Part 1. Overview Information

Key Dates

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.

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 Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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



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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose
The Division of Kidney, Urologic, and Hematologic Diseases (KUH) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) aims to reshape and refocus its Institutional Training Award (T32) program. Compared to the traditional NIDDK/KUH NRSA T32 programs, the program supported by this Notice of Funding Opportunity (NOFO) will have fewer, larger Institutional Network Awards (U2C-TL1). These U2C-TL1 awards will be designed to cultivate a highly integrated cohort of people and resources to propel KUH training and research. The U2C cooperative component will coordinate and provide administrative support for the Institutional Network Award activities, while the TL1 training component will allow the institution to recruit and fund at least 5 highly competitive pre- and/or post-doctoral trainees across K-, U-, and H-mission focused research. With coordinated support from an Administrative Core, each U2C-TL1 Award is expected to:

• Enhance Career Preparation (U2C Professional Development Core). Promote interdisciplinary approaches to prepare trainees for the next step in their scientific careers by exposing them to diverse and innovative technologies and critical research resources. Develop tailored and structured educational experiences, including specific training in professional development, leadership, entrepreneurship, and mentorship.
• Increase Networking and Outreach (U2C Networking Core). Coordinate a vibrant and dynamic cohort of K, U, and H trainees, including those supported directly by the TL1 component of this award and those institutional trainees already supported by other NIH training mechanisms, such as Fellowships (Fs), Career Development Awards (Ks), Short-term Training Grants (T35s), and Education Program Grants (R25s). Support a robust mentoring environment, including active peer-to-peer and alumni networks.
• Recruit and Train Interdisciplinary Researchers (TL1 Training Core). Fund highly talented trainees from demographically and scientifically diverse backgrounds via the TL1 component of this award.

Successful programs will provide an environment that will optimize the ability of trainees to conduct rigorous, ethical research to generate new knowledge, apply interdisciplinary approaches to research questions, and utilize principles of team-science to further their leadership and problem-solving skills. Programs should also support the development of a peer-to-peer network and provide ample career development resources for the community of K, U, and H trainees within the institution. Trainees who complete training under this program are expected to experience a strong, individually tailored, research foundation that permits them to communicate effectively through scientific presentations, compete for additional research support and be prepared to successfully navigate the next steps in a research or scientific career. Resources provided through the U2C activities are expected to accelerate the achievement of these milestones and enhance the establishment of a training community at the awardee institutions.

To foster a true community of trainees, applicant organizations may submit only one Institutional Network Award application. A single, consolidated application from several institutions within the same metropolitan area, that include multiple departments with a different research focus are strongly encouraged. Programs should be inclusive of all trainees across the entire KUH research mission. In other words, trainees may be engaged in benign kidney, urologic, or hematologic research within a single program. Institutional Network Awards applications that engage trainees across all three K-, U-, and H- disciplines are encouraged. While equal representation across these disciplines is not required, NIDDK encourages applicants to leverage available resources -- to the extent possible -- to maximize the training opportunities across K-, U- AND H- research. This may be accomplished by partnering with other departments within a given institution or by partnering with other institutions in the Metropolitan Statistical Area (if feasible). Multi-institutional applications are not required, but they are encouraged if partnership enhances the training environment and experience.

Over time, it is expected that each Institutional Network Award will actively participate in a nationwide program -- formed by the collection of individual KUH U2C-TL1 awards -- to train a cohort of researchers capable of achieving the scientific breakthroughs necessary to improve the care of people with kidney, urologic, and hematologic diseases

Background
The National Institutes of Health has supported institutional training programs since the enactment of the National Research Service Award (NRSA) legislation in 1974. NIDDK/KUH has historically supported institutional NRSA programs (T32s), primarily supporting the training of post-doctoral fellows in research areas relevant to the mission of the NIDDK/KUH. These individual programs were typically small and focused on individual departments, and at times resulting in multiple T32 programs at one institution with little research collaboration nor peer-to-peer networking among trainees across programs.

While the overall structure of the T32 program has remained static since its inception, the nature of scientific inquiry has evolved. Today’s scientists must be facile in utilizing many different and complex technologies and be able to work effectively within a team of researchers across several different disciplines. Solutions to difficult and complicated scientific questions within the NIDDK/KUH research mission demand trained researchers who are able to employ their skills in a team-based setting and apply rigorous experimental approaches utilizing novel techniques. In order to develop this workforce, training programs must evolve to provide trainees with these necessary skills.

The NIDDK/KUH is committed to supporting the development of this new generation of scientists and has recently evaluated many of its training and career development programs to examine the contribution of these programs to our research workforce. The evaluation revealed that trainees supported by T32s had the lowest retention in the workforce as measured by application and acquisition of subsequent NIH support compared to other programs (e.g., NRSA fellowship awardees and career development awardees). In response, the NIDDK/KUH convened a workshop in May 2019, inviting all stakeholders in institutional training programs to discuss best training practices and consider new approaches to training. The summary of this workshop is available at https://cjasn.asnjournals.org/content/early/2020/04/02/CJN.14741219.

Based on the outcomes of this workshop and our own divisional evaluation practices, NIDDK/KUH seeks applications for institutional training programs (U2C-TL1). This opportunity is in lieu of NIDDK/KUH participation in the traditional NRSA (T32) institutional training program. The U2C-TL1 program, or the Institutional Network Award described in this NOFO, has been developed to address the needs of modern scientific research training as discussed at the workshop and is designed to strengthen institutional and individual training supported by the NIDDK/KUH.

Programmatic Approach
Each application for an Institutional Network Award will consist of two parts, which are linked at the time of application but will be separated at the time of award, and will maintain their own, separate budgets:

• U2C Award: Cooperative mechanism that provides central coordination and resources to support the following components, as well as administrative support for these activities
  • Administrative Core
  • Professional Development Core
  • Networking Core
• TL1 Award: Training mechanism to support the pre- and post-doctoral trainees
  • National Research Service Award (NRSA) Training Core

The U2C and TL1 will be separated upon award and each component will maintain its own Principal Investigator/Program Director (PI/PD) and budget. However, in order for an award to be made, there must be a competitive U2C and a competitive TL1 component. In other words, no TL1 award will be made unless the associated U2C is also funded. Applicants are expected to submit only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) per receipt date. A single consolidated application from several institutions within the same metropolitan area (see definition in Section III.3) are strongly encouraged. Each application should propose to support at least 5 trainees across benign K, U, and H research areas through the TL1 award. Upon receipt of an Institutional Network Award, any participating institution is expected to relinquish all active T32s supported by the NIDDK/KUH, thus consolidating NIDDK/KUH research training under the single U2C-TL1. In addition, no subsequent new NIDDK/KUH U2C-TL1 applications will be allowed from the awarded institution.

Note: While this NOFO is designated as "Clinical Trial Not Allowed", appointed Trainees are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor.

Specific Objectives:
With coordinated support from the Administrative Core (U2C), each Institutional Network Award should accomplish the following objectives:

Professional Development Core (U2C): Enhanced career preparation

Programs should provide the necessary professional development resources to ensure the acquisition of knowledge and skills needed to navigate a research career pathway. These resources may include:

• Grants-writing and/or scientific writing workshops or courses;
• Presentation and communication workshops or courses;
• Business management and/or entrepreneurship courses for scientists and engineers;
• Leadership training and mentor training to prepare trainees to manage their own research teams in the future;
• Technical electives (available depending on the trainee’s interests and needs), that could include parts of a formal degree-granting program (e.g., master’s in clinical investigation or public health) or other graduate-level courses in specific technologies, research methodologies, or data science and statistics.
• Innovative approaches to training that promotes the incorporation of diverse perspectives across the spectrum of scientific careers.

Networking Core (U2C): Increased networking and outreach

Institutions should foster a community of trainees by developing the infrastructure to support peer- and near-peer networking opportunities across the funded institution(s), encompassing all NIH-supported trainees in K-, U-, and H-mission focused research (not only trainees directly supported by the TL1 portion of the Institutional Network Award). This should include:

• Developing and maintaining a virtual platform for trainee interaction that is trainee-led and provides an open forum for all trainees (including local Fellowship (F) and Career Development (K) awardees) to exchange ideas and troubleshoot issues;
• Leveraging current seminar series and other educational opportunities to promote inter-departmental crosstalk and team science;
• Developing community outreach programs (i.e. to undergraduate schools and/or local high schools) to promote research opportunities in NIDDK/KUH mission areas and continue to foster a robust research ecosystem to attract talent to KUH research;
• Strengthening participation in existing R25 summer undergraduate programs or NIDDK T35 programs (if applicable).

Training Core (TL1): Interdisciplinary scientific recruitment and training

• Programs should support a minimum of 5 trainees to engage in KUH research. Research training plans should include tailored research experiences that reinforce skills development, the conduct of rigorous science, and provide for the development of meritorious lines of future investigation;
• Programs should develop innovative strategies to recruit trainees from a variety of scientific backgrounds. Recruitment efforts should be broad-based, engaging scientific communities across the research spectrum;
• Programs should especially consider outreach strategies that will enhance the recruitment of trainees from underrepresented groups in science. See NOT-OD-20-031 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html);
• Programs that focus on recruitment of clinical fellows should include recruitment outreach to disciplines that can enhance research perspectives in NIDDK/KUH mission areas. Such disciplines may include, but are not limited to, critical care, neurology, endocrinology, geriatrics, pediatrics, gynecology, in addition to the traditional clinical disciplines of nephrology, urology, and hematology-oncology;
• Recruitment of basic science pre-doctoral and post-doctoral fellows should include plans to target students and fellows across all scientific disciplines and describe specific strategies to enhance outreach to undergraduate, graduate and engineering schools, as well as medical school departments that support basic science investigation.

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

Section II. Award Information

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The PD/PI should be an active investigator in the scientific area relevant to the mission of NIDDK/KUH and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI 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/PI will be expected to monitor and assess the program and submit all documents and reports as required.

The NIDDK encourages multiple PDs/PIs, particularly when each brings a unique perspective and skill set that will enhance the training program. At least one of the multiple PDs/PIs 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 PDs/PIs, 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 training goals.

In keeping with the effort to enhance the involvement of individuals from diverse backgrounds and perspectives in training, and in providing role models that bring diversity to a training environment, it is strongly encouraged that institutions include women and/or individuals from diverse backgrounds when forming the leadership team of the program.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Number of Applications Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed. A single consolidated, application from several institutions within the same Metropolitan Statistical Area, as defined by the Office of Management and Budget (MSA, https://www.whitehouse.gov/omb/information-regulatory-affairs/statistical-programs-standards) is strongly encouraged and preferred. A MSA consists of the county or counties (or equivalent entities) associated with at least one urbanized area of at least 50,000 population, plus adjacent counties having a high degree of social and economic integration with the core as measured through commuting ties (https://www.census.gov/programs-surveys/metro-micro/about/glossary.html). To assist applicants in determining the boundaries of MSAs, please utilize the delineation files resource at the U.S. Census website (https://www.census.gov/geographies/reference-files/time-series/demo/metro-micro/delineation-files.html) or contact the NIDDK program staff listed below..

Additional Information on Eligibility for the Training Core (TL1)

Preceptors

The program faculty should be active researchers in the sciences as demonstrated by recent publications and research support. When building a training team, programs should include faculty who are committed to training, mentoring, and providing supportive and inclusive research environments. Programs are encouraged to build a diverse team of mentors that includes, for example, faculty from underrepresented groups (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html), women, and faculty at different career stages (i.e., junior as well as senior faculty). In addition to demographic diversity, including program faculty across a broad range of scientific disciplines is also strongly encouraged.

Trainees

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.

Trainees may include predoctoral and post-doctoral fellows with diverse backgrounds (defined as demographic and/or scientific diversity). 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 NIH awarding unit.

• Pre-doctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA appointment and be enrolled in a program leading to a Ph.D. or an equivalent research doctoral degree program. Health-professional students who wish to interrupt their studies for one year or more to engage in full-time research training before completing their formal training programs, are also eligible. The use of training grant support in the first three years of graduate research training is strongly encouraged to provide maximum flexibility in the participation in courses, laboratory rotations, professional development, and cohort-building activities.
  
• Postdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a Ph.D., M.D., D.D.S., D.M.D., or comparable doctoral degree from an accredited domestic or foreign institution. Comparable doctoral degrees include, but are not limited to, the following: D.C., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng.D., Dr.PH., D.N.Sc., D.P.T., Pharm.D., N.D. (Doctor of Naturopathy), D.S.W., Psy.D., 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.
  

Additional information on postdoctoral eligibility: postdoctoral trainees are expected to be individuals who have received a doctoral degree (or equivalent) and are engaged in a temporary and defined period of mentored advanced training to enhance the professional skills and research independence needed to pursue their chosen career path. (See the NIH-NSF Definition of a Postdoctoral Scholar. (PDF-85 KB)).

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 and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

John Connaughton, Ph.D.
Chief, NIDDK Scientific Review Branch
Telephone: 301-594-7797
Email: [email protected]

Page Limitations

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required (Minimum: 1; Maximum: 1)
• Administrative Core: required (Minimum: 1; Maximum: 1)
• Professional Development Core: required (Minimum: 1; Maximum: 1)
• Network Core: required (Minimum: 1; Maximum: 1)
• Training Core: required (Minimum: 1; Maximum: 1)

Overall Component

When preparing the application, use Component Type Overall .

All instructions in the SF424 (R&R) 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 for promoting high-quality, collaborative, training in the mission areas of the NIDDK/KUH.

Research Strategy: This section should address the overall vision and mission of the program, the institutional track record of supporting inter-disciplinary training in the mission areas of the NIDDK/KUH, evidence of collaborative, inter-disciplinary research, 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 inter-disciplinary science within the mission areas of the NIDDK/KUH. Applicants should lay out a clear mission statement and discrete goals for their program, describing strategies aimed at trainee professional and scientific development and expectations for success.
• Address the vision for integrating current K, U, and H focused departmental training programs into a single institutional program. Strategic goals may include providing incentives for participation, promotion of inter-departmental collaborations, increased resource and facility sharing, and dissemination of scientific expertise.
• Describe the vision for engagement of trainees at all career stages at their institution and their vision for outreach to high school and undergraduate students to promote interest in research. Applicants should also describe their vision and strategic goals for peer-networking and peer-to-peer mentoring with the program.

Institutional Track Record of inter-disciplinary training

Describe the institution’s record over the last five years in promoting interdisciplinary training. Highlight the accomplishments of recent trainees that have benefited from such training.

Institutional Record of Collaborative Research

Describe the institution’s track record over the previous five years in inter-departmental collaborative research. Describe high-impact publications or advances that demonstrate successful collaborations.

Fostering of a Trainee Cohort

Describe institutional programs and incentives for promoting trainee interaction and communication across the participating departments. Describe any incentives provided by the institution to promote trainee engagement in professional development activities and outreach activities. Describe the overall vision for enhancing trainee engagement across several career stages (undergraduate to junior faculty).

Letters of Support: Letters of Support should describe the institutional support for the program and commit 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: Not applicable

Generally, Resource Sharing Plans are expected, but they are not applicable for this NOFO.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

All instructions in the SF424 (R&R) 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 the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (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 SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, 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 SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed.

Not applicable. Do not complete.

PHS Assignment Request Form (Overall)

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

Administrative Core

When preparing your application, use Component Type Admin Core.

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

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 regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• 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 PDs/PIs 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 Overall PIs and Core Directors across all U2C cores and the TL1 core should not exceed six calendar months per year. This applies across all U2C cores and the TL1 core. Minimum effort requirements for PIs of the application will no longer be in effect, though effort commitment should ensure the success of the program. The six-months of salary support for the effort of all overall PI(s) and Core Director(s) can be divided amongst participating faculty as needed. There is no cap on other personnel effort, provided the total cost of the award adheres to the restrictions outlined above.

Additionally, applicants must include a budget for travel of the overall PDs/PIs and Core PDs/PIs to travel to the annual meeting. A budget for hosting the annual meeting once during the project period must also be included.

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 that clearly presents a pathway to attain the goal of the Institutional Network Award.

Research Strategy:
The overall goal of the Administrative Core is to provide and oversee program organization, governance, collaboration, communication, as well as evaluation and continuous improvement. The application should describe:

• The organizational and governance structure of the Institutional Network Award 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 for collaborative leadership and communication between various research, career development, and training components of the program.
• Plans to develop milestones and collect data to define and evaluate success of the Institutional Network Award, including metrics to evaluate preceptors.
• How quality of the program will be planned, monitored, and how corrective interventions will be implemented when needed.
• Plans for organizing one of the annual face-to-face meeting of all awardees supported by this FOA during the award period, in collaboration with the NIDDK. The meeting should aim to bring together all stakeholders and highlight the progress of the programs, including opportunities for all trainees to present their project and network with peers and mentors across all supported programs. It is expected that each grantee will host and organize one face-to-face meeting during the award period.
• Plans for establishing an External Evaluation Board (EEB), which should meet annually, to review progress and offer recommendations to the program PD(s)/PI(s). The applicants should describe the types of expertise to be represented on the EEB, which should be broad and include experts that can bring a range of important perspectives including, but not limited to training, education, basic, clinical and translational research. Applicants should describe their plan for EEB membership accordingly but should not specify names and should not contact potential EEB members in advance of review of the application.

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

Resource Sharing Plan: Generally, Resource Sharing Plans are expected, but they are not applicable for this NOFO.

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

PHS Human Subjects and Clinical Trials Information (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 SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

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 SF424 (R&R) Application Guide must be followed.

Not applicable. Do not complete.

Professional Development Core

When preparing your application, use Component Type Core.

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

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

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (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) (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 (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 regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (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 (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 Professional Development Core towards achieving enhanced trainee competitiveness in research and in developing and supporting effective mentoring by preceptors.

Research Strategy:

The overall goal of the Professional Development Core is to develop, and support, activities and curricula designed to enhance trainee competitiveness in research and other scientific careers. The Professional Development Core should also include programs to enhance preceptor training and continued improvement.

Trainee professional development

• Describe the 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.
• Describe didactic courses and informal forums to improve trainees ability to develop a focused scientific question and a competitive grant application. Describe additional didactic courses or workshops available to improve trainees technical skills in novel methodologies and exposure to emerging areas of science.
• Describe a formal approach for training in team science. Leveraging existing resources at and across any participating institutions is encouraged.
• Describe other innovative approaches to training the next generation of scientists
  
  Preceptor professional development
  
• Describe the approach to identify and train preceptors in effective mentoring. The approach can include formal didactic training and informal experiential training. Describe continuing education approaches for existing preceptors and how trainee evaluations of their training experience are utilized to improve mentoring. Describe approaches for providing support for improving less effective mentors and rewarding effective mentors.

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

Resource Sharing Plan: Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

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

PHS Human Subjects and Clinical Trials Information (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 SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

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 SF424 (R&R) Application Guide must be followed.

Not applicable. Do not complete.

Network Core

When preparing your application, use Component Type Network Core.

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

SF424 (R&R) Cover (Network 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 (Network Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Network 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) (Network 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 (Network 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 regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Network 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 (Network 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 Network Core towards developing a robust peer-to-peer network and collaborations across all trainees supported by this Institutional Network Award, as well as those trainees supported by either institutional or extramural training awards within the mission of the NIDDK/KUH.

Research Strategy:

The overall goal of the Network Core is to develop systems and processes that support direct peer communication and near-peer mentoring amongst all trainees supported directly by the TL1 component of this award, and including those institutional trainees already supported by other NIH training mechanisms, such as Fellowships (Fs), Career Development Awards (Ks), Short-term Training Grants (T35s), and Education Program Grants (R25s). The Core should also actively engage the institutional community to broaden exposure of NIDDK/KUH science to neighboring undergraduate and high schools. Community outreach to institutions that serve diverse students is particularly encouraged.

Trainee Peer Network

Describe the overall approach for developing a Peer Network. 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.

Describe how the Peer Network would be initiated and monitored.

• Describe plans for sustaining the Peer Network over the proposed project period.
• Describe how the Institutional Training program will continually engage and include trainees across the institution, even those not directly supported by the program, into the peer network.
• Describe collaborative activities that would support interaction and peer support across the institution.
  
  Community Outreach
  
• Describe plans to enhance outreach to and engage with pipeline training communities within the Institution’s metropolitan area. Pipeline communities include high schools, undergraduate institutions, as well as community colleges.
• Describe trainee involvement in developing and executing the outreach. If the institution also supports a KUH R25 Program, describe how the Institutional Network Award will synergize and collaborate with the undergraduate program.
• Describe any strategies for engaging trainees from diverse institutions in the training pipeline.

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

Resource Sharing Plan: Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

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

PHS Human Subjects and Clinical Trials Information (Network 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 SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

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 SF424 (R&R) Application Guide must be followed.

Not applicable. Do not complete.

Training Core

When preparing your application, use Component Type Training Core'.

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

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

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)

The Training Core Leader and any other individuals whose contributions are critical to the development, management and execution of the Training Core in a substantive, measurable way (whether or not salaries are reimbursed) should be identified as senior/key persons. These would include co-Leader(s), if applicable, and other Training Core staff.

• 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 regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

The Project Lead may not be the PD/PI 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/PI 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.

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.

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 Training Program 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 Sections
Appendix- Note that the Appendix should only be used in circumstances covered in the NIH policy on appendix materials.

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

Particular attention must be given to the required Training Data Tables. Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the applicant pool, faculty mentors, the educational and career outcomes of 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
Program Plan

Background:
Provide a rationale for the proposed training 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 address those challenges.

Proposed Training:
The PD/PI should describe program activities intended to develop the working knowledge needed for trainees to select among and prepare for the next step in varied research career options available in the biomedical workforce. For example, programs should provide all trainees with instruction and training in oral and written presentation and in skills needed to apply for individual fellowship or grant support. All postdoctoral trainees should also be provided with instruction in laboratory and project management.

Describe how the program activities provided in the Professional Development Core will be used to develop individualized trainee experiences in collaborative team science and interdisciplinary research approaches. Describe a framework for trainee development of abstract presentations, publications, and constructing a grant proposal.

Once trainees have been appointed to the TL1 award, the use of Individual Development Plans to plan and track career development is strongly encouraged. Applicants should describe how this tool is developed in consultation with the trainee and adapted over the training experience to reflect current training needs and experiences.
Training Program Evaluation:
Describe the conceptual framework for the training program evaluation, tying evaluation metrics to the stated goals of the program. Describe how trainee input will be incorporated into the evaluation to improve the program for the duration of the project period. Describe the role of the External Evaluation Board in program evaluation.

Institutional Environment and Commitment to Training

The sponsoring institution must assure support for the program, including ensuring the Training Core PD/PI and other Faculty will be afforded sufficient time to effectively manage the program. It is expected that all departments involved in the program will provide support letters, assuring commitment to the program goals for interdisciplinary training. For institutions with existing institutional training or career development programs, describe how this program is unique and how existing programs will either synergize with this program or are complementary to this program and, therefore, filling a different training niche.

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.

Program Faculty:

If any mentors will supervise a Trainee proposing to gain research experience in a clinical trial, provide documentation of his/her expertise, experience, and ability to provide guidance in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help them meet the study timelines.

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

PHS Human Subjects and Clinical Trials Information (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 SF424 (R&R) Application Guide, with the following additional instructions:

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Not applicable. Do not complete.

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH 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 the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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 the SF424 (R&R) Application Guide.

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.

Requests of $500,000 or more for direct costs in any year

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

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 the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular Notice of Funding Opportunity, note the following:

Reviewers will be asked to evaluate the following individual sections and assign component impact scores. The overall impact score is not the average for these components.

Administrative Core

• Demonstrated ability of the leadership team to coordinate, manage, and integrate the components of the proposed program
• The appropriateness of the plans to include partnering institutions in all aspects of program management and decision-making, if applicable
• The strength of the strategies for ongoing monitoring of the program and plans for corrective action
• The conceptual basis and robustness of the proposed evaluation plans for the program
• The planned approach for developing the annual meeting of trainees and other stakeholders
• The appropriateness of the proposed External Evaluation Board in terms of meeting frequency, progress metrics evaluated, and how feedback would be incorporated into the program

Professional Development Core

• The demonstrated ability of the Core leadership to develop and implement the proposed Core activities
• The strength of the planned trainee curricula, including how the curricula will be tailored to individual trainee goals
• The appropriateness of the courses and forums proposed to enhance trainees ability to successfully compete for extramural research funding
• The novelty and innovation of proposed approaches to address trainees goals and prepare them for entry into the research or scientific workforce
• The robustness of the approach to train trainees in team science and multi-disciplinary collaborative research
• The strength of the plans to prepare proposed sponsors for mentoring and for continued improvement of mentoring skills, as well as the approach to address mentoring shortcomings and recognizing excellence

Networking Core

• The demonstrated ability of the Core leadership to develop and implement the proposed Core activities
• The strengths of the approach to develop the Peer Network, including the involvement of trainees in the design, implementation, and ongoing improvement
• The strategies proposed to incorporate all NIDDK/KUH supported trainees and scholars into the peer network and activities of the program
• The robustness of the planned approach to provide collaborative opportunities across the career stages and departments of NIDDK/KUH-supported trainees
• The strategies proposed to engage potential partners within the applicants metropolitan or community area
• How well trainees are incorporated into the proposed outreach activities of the Core and how appropriate the plans are to synergize with existing R25 or T35 programs, if applicable
• The strengths of the plans to develop outreach to diverse institutions

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).

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 network that it will coordinate? 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 training and career development network?

Specific for this NOFO

How well does the program address an important problem or a critical barrier to progress in research or research education? How will successful completion of the aims change the biomedical research capacity and/or the development of a diverse pool 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 of promoting an interdisciplinary workforce within the benign kidney, non-malignant and hematologic research fields? How robust is the plan to measure and evaluate these goals?

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 career development and training activities? Do the investigators demonstrate significant experience with coordinating collaborative 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?

Innovation

Does the application propose novel [organizational concepts and management strategies in coordinating the career development and training network 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 proposed?

Specific for this NOFO

How does the overall vision and conceptual framework for the program present a novel approach to research training for those supported by the TL-1 component?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the career development and training network the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the network as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the network is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the network? Is 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 for those supported by the TL-1 component and inter-departmental collaboration?

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research network 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?

Specific for this NOFO

How robust is the track record of the applicants for preparing trainees across multiple career stages? How strong is the track record of inter-departmental collaboration and how well is the institution positioned to promote inter-disciplinary research?

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 Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable.

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

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

• Are the research facilities and research environment conducive to preparing trainees for successful careers as biomedical research scientists?
• Are the objectives, design and direction of the proposed research training program likely to ensure effective training?
• Do the courses, where relevant, and research experiences provide opportunities for trainees to acquire skill and expertise in transparent, rigorous, and reproducible research methodologies and state-of-the-art scientific methods and tools applicable to the goals of the training program, including relevant areas of data science?
• Does the program provide appropriate inter- or multidisciplinary research training opportunities?
• Is the proposed training program likely to ensure trainees will be well-prepared for research-intensive and research-related careers?
• Is the level of institutional commitment to the training program, including administrative and research training support, sufficient to ensure 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 cohesive is the training experience for the trainees, and how well will it enhance their competitiveness for the next stages of their careers?
• How well is the proposed training program likely to encourage trainees to pursue a career in benign kidney, benign urologic, or benign hematologic research?
• How are institutional resources leveraged to enhance the training program?
• How committed are the participating departments to the success of the program?

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

• Does the PD/PI have the scientific background, expertise, and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program?
• Does the PD/PI plan to commit sufficient effort to ensure the program’s 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

• Are sufficient numbers of experienced preceptors/mentors with appropriate expertise and funding available to support the number and level of trainees (including short-term trainees, if applicable) proposed in the application?
• Do the preceptors/mentors have strong records as researchers, including recent publications and successful competition for research support in areas directly related to the proposed research training program?
• Do the preceptors/mentors have strong records of training individuals at the level of trainees (including short-term trainees, if applicable) proposed in the program? Are appropriate plans in place to ensure that preceptors lacking sufficient research training experience are likely to provide strong and successful mentoring?
• If the program will support clinical trial research experience for the Trainees, do the mentor(s) who will supervise the Trainee(s) have the expertise, experience, resources, and ability to provide appropriate guidance and help the Trainee(s) to meet the timelines?

Trainees

• Is a recruitment plan proposed with strategies likely to attract well-qualified trainees for the training program?
• Is there a competitive applicant pool of sufficient size and quality, at each of the proposed levels (predoctoral, postdoctoral and/or short-term), to ensure a successful training program?
• Are there well-defined and justified selection and re-appointment criteria as well as retention strategies?

Training Record

• How successful are the trainees (or, for new applications, other past students/postdoctorates in similar training) in completing the program?
• Has the training program ensured that trainees are productive (or, for new applications, other past students/postdoctorates in similar training) in terms of research accomplishments, publication of research conducted during the training period, and subsequent training appointments and fellowship or career development awards?
• How successful are the trainees (or, for new applications, other past students/postdoctorates in similar training) in achieving productive scientific careers as evidenced by successful competition for research science positions in industry, academia, government or other research venues; grants; receipt of honors, awards, or patents; high-impact publications; promotion to scientific leadership positions; and/or other such measures of success?
• To what extent do trainees subsequent positions in industrial, academic, government, non-profit, or other sectors benefit from their NRSA-supported research training and directly benefit the broader biomedical research enterprise?
• Does the program propose a rigorous evaluation plan to assess the quality and effectiveness of the training? Are effective mechanisms in place for obtaining feedback from current and former trainees?

Specific to this NOFO:

How appropriate is the proposed evaluation framework and how clearly is it tied to program goals?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

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?

Resubmissions

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

Renewals

For Renewals, the committee will consider the progress made in the last funding period, including on the Recruitment Plan to Enhance Diversity, and Training in the Responsible Conduct of Research. Does the application describe the program’s accomplishments over the past funding period(s)? Is the program achieving its training objectives? Has the program evaluated the quality and effectiveness of the training experience (and when applicable, short-term training experience), and is there evidence that the evaluation outcomes and feedback from trainees have been acted upon? Are changes proposed that are likely to improve or strengthen the research training experience during the next project period (may not be applicable to short-term training)? Does the program continue to evolve and reflect changes in the research area in which the training occurs?

Revisions

Not Applicable

Additional Review Considerations

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

Recruitment Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of prospective individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

All applications for support under this 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?

Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

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

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

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

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 National Diabetes and Digestive and Kidney Diseases Advisory Council (NDDKAC). The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS Assurance of Compliance form (HHS 690)) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

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

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

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

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 (DHHS) grant administration regulations at 45 CFR Part 75, 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 award 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 the NIH as defined below.

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

• Ensuring adherence to the overall goals of the Institutional Network Award;
• All administrative, programmatic, and evaluation aspects of the Institutional Network Award;
• 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 Institutional Network Award recipients 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 Institutional Network Award programs 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 Institutional Network Award recipients;
• Assist in guidance of the development of each Institutional Network Award 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 Institutional Network Award 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 Institutional Network Award 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 Training network (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. 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 award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Training Program Evaluation Board 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 DHHS regulations 45 CFR Part 16.

3. Data Management and Sharing

Not Applicable

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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. 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

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

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

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

Tracy L. Rankin, Ph.D., M.P.H.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4748
Email:[email protected]

Jason D. Hoffert, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-496-9010
Email: [email protected]

Aricia Ajose
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-9023
Email:[email protected]

Section VIII. Other Information

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.