EXPIRED

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 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

Kidney disease is an important cause of illness and death in infants, children, adolescents, and teenagers. Kidney disease in childhood occurs within a developmental trajectory and can impair attainment of important milestones in growth, cognition, emotional development, and quality of life. The long-term consequences of childhood kidney disease extend into adulthood. Further, the incidence and impact of kidney disease in childhood are greater among underrepresented minorities and those with inconsistent access to pediatric care. The PCEN are expected to be an integral part of a national effort to improve the lives of children with kidney disease.

The causes of childhood kidney disease are often distinct from those in adults and include congenital anomalies of the kidney and urinary tract, primary glomerulonephropathies, acute kidney injury, hemolytic uremic syndrome, and genetic diseases. NIDDK funds several multicenter studies with pediatric participants including the multicenter Chronic Kidney Disease in Children study (CKiD), the Nephrotic Syndrome Study Network (NEPTUNE), Cure Glomerulonephropathy (CureGN), and the Polycystic Kidney Disease Research Resource Consortium (PKD-RRC). Further, the (Re)Building a Kidney Consortium (RBK), the GenitoUrinary Development Molecular Anatomy Project (GUDMAP) and the Kidney Precision Medicine Project (KPMP) represent valuable basic science resources for the pediatric nephrology research community. While progress has been made in molecular and genetic analyses that link specific gene products to normal and abnormal kidney growth and development and are causative in some human pediatric kidney diseases, much remains to be explored.

The NIDDK currently supports George M. O Brien Kidney and Urological Research Centers as well as the Pediatric Centers of Excellence in Nephrology (PCEN). Applicant institutions are expected to leverage existing institutional resources which may include O Brien Centers, Clinical Translational Science Awards, Institutional Network Awards for Promoting Kidney, Urologic, and Hematologic Research Training (U2C/TL1) and other research consortia.

Research Goals and Scope

The goals of the PCEN program are: 1. to attract new scientific expertise to the study of human pediatric renal physiology, kidney development, and pediatric kidney disorders; 2. to encourage multidisciplinary research in these areas; and 3. to develop the pediatric nephrology research community through a national research symposium, broad sharing of research resources, and a national Pilot and Feasibility grant program. These efforts are expected to lead to innovative approaches to study kidney disease in children and the eventual submission of substantial, competitive, investigator initiated research applications. The PCEN will complement the O Brien Kidney and Urological Research Centers and are expected to leverage existing institutional resources which may include Clinical Translational Science Awards, Institutional Network Awards for Promoting Kidney, Urologic, and Hematologic Research Training (U2C/TL1), and other KUH-funded consortia. It is anticipated that collaboration will occur among individuals in the clinical and basic sciences, including cell biology, molecular biology, immunology, genetics, epidemiology, biochemistry, physiology and pathology. Resources and studies that foster new approaches into the causes, early diagnoses and treatments, and where possible, prevention of these diseases and disorders are appropriate.

Each Center within the PCEN program will be thematically distinct, yet complementary to the national network of PCEN. The Centers will jointly arrange and sponsor a yearly, open, broadly advertised, scientific symposium featuring the research projects and biomedical cores at each site in the Bethesda MD/Washington DC area. Junior faculty will be particularly encouraged to present their work. Pilot and Feasibility awardees will present the results of their funded projects. (Further details provided below under Educational Enrichment activities).

The Pilot and Feasibility project application processes will be coordinated between Centers to avoid unnecessary duplication or conflicts and to attract and support the best people and ideas to further pediatric kidney research. (Further details provided below in section Pilot and Feasibility Program).

To promote collaboration, the PIs/PDs of each of the PCEN will have conference calls at least quarterly, joined by NIDDK program staff. It is anticipated these conference calls will include planning for the yearly open scientific meeting, coordination of widely publicized announcements and NIH-style reviews of Pilot and Feasibility project applications, and should include sharing of progress on research projects.

Project organization

Each PCEN will include:

• An Administrative Core, including an Educational Enrichment Program to promote a diverse and collaborative research environment and a national Pilot and Feasibility Program to solicit and fund pilot projects targeting innovative science and investigators new to pediatric kidney research.
• One or more interdisciplinary and complementary Research Projects.
• One or more Biomedical Research Cores that serve as local and national resources.

NOTE: In addition to the Administrative Core, a successful PCEN would require a minimum of three highly meritorious components (i.e. two Research Projects and one Biomedical Research Core, or one Research Project and two Biomedical Research Cores).

The use of an External Advisory Committee (EAC) for each PCEN is highly recommended. The EAC may advise the Center in areas of scientific direction, budget, policy, collaboration, etc.

Administrative Core

The Administrative Core supports the Research Center operations to foster its diverse, integrated activities and to address the goals of the PCEN Program. Where appropriate, the Administrative Core will work to leverage existing institutional resources including O Brien Kidney and Urological Research Centers, Clinical Translational Science Awards, Institutional Network Awards for Promoting Kidney, Urologic, and Hematologic Research Training (U2C/TL1), and other KUH-funded consortia. The Administrative Core will interact with its counterparts at the other funded PCEN sites as specified below. The Administrative Core will direct the Educational Enrichment Program and the Pilot and Feasibility program.

Key responsibilities of the Administrative Core are to:

• Ensure adherence to the overall goals of the Research Center and the PCEN program.
• Coordinate, manage and integrate the Research Center components and activities, which include coordinating ongoing research between the Research Projects and the Biomedical Research Core and sharing of Biomedical Research Core resources with local and outside researchers.
• Create mechanisms for internal monitoring, evaluation, and planning, including for the Research Center budget and personnel considerations.
• Establish and maintain internal communication and cooperation among all Research Center investigators.
• Establish and maintain communication and cooperation with the Administrative Cores of the other PCEN to coordinate the planning of the yearly scientific meeting and the national Pilot and Feasibility program.
• Track and document collaborative interactions, dissemination of research findings and sharing of research resources with the local and outside research community.
• Review and evaluate productivity and effectiveness of Research Center activities and create a mechanism for addressing deficits, including selecting and replacing Center personnel or changes in research strategy.
• Develop reports on research Center activities and progress for external review.
• Develop, administer, and maintain oversight of the Educational Enrichment Program.
• Inform the national research community about the opportunity for Pilot and Feasibility funding through the Center. Plan and administer NIH-style application and review processes.
• Administer and maintain oversight of the Opportunity Pool funds dedicated to the national Pilot and Feasibility Program.

PCEN Interactions: The PCENs will jointly sponsor and arrange a yearly, open scientific meeting that will be widely advertised to the broad research community. Each PCEN will contribute scientific presentations and opportunities for junior faculty. While each PCEN will fund their own Pilot and Feasibility awards, the topic areas, deadlines, and application reviews will be coordinated between Centers to make optimal use of the funds. In order to accomplish these interactions, the Research Center Directors and other relevant Center personnel will arrange web conferences at least quarterly.

Educational Enrichment Program: The Educational Enrichment Program should be designed to attract and engage individuals interested in careers in biomedical, behavioral, data analytic, and clinical research that are relevant to pediatric kidney disease. The Program may consist of seminar series, guest lectures, symposia or other activities that educate students, trainees, Research Center members, and the research community on how to develop and conduct sound research studies and how to utilize local and national resources and databases. These efforts could include webinars on how to explore data from other consortia including GUDMAP, KPMP, CKiD, Neptune, CureGN or non-DK cohorts that may have appropriate ancillary kidney outcomes. Students, fellows, and junior faculty should be encouraged to take full advantage of all Educational Enrichment Program events in order to complement their ongoing training and professional development. Support to attend meetings or engage in research experiences outside of an individual’s discipline is encouraged. Summer student experiences (at the high school, college and graduate or medical student level) are expected every year. Efforts to include under-represented minorities and participants from rural areas and under-resourced educational settings are strongly encouraged.

Pilot and Feasibility Program: The primary goal of the Pilot and Feasibility program is to solicit and fund pilot projects proposing innovative science and investigators new to pediatric kidney disease. Efforts to encourage applications from under-represented minorities are strongly encouraged. The awards are limited to (a) early stage investigators (ESIs) and New Investigators (NI) or (b) established investigators not previously involved in pediatric kidney research. Projects may represent new collaborations with current Research Center investigators and Cores. The PCEN will solicit applications broadly from the larger research community; Centers are not expected to make awards primarily or predominantly within their own institution. The Pilot and Feasibility program is not intended to support or supplement ongoing research of an established investigator. It is expected that Pilot and Feasibility projects will generate preliminary data to support future research applications, such as investigator-initiated research projects. Pilot and Feasibility research projects are expected to have total costs of $62,500 per year funded by an Opportunity Pool. Funding decisions regarding the Pilot and Feasibility applications will be based upon NIH-style peer review. Centers will report data on letters of intent received, applications reviewed, and awards made in their yearly RPPRs.

The Pilot and Feasibility Program funding should be requested through an Opportunity Pool within the Administrative Core’s budget and will be restricted to sole support of the Program. PCEN institutions may develop and co-fund joint Pilot and Feasibility activities.

Website: The Administrative Core will develop an easily navigated website that provides accessible information about the Center. It should highlight resources and protocols available through the Biomedical Research Cores, active Research Projects, Educational Enrichment activities, and the Pilot and Feasibility award application process. Other uses of social media to apprise the kidney research community of the work of the PCEN are encouraged. The Administrative Core will collect relevant analytics on the utility of their website and social media efforts (number of hits, frequent users, etc.) and those data in their annual RPPR.

Research Projects

Research Projects must be integrated with and contribute to the overall goals of the Center program. Discovery and hypothesis-generating projects that produce a research resource for the broader community are strongly encouraged. They may include clinical, translational, or basic science studies and are expected to propose innovative science performed by an interdisciplinary team. Projects should be designed to provide critical new information on pediatric kidney diseases and disorders and should foster and promote a robust community of diverse and highly trained scientists.

Research projects are encouraged to leverage insights and available resources from other NIDDK-sponsored studies, including data and biological samples available through NIDDK Central Repository (https://repository.niddk.nih.gov/home/).

Cutting-edge scientific investigations of the following are considered high priority; however, this list is not exclusive.

• Studies of renal disorders of genetic and congenital origin
• Identification and study of genes, gene mutations and molecular events involved in renal morphogenesis and differentiation
• Studies of immune-mediated renal disorders affecting children, including post-infectious glomerulonephritis, immunoglobulin A (IgA) nephropathy and lupus nephritis
• Clinical, cellular, and molecular studies of glomerular, tubulointerstitial and cystic kidney disease in children
• Studies of mechanisms and outcomes of acute kidney injury with relevance to infants and children
• Studies to understand renal causes of hypertension in infants and children
• Identification of risk factors and predisposing factors that contribute to the development and progression of kidney disease in infants and children
• Studies addressing the etiology, pathophysiology, and treatment strategies for end-stage kidney disease (ESRD) in infants and children
• Implementation science or intervention trials to improve care of children with kidney disease, ESRD, or kidney transplants.

Biomedical Research Core

A Biomedical Research Core is defined as a highly innovative, shared resource that provides specialized and essential services, techniques, or instrumentation to local and national Research Center investigators allowing studies to be conducted more efficiently and effectively. A proposed Biomedical Core should be used by one or more of the parent Research Centers Research Projects, be available for Pilot and Feasibility awardees, and must support the overall goal of making the PCEN a national resource for the pediatric kidney research community. The Biomedical Research Core should be easily accessible to investigators within and outside the PCEN and the sponsoring institution.

Examples of types of Biomedical Research Core resources may include, but are not limited to:

• Analysis, storage and distribution of unique data and samples
• Provision of specialized tools and technologies or access to specialized expertise
• Development, beta-testing and dissemination of specialty assays, methods and services
• Development, standardization and distribution of unique reagents and/or protocols
• Coordination and monitoring of recruitment of study participants and collection of clinical data and biological samples.

Biomedical Cores will be highly innovative and provide unique resources and/or technical contributions that are clearly distinct from those typically found at research institutions.

PCEN Director

The PCEN Director will be responsible for scientific and administrative leadership of the Center. One or more Associate Directors may be named. This role includes, but is not limited to the following duties:

• Maintaining the PCEN’s vision and ensuring the relevance of the Center’s goals to the NIDDK mission interests in kidney disease affecting infants, children, adolescents and teenagers.
• Ensuring internal communication and cooperation among internal Center investigators and with the other PCENs
• Oversight of the Administrative and Biomedical Research Cores, including the Educational Enrichment and national Pilot and Feasibility Programs
• Internal monitoring to ensure efficient and productive PCEN operations, including performance of all personnel
• Communicating with the NIDDK Program Staff and associated NIDDK Programs and Consortia, and with the outside research community
• Participation in meetings of the External Advisory Committee (EAC).

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

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

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

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

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH 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.
  • 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 PCEN Director must be an established investigator with demonstrated research accomplishments and prior success in obtaining external funding.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the 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.

Letter of Intent

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

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

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

The letter of intent should be sent to:

John F. Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7797
Email: [email protected]

All page limitations 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
• Administrative Core: required
• Cores (Use for each Biomedical Research Core)
• Projects (Use for each Research Project)

NOTE: In addition to the Administrative Core, a successful Research Center would require a minimum of three highly meritorious components (i.e., two Research Projects and one Biomedical Research Core or one Research Project and two Biomedical Research Cores, as a minimum).

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.

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Locations (Overall)

Enter primary site only.

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

Research and Related Senior/Key Person Profile (Overall)

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

Budget (Overall)

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

Applicants should also include:

• Support for the Center Director to devote a minimum of 2.4 person months to the Center, and at least 1.2 of those months must be within the Administrative Core to ensure adequate oversight of the center. If a multiple PD/PI application, the combined effort of the PD/PIs must be a minimum of 2.4 person months. Most Centers find the size and complexity of a PCEN warrant inclusion of a program administrator, so salary support for this individual should be included in the Administrative Core.
• Support for an Opportunity Pool of $125,000 or more per year (inclusive of all F&A costs) within the Administrative Core to support pilot and feasibility awards. The Center should not calculate F&A on the Opportunity Pool set aside. Rather, the Center should budget for costs associated with the administration of the Opportunity Pool (including key personnel) within the Administrative Core. The Center is also entitled to F&A costs on the first $25,000 of each subaward made from the Opportunity Pool. It is anticipated that the Opportunity Pool will support about 2 subawards per year over the 5-year project period of the Center (with each subaward being about $62,500 total costs per year). Please note that the F&A costs for the subawardee institution are included in the total costs of each subaward.
• Support for a yearly meeting jointly funded by all the Centers of the PCEN program. The meeting will include a session exclusively for PCEN members and an open portion with scientific presentations for the wider pediatric nephrology research community. Each Center will support in-person travel for PD/PI, Core Directors and Research Project Directors to Bethesda MD/Washington DC area.

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

PHS 398 Research Plan (Overall)

Specific Aims: State the overall goals of the Research Center and their significance to research in pediatric kidney disease. Summarize the general approach and expected outcomes and impact of the outcomes to achieving the goals of the Pediatric Centers of Excellence in Nephrology program, as outlined in Section I. Funding Opportunity Description.

Research Strategy:

Describe the major themes, goals, and objectives of the PCEN, including any background information. List the individual components (Research Projects and Cores, as well as the Education Enrichment and Opportunity Pool Programs) of the PCEN and explain their overall importance and contributions and how they will interact collaboratively to achieve the goals and objectives of the Center and the overall goals of the Pediatric Centers of Excellence in Nephrology program as outlined in Section I. This should include a vision statement that describes how the Center as a whole is greater than the sum of its parts. The Center should also describe the specific strategies through which the Research Center will support the broader pediatric nephrology research community and productively integrate with the other PCENs. Note the scientific and clinical disciplines represented in the Research Center components and respective, broad approaches for each Research Project (clinical, translational, and/or basic science). Inclusion of multiple institutions is permissible but must be strongly justified and requires specific descriptions of how Cores and Research Projects at different institutions will regularly and productively interact.

Describe the overall scientific and administrative framework of the Research Center. Include an organizational chart. Note research and/or administrative leadership of Research Center personnel and note their expertise. Provide a leadership plan for oversight and operations of the overall Research Center, including conflict resolution for Center personnel. Provide a brief description and rationale for any proposed consortia or additional consultants. Investigators should fully explore their institutions to identify critical, interdisciplinary expertise to support the research and outreach goals of the Center. Describe existing institutional resources including O Brien Kidney and Urological Research Centers, Clinical Translational Science Awards, Institutional Network Awards for Promoting Kidney, Urologic, and Hematologic Research Training (U2C/TL1), and other NIDDK-funded consortia, which could be leveraged to benefit the Research Center activities.

Describe the function of any External Advisory Committees (EAC) and proposed expertise to be represented, but do not list specific members. For renewal applications, please list members of the external advisory committee and provide a summary of their activities in the previous project period.

Facilities and Other Resources: Describe the existing environment and facilities briefly in the context of how the Center will use or change existing access, space, and usage. Scientific personnel and institutional resources capable of supporting the local and national research base must be available, but those listed should be tied to Center activites. Applicants should address how the institution and pertinent departments will commit to supporting the center, such as through dedicated space, staff recruitment, salary-support for investigators, pilot and feasibility program funding, dedicated or shared equipment, or other financial support for the proposed center.

Equipment: A listing of major, shared pieces of equipment tied to Center activities and to be used by Center members should be provided. Note: Specific research core facilities, equipment, and special resources should be listed in each proposed biomedical research core component.

Progress Report Publication List (renewal applications only): In this attachment, list the titles and complete references to all appropriate publications and manuscripts accepted for publication, that have resulted from the project since it was last reviewed competitively. Identify the core(s) utilized in association with the publication. Indicate if the publication resulted from a Pilot and Feasibility award. Only list publications once. Within individual biomedical research core descriptions, refer to publications associated within the core by number, as listed. Use an asterisk to indicate any publication that fails to cite Center grant support.

Letters of Support: Include all assurance letters from Center investigators clearly noting their active projects, expertise, availability, and effort commitments. Assurance letters from institutions should note financial, logistical, space and personnel support provided.

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.

The following modifications also apply:

All applications, regardless of the amount of direct costs requested for any one year, should address a Resource Sharing Plan including a Data Sharing Plan . Depending upon the work proposed the resource sharing plan may also need to include a Sharing Model Organisms Plan and a Genomic Data Sharing Plan.

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.

The following modifications apply:

Other Attachments: The following attachment should be included with the Center Overview Component in order to aid in the review of applications. The filename provided for the attachment will be the name used for the bookmark in the application image. All attachments need to be in .pdf format.

Institution Relation to Overall PCEN: Please title this attachment "Relation to Overall PCEN". In a single page, provide a chart or other visual depiction to illustrate the structure, interactions, and leaders of the institution and the PCEN.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form (Overall)

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

Administrative Core

When preparing your application, use Component Type Admin Core.

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

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

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

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

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

List all performance sites that apply to the specific component.

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

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The overall Research Center Director will serve as the Administrative Core Director

Budget (Administrative Core)

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

The overall Research Center Director will serve as the Director of the Administrative Core and will oversee all scientific and administrative activities of the Center. Support for the Research Center’s Director can be divided between the Administrative Core and a Biomedical Research Core or a Research Project with a minimum total level of effort of 2.4 person months (20%). The minimum level of effort for the Research Center Director (as Administrative Core Director) is 1.2 person months (10%). The Administrative Core may also include an administrative assistant(s), if justified.

The Administrative Core budget may request $125,000 or more per year to fund the Opportunity Pool Program (inclusive of all F&A costs) to support pilot and feasibility awards. The Center should not calculate F&A on the Opportunity Pool set aside. Rather, the Center should budget for costs associated with the administration of the Opportunity Pool (including key personnel) within the Administrative Core. The Center is also entitled to F&A costs on the first $25,000 of each subaward made from the Opportunity Pool. It is anticipated that the Opportunity Pool will support about 2 subawards per year over the 5-year project period of the Center (with each subaward being about $62,500 total costs per year). Please note that the F&A costs for the subawardee institution are included in the total costs of each subaward.

The Administrative Core budget must include sufficient direct costs per year to support the Educational Enrichment Program, with a minimum of $25,000 of direct costs specifically devoted to support for a summer student enrichment program. In addition to planning and supporting the yearly joint PCEN scientific meeting, the Educational Enrichment Program may support activities outlined in Section I and could include travel support for investigators to learn new laboratory techniques, develop new collaborations or engage in scientific information exchange. Additionally, the Administrative Core budget must include funds to support travel of the Research Center Director and senior/key personnel to attend the yearly joint PCEN scientific meeting.

Budget Justification: Describe the specific functions of all key personnel, consultants, collaborators, and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations. For years 2-5 of support requested, justify any significant increase or decrease in any category over the initial budget period. Identify such changes with asterisks against the appropriate amounts.

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 (Administrative Core)

Specific Aims: Describe the specific aims of the Administrative Core including the Educational Enrichment and Opportunity Pool Pilot and Feasibility programs.

Research Strategy:

The Administrative Core will serve as the primary managerial component for all activities of the Research Center. It will be responsible for the management of resources within the Research Center and outreach to the wider pediatric nephrology research community. The goals of this Administrative Core are to develop and maintain the relevant goals of the Research Center; coordinate, manage and integrate the Research Center’s components and activities, which includes coordinating ongoing research between the Research Project(s) and the Biomedical Core(s). The Administrative Core will work collaboratively and productively with the other PCENs on joint efforts including the annual scientific meeting and a collaborative approach to optimize the use of Opportunity Pool funds for Pilot and Feasibility awards.

Describe the organization and leadership plan of the Administrative Core, including the Educational Enrichment and the Opportunity Pool Programs, and their importance to the research theme of the Research Center. Describe the Administrative Core’s strategy for supporting the Research Centers specific aims and goals and cooperating with the other PCENs and with NIDDK program staff. Describe strategies for building and maintaining a functioning inter-and transdisciplinary team (bringing scientists out of their research silos and creating new ways of approaching research questions).

Describe an outreach plan whereby the Administrative Core will inform the wider kidney research community of the resources available through the Biomedical Research Cores, Research Projects, Educational Enrichment activities, and the Pilot and Feasibility awards. Describe plans for an easily navigated website and other social media strategies to provide information about Center activities.

Describe the strategy by which the Administrative Core will effectively lead, organize and provide (1) fiscal and resource management for the Research Center; (2) management of the Biomedical Core(s); (3) coordination for Research Project(s); and (4) effective interactions and collaborations with institutional resources that may support or enhance the efforts of the Research Center. Indicate who will be responsible for these activities. Describe the relationship and lines of authority and sanctioned by appropriate institutional officials.

In addition, outline the approaches to be utilized for (1) internal monitoring, including Research Center operations management, fiscal administration, personnel management, planning, budgeting and other appropriate capabilities; (2) establishing and maintaining internal communications and cooperation among Research Center investigators; and (3) reviewing productivity and effectiveness of Research Center activities, conflict resolution, and improving or terminating ineffective Research Projects or Cores.

Educational Enrichment Program

Describe the proposed activities of the Educational Enrichment Program. This Program may consist of seminar series, guest lectures, workshops, symposia, or other instructional opportunities that further the overall goals of the Research Center and broaden the reach of Center activities to the larger pediatric nephrology research community. Students, fellows, and junior faculty should be encouraged to take full advantage of all Educational Enrichment Program events. Travel support to attend meetings outside of the investigator’s or attendee’s discipline is encouraged.

Describe the organization, oversight, outreach efforts, and the procedures for overall assessment of the summer student enrichment experience. Describe plans to include students from under-represented minorities, rural areas and under-resourced educational settings.

Opportunity Pool Program

Opportunity Pool program will solicit and fund pilot projects targeting innovative science and investigators new to pediatric nephrology research. Project should be led by an (a) early stage investigator(s) (ESI(s)) or new investigator(s) (NI(s)) or (b) established investigator(s) not previously involved in pediatric nephrology research. Projects may represent new collaborations with current Research Center investigators and Cores, but the applicant pool is expected to be national, not limited to the Research Center institution. The application should describe how these studies or projects would be broadly solicited, how peer review will be arranged and conducted at the Administrative Core of the Center, and how the Center will work collaboratively with the other PCENs to avoid duplication of applications or funding.

The period of support for an Opportunity Pool Program study must reflect the scope of the work proposed. The maximum period of support is two years. Describe the internal institutional plans and procedures to ensure that all projects supported from this award will comply fully with all applicable Federal regulations, policies, and guidelines for research involving laboratory animals and human subjects, including the evaluation of risks and protections in project proposals, appropriate ethical oversight, and plans for data and safety monitoring for clinical studies and clinical trials, if applicable.

External Advisory Committee

Although optional, the use of an External Advisory Committee (EAC) for each Center is highly advisable. For new applications, the members must not be named in the grant application, although proposed areas of expertise may be noted. The process by which members are selected must be described in detail as part of the Research Strategy of the Administrative Core. This group, comprised of 3-5 members, may advise the Research Center Director and Center personnel in areas of scientific direction, budget, policy, collaboration, or other matters. Please do not contact potential EAC members before the review of the application has been completed. For renewal applications, please list members of the EAC that have served in the previous project period and provide a summary of their activities.

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, and all applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

The applicant can note that the Data Sharing Plan outlined in the Overall Component applies to the Project.

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.

Other Attachments: For renewal applications only, the following attachments should be included with the Administrative Core in order to aid in the review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image. All attachments need to be in .pdf format.

Educational Enrichment: Please title this attachment "Educational Enrichment" and list the previous Educational Enrichment activities during the last project period.

Summer Students: Please title this attachment "Summer Students" and list the names of students who participated in the summer program, noting their education level, school or institution, project worked on, and outcome of project during the previous project period.

Pilot and Feasibility: Please title this attachment "Pilot and Feasibility" and list the names of P&F awardees, noting their training level, institution, project title and outcome, during the previous project period.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Biomedical Research Core

When preparing your application, use Component Type Core.

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

SF424 (R&R) Cover (Biomedical Research 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 (Biomedical Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Biomedical Research 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) (Biomedical Research Core)

List all performance sites that apply to the specific component.

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

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

A Biomedical Research Core Director should be named and should contribute a minimum level of effort of 1 month (8.3%). The overall PD/PI may serve as a Biomedical Research Core Director. A Core Director with requisite expertise may devote greater effort to the core with justification. Salary support for technicians and other core personnel is allowable with justification in accordance with the volume and type of work in the core. Stipends (and tuition) for research trainees (e.g. graduate students, postdoctoral fellows) are not available through the Center.

Budget Justifications: Describe the specific functions of all Biomedical Core key personnel, consultants, collaborators, and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations. For years 2-5 of support requested, justify any significant increase or decrease in any category over the initial budget period. Identify such changes with asterisks against the appropriate amounts.

PHS 398 Research Plan (Biomedical Research Core)

Specific Aims: Describe the major function, capability, and objectives of the Biomedical Core(s).

Research Strategy:

A Biomedical Core must function as a highly innovative, shared resource that provides specialized and essential services, techniques, or instrumentation to Research Center investigators and to outside investigators involved in research in pediatric kidney disease. A Biomedical Core must act as a resource for the larger PCEN program and the nephrology research community. While the Biomedical Core should serve one or more Research Projects, significant capacity to act as a national resource for the larger nephrology community should be described in the application with sufficient allocation of resources.

Describe the purpose and objectives of the Biomedical Core(s) and its administration, organization, and operations. Describe the types of resources or services provided and how they will be useful to the Center and to the broader pediatric kidney disease research community. Describe the expected users and how they will be solicited or encouraged to use the Core. Describe how access to the Biomedical Core(s) by Research Center investigators and the larger nephrology research community will be prioritized, advertised, operationalized, and any fee structure. Describe how the Core will assist in accomplishing the scientific goals of the PCEN. Document cost-effectiveness and plans for quality control. If a Biomedical Core already exists, include a description of past services provided, new technologies developed, changes in protocols or Core administration, and publications that have arisen based upon Core services.

Provide a description of how the Biomedical Core(s) contributes to the goals of the Administrative Core, especially the Educational Enrichment and Opportunity Pool Programs.

In addition, provide the following information:

• Brief description of Core scientific, technical, and support staff functions

• Description of current and/or projected services to the Research Projects or other Cores

• Provide a summary of projected usage of Core services (e.g., assays performed, animals supplied, etc.) by Research Center Projects or other users, including PD/PI, name of grant, and funding source.

• For renewal applications, provide a maximum of one page summary (or a graphic visualization) of Core usage resource distribution and the 5 most impactful publications.

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.

The applicant can note that the Data Sharing Plan outlined in the Overall Component applies to the Project.

Research Project

When preparing your application, use Component Type Research Project.

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

SF424 (R&R) Cover (Research Project)

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 (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

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) (Research Project)

List all performance sites that apply to the specific component.

Research & Related Senior/Key Person Profile (Research Project)

• 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 (Research Project)

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

Minimum level of effort is 1.2 person months (10% effort) for the Project Leader. The salary amount charged to the PCEN grant must be commensurate with the time spent on project activities and is subject to institutional and NIH salary policies. A Research Center Director may also serve as a Project Leader. Salary support for technicians and other personnel is allowable with justification. Stipends (and tuition) for research trainees (e.g. graduate students, postdoctoral fellows) are not available through the Center.

Budget Justifications: Describe the specific functions of all personnel, consultants, collaborators, and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations. For years 2-5 of support requested, justify any significant increases, or decreases in any category over the initial budget period. Identify such changes with asterisks against the appropriate amounts.

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 (Research Project)

Specific Aims: Describe the research focus with any required background information, the overall goals and hypotheses, relevance to research in pediatric kidney disease and the Specific Aims of the project.

Research Strategy: Describe the research strategy of the Research Project in the same detail and format as expected for an investigator-initiated R01 grant application. Describe how the project might yield discoveries or generate hypotheses to advance research in pediatric kidney disease. If appropriate, describe how the project would result in the development of new tools or technologies that will advance research in pediatric kidney disease. In addition, include a description of the relationship of the Research Project to the other Research Projects and how the Project addresses the overall goals of the Research Center and the larger PCEN program. Describe how the Research Project will interact with the Research Center Cores and any planned interactions with the Educational Enrichment and Opportunity Pool Programs.

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.

The applicant can note that the Data Sharing Plan outlined in the Overall Component applies to the Project.

PHS Human Subjects and Clinical Trials Information (Research Project)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

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.

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

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

Section V. Application Review Information

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

For this particular announcement, note the following:

Reviewers will be asked to evaluate the following individual sections:

• Overall, to reflect their assessment of the likelihood for the PCEN to exert a sustained, powerful influence on the research field. The overall Research Center should be evaluated as an integrated research effort focused on kidney research. The relationship and contributions of each proposed Research Project(s) and Biomedical Core(s) to the overall Research Center goals will be evaluated and contribute to the overall impact score.

• Center Director (PD/PI),including leadership and commitment to the stated goals of the PCEN.

• Administrative Core,including committee structure, Center membership criteria, lines of communication, and description of approaches for enhancing diversity and inclusion. Within the Administrative Core reviewers will evaluate the following:

  • Pilot and Feasibility Program,including the organization of the overall solicitation and competitive review and selection processes, and monitoring of P and F Projects; and for renewal applications, the quality, appropriateness and outcomes of supported P and F Projects.

  • Enrichment Program,if requested, including the quality of proposed activities and likelihood for promoting new scientific collaborations and directions/approaches.

• Research base,including the focus, quality of research, collaborations among members, relevance to the Center's stated research focus, and for renewal applications, the maintenance, growth, re-focusing, or evolution of the research base.

• Each Biomedical Research Core,including the documented need for the proposed services; number of users; qualifications of personnel; management, including prioritization and responsiveness to the needs of the users; quality control management; and any appropriate developmental work.

• Each Research Project, will be evaluated using standard R01 review criteria.

In addition, for applications involving clinical trials: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the proposed Center address the needs of the Pediatric Centers of Excellence research program that it will administer? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research program?

Specific to this FOA: Have the applicants addressed the goals of the PCEN :1. to attract new scientific expertise to the study of human pediatric renal physiology, kidney development, and pediatric kidney disorders; 2. to encourage multidisciplinary research in these areas; and 3. to develop the pediatric nephrology research community through a national research symposium, broad sharing of research resources, and a national Pilot and Feasibility grant program)? Have the applicants demonstrated that the whole of the Research Center is greater than the sum of its parts?

Investigator(s)

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

Specific to this FOA: Is appropriate multi- or interdisciplinary expertise represented to achieve the goals of the Research Center? Is pediatric nephrology-relevant expertise represented in the Research Center either as a Director/Associate Director or as a Project investigator?

Innovation

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

Approach

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

Specific to this FOA: Are the strategies for achieving the goals of the Research Center well-defined and feasible? Are they likely to lead to a multi-disciplinary effort within the Research Center, advance kidney research, and increase the research capability of the larger pediatric nephrology research community? Are there adequate institutional plans and procedures to assure human research participants, including the evaluation of risks and protections in project proposals, and appropriate ethical oversight of funded projects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Environment

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

Specific to this FOA: Is there clear evidence of Institutional commitment to the Research Center such as space, protected time and/or additional financial support for cofounded activities such as the Educational Enrichment and Opportunity Pool Programs? Is there a suitable environment for Research Center interactions and cross-fertilization with scientists from other areas of expertise?

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.

Team Integration

• Will there be coordination, interrelationships, and synergy among the Research Projects and Cores as they relate to the central research goals?

• Will the Research Center structure enhance the value of the individual Research Projects?

• If proposed, is there strong justification for a multi-institution Research Center and a defined plan for how Cores and Research Projects at different institutions will interact?

• Are mechanisms proposed for regular communication among the Project Leaders and outside collaborators?

• Are the administrative structures in place for daily management of the Research Center, including internal evaluation of the Research Projects?

• Has the Research Center appropriately documented how it will integrate with other funded Pediatric Centers of Excellence in Nephrology?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the scientific progress and resource distribution made in the last funding period. The following will also be considered:

• Does the Center show evidence of fostering multi-disciplinary collaborations among Center members? Does it foster collaborations with other departments/institutions or NIDDK funded programs?
• Are the number and type of P and F awards well justified? Did the pilot and feasibility projects lead to independent grant funding and/or new Center members?
• Is the impact of research publications that acknowledge the Center sufficient to justify continuation of each Core or the proposed modification of a Core?
• Does the Center show evidence of continued success in securing peer-reviewed research funding related to the focus of the Center?

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

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

Overall Impact - Administrative Core

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

Scored Review Criteria Administrative Core

Significance

Does the proposed Core address the needs of the Research Center that it will serve? Is the scope of activities proposed for the Core appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research program?

Investigator(s)

Are the Core leader(s) and other personnel well suited to their roles in the Core? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing kidney research? Do the investigators demonstrate significant experience with coordinating collaborative basic and/or research? If the Core 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 Core? Does the applicant have experience overseeing selection and management of subawards, if needed?

Innovation

Does the application propose novel organizational concepts in coordinating the research 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, management strategies or instrumentation proposed?

Approach

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

Specific to this FOA: Does the application describe planning and administration of a national Pilot and Feasibility Program with broad outreach? Are the Educational Enrichment programs proposed broadly targeted and inclusive of students, fellows, and junior faculty both at the applicant institution and to the wider pediatric nephrology research community? Is there a feasible and well-thought out strategy for wide dissemination of the resources, projects and programs of the Center? Does the application include a plan to include students from under-represented minorities, rural areas and/or under-resourced educational settings?

Environment

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

Specific to this FOA: Is institutional support available to provide appropriate oversight of any awardee-selected human subjects research projects in the Opportunity Pool Pilot and Feasibility program?

Additional Review Criteria - Administrative Core

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.

Protections for Human Subjects

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

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects (//grants.nih.gov/grants/guide/url_redirect.htm?id=11175).

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed program involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research (//grants.nih.gov/grants/guide/url_redirect.htm?id=11174).

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section(//grants.nih.gov/grants/guide/url_redirect.htm?id=11150).

Biohazards

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

Resubmissions

Not applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period including outcomes of the Pilot and Feasibility program and the Educational Enrichment program.

Revisions

Not applicable

Additional Review Considerations - Administrative Core

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (//grants.nih.gov/grants/guide/url_redirect.htm?id=11151); 2) Sharing Model Organisms (//grants.nih.gov/grants/guide/url_redirect.htm?id=11152); and 3) Genomic Data Sharing Plan (//grants.nih.gov/grants/guide/notice-files/NOT-OD-19-023.html).

Authentication of Key Biological and/or Chemical Resources

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

Budget and Period of Support

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

Overall Impact - Biomedical Research Core(s)

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Biomedical Research Core(s) 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 Core(s) proposed).

Scored Review Criteria - Biomedical Research Core(s)

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 Core that by its nature is not innovative may be essential to advance a field.

Significance

Does the Core address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the Core are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the Biomedical Core(s) demonstrate innovation and high value contributions beyond conventional technical contributions typically found at a research institution?

Specific to this FOA: Will the resources or services of the Core assist in accomplishing the scientific goals of the PCEN? Does the Biomedical Core serve a Center Research Project(s)? Does the Biomedical Core have utility as a national resource to serve the larger pediatric kidney research community?

Investigator(s)

Are the Core Director(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 their field(s)? If the Core 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 research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions 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, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Core? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the Core involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Environment

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 Core proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria - Biomedical Research Core(s)

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.

Protections for Human Subjects

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

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects (//grants.nih.gov/grants/guide/url_redirect.htm?id=11175).

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed program involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research (//grants.nih.gov/grants/guide/url_redirect.htm?id=11174).

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section(//grants.nih.gov/grants/guide/url_redirect.htm?id=11150).

Biohazards

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

Resubmissions

Not applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period including past distribution of tools and services, new technologies developed, and publications that have arisen based upon Core services.

Revisions

Not applicable

Additional Review Considerations - Biomedical Research Core(s)

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (//grants.nih.gov/grants/guide/url_redirect.htm?id=11151); 2) Sharing Model Organisms (//grants.nih.gov/grants/guide/url_redirect.htm?id=11152); and 3) Genomic Data Sharing Plan (//grants.nih.gov/grants/guide/notice-files/NOT-OD-19-023.html).

Authentication of Key Biological and/or Chemical Resources

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

Budget and Period of Support

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

Overall Impact - Research Projects

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Research Project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Research Project proposed).

In addition, for applications proposing clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Scored Review Criteria - Research Projects

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 Research Project that by its nature is not innovative may be essential to advance a field.

Significance

Does the Research Project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the Research Project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA: Is this project likely to yield discoveries or generate hypotheses that would advance research in pediatric kidney disease?

In addition, for applications involving clinical trials:

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the Research Project leader(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 their field(s)? If the Research 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?

In addition, for applications involving clinical trials:

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions 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, instrumentation, or interventions proposed?

In addition, for applications involving clinical trials:

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Research Project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work 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? How will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the Research Project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials:

Does the application adequately address the following, if applicable:

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

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?

In addition, for applications involving clinical trials:

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria - Research Projects

As applicable for the Research 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.

Study Timeline

Specific to applications involving clinical trials:

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the Research Project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative databases, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

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

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects (//grants.nih.gov/grants/guide/url_redirect.htm?id=11175).

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed program involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research (//grants.nih.gov/grants/guide/url_redirect.htm?id=11174).

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section(//grants.nih.gov/grants/guide/url_redirect.htm?id=11150).

Biohazards

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

Resubmissions

Not applicable

Renewals

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

Revisions

Not applicable

Additional Review Considerations - Research Project

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (//grants.nih.gov/grants/guide/url_redirect.htm?id=11151); 2) Sharing Model Organisms (//grants.nih.gov/grants/guide/url_redirect.htm?id=11152); and 3) Genomic Data Sharing Plan (//grants.nih.gov/grants/guide/notice-files/NOT-OD-19-023.html).

Authentication of Key Biological and/or Chemical Resources

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

Budget and Period of Support

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

2. Review and Selection Process

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

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

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

Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council (NDDKAC). The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

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

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

Prior Approval of Pilot Projects

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

• The awardee institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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.

Not Applicable

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.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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 agreementsare required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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.

Section VII. Agency Contacts

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

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

Finding Help Online: 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: [email protected] (preferred method of contact)
Telephone: 301-945-7573

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

Susan R. Mendley, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-827-1861
Email: [email protected]

Paul Rushing, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8895
Email: [email protected]

Tommy Gunter
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-3447
Email: [email protected]

Section VIII. Other Information

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

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