networks they need to succeed and lead. 
 
Program Plan

Program Administration (Training Program Director(s)/Principal Investigator(s)):

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

  • The appropriate expertise (for example, a record of rigorous research), as well as the administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program.
  • The time to commit sufficient effort to ensure the program's success, given other professional obligations (applicants should indicate the program director's percent effort in the proposed program).
  • A demonstrated commitment to training future biomedical research researchers.
  • Received training (or have a plan in place to ensure they receive training) on how to effectively mentor the entire trainee pool prior to the start of the program.

This section should describe how previous mentoring experiences of the PD(s)/PI(s) will support the success of the proposed training program. 

Program Faculty:

The application should describe (a) the faculty participants and (b) planned mentor training and oversight.

Faculty Participants, please describe:

  • The efforts made to recruit a pool of prospective program faculty from a range of career stages and scientific disciplines relevant to the training goals, to provide potential role models within the training program and to enhance the training environment.

Preceptor/Mentor Training and Oversight, please describe:

  • The planned strategy and administrative structure to oversee and monitor the program and ensure appropriate and timely trainee progress. This should include a mechanism to monitor mentoring, including oversight of the effectiveness of the trainee/participating faculty match, and a plan for removing faculty who continue to display unacceptable mentorship qualities from the training program.
  • How the participating faculty are trained to ensure the use of evidence-informed mentoring practices that promote the development of trainees in the biomedical sciences. Include the planned format, duration, and frequency of mentor training activities for program faculty and a description of how mentor training has been tailored to the goals and objectives of the broader training program. Describe the major topics covered in mentor training. Examples of relevant topics include, but are not limited to:
    • Aligning expectations.
    • Maintaining effective communication.
    • Fostering independence.
    • Assessing scholars’ understanding of scientific research.
    • Enhancing professional development.
    • Articulating your mentoring philosophy and plan.

Proposed Training: 
In addition to the information specified in the Application Guide, describe:

  • How the training activities will employ evidence-informed approaches to trainee learning, mentorship, and professional development, and how these activities will address the program’s training goals and objectives.
  • How trainees will be instructed on data science principles that are relevant to their areas of research. Examples include statistics, computational science, bioinformatics, data sharing and access, data management, data security, and data privacy in human subjects research.

Career Development

The proposed training should include a section on career development activities for trainees involved in the program, and should describe:

  • How the pool of potential applicants and trainees will be provided with information about the overall biomedical research workforce employment landscape, the variety of careers in the biomedical research workforce for which their training would be useful, and the career outcomes of graduates of the program (e.g., on publicly accessible websites).
  • How the proposed program will engage a range of potential employers to ensure the trainees will acquire the appropriate skills, knowledge, and steps needed to attain positions in the sectors of the biomedical research workforce that are of interest to them and consistent with their values.
  • How the training program or institution will provide appropriate experiential learning opportunities (e.g., internships, shadowing, informational interviews, teaching opportunities) that allow trainees to develop the professional skills and networks necessary to transition into careers in the biomedical research workforce.

Training Program Evaluation: 
The application should describe:

  • How the proposed evaluation will assess the extent to which the overall program is effective in meeting its training goals and objectives, and whether the research training environment is supportive of trainee development.
  • The program’s procedures for responding to program evaluation findings.

Trainee Candidates and Retention Plans:

Through the narrative and summaries of the information presented in the Training Data Tables and the attachments, the application should:

  • Provide a strong justification for the number of requested trainee positions.
  • Describe a multifactorial candidate review process (i.e., a process that considers metrics beyond previous institution, GPA, and standardized test scores) that will allow research-oriented trainees who have taken advantage of the research opportunities available to them and are committed to contributing to the biomedical research enterprise the ability to participate in the training program.   Programs are encouraged to consider individuals who have the potential to strongly benefit from, and with proper training and support, succeed in the program (see also, Program Considerations in section I above).

Retention Plans

Describe efforts to sustain the scientific interests as well as monitor the academic and research progress of trainees from all backgrounds within the program (i.e., retention). Applicants are encouraged to use evidence-informed practices for retention with the recognition that the variety of trainee educational backgrounds and experiences may necessitate the need to tailor retention approaches. Describe the specific efforts to be undertaken by the training program and how these might coordinate with broader trainee retention efforts of the institution(s).

Institutional Environment and Commitment to Training:

  • The application should describe how the level of institutional and departmental commitment to recruit, train, and retain the next generation of researchers and provide them with the coordinated support, resources, and networks they need to succeed and lead.
  • For institutions that have multiple NIH-funded training grants, explain what distinguishes the proposed program from existing ones at the same training level, how the programs will synergize and share resources when appropriate, and how the training faculty, pool of potential trainees, and resources are sufficiently robust to support the proposed program in addition to existing ones.

Training Outcomes:

This section is intended to provide outcomes for the program described in the application (or for new programs, to provide outcomes for recent graduates in similar training to the proposed program). The application should provide the information below about recent outcomes through narrative descriptions and a summary of the data presented in the required training tables. The application should describe the following:

  • Evidence that recent program graduates conducted rigorous research that advanced scientific knowledge and/or technologies, with increasing self-direction (e.g., peer-reviewed publications in Training Table 5, or other measures of scientific accomplishment appropriate to the field);
  • The rate of program completion and length of training (for predoctoral trainees, explain how time-to-degree Training Table 8 ).
  • The success of recent graduates transitioning to careers in the biomedical research workforce (Training Table 8).

Progress Report for Renewal Applications:

For renewal applications describe how the trainees gained technical, operational, and professional skills to transition into careers in the biomedical research workforce. Highlight how the training program has evolved in response to changes in relevant scientific and technical knowledge, educational practices, and evaluation of the training program. Describe successes and challenges with implementation of the programmatic elements described in the previous application (e.g., curricular elements, mentor training activities etc.) and provide justifications for failing to implement previously proposed programmatic elements. Include success rates for graduation and transitions to postdoc or careers in the biomedical research workforce.

Faculty, Trainees, and Training Record

Participating Faculty Biosketches:

Program faculty are encouraged to provide a personal statement that describes their prior experience with:

  • Training, mentoring, and promoting a supportive scientific environment.
  • Providing training in rigorous and unbiased experimental design, methodology, analysis, interpretation, and reporting of results.
  • Aiding and supporting trainees in identifying and transitioning into careers in the biomedical research workforce that are consistent with trainees' skills, interests, and values.

Letters of Support: 

Institutional Support Letter.  Applications are required to include a signed letter on institutional letterhead from a President, Provost, Dean or key institutional leader that describes the activities and resources provided by the institution that will ensure the success of the planned training program and the productivity of its trainees (not to exceed 10 pages). Institutional commitment to the following areas must also be described in the letter:

  • Developing and promoting a culture in which the highest standards of scientific rigor, reproducibility and responsible conduct are advanced.
  • Ensuring sufficient resources and support will be available to the training faculty and trainees, for example, to permit early stage faculty to participate in training and trainees to continue in training if their mentors experience a hiatus in research funding.
  • Supporting core facilities and technology resources and describing how they can be used to enhance training.
  • Providing adequate staff, facilities, and educational resources to the planned program.
  • Supporting the PDs/PIs and other key staff associated with the planned training program; ensuring faculty have protected time available to devote to mentoring, training and research; considering activities integral to excellent training (such as teaching and mentorship) in tenure and promotion decisions.
  • Promoting safe and supportive research training environments at all levels (trainees, staff, faculty, and leadership); ensuring the research facilities and laboratory practices promote the safety of trainees (see The NIH Grants Policy Statement Section 4 regarding NIH recipient institutions expectations to provide safe and healthful working condition for their employees and foster work environments conducive to high-quality research.
  • Ensuring that proper policies, procedures, and oversight are in place to prevent  discrimination, harassment and other discriminatory practices and to appropriately respond to allegations of such discriminatory practices, including providing any required notifications to NIH (see NOT-OD-20-124).
  • Providing the types and levels of support necessary for trainees to successfully complete the research training program.
  • Supporting evaluation of the training program and procedures for responding to evaluation findings.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

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.

Other Plan(s)

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Training Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

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 How to Apply- Application Guide must be followed.

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

See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply- 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads must include their eRA Commons ID in the Credential field of 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.

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 How to Apply - Application Guide

See more tips for avoiding common errors.

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

Mandatory Disclosure

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful 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 - Overall

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. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the proposed [Center] address the needs of the research [programs/projects/network/consortium/resource] that it will [coordinate/administer/serve]? Is the scope of activities proposed for the [Center] appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research [program/projects/network/consortium/resource]?

Specific for this NOFO

How will successful completion of the aims change the biomedical research capacity and/or the development of scientists who pursue biomedical research careers? How well articulated is the overall vision for the proposed program and how consistent is it with the goal to recruit, train, and retain trainees engaged in research in KUH mission areas and provide them with the coordinated support, resources, and networks they need to succeed and lead? 

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the [Center]? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing [adjective] research? Do the investigators demonstrate significant experience with coordinating collaborative [basic or clinical] research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their [leadership approach, governance, plans for conflict resolution, and organizational structure] appropriate for the [Center]? Does the applicant have experience overseeing selection and management of subawards, if needed?

Specific for this NOFO

How robust are the commitment and accomplishments of the applicants for preparing trainees across multiple career stages to transition into careers in the biomedical research workforce? 

Innovation

Does the application propose novel [organizational concepts, management strategies, or instrumentation] in coordinating the research [program/projects/network/consortium/resource] the [Center] will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of [organizational concepts, management strategies or instrumentation] proposed?

Specific for this NOFO

How does the overall vision and conceptual framework for the program present a novel approach to research training?

How novel and innovative are the proposed approaches to address trainees’ goals and prepare them for entry into the scientific research workforce?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research [program/projects/network/consortium/ resource] the [Center] will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the [program/projects/network/consortium/resource], as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the [program/projects/network/consortium/ resource] is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the [program/projects/network/consortium/resource]? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

Specific for this NOFO

How feasible and reasonable are the described approaches for fostering trainee networking and professional development?

Where and when applicable, how appropriate are the plans to include partnering institutions in all aspects of program management and decision-making?

How robust are the strategies for ongoing monitoring and evaluation of the program and plans for corrective action?

How robust is the approach to develop the local peer network, including the involvement of trainees in the design, implementation, and ongoing improvement of the program?

How robust are the plans for continual improvement of mentoring skills, as well as the approach to address mentoring shortcomings and recognizing excellence?

Environment

Will the institutional environment in which the [Center] will operate contribute to the probability of success in facilitating the research [program/projects/network/consortium] it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the [Center] proposed? Will the [Center] benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Additional Review Criteria - Overall

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.

Inclusion of Human Subjects Policies

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medicine Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

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.

Resubmissions

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

Renewals

For Renewals (as applicable), the committee will consider the progress made in the last funding period.

Revisions

For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations - Overall

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.

Applications from Foreign Organizations

Not Applicable

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).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For [programs/projects/networks/consortia/resources] 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.

Overall Impact-Training Core

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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

Training Program and Environment

  • Does the application provide a compelling rationale for the proposed research training program and propose appropriate training goals and objectives relevant to the rationale?
  • Will the courses, structured training activities, mentoring, and research experiences achieve the training program’s goals and objectives, and provide opportunities for trainees to acquire skill and expertise in transparent, rigorous, reproducible and relevant research methodologies and tools applicable to the goals of the training program?
  • Is there an effective mechanism to monitor mentoring and to promote the development, retention and success of all trainees throughout their training?
  • Will the proposed training program provide the trainees appropriate information regarding the breadth of careers in the biomedical research workforce for which their training may be useful, and appropriate learning opportunities that allow them to develop the professional skills and networks necessary to transition into those careers?
  • Does the research training environment have adequate and appropriate facilities to support the proposed research training program?
  • Is the level of institutional commitment to the training program, including administrative and research training support, sufficient to promote the success of the program?
  • Is it clear how the proposed training program is distinguished from other externally funded training programs at the institution?

Specific to this NOFO:

  • How well is the proposed program likely to recruit, train, and retain the next generation of non-malignant kidney, urologic, and/or hematologic researchers and provide them with the coordinated support, resources, and networks they need to succeed and lead?
  • How likely is the proposed program to produce a pool of trainees with the technical, operational, and professional skills necessary to conduct rigorous and reproducible research, and transition into careers in the biomedical research workforce? Reviewers should note that careers in the biomedical research workforce refers to the breadth of careers that sustain the biomedical research enterprise (which includes, but is not exclusive to, careers as independent NIH-funded investigators).
  • How are all available resources and partner institutions, if applicable, leveraged to maximize recruitment, training, and retention?

 

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

  • Do the PD(s)/PI(s) have the appropriate background, expertise, and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program?
  • Do the PD(s)/PI(s) plan to commit sufficient effort to promote the program’s success?
  • Have the PD(s)/PI(s) demonstrated a strong commitment to training future researchers?
  • Does the application describe how the PD(s)/PI(s) will receive appropriate training on effective mentoring practices to promote trainee success?
  • For applications designating multiple PDs/PIs:
    • Is a strong justification provided that the multiple PD/PI leadership approach will benefit the training program and the trainees?
    • 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 training program and the complementary expertise of the PDs/PIs?

 

Preceptors/Mentors

  • Does the proposed program demonstrate the presence of a sufficient pool of preceptors/mentors with appropriate expertise and adequate resources available to support the training goals and objectives proposed in the application?
  • Is there a strong plan to ensure participating faculty receive appropriate training in the use of evidence-informed mentoring practices in the biomedical sciences?
  • Do participating faculty appropriately promote the trainees' career progression?

 

Trainees

  • Does the proposed program demonstrate the presence of  a sufficient pool of potential trainees in appropriate disciplines and training stages to achieve the training program's objectives ( including short-term training, if applicable)? Do the recruitment strategies identify trainee candidates with the potential to strongly benefit from, and with proper training and support, succeed in the training program?
  • Does the program propose an appropriate multifactorial candidate review process to allow a broad group of research-oriented trainees the ability to participate in the training program (for example, a process that considers, consistent with applicable law, metrics beyond previous institution, GPA, and standardized test scores)?
  • Are there well-defined and justified selection and re-appointment criteria?

 

Training Record

  • How successful are the trainees (or, for new applications, recent graduates in similar training) in completing the program?
  • Does the application provide evidence that trainees (or, for new applications, other recent graduates in similar training) conducted rigorous research that, appropriate to the training stage of the proposed program, advanced scientific knowledge and/or technologies with increasing self-direction (such as peer-reviewed publications and other accomplishments appropriate to the field)?
  • How successful are the trainees (or, for new applications, recent graduates in similar training) in transitioning to careers in the biomedical research workforce that utilize their training and directly benefit the broader biomedical research enterprise?
  • Does the program propose a rigorous evaluation plan to assess the effectiveness of the training program and the extent to which it is meeting its overall goals and objectives? Are effective mechanisms in place for obtaining feedback from current and former trainees, and appropriate plans to respond to trainee feedback?

 

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 Human Subjects Policies

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.

 

Training in the Responsible Conduct of Research

All applications for support under this NOFO must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter – 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 training 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?

 

Training in Methods for Enhancing Reproducibility

Does the plan for Instruction in Methods for Enhancing Reproducibility describe how the program will provide training 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 trainees?

For renewal applications, does the application document appropriate changes in the plan for Methods for Enhancing Reproducibility in response to feedback and to evolving issues related to the conduct of rigorous and reproducible research? 

Resubmissions

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

Renewals

  • Does the application describe the program’s accomplishments over the past funding period(s)? Is the program achieving its training objectives?
  • To what extent have the training goals and objectives been achieved since the last cycle?  If certain goals were not met, did the program provide reasonable explanations and describe appropriate alternative approaches taken?
  • Has the program evaluated the quality and effectiveness of the training experience, and is there evidence that the evaluation outcomes and feedback from trainees have been acted upon?
  • Are appropriate changes proposed that are likely to improve or strengthen the research training experience during the next project period?
  • Does the program use current, evidence-informed training and mentoring approaches and continue to evolve and reflect changes in the research area in which the training occurs?

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific aspect of the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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.

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 CSR, in accordance with NIH peer review policies and practices, 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 of initial peer review will not be accepted for applications submitted in response to this NOFO.

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

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access their 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 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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 must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that 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.

Prior Approval of Pilot Projects

Recipient-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director’s Statement of Priorities, entitled “Advancing NIH’s Mission Through a Unified Strategy.” 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

  1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and
  2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

  • Ensuring adherence to the overall goals of the U2C-TL1.
  • All administrative, programmatic, and evaluation aspects of the U2C-TL1.
  • Recruiting and appointing trainees to the program and ensuring trainee progress towards program goals.
  • Coordinate and manage the training and development of research trainees and mentors in their respective institutions per the guidelines of this program.
  • Collaborating with the other funded U2C-TL1recipients in planning and executing the training programs relevant to this award.
  • Providing progress reports, when requested or agreed upon, that includes, but not limited to, information and data regarding the coordinated training programs to the NIDDK.
  • Developing and implementing programs and courses for trainee and mentor professional development.
  • Supporting the peer-to-peer trainee network infrastructure and ensuring continuity of the network throughout the project period.
  • Participating in any additional meetings and activities of the funded U2C-TL1programs to promote cross-program sharing of best practices.
  • Implementing the goals, priorities, procedures, protocols, and policies agreed upon by the Steering Committee and subcommittees.
    • The PD/PI or contact PD/PI in the case of multi-PD/PI awards will serve as a voting member of the Steering Committee and will attend all meetings of the Steering Committee.
    • Each full member will have one vote.
  • Recipients(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The NIDDK will designate program staff, including a Program Official and a Grants Management Specialist to provide stewardship and administrative oversight of the cooperative agreement. The Program Official and Grants Management Specialist will be named and provided in the Notice of Grant Award.

An NIDDK Project Scientist will have substantial involvement with the following responsibilities:

  • Serve as the primary point of contact for all facets of the interactions with the recipients.
  • Serve as a coordinator and facilitator for interactions between all the funded U2C-TL1 recipients.
  • Assist in guidance of the development of each U2C-TL1 recipients by providing advice and coordination.
  • Facilitate the partnership between the recipients and the NIDDK.
  • Promote communication between the recipients and the NIDDK.
  • Participate and facilitate the organizing of the annual meeting of the training program stakeholders.
  • Facilitate the overall interactions and collaboration between all the U2C-TL1 recipients with respect to overall program data capture and evaluation.

The NIDDK Program Official identified in the Notice of Award will:

  • Interact with the Program Director(s)/Principal Investigator(s) on a regular basis to monitor the progress of the overall training programs between and within all the Institutional Network Award recipients. Monitoring activities may include: regular communications with the PD(s)/PI(s), fiscal review, and other relevant matters; as well as attendance at the annual meeting, Training Program Evaluation Board meetings, and any other relevant meetings.
  • Review and approve any training programs across the U2C-TL1 in order to ensure that the programs are within the scope of the peer reviewed projects and within the NIDDK mission and goals.
  • Make recommendations for continued funding based on: a) overall progress; b) cooperation in carrying out the goals of the U2C-TL1 (e.g. attending any relevant meetings via in-person or virtual means, implementing the training programs; and compliance with the terms and conditions of award and reporting requirements); c) maintenance of a high-quality training program and sharing of any best practices that may develop within the network of recipients.

Areas of Joint Responsibility include:

Steering Committee (SC)

A Steering Committee organized by the study investigator(s) will be the main governing body of the study.

The Steering Committee has primary responsibility to develop the agenda for the annual meeting, coordinate data collection for evaluation purposes, and cooperate on the sharing of best practices and training resources developed by consortium members

The Steering Committee will be composed of all Program Director(s)/Principal Investigator(s), co-investigator(s) as deemed necessary, and the NIDDK Project Scientist. The final structure of the Steering Committee and voting procedures will be established at the first meeting. The NIDDK Project Scientist will have voting membership on the Steering Committee, and as appropriate, its subcommittees. All NIH staff combined will have one vote in support of the project. The frequency of Steering Committee meetings will be dictated by a vote of the members of the Steering Committee. The NIDDK Program Official may serve as a non-voting member on the Steering Committee.

A Chairperson of the Steering Committee will be selected and voted on by the Steering Committee members. The NIDDK Project Scientist may not serve as Chairperson. The NIDDK Program Official should be consulted regarding the selection of the Chairperson to provide any feedback regarding concerns regarding potential for bias or conflict of interest or lack of required expertise.

Training Program Evaluation Board:

An independent Training Program Evaluation Board may be established as agreed to by the Steering Committee and has the responsibility to review progress and develop recommendations for program improvements and collaborations. The Training Program Evaluation Board will provide written reports of their recommendations to the Steering Committee and the NIDDK Program Official.

Membership of the Training Program Evaluation Board will be established by the Steering Committee in consultation with the NIDDK Program Official.  The NIDDK Program Official will provide feedback regarding any concerns for bias or conflict of interest or lack of required expertise.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. 

4. Reporting

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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

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 submission by the due date, and post-submission issues.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

Scientific/Research Contact(s)

Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Email: NIDDK_KUH@nih.gov

 

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Grants Management Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Email: NIDDKGMBManagementTeam@niddk.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.

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 2 CFR Part 200.