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

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

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 Funding Opportunity Announcement 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. Together, each U2C/TL1 Award is expected to:

• 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.
• Enhance Career Preparation (U2C Professional Development Core). Promote interdisciplinary team science by exposing trainees 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.
• 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 should be able to use their skills to publish in the scientific literature, compete for additional research support, and be prepared to successfully navigate the next steps towards a scientific research career.

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 and preferred. Programs should be inclusive of all trainees across the entire research mission of the Division of KUH. In other words, trainees may be engaged in benign kidney, urologic, or hematologic research within a single program.

Overtime, 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

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 and 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 with 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 data 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 new, redesigned, 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 described in this FOA, or the Institutional Network Award, has been developed to address the needs of modern scientific research training as discussed at the workshop and is designed to strengthen institutional training supported by the NIDDK/KUH.

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/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 Section III.3) are strongly encouraged and preferred. 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 Funding Opportunity Announcement 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, each Institutional Network Award should accomplish the following objectives:

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, 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 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 pipeline;
• Strengthening participation in existing R25 summer undergraduate programs or NIDDK T35 programs (if applicable).

Professional Development Core: 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 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 courses (available depending on the trainee’s interests and needs). These could include those part of a formal degree-granting program (e.g. master’s in clinical investigation or public health) or other graduate-level courses in specific technologies, data science and statistics, or research methodologies.

Training Core (TL1): Interdisciplinary scientific recruitment and training

Programs should support a minimum of 5 trainees to engage in research across the fields of benign kidney, benign urology, and benign hematology.

• Research training plans should include tailored research experiences that reinforce skills development, the conduct of rigorous science, and provide for the development of independent lines of 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;
• 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.

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

Higher Education Institutions

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

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

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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 Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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

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

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

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 underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

The PD/PI should be an established investigator in the scientific area relevant to the mission of the Division of Kidney, Urologic, and Hematologic Diseases 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.

The PDs/PIs are expected to commit at least two person months and preferably three to six person months effort on the award annually. For programs with multiple PD/PIs, each PD/PI must contribute at least two person-months effort.

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

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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

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. 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 his or her 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

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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement 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.

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: NIDDKLetterofIntent@mail.nih.gov

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	6 pages
Admin Core	6 pages
Core (use for Professional Development Core)	6 pages
Network Core	6 pages
Training Core	25 pages

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

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)

When preparing your application, use Component Type Overall .

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

Complete entire form.

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

Follow standard instructions.

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.

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

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.

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each 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 inter-disciplinary training. Highlight 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: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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 (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

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).

Not applicable. Do not complete.

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

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.

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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.

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.

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 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.

Introduction to Application: For Resubmission 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 a 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: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide

• 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.

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

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).

Not applicable. Do not complete.

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.

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 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. 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.

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: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

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

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).

Not applicable. Do not complete.

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.

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 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 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 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: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

• 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

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).

Not applicable. Do not complete.

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.

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.

PHS 398 Research Training Program Plan (Training Core)

Introduction to Application: For Resubmission 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 inter-disciplinary 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 him/her to 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)

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

For information on how your application will be automatically assembled for review and funding consideration after submission go 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 Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

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

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

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 Funding Opportunity Announcement, note the following:

Reviewers will be asked to evaluate and score the following individual sections:

• The Administrative Core
• The Professional Development and Network Core (will receive a single, combined score)
• The Training Core

The overall impact score is not the average of these components, but will reflect a balance of all components.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the program 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 program 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 program that by its nature is not innovative may be essential to advance a field.

Does the proposed program address the needs of the research community that it will serve? Is the scope of activities proposed for the program appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research community? 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? Is the overall vision for the proposed program consistent with the goal of promoting an inter-disciplinary workforce within the benign kidney, benign urologic, and benign hematologic research fields? Do applicants provide a plan to measure and evaluate these goals?

Is the PD/PI capable of providing both administrative and scientific leadership to the development and implementation of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's intended goal is accomplished? If applicable, is there evidence that the participating faculty have experience in mentoring students and teaching science? If applicable, are the faculty good role models for the participants by nature of their scientific accomplishments? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Have the PDs/PIs demonstrated the ability to perform in a team environment to accomplish objectives that require coordination across multiple organizational entities?

Does the application challenge and seek to shift current paradigms by utilizing novel theoretical concepts, approaches or methodologies? Are the concepts, approaches or methodologies novel to one area of research education or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies proposed? 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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the goals of the program? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the program proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Are the described approaches for fostering trainee networking for those supported by the TL-1 component and inter-departmental collaboration reasonable and feasible?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Do the applicants describe a robust track record for preparing trainees across multiple career stages? Is there a track record of inter-departmental collaboration and is the institution well-positioned to promote inter-disciplinary research?

As applicable for the program 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.

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

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

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

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

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

Not Applicable

Not Applicable

As applicable for the program 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.

Not Applicable

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

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

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

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Core 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 program 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, an Administrative Core that by its nature is not innovative may be essential to advance a field.

Significance

Does the proposed Administrative Core address the needs of the program that it will coordinate? Is the scope of activities proposed for the Administrative Core appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the program? Will the proposed specific aims of the Administrative core, including organization, governance, collaboration, communication, and evaluation and continuous improvement result in successful management of the Institutional Network Award? To what extent have applicants provided information related to their capacity and commitment to collect metrics measuring the success of their Institutional Network Award? As proposed, will the annual, face-to-face meeting of the Institutional Network Award provide increased opportunities for networking and enhanced research training experiences for the trainees supported via the TL-1 component?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the program? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing research programs, research education programs, research training programs or networks? Do the PD(s)/PI(s) demonstrate significant experience with coordinating collaborative basic and clinical research? If the program 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 proposed program? Do the PD(s)/PI(s) have experience overseeing selection and management of subawards, if needed? Does/do the PD(s)/PI(s) have a track record of involvement in, or leadership of, successful efforts to enhance diversity within the biomedical research workforce?

Innovation

Does the application propose novel organizational concepts, or management strategies, in coordinating the program the Core 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 or management strategies proposed? Do the PD(s)/PI(s) make a strong case for the Institutional Network Award effectively reaching an audience in need of the program’s offerings? Where appropriate, is the proposed program developing or utilizing innovative approaches and latest best practices to improve the knowledge and/or skills of the intended audience? Does the application propose novel organizational concepts in coordinating the Institutional Network Award the Administrative Core will serve? To what extent are the PD(s)/PI(s) likely to contribute by means of collaboration with other similar Institutional Network Awardees to test innovative ideas in education?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the program the Administrative Core will serve? Will the investigators promote strategies to ensure a robust and unbiased 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 workflow and a well-established timeline proposed? To what extent will the Administrative core support and maintain ongoing communication between research, professional development, networking, and training components of the Institutional Network Award? Is the plan for program evaluation sound and likely to provide information on the effectiveness of the Institutional Network Award? To what extent are the applicants committed to developing metrics to identify best practices and opportunities for improvements of the Institutional Network Award? How well are the plans and vision for the annual, face-to-face meeting of the Institutional Network Award developed? To what extent has the applicant described how the interaction between the Institutional Network Award leadership and its External Evaluation Board will lead to identifying opportunities for improvement and action to mitigate any problems identified?

Environment

Will the institutional environment in which the Core will operate contribute to the probability of success in facilitating the program it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Core proposed? Will the network benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, organizations, and institutions? Is there tangible evidence of organizational commitment?

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 concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

Not Applicable.

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 concerns to the attention of the Scientific Review Officer.

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources

Generally not applicable. Reviewers should bring 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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Cores 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 program proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each of the criteria. Scores will be assigned to the named components (Professional Development Core and Network Core) as an aggregate. The aggregate does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a component that by its nature is not innovative may be essential to advance a field.

Significance

Does the proposed program address the needs of the research community that it will serve? Is the scope of activities proposed for the Professional Development Core and Network Core appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research program? Does the program address an important problem or a critical barrier to progress in research? How will successful completion of the aims change the biomedical research capacity and/or the development of a diverse pool of students who pursue biomedical research careers? Will the Professional Development activities enhance the competitiveness of the trainees supported via the Training Core for their next career stage? Are the approaches to developing and improving mentoring likely to result in effective mentoring of the target trainees supported by the Training Core? Will the Peer Network promote direct and open communication between trainees supported by the Training Core and across the institution? Will it enhance the overall training experience of the supported trainees? Are the outreach activities likely to enhance exposure and recruitment of participants into NIDDK/KUH science?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced biomedical research education efforts? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current paradigms by utilizing novel theoretical concepts, approaches or methodologies? Are the concepts, approaches or methodologies novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, proposed? Does the program outline novel didactic courses to improve participant competitiveness and mentor effectiveness? Do the networking activities utilize innovative approaches for promoting direct communication between trainees supported by the Training Core and across the institution? Are novel approaches described to promote outreach to neighboring undergraduate and high schools?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the program? Have the PDs/PIs presented strategies to ensure a robust and unbiased approach, as appropriate for the program proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed? Is the didactic curriculum well-designed and appropriate for the career stage of the trainees supported by the Training Core? Will the curriculum enhance their ability to engage in inter-disciplinary team science and collaboration? Are the strategies outlined to develop and improve mentors appropriate? Is the input of trainees supported by the Training Core adequately considered in mentor performance? Does the peer network utilize appropriate tools and approaches to promote peer communication? Are the plans to maintain the peer network reasonable? Are the strategies to include all institutional participants in the program appropriate? Are outreach activities appropriate and robust?

Environment

Will the institutional environment in which the program will operate contribute to the probability of success in facilitating the research community it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the proposed program? Will the program benefit from unique features of the institutional environment, infrastructure, personnel or collaborative arrangements? Are existing resources at the institution leveraged effectively to enhance the professional development of trainees supported by the Training Core and mentors?

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 concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

Not Applicable.

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 concerns to the attention of the Scientific Review Officer.

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources

Generally not applicable. Reviewers should bring 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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will produce a diverse pool of well-trained scientists with the skills necessary to conduct rigorous and reproducible research. The overall impact score should reflect reviewers 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 program proposed).

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

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 state-of-the-art scientific knowledge, methods, and tools that are relevant to the goals of the training program?

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 FOA:

Does the program present a cohesive training experience for the trainees that is likely to enhance their competitiveness for a career in interdisciplinary research?

Is the proposed training program likely to encourage trainees to pursue a career in benign kidney, benign urologic, or benign hematologic research?

Are institutional resources leveraged appropriately to enhance the training program?

Are the participating departments clearly committed to the success of the program?

Training Project Lead(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/post-doctorates in similar training) in completing the program?

Has the training program ensured that trainees are productive (or, for new applications, other past students/post-doctorates 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/post-doctorates 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 FOA:

Is the proposed evaluation framework appropriate and clearly tied to program goals?

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.

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

Not Applicable.

Revisions

Not Applicable.

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

Recruitment Plan to Enhance Diversity

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

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the 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?

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

Generally not applicable. Reviewers should bring 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.

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:

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

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:

o Scientific and technical merit of the proposed project as determined by scientific peer review.

o Availability of funds.

o Relevance of the proposed project to program priorities.

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

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

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

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

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

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

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

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. 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.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please 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 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

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 awardees 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees 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;
• Convening regular meetings of the External Evaluation Board;
• Cooperating with the other funded Institutional Network Award recipients in planning and executing the annual meeting of all program stakeholders;
• Providing information and data to the External Experts Panel as requested by the NIDDK/KUH;
• 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.

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 normal program stewardship and administrative oversight of the cooperative agreement. The Program Official and Grants Management Specialist will be named in the Notice of Grant Award.

The NIDDK will invite External Experts with relevant scientific expertise. The External Experts will meet to review the progress of the research projects and to advise NIH staff of scientific developments and opportunities that may enhance the achievement of the study goals.

An NIH IC Project Scientist will be substantially involved in this project above and beyond the normal stewardship of an NIH IC Program Official as follows:

• Coordinating and facilitating interactions between all funded Institutional Network Award;
• Help guide the development of each Institutional Network Award by providing advice and coordination;
• Facilitating a partnership with the NIDDK/KUH and ensure that the directions taken by the Institutional Network Award are consistent with NIDDK/KUH missions and goals;
• Promoting communication between the grantee and the NIDDK;
• Participating in organizing the annual meeting of program stakeholders;
• Facilitating interactions between the Institutional Network Award recipients.

Areas of Joint Responsibility include:

The NIDDK/KUH Project Scientist(s) and the PD/PI of the Cooperative Agreement award funded under this initiative will be jointly responsible for participating in initiative-wide activities and for establishing collaborations across awarded programs.

External Experts:

An independent panel of External Experts will be established by the NIDDK. The External Experts will review interim progress of the U2Cs periodically and report to NIDDK staff.

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 Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees 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.

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

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

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

Victoria Spruance, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-827-5091
Email: victoria.spruance@nih.gov

Jason D. Hoffert, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-496-9010
Email: jason.hoffert@nih.gov

Aricia Ajose
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-9023
Email: ajosea@mail.nih.gov

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.