Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Opportunity Title
Kidney Precision Medicine Project Central Hub (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
Reissue of RFA-DK-16-028
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-DK-20-029
Companion Funding Opportunity
RFA-DK-20-026 , U01 Research Project (Cooperative Agreements)
RFA-DK-20-027 , U01 Research Project (Cooperative Agreements)
RFA-DK-20-028 , U01 Research Project (Cooperative Agreements)
Assistance Listing Number(s)
93.847
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) requests applications for the Kidney Precision Medicine Project (KPMP) - Central Hub (CH) to support the KPMP cohort, collect and de-identify all existing and new clinical data and samples, and provide scientific, infrastructure, quality control, project management, and administrative support. The CH will collaborate with the Recruitment Sites (RS), Tissue Interrogation Sites (TIS), and Kidney Tissue Atlas Coordinating Center (KTACC) to obtain and evaluate kidney biopsies from participants with acute kidney injury (AKI) or chronic kidney disease (CKD), create a Kidney Tissue Atlas, define disease subgroups, and identify critical cells, interstitial components, pathways, and targets for novel therapies.

Key Dates

Posted Date
April 22, 2021
Open Date (Earliest Submission Date)
August 23, 2021
Letter of Intent Due Date(s)

August 23, 2021

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
September 23, 2021 September 23, 2021 Not Applicable March 2022 May 2022 July 2022

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
September 24, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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

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


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

Although AKI and CKD impose a significant global health burden, no effective therapies currently exist for AKI, and only a few for CKD. AKI and CKD have historically been described as single, uniform diseases. However, growing consensus suggests that they are interrelated and that different disease pathways lead to different subgroups of AKI and CKD (AKIs and CKDs). Access to human kidney biopsy tissue is a critical step to define disease heterogeneity and determine the precise molecular pathways that will facilitate identification of specific drug targets and ultimately enable individualized care for people with AKI and CKD.

As established in 2017, the objectives of the Kidney Precision Medicine Project (KPMP) are:

  • Diverse longitudinal cohort. Recruit adults from varied age, sex, racial, ethnic, socioeconomic, and geographic backgrounds with AKI and CKD to undergo protocol research biopsies linked to longitudinal clinical data and biosamples.
  • Public resource. Create a publicly available data hub with de-identified clinical, physiologic, imaging, cellular, and molecular data using FAIR principles (findable, accessible, interoperable, and reusable).
  • Kidney tissue atlas. Create a collection of maps to locate and classify different cell types and interstitial components accounting for health, disease, age, sex, race, ethnicity, socioeconomic, and geographic backgrounds. The atlas will help define disease subgroups and identify critical cells, interstitial components, pathways, and targets for novel therapies.
  • State/transition markers. Identify cellular and molecular markers that classify cells as healthy, injured, activated, or undergoing recovery via adaptive or maladaptive repair.
  • Clinical subgroups. Use all available data to define disease subgroups to allow for clinical stratification into distinct endophenotypes.
  • Molecular pathways. Identify and understand healthy and disease pathways that are activated in a cell type in a subgroup of people.
  • Biomarkers. Discover sets of subgroup and pathway biomarkers.

To fully meet these objectives, the KPMP aims to increase the number and diversity of individuals biopsied; enhance the throughput and depth of clinical and molecular phenotyping; expand the capacity of the KPMP bio-repository; and provide more dedicated effort to data analysis and visualization. As such, the second phase of the KPMP will include 4 distinct, but highly interactive activities:

  1. Recruitment Sites (RS): enroll adults with AKI and/or CKD from varied age, sex, racial, ethnic, socioeconomic, and geographic backgrounds into a longitudinal cohort study that includes a research kidney biopsy [RFA-DK-20-026; U01].
  2. Tissue Interrogation Sites (TIS): use and develop innovative technologies to analyze human kidney tissue [RFA-DK-20-028; U01].
  3. Central Hub (CH): collect and de-identify all clinical and social risk data and samples, and provide quality control, project management, and administrative support for the entire KPMP [this RFA-DK-20-029; U24].
  4. Kidney Tissue Atlas Coordinating Center (KTACC): clean, harmonize, store and curate all de-identified KPMP data, perform integrative analyses, and create an interactive Kidney Tissue Atlas [RFA-DK-20-027; U01].

Given the risk of complications from kidney biopsy, the KPMP will continue to hold ethical and participant safety considerations paramount. The KPMP will work closely with diverse patient partners (e.g., patients serving as study investigators) and KPMP research subjects (participants) to ensure that their viewpoints, priorities, and preferences inform all aspects. Participants have insurance through the consortium and participating medical centers will not charge them for costs associated with complications related to research kidney biopsies.

All aspects of the study will be governed by the KPMP Steering Committee (SC) and overseen by two NIDDK-appointed boards: (1) a Data Safety Monitoring Board (DSMB) focused on participant safety, study burden and scientific validity of the clinical data, and (2) a Consortium Management Board (CMB) focused on the overall scientific progress and direction.

All KPMP activities must meet rigorous sharing and quality assurance and quality control (QA/QC) standards, including the sharing of all data (including, but not limited to, raw data, metadata, digital pathology images, and computational data sets), protocols (including analytical methods), ontologies, technologies, biological samples (including, but not limited to, biopsies, nephrectomy tissue, tissue blocks, all slides in any form, blood, urine and stool), and other research resources. All de-identified KPMP data will be released to the research community immediately upon validation. KPMP data will only be made publicly available once the risk of explicit or inferred identification has been mitigated in consultation with the KPMP Community Engagement Committee and the DSMB. The CH will house all personally identifiable data (under the control of an Honest Broker), while the KTACC will house all de-identified data.

It is expected that the KPMP will seed future partnerships, ancillary studies, investigator-initiated endeavors, and industry collaborations, and play an active role in recruiting and training the next generation of kidney researchers. Importantly, this will include a dedicated effort to recruit, train, and retain underrepresented scientists and stakeholders.

Purpose

This Funding Opportunity Announcement (FOA) requests applications for the KPMP Central Hub (CH). The CH will have two coordinated responsibilities:

  1. Clinical Data and samples Coordinating Center (CDCC) to facilitate common clinical protocol development and modification; provide sample size and statistical calculations; collect, manage, and de-identify participant data and biosamples; monitor recruitment, retention, and follow-up of participants; establish and/or maintain a central laboratory and sample repository for all KPMP standardized assays and biological samples; coordinate sample (including biopsy tissue) tracking, storage, and distribution; lead efforts to ensure QA/QC of all data, workflows, and biosamples across the KPMP; ensure participant re-identification risk is minimized; and arrange for whole genome sequencing.
  2. Administrative Core (AC) to provide scientific leadership, project management, and administrative support; establish necessary working groups; develop and manage a central website for internal and external communication; solicit participant and provider input and feedback to inform all aspects of the KPMP; administer an Opportunity Pool of funds to address gaps or catalyze new partnerships; serve as the signatory institution on behalf of the KPMP for legally binding agreements negotiated with external collaborators.

Projects proposed in response to this FOA will need a multidisciplinary team including nephrologists, radiologists, pathologists, statisticians, ethicists, researchers with experience partnering with diverse communities, researchers with expertise in social determinants of health, biologists, bioinformaticians, website and software developers, data curators and managers, QA/QC specialists, administrators, contracting and legal experts, project managers, and patient partners (e.g. patients serving as study investigators). This FOA is not intended to support hypothesis testing. This application should allow for both animal studies and international collaboration via the Opportunity Pool.

Research Objectives

The KPMP CH will consist of a Clinical Data and sample Coordinating Center (CDCC) and an Administrative Core (AC).

Essential objectives include:

  1. Clinical Data and sample Coordinating Center (CDCC)
  • Oversee the renewal of the KPMP common research kidney biopsy protocols and the retention of currently enrolled KPMP participants.
  • Monitor and report on study progress to ensure optimal and diverse enrollment, participant safety and retention, rigorous execution of the study protocol, and exceptional data quality.
  • Train and monitor performance of KPMP study personnel.
  • Manage the KPMP repository of protected health information (PHI). Develop plans for secure capture of PHI, to be controlled by a dedicated Honest Broker, and processes to minimize risks of PHI disclosures and participant re-identification.
  • Manage the KPMP central laboratory and repository of biosamples.
  • Ensure QA/QC of all data, workflows, and biosamples across the entire KPMP.
  • Arrange for whole genome sequencing.
  1. Administrative Core (AC)
  • Develop and support KPMP-wide governance, goal setting, and milestones.
  • Coordinate interactions of the KPMP investigators with oversight bodies (i.e., DSMB and CMB).
  • Establish necessary working groups (including a Community Engagement Committee).
  • Represent the KPMP to external partners and develop a process to formalize external partnerships.
  • Communicate KPMP goals and achievements to appropriate stakeholders in the community. Solicit their input and feedback to inform KPMP efforts.
  • Create and administer an Opportunity Pool to address gaps or form new partnerships.
  1. Collaboration and Sharing
  • Work collaboratively as a member of the KPMP SC to identify important scientific questions, adapt to new findings, and update protocols and policies as appropriate to the study goals and participant safety.
  • Lead efforts to develop common protocols and QA/QC systems to bridge discovery science and clinical science and improve outcomes for people with kidney disease.
  • Participate in working groups and sub-committees as an active member of the KPMP community. This includes the AKI /CKD adjudication committee.

Expected outcomes from the project period will be:

  • Adhere to the highest ethical principles of clinical research.
  • Support common clinical protocol development and revisions, provide biostatistical and data management support.
  • Lead a KPMP-wide effort to maximize QA/QC.
  • Ensure participant re-identification risk is minimized.
  • Work collaboratively with the KPMP investigators and adhere to sharing policies.
  • Implement and strictly adhere to FAIR principles.
  • Contribute to the scientific output of the KPMP.

Due to the rapidly changing biological and biomedical research landscape it will be essential for the CH to be flexible and adapt to changes in data types and technologies, and to package data appropriately with the possibility of mobilizing data to a cloud environment.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New
Renewal

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

Clinical Trial?

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

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIDDK intends to commit $14,660,000 in FY 2022 to support four related funding opportunities, RFA-DK-20-026, RFA-DK-20-027, RFA-DK-20-028 and RFA-DK-20-029.

We expect to award 1 Central Hub under this Funding Opportunity Announcement.

Award Budget

The direct costs for the U24 award are expected to be approximately $2,200,000 per year (excluding opportunity pool). Applicants may ask for $1,000,000 or more per year for the opportunity pool. All Opportunity Pool costs are inclusive of any F&A for the Central Hub and the subawardees. As such, the Central Hub should not calculate F&A on the Opportunity Pool set aside.

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

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

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

Other

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

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

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

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

Required Registrations

Applicant organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research 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.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

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

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Statement of willingness: The filename "Willingness Statement.pdf" should be used. The statement should be signed by a business official on organization letterhead and should include the following information:

  • Key Personnel will plan and attend the KPMP launch meeting September 20-22, 2022 in Bethesda MD/Washington DC.
  • The study investigators will cooperatively interact with the NIDDK in support of the KPMP.
  • The study investigators will actively seek input from the NIDDK regarding resource or expertise needs.
  • The study investigators will make available to the KPMP any preliminary data included in this application upon award.
  • The study investigators will work collaboratively with other KPMP investigators on weekly/monthly conference calls, Working Groups, SC meetings, and in the dissemination of research findings consistent with all Publications and Presentations (P&P) policies (as determined by the SC).
  • The study investigators will accept common protocols (https://www.kpmp.org/for-researchers#protocols) and agreements (https://www.kpmp.org/for-researchers) developed by the KPMP.
  • The institution will select and rely on the KPMP single Institutional Review Board (sIRB).
  • The institution and the study investigators will sign the KPMP Confidential Disclosure Agreement (CDA, https://drive.google.com/file/d/1VfTWMXus2c51R5c9L2sBZ-5mu67mUEXy/view) and Material/Data Transfer Agreement (MTA, https://drive.google.com/file/d/1NJMhDkIChP4XI3kMq9bCFeS1pYj1m2f9/view) documents. No edits to either the CDA or MTA will be allowed.
  • Negotiate and execute Research Collaboration Agreements to facilitate partnerships with Industry (Pharmaceutical and Biotechnology), external partners in academia, and nonprofit institutions on behalf of the consortium in a pre-competitive research arena to expand the scope, size, and/or sophistication of the KPMP.
SF424(R&R) Senior/Key Person Profile

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

    • A key individual (KPMP Project Manager) with the track record and expertise to manage a large, complex scientific consortium and run the day-to-day operations of the CH should be included.
    • A key individual (Quality Coordinator) with appropriate clinical laboratory medicine expertise to effectively lead, and be responsible for, a KPMP-wide effort to maximize the QA/QC of all data, workflows, and biosamples, including the implementation and surveillance of fit-for-purpose internal and external controls should be included.
    • A key individual (Communication Coordinator) to develop an overarching KPMP Communication Plan and coordinate efforts to educate the broader research and patient community about the goals, objectives, activities, and progress of the KPMP should be included.

R&R Budget

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

    • PD(s)/PI(s) will be required to declare a minimum effort of 2.4 person-months (20 percent) effort per year. Applications proposing Multiple PD(s)/PIs(s) must have a minimum combined PD/PI effort of 2.4 person-months. Applications that do not propose this minimum effort with be withdrawn and will not be reviewed.

Applicants should also include:

  • Support for the single/central Institutional Review Board to manage the KPMP biopsy protocol for all KPMP sites (CH, KTACC, RS and TIS).
  • Support for training of clinical site personnel in data and sample collection, RS initiation visits, site monitoring and quality control.
  • Establishment and maintenance of a central laboratory and sample repository with the necessary capacity and throughout to meet the KPMP objectives. Budget for shipment of biopsies and biosamples to and from the central laboratory and sample repository.
  • Do not budget for whole genome sequencing on all study participants or for shipment of biosamples to the NIDDK Central Repositories.
  • Website and software development and data storage costs including costs associated with moving data to a cloud-based environment in the final budget period.
  • Support for the activities as member(s) of the SC, including in-person travel to Bethesda MD/Washington DC area at least two times per year throughout the project period, including the launch meeting anticipated for September 20-22, 2022.
  • Travel, lodging and per diem for four patient partners and twelve CMB members to attend two SC meetings per year in Bethesda, MD/Washington, DC.
  • Support for an Opportunity Pool of $1,000,000 or more per year (inclusive of all F&A costs) to address gaps or catalyze new partnerships. The CH should not calculate F&A on the Opportunity Pool set aside. Rather, the CH should budget for costs associated with the administration of the Opportunity Pool (including key personnel) within the AC. The CH 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 40 subawards over the 5-year project period of the CH (with each subaward being about $112,500 total costs per year). Please note that the F&A costs for the subawardee institution are included in the total costs of each subaward.
R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: Applicants should propose to continue support for the KPMP cohort, collect and de-identify all clinical data and samples, and deliver scientific, infrastructure, QA/QC, project management, and administrative support.

Research Strategy: Applicants should organize the Research Strategy in the subsections identified below.

1) Overview

The Overall section of the application should describe proposed plans for the organization and staffing of the CH, how the components of the organization, including key personnel, will interact and ensure efficient cooperation, communication and coordination, and how the proposed organization of the individual cores (CDCC and AC) will create an integrated entity capable of effectively providing scientific, infrastructure, and administrative support for the entire KPMP and facilitating the KPMP objectives.

Include the following:

  • An organizational chart showing the two required CH responsibilities (CDCC and AC), as well as any additional organizational entities, identifying the proposed PD(s)/PI(s), the CDCC and AC leaders, and staff serving in a senior role.
  • A discussion of governance, internal and external communication, and coordination concepts important to the success of a large, multicomponent project.
  • Considerations of protocol design and implementation, the development of the KPMP biosample repository and data collection, and the principles and procedures for data and biosample de-identification (under the control of an Honest Broker).
  • A detailed description of the relevant expertise, experience, and accomplishments of the applicants in the successful planning, direction, coordination, and management of a complex multi-institution consortium like the KPMP

Clinical Data and samples Coordinating Center (CDCC). This section of the application should propose plans to facilitate clinical protocol development; ensure the highest ethical standard will be used by study personnel; ensure the safety of all participants; provide sample size and statistical calculations; collect, curate, manage, and de-identify participant data and biosamples; monitor recruitment, retention, and follow-up of participants; coordinate sample (including biopsy tissue) tracking, storage, and distribution; lead efforts to ensure QA/QC; and facilitate whole genome sequencing. Include an organizational chart listing the tasks that this Center will accomplish. Identify the types of staff associated with each task and describe their respective roles and responsibilities. Discuss prior experience in coordinating research networks and present examples of challenges that were encountered, and solutions offered.

The Clinical Data and samples Coordinating Center (CDCC) should outline plans to:

  • Provide oversight to ensure adherence to the highest ethical, research, and clinical standards and any required regulatory standards in line with the Regulatory Policies and Guidance document found on the NIDDK Policies for Clinical Researchers web page at https://www.niddk.nih.gov/research-funding/human-subjects-research/policies-clinical-researchers.
  • Coordinate the renewal of a standardized kidney biopsy protocol for implementation at the RS. Ensure the study protocol is optimized to encourage participation of and promote health equity for participants from Hispanic, Black, and Indigenous racial and ethnic groups who bear a disproportionate burden of kidney disease, but are often excluded from research.
  • Ensure safety of participants before, during, and after the biopsy procedure.
  • Coordinate with the RS for the continued longitudinal follow-up of currently enrolled participants as per the KPMP protocol.
  • Coordinate the development of study protocols and a longitudinal cohort study of diverse participants with AKI and CKD.
  • Monitor and report on study progress toward enrollment and retention goals.
  • Describe the sIRB or the process for its selection. Include a statement confirming that participating sites will adhere to the sIRB Policy (https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm) and describe how communications between sites and sIRB will be handled.
  • Develop uniform case report forms and manage sIRB submissions on behalf of the KPMP investigators.
  • Ensure that appropriate sIRB approvals and appropriate participant consent are obtained for data and sample acquisition, transfer, and use.
  • Monitor adverse complications and prepare regular reports for the DSMB and CMB. Do not propose DSMB or CMB members.
  • Provide sample size calculations and statistical advice.
  • Lead KPMP-wide efforts to establish and monitor QA/QC plans and metrics, including dynamic measurements that can be quantified and compared to a threshold metric or benchmark. Discuss the inclusion of fit-for-purpose internal and external controls. Name an overall Quality Coordinator with appropriate clinical laboratory medicine expertise who will be ultimately responsible for QA/QC of all KPMP data, metadata, workflows, and biosamples.
  • Conduct standard clinical data assessments, including development of data reports, recruitment tables, observational study reports, and QA/QC evaluation, etc.
  • Ensure the capture of data that measures social determinants of health to assess social risk of participants (e.g., socioeconomic status, food insecurity, residential segregation, perceived discrimination, measures of stress/allostatic load).
  • Develop and coordinate staff training and tutorials for all KPMP activities, including participant recruitment and retention, biopsy performance, participant safety, return of results, biological sample collection, interrogation, and handling, etc.
  • Develop Electronic Health Record (EHR) integration plans for the RS and encourage (re)incorporation of study and diagnostic data back into EHR systems as feasible and appropriate.
  • Develop rigorous processes to ensure participant re-identification risk is minimized. Data will only be made publicly available once the risk of explicit or inferred identification has been mitigated. Name a neutral third party as an Honest Broker, who can provide de-identified data and samples to the KPMP.
  • Catalyze the incorporation and harmonization of clinical data and samples from other existing longitudinal cohorts and share de-identified data with the KTACC.
  • Establish and maintain a central laboratory and sample repository for the entire KPMP. Include a plan to archive biosamples and clinical data at the NIDDK Central Repositories.
  • Arrange for whole genome sequencing on all study participants. Do not budget for whole genome sequencing.

Administrative Core (AC). This section of the application should propose plans to lead and coordinate the operations of the KPMP, establish necessary working groups (including a Community Engagement Committee), and administer an Opportunity Pool to address gaps or form new partnerships. Include an organizational chart listing the tasks that the AC will accomplish. Identify the types of staff associated with each task and describe their respective roles and responsibilities. Discuss prior experience in coordinating research networks and engaging diverse communities in research; present examples of challenges that were encountered, and solutions offered. The structure of the proposed AC should identify lines of authority, personnel with specific responsibilities for internal function, contracting and legal agreements, and personnel with financial responsibilities for the management of the CH Award.

The Administrative Core (AC) should outline plans to:

  • Lead, coordinate and manage common research activities and harmonize aspects of the work conducted by the KPMP to promote synergy and reproducibility.
  • Coordinate all functions of the SC, DSMB, and CMB and their interactions with the KPMP investigators.
  • Organize and support at least two face-to-face, or virtual if necessary, meetings of the SC per year, the first to be held in September 2022.
  • Provide travel and other expenses for the DSMB and CMB.
  • Provide scientific, technical, administrative, operational, and logistical support for working groups tasked by the KPMP SC (e.g., Clinical Recruitment and Retention, Publication, External Collaboration, Community Engagement, Data Integration).
  • Develop procedures to require study investigators and others associated with the study to identify financial and other conflicts/dualities of interest on a routine basis, at least annually, and share this information with the NIDDK.
  • Identify fixed and variable project costs, establish procedures for oversight of subawards/subcontracts, and develop processes to efficiently administer and manage throughout the project.
  • Negotiate, establish, execute, and manage agreements (e.g., confidentiality, data sharing, publications, research collaboration) between all KPMP investigators and other external collaborators, including but not limited to, interactions with organizations from industry, academia, and nonprofit institutions.
  • Present a Management Plan to rapidly build an effective trans-KPMP team employing expertise in group dynamics/performance and systems thinking to enhance stakeholders’ engagement in shared decision-making and shared accountability for setting and reaching goals. Name an overall Project Manager with appropriate track record and expertise to run the day-to-day operations of a large, complex scientific consortium.
  • Develop an overarching KPMP Communication Plan to educate the research and patient communities about the goals, objectives, activities, and progress of the KPMP. Address strategies to handle serious adverse events which may be experienced by KPMP participants. Name an overall KPMP Communication Coordinator.
  • Lead a Community Engagement Committee to involve diverse kidney disease patient partners, clinicians, and other stakeholders in all aspects of the KPMP. The Community Engagement Committee should:
    • Identify key patient-centered factors to be included in the development of common protocols for obtaining informed consent and performing kidney research biopsies.
    • Develop novel approaches for actively engaging relevant and diverse local stakeholders (e.g., participants, physicians, IRB representatives, ethicists, providers) in the development of research kidney biopsy protocols that ensure safety, minimize risk and adhere to the principles delineated in federal guidelines for research.
    • Identify and promote best practices to ensure equitable engagement of participants from Hispanic, Black, and Indigenous racial and ethnic groups.
    • Disseminate engagement strategies, based on patient partner, patient participant and provider input.
    • Develop and implement a plan for continued engagement with participants as the research progresses, including a patient-centered information system for participant use that will offer clinical diagnoses for the enrolled participants and their providers and update them on the progress of research in the KPMP Consortium.
    • Solicit participant and provider input and feedback to inform all aspects of the KPMP.
    • Contribute to a communication plan to disseminate proposed operating procedures and results to the larger research and patient communities in collaboration with the KPMP Communication Coordinator.
  • Create and administer an Opportunity Pool to address gaps or form new partnerships. The organization of the Opportunity Pool Program should be flexible as the size and use of the pool may change, but at a minimum, it should:
    • Support the KPMP SC in its yearly assessment of infrastructure and resource needs.
    • Help develop and publicly announce requests for applications, advertise solicitations, manage acceptance, and organize external peer-review.
    • Establish an administrative structure to disburse and track awards.
    • Establish procedures, formats, and timelines for integrating awardees and monitoring and reporting progress and outcomes (e.g., publications, subsequent awards).
    • Establish a plan to integrate and harmonize the activities of supported projects with the activities of the KPMP.
    • Allow for both animal studies and international collaboration via the Opportunity Pool.

2) Scientific, Technical and Management Strategy

  • Briefly describe the key features of the application that highlight any conceptual, technical, and/or methodological innovations.
  • The Opportunity Pool will promote adoption of emerging technologies and approaches that may be unknown at the time of application. Applicants should outline a plan to adapt to evolving objectives and approaches.

3) Milestones and Timelines

  • Provide a timeline and milestones. Milestones are objectives that create go/no-go decision points in the project and must include clear and quantitative criteria for success. Milestones should function as indicators of continued progress, thus revealing emergent difficulties, and will be used to evaluate the application not only in peer review, but also when considering the awarded project for funding of non-competing award years. Timelines must state when metrics for assessment of progress will be achieved.
  • Provide appropriately detailed (quantitative) criteria by which milestone achievement will be assessed.
  • Provide a detailed timeline for the anticipated attainment of each milestone and the overall objective.
  • Identify any impediments that could require modification to the research plan, milestones, and/or timeline with a discussion of alternative approaches.

4) Activities and Management of the Multidisciplinary Team

  • Present a plan to rapidly build an effective trans-KPMP team employing expertise in group dynamics/performance and systems thinking to enhance stakeholders’ engagement in shared decision-making and shared accountability for setting and reaching goals.
  • Clearly describe the formal organizational structure of the multidisciplinary team, including lines of authority and responsibility, with attention to the relationship of the organizational structure to the major objectives of the KPMP.
  • Document the collaborative nature of the research team and emphasize the qualifications, past performance, and experience of the key personnel, particularly working on actively managed, milestone-driven projects.
  • Discuss how the diverse expertise of the team members increases the capability for innovation, the ability to anticipate new directions, and the flexibility to redirect research when needed.
  • Propose the use of collaborative tools to track consortium-wide progress toward milestones.
  • Discuss how the site will promote active participation in all relevant KPMP activities, including community engagement and weekly adjudication of biopsies.
  • Describe the role of the Quality Coordinator, a key individual with appropriate clinical laboratory medicine expertise, who will be ultimately responsible for QA/QC of all KPMP data and metadata; processes, protocols, and workflows; and biosamples across the network, including the implementation and surveillance of dynamic metrics that can be quantified and compared to a threshold metric. Discuss the inclusion of fit-for-purpose internal and external controls.
  • Describe the role of the Honest Broker, a neutral third party, responsible for sharing de-identified data and samples with the KPMP.
  • Describe the role of the KPMP Project Manager, a key individual with the appropriate track record and expertise to manage a large, complex scientific consortium.
  • Describe the role of the Communication Coordinator, a key individual who will develop an overarching KPMP Communication Plan and coordinate efforts to educate the broader research and patient community about the goals, objectives, activities, and progress of the KPMP, with consideration of approaches to disseminate information to hard-to-reach, marginalized groups.
  • Confirm willingness to share all de-identified data and samples and discuss how they will be harmonized with ongoing and new efforts. Include a plan to archive a representative subset of biosamples and clinical data at the NIDDK Central Repositories.

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 Data Sharing Plan

  • The NIDDK intends the resource sharing plans for the data and samples generated under the KPMP to follow the policy and objectives stated in the original KPMP FOAs. Specifically, consistent with achieving the objectives of the KPMP, all study data (including, but not limited to, raw data, metadata, digital pathology images, and computational data sets), protocols (including analytical methods), ontologies, technologies, biological samples (including but not limited to biopsies, nephrectomy tissue, tissue blocks, all slides in any form, blood, urine and stool) and other research resources are to be shared immediately across the consortium, and made publicly available to the larger community as soon as QA/QC procedures have been completed, and in accordance with KPMP SC policies, subject to approval by the NIDDK. Data derived from participant clinical records linked to biological data will only be made publicly available once risk of explicit or inferred identification has been mitigated in consultation with the KPMP Community Engagement Committee and the DSMB. Any preliminary data included in this application must be made available to the KPMP upon award. Limited exceptions to the requirement for community dissemination may be identified by the KPMP SC and are subject to approval by the NIDDK. The NIDDK, in consultation with the SC for this project, will make all final decisions concerning data and sample deposition and data access policies, and all policies are subject to change by the NIDDK as deemed necessary to sustain program principles and priorities, or to ensure the highest standards for responsible research conduct within the project.
  • Awardees will comply with and implement the recommendations and decisions of the SC with respect to the sharing of information, data, biosamples, protocols, resources, methods, and analyses developed by the KPMP investigators under the KPMP.
  • Awardees will comply with the KPMP agreements including the Publications and Presentations (P&P) policies (as determined by the SC). Participating Institution(s) must sign the KPMP Confidential Disclosure Agreement (CDA, https://drive.google.com/file/d/1VfTWMXus2c51R5c9L2sBZ-5mu67mUEXy/view) and Material Transfer Agreement (MTA, https://drive.google.com/file/d/1NJMhDkIChP4XI3kMq9bCFeS1pYj1m2f9/view) documents. No edits to either the CDA or MTA will be allowed.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) 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 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.

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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" (https://cde.nlm.nih.gov/home) 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.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

Overall Impact

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

Scored Review Criteria

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 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 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 for this FOA: Will successful completion of the aims ensurethe collection of clinical data and biological samples, and provide scientific, infrastructure, QA/QC, and administrative support?

Investigator(s)

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

Specific for this FOA:

Have the applicants appointed a Quality Coordinator, Honest Broker, Project Manager, and Communications Coordinator with the appropriate expertise and track record?

Have the applicants positioned themselves to excel in collaborative team science?

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?

Specific for this FOA:

Do the applicants provide innovative strategies for managing the goals and milestones of the consortium overall and establishing effective external partnerships?

Do the applicants propose innovative strategies for rapidly building an effective trans-KPMP team employing expertise in group dynamics/performance and systems thinking to enhance stakeholders’ engagement in shared decision-making and shared accountability for setting and reaching goals?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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 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 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?

Specific to this FOA:

Do the proposed milestones lay out an effective plan to ensure clear and quantitative criteria are applied at appropriate go/no-go decision points? Is the timeline feasible and appropriate?  

Do the applicants propose adequate strategies to develop and coordinate staff training for all activities, including participant recruitment and retention, biopsy performance/participant safety, biological sample collection, tissue interrogation and handling, QA/QC, etc.?  

Does the proposed engagement of the stakeholder community adequately facilitate engagement from racially and ethnically diverse groups? Will the proposed engagement of the stakeholder community inform all aspects of the KPMP?

Do the applicants present adequate strategies to ensure data and sample QA/QC across the entire KPMP consortium?

Do the applicants present adequate strategies to curate, track, de-identify, and distribute samples with FAIR principles?

Is the plan to minimize re-identification of participants appropriate?

Is the overall Communication Plan appropriate to educate the broader community —including hard to reach populations—and address serious adverse events?

Do the applicants propose adequate plans to administer an Opportunity Pool of funds, including solicitation, rigorous peer review, and active integration into the KPMP?

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?

Specific for this FOA:

Does the institution have the necessary experience and infrastructure to coordinate sample (including biopsy tissue) storage and distribution?

Additional Review Criteria

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

Protections for Human Subjects

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 progress made in the last funding period.

Revisions

Not applicable

Additional Review Considerations

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

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 (GDS).

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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Awardees must comply with any funding restrictions described in Section IV.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.

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

2. Administrative and National Policy Requirements

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

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

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

The primary responsibilities of the PD(s)/PI(s) are to:

  • Determine experimental approaches, design protocols, ensure participant safety, set project milestones, conduct experiments, analyze, and interpret research data and publish results.
  • Provide objectives for projects and protocols and costs to the NIH Program Officer (PO) and Project Scientist (PS), at the outset of the award, following re-negotiation of the milestones after the first meeting of the Steering Committee (SC) and at six-month intervals thereafter, in consultation with the Kidney Precision Medicine Project (KPMP) PO and PS.
  • Ensure that all projects involving human subjects have the appropriate clearances (e.g., IRB, Federalwide Assurance, certification of human subject’s research training, and other required documentation) prior to implementation.
  • Serve as a voting member of the SC, and participate, along with critical staff, in SC meetings including face-to-face meetings as scheduled in the Bethesda MD/Washington DC area or at an alternate location approved by the NIDDK.
  • Adhere to the KPMP guidelines and other policies that might be established, as agreed upon by the SC, and the PO to the extent consistent with the applicant’s submitted statements and applicable grant regulations.
  • Apprise the PO and PS of any potential impediments to execution of the objectives of the project.
  • Ensure that all data (including, but not limited to, raw data, metadata, digital pathology images, and computational data sets), protocols (including analytical methods), ontologies, technologies, biological samples (including but not limited to biopsies, nephrectomy tissue, tissue blocks, all slides in any form, blood, urine and stool), and other research resources are made available to the KPMP (e.g., deposited in a centralized NIDDK-approved database) according to a timeline agreed upon by the SC and the NIDDK and to the extent consistent with applicable grant regulations.
  • Provide representation on all relevant subcommittees and working groups established by the SC. Issues to address in working groups may include participant safety, quality control, pathology, molecular interrogation, ancillary studies, publication, intellectual property, data access, etc.
  • Establish procedures for data quality and completeness. Awardees are responsible for ensuring accurate and timely assessment of the progress of each study, including development of procedures to ensure that data collection and management are: (1) adequate for quality control and analysis; (2) for clinical trials, as simple as appropriate in order to facilitate cooperation/referral of study participants by physicians to avoid unnecessary expense; and (3) sufficiently staffed across the participating institutions. For research involving multiple sites, a plan for analysis of pooled data will be developed by the SC.
  • Report the study findings. Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies. The awardee must also be adherent to Study Publication and Presentation Policy. The NIDDK will have access to and may periodically review all data generated under an award. NIDDK staff may co-author publications of findings with awardees consistent with NIH and study policies.
  • Study investigators are required to publish and to release publicly and disseminate results and other products of the study, in accordance with study protocols and SC policies on publications.
  • Agree not to disclose confidential information obtained from other members of the KPMP (i.e., protocols, data analysis, conclusions, etc.) as well as proprietary information of an individual company or other entity collaborating with the study. and agree to the KPMP intellectual property agreements, consistent with the terms and conditions of the cooperative agreement awards, applicable regulations, and the policies and practices of the awardee institutions. Any exception requires written approval from NIDDK Program staff.
  • Agree that any third party collaboration (including but not limited to interactions with organizations from industry, academia, and nonprofit institutions) should be governed by a research collaboration agreement (e.g. Clinical Trial Agreement, Research Collaborative Agreement, etc.) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH/NIDDK policies and procedures. and with written approval from NIDDK Program staff. Any relevant proposed third-party agreements related to the network studies between grantee and third-party will be provided to the NIDDK Program staff and NIDDK Technology Advancement Office for review, comment, and approval to assure compliance with NIH/NIDDK policies and network policies. Further, at the request of the NIDDK Program staff, any other network-relevant third-party agreements must be shared with NIDDK. Failure to comply with this term may prompt action in accordance with NIH Grants Policy Statement, Section 8.5 titled: “Special Award Conditions and Remedies for Noncompliance (Special Award Conditions and Enforcement Actions”, and Section 8.5.2, titled: “Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding Support”, noncompliance with the terms and conditions of award will be considered by the funding IC for future funding and support decisions and may result in termination of the award.”
  • Ensure involvement of any third party (including but not limited to interactions with organizations from industry, academia, and nonprofit institutions) in the study and network activities that includes access to any network study data; study results that are not publicly available; or using the name of the study; or the name of the NIH or the NIDDK, is permitted only after written permission by the NIDDK PO who may consult with others at NIH including the NIDDK Technology Advancement Office.
  • Be prepared for annual administrative site visits by NIH staff or designees.
  • Be solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed for the awardee to perform the project.
  • Be required to report to the U.S. Government all inventions made in the performance of the project, as specified by 35 U.S.C. Sec. 200-212 (Bayh-Dole Act).
  • Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the awardee any proprietary rights, including intellectual property rights, or any materials needed by the awardee to perform the project.
  • Awardees will retain custody of and have primary rights to the data, tools, methods, and software developed under these awards, subject to the KPMP resource sharing plan and Government rights of access consistent with current DHHS, PHS, and NIH policies.
  • Data Management and Sharing Plan: In accordance with the NIH Policy for Data Management and Sharing (NIH NOT-OD-21-013), the NIDDK approved plan will become a term and condition of award, be routinely monitored during the award period, and compliance may factor into future funding decisions. By the end of the funding or proprietary period, a recipient or study group may not continue to use or share study generated resources until those resources are available to the public via an NIDDK approved repository per the NIDDK approved sharing plan. The NIDDK has established a Central Repository to support the receipt, storage, and distribution of data, biosamples, and other resources generated in clinical studies funded by the NIH/NIDDK. When the NIDDK Central Repository is to be utilized, prior to enrolling participants, the PI or his/her designee will coordinate with the NIDDK Program and Central Repository staff to prepare for eventual archiving and distribution of the study generated resources that are to be maintained in the Central Repository. All resources transferred to the Central Repository will be under the custodianship of the NIDDK. The study’s leadership will have proprietary control of and exclusive access to the resources per the NIDDK approved sharing plan.Subsequently, these resources will be available to the wider scientific community in accordance with the NIH policy on Data Sharing (http://grants.nih.gov/grants/policy/data_sharing/ and, https://grants.nih.gov/policy/sharing.htm, and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm) as well as the NIDDK policy for resource sharing,

    https://www.niddk.nih.gov/-/media/Files/Research-Funding/Process/PublicversionNIDDKdatasharingpolicy2013July2013.pdf.

    .

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

NIH Project Scientists (PS)

The role of the PS in the cooperative agreement is to support and encourage the recipient's activities by substantial involvement as partners and facilitators in the process without assuming responsibilities that remain with the PD(s)/PI(s). The PS will:

  • Work closely with the PD(s)/PI(s) and other KPMP investigators to facilitate collaborations and to leverage the resources available to the sites and the KPMP. They will assist in the integration of the individual Recruitment Sites (RS), Tissue Interrogation Sites (TIS), Kidney Tissue Atlas Coordinating Center (KTACC) and Central Hub (CH) sites into a collaborative research project.
  • Monitor the progress of the RS, TIS, KTACC and CH, help coordinate research approaches, and contribute to the shaping of research projects or approaches as warranted. The PS will support and facilitate this process but will not direct it.
  • Assist in avoiding unnecessary duplication of effort across the KPMP and help coordinate collaborative research efforts that involve multiple sites.
  • Keep the PDs/PIs informed about other ongoing studies supported by the NIH to avoid duplication of effort and encourage resource sharing and collaboration. The PS will coordinate access to other NIH resources, as well as assist the research efforts of the KPMP by facilitating access to fiscal and intellectual resources provided by industry, private foundations, NIH intramural scientists and other federal government agencies as appropriate.
  • Serve as voting members of the SC and assist in developing the KPMP priorities and research agenda, operating guidelines, and consistent policies for dealing with situations that require coordinated action.
  • Retain the option to recommend to the PO the withholding or reduction of support from any cooperative agreement that substantially fails to achieve its objectives according to the approved milestones or fails to comply with the Terms and Conditions of the award, or for the good of the consortium as a whole.
  • Serve as scientific liaison between the awardees and other NIH program staff.
  • Review and comment on critical stages of the KPMP progress.
  • Identify appropriate advisors for a Consortium Management Board (CMB) and Data and Safety Monitoring Board (DSMB). These Boards will review study progress, safety data, and interim results, as appropriate, and provide guidance to the NIDDK.
  • Share opportunities and discuss strategies and potential avenues of collaborations (such as with industry, private foundations and/or NIH intramural scientists).
  • The PS may be co-authors on study publications. In general, to warrant co-authorship, the NIDDK staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; (c) participation in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscripts.

NIH Program Official (PO)

The PO is responsible for the normal scientific and programmatic stewardship of the award. The PO will:

  • Interact with the Program Director(s)/Principal Investigator(s) on a regular basis to monitor study progress. Monitoring may include: regular communications with the Program Director/Principal Investigator and staff, periodic site visits, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at SC, data safety and monitoring board, and related meetings. The NIDDK retains, as an option, periodic review of progress by researchers not involved with the study.
  • Serve as Executive Secretary to the DSMB and CMB or delegate these responsibilities.
  • Have the option to recommend, following evaluations of consortial progress by the CMB and DSMB (if applicable), the possible withholding, reduction, or reallocation, as appropriate, of support from any KPMP component that substantially fails to achieve its objectives according to the approved milestones or fails to comply with the Terms and Conditions of the award, at the appropriate times. The NIDDK will not permit further expenditures of NIDDK funds for a study after requesting closure except as specifically approved by the NIDDK.
  • Have the option to recommend, following evaluations of consortial progress by the CMB and DSMB (if applicable), an increase in support to engage in further research efforts within the original research scope, as appropriate, for any KPMP component exceeding its objectives according to the approved milestones and substantially improving state-of-the-art capabilities, at the appropriate times.
  • Participate in the SC meetings as an ex officio (non-voting) member.
  • Retain the option to recommend, with the advice of the NIH PS, re-allocation of NIH support among awardees, as scientific objectives evolve.
  • Carry-out continuous review of all activities to ensure objectives are being met.
  • Consult the NIDDK Technology Advancement Office to facilitate review, comment, and approval of any consortial management agreements or research collaboration agreements with third party collaborators to assure compliance with NIH/NIDDK policies and network policies.
  • Serve as the official NIH representative in all communication with the SC.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

The SC will be the primary governing body for all KPMP scientific activities. The goal is to create a kidney tissue atlas; define disease subgroups; and identify critical cells, interstitial components, pathways, and targets for novel therapies directed toward acute kidney injury and chronic kidney disease. The SC will coordinate all research performed by successful awardees for KPMP FOAs. The voting membership of the SC will include: one PD/PI from each award made under this and the companion FOAs, the NIH PS, and a representative from the Community Engagement Committee of the CH. The Chair(s) of the SC will be assigned by NIH Program Staff and may be chosen from outside the KPMP. Face-to-face meetings of this committee will occur at least two times a year. A portion of the SC meetings may be open to the public.

SC Composition - Voting members of the SC may include:

  • The Program Directors/Principal Investigators (PDs/PIs) of each KPMP award.
  • The PS (together representing a minority of voting members - not to exceed 1/3 of SC membership). Other NIH Program staff may attend the meeting as non-voting members.
  • A representative from the Community Engagement Committee of the CH.

SC Functions

The SC will be the primary governing body for all the KPMP scientific activities and makes recommendations to the NIDDK. The SC will coordinate all projects awarded under the KPMP FOAs.

The role of the SC includes:

  • Develop protocols and guidelines delineating the scientific and other interactions of the RS, TIS, KTACC and CH.
  • Foster collaboration, synergy and sharing among the KPMP sites and investigators.
  • Provide the primary mechanism for interactions with the NIH.
  • Oversee the planning of the KPMP scientific activities, including dynamic adjustment as needs and opportunities arise.
  • Guide the development and documentation of the KPMP standards and guidelines.
  • Prioritize the use of the KPMP resources including systems biology analyses and bioinformatics.
  • Evaluate progress in the KPMP sites and recommend adjustments in approaches if necessary, including implementation of new projects and changes to ongoing studies and termination of projects.
  • Foster partnerships and collaborations that will facilitate the extension of the approach to new technologies and their application to related kidney disease.
  • Develop and approve the KPMP-wide intellectual property agreements consistent with the terms and conditions of the cooperative agreement awards, applicable regulations, and the policies and practices of the awardee institutions.

Responsibilities of the SC include:

  • The SC will convene at least two face-to-face meetings a year in the Bethesda, MD/Washington, DC area or in an alternate location approved by the NIDDK. The first meeting will be a two-day meeting in September 2022. Additional regular meetings will be conducted by teleconference or videoconference. Prior to each meeting, teleconference or videoconference, the SC Chair or CH will prepare an agenda for review and approval, and distribute to members of the SC. Following these meetings, a list of participants and summary of discussion, action items, and recommendations will be prepared and submitted to the PO by the SC. Part of these meetings may be open to the public. The SC Chair/CH may convene additional teleconferences, videoconferences, or electronic reviews to avoid delays in addressing key issues that cannot be evaluated at the regularly scheduled meetings.
  • Regularly scheduled SC meetings will be convened in order to:
    • Review progress of the KPMP sites; review progress of standardization and validation studies, other performance assessments, and future plans; and take remedial actions to address delays or other problems.
    • Make recommendations to the KPMP sites about informatics and data and/or information management processes.
  • Awardee members of KPMP will be required to accept and implement policies approved by the SC.
  • The SC may make recommendations to the CH to establish working groups or assign responsibility to key staff for other KPMP-related activities.

Resource and Data Sharing

  • Awardees must comply with the Public Health Service (PHS) policies relating to distribution of unique research resources produced with PHS funding and sharing of all research protocols, data, samples, and other research resources. Appropriate agreements must be executed prior to resource and data sharing. For further information, see the NIH Data Sharing Policy at https://grants.nih.gov/grants/policy/data_sharing/.
  • The NIH intends the resource sharing plans for the data and samples generated under the KPMP to follow the policy and objectives stated in the FOA. Specifically, consistent with achieving the objectives of the KPMP, all study data (including, but not limited to, raw data, metadata, digital pathology images, and computational data sets), protocols (including analytical methods), technologies, biological samples (including but not limited to biopsies, nephrectomy tissue, tissue blocks, all slides in any form, blood, urine and stool), and other research resources are to be shared immediately across the consortium, and made publicly available to the larger community as soon as quality control procedures have been completed, and in accordance with KPMP SC policies, subject to approval by the NIDDK. Data derived from participant clinical records linked to biological data will only be made publicly available once risk of explicit or inferred identification has been mitigated in consultation with the Community Engagement Committee and the DSMB. Limited exceptions to the requirement for community dissemination may be identified by the KPMP SC and are subject to approval by the NIDDK. The NIDDK, in consultation with the SC for this project, will make all final decisions concerning data and sample deposition and data access policies, and all policies are subject to change by the NIH as deemed necessary to sustain program principles and priorities, or to ensure the highest standards for responsible research conduct within the project.
  • Awardees will comply with and implement the recommendations and decisions of the SC with respect to the sharing of information, data, biosamples, protocols, resources, methods, and analyses developed by the KPMP investigators under the KPMP.
  • This plan should also address methods for continuing to make the KPMP data, tools, methods, and software available to the NIH and the research community upon completion of studies or termination of the site so that accumulated data remain accessible, for example, through the NIDDK Central Repositories.

Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: one selected by the awardee (or the SC, with the NIDDK member not voting), a second member selected by NIDDK, and the third member elected by the two prior selected members. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16

3. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

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

Scientific/Research Contact(s)

Tracy Rankin, PhD, MPH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4748
Email: rankint@niddk.nih.gov

Ivonne H. Schulman, MD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-435-3350
Email: Ivonne.Schulman@nih.gov

Cindy N. Roy, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8805
Email: cindy.roy@nih.gov

Peer Review Contact(s)

Lan Tian, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-496-7050
Email: tianl@niddk.nih.gov

Ryan Morris, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-480-1296
Email: ryan.morris@nih.gov

Financial/Grants Management Contact(s)

Diana Ly
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-9249
Email: Diana.Ly@nih.gov

Section VIII. Other Information

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

Authority and Regulations

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


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