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)

National Institute of Environmental Health Sciences (NIEHS)

Fogarty International Center (FIC)

Funding Opportunity Title
Chronic Kidney Diseases of UnceRtain Etiology (CKDu) in Agricultural Communities (CURE) Research Consortium - Field Epidemiology Sites (U01 - Clinical Trial Not Allowed)
Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices
  • September 28, 2020 - Notice of Correction to Page Limitation Instructions for RFA-DK-20-017. See Notice NOT-DK-20-050.
  • August 28, 2020 - Notice of Correction to Eligibility in NIH Funding Opportunity Announcements. See Notice NOT-OD-20-171.
  • August 20, 2020 - Notice of Revision to Funding Opportunity Description for RFA-DK-20-017. See Notice NOT-DK-20-041.
  • July 29, 2020 - Notice of Pre-Application Webinar for the Chronic Kidney Diseases of UnceRtain Etiology (CKDu) in Agricultural Communities (CURE) Research Consortium. See Notice NOT-DK-20-037.
Funding Opportunity Announcement (FOA) Number
RFA-DK-20-017
Companion Funding Opportunity

RFA-DK-20-018, U01 Research Project - Cooperative Agreements,
RFA-DK-20-019, U24 Resource-Related Research Projects - Cooperative Agreements

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.847, 93.113, 93.989

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications for Field Epidemiology Sites (FES) to enroll research participants in the consortium to study Chronic Kidney Disease of UnceRtain Etiology (CKDu) in Agricultural Communities (CURE). The FES will recruit, enroll and follow participants with evidence of CKDu and appropriate control participants; collect data and conduct clinical assessments; collect biological and environmental samples; and maintain partnerships with local leaders, health care providers, health ministries, or governments.

This collaborative research consortium will bring together a broad range of expertise and enable discovery science to understand the cause or causes of CKDu and disease progression. The Consortium will also work to identify potential therapeutic targets and public health interventions. The Consortium will consist of a Scientific Data Coordinating Center (SDCC), Field Epidemiology Sites (FES), a Renal Science Core (RSC), and the Human Health Exposure Analysis Resource (HHEAR). The Consortium will work together to finalize ethical epidemiology research designs, execute common strategies for biological sampling and environmental assessment, apply the best analytic strategies for collected samples and data, and disseminate results to the global research and public health communities. The final design of the study, as determined by the Steering Committee, may significantly vary from individual applications. It is required that all funded sites fully abide with the final harmonized design set by the Consortium Steering Committee.

This FOA will not support clinical trial or intervention trials. This FOA is intended to support only human studies; applications that include animal or model systems are not responsive.

Key Dates

Posted Date
July 24, 2020
Open Date (Earliest Submission Date)
October 10, 2020
Letter of Intent Due Date(s)

October 10, 2020

Application Due Date(s)

November 10, 2020

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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February/March 2021

Advisory Council Review

May 2021

Earliest Start Date

July 2021

Expiration Date
November 11, 2020
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

Purpose

The Field Epidemiology Sites will be part of a new consortium, Chronic Kidney Disease of UnceRtain Etiology (CKDu) in Agricultural Communities (CURE). The Consortium will also include the Scientific Data Coordinating Center (SDCC), a Renal Science Core (RSC), and the NIEHS Human Health Exposure Analysis Resource (HHEAR). The Consortium will work together to enable discovery science to understand the etiologies of CKDu, potential therapeutic targets, and public health interventions. The Consortium will develop common protocols for evaluation of participants who are currently affected with manifestations of CKDu and appropriate unaffected control participants, to define common strategies for biological sampling and environmental exposure assessment, and to determine analytic strategies to best use the samples collected by the consortium. This consortium is intended to also serve as a resource for ancillary studies testing hypotheses pertaining to the development, progression, prevention and/or treatment of CKDu.

Background

Chronic Kidney Disease of uncertain etiology (CKDu, also known as Mesoamerican Nephropathy, Chronic Interstitial Nephritis of Agricultural Communities, and Kidney Disease of Unknown Cause in Agricultural Laborers), reflects a pattern of endemic kidney diseases described as progressively declining glomerular filtration rate (GFR) with no or mild proteinuria, and typically the absence of usual risk factors for Chronic Kidney Disease (CKD) (e.g., hypertension, diabetes, or immune-mediated glomerular disease). Clinical characteristics and available kidney biopsies suggest a primarily tubulo-interstitial disease, rather than a glomerular process. The disease has been reported most consistently among young male agricultural workers in hot and humid regions, primarily Mesoamerica, Sri Lanka, and India. There are also reports of familial clustering. The etiologies of CKDu are unclear, but could involve a complex interplay of environmental exposures, genetic variation, infections, and/or lifestyle factors. For example, specific genetic variants may contribute to increased susceptibility and/or predispose to more severe disease progression. Exposures such as nephrotoxicant chemicals, herbal or prescription medication use, infectious agents, lifestyle factors such as alcohol consumption or tobacco use, or occupational conditions such as heat, workload, and dehydration may influence susceptibility to CKDu independently or in combination with other factors.

For the purposes of this consortium, individuals with presumed CKDu are defined as:

  • Participants age 18-45 years
  • Serum creatinine concentration >1.2 mg/dl (females) or >1.5 mg/dl (males)
  • Urinalysis = 2+ protein, = 1+ hematuria
  • Residing in a CKDu-endemic community or location

The final definition and selection of cases and controls will be based on deliberations by the full CURE Consortium, once it is formed.

Consortium Structure

The CURE Consortium will be formed to respond to this devastating epidemic of kidney failure. Its structure will consist of a Scientific Data Coordinating Center (SDCC), Field Epidemiology Sites (FES), the Renal Science Core (RSC), and the Human Health Exposure Analysis Resource (HHEAR).

  • The SDCC will lead the Consortium in the development and successful execution of the study designs and protocols. The SDCC will review, coordinate and integrate the study protocols from the FES, the RSC, and their own proposed study design, and will lead the Consortium as it develops and implements a harmonized, study-wide protocol reflecting the scientific goals of the FOA. The SDCC will be responsible for the development of data collection tools, data management and statistical analysis strategies as well as overall project management. The SDCC will maintain a temporary biorepository and arrange sample shipping and storage from the FES to the RSC and to HHEAR laboratories.
  • The FES will conduct the field epidemiology of the Consortium. The FES will identify, recruit, enroll, and follow study participants in CKDu-endemic regions, including individuals with evidence of CKDu and appropriate controls. The FES will complete clinical assessments and collect data, biological samples (including blood, urine, and other matrices), and environmental samples over multiple visits. Where safe and feasible, the FES will perform kidney biopsies in a selected subset of participants with CKDu. Biological and environmental samples will be sent from the FES to the SDCC for distribution to the RSC and to HHEAR. Following final consortium-wide protocols, the FES will collect data on relevant risk factors and covariates including environmental and occupational exposures and will review data with the SDCC. The FES will also facilitate the return of results to study participants where agreed upon by the Consortium Steering Committee and local ethical review boards.
  • The RSC will provide scientific expertise in planning, clinical phenotyping, and measures of renal function, which will be collected at the FES. The RSC will guide strategies for biological sampling and handling and will provide needed clinical laboratory-based measures and renal pathology. The RSC will also provide renal pathophysiologic expertise to propose approaches, novel measures (e.g., omics and molecular markers) and interpret discovery science to elucidate the cause or causes of CKDu.
  • The HHEAR will provide scientific expertise in environmental health and will perform the exposure analyses for the Consortium. HHEAR is an existing NIH-funded resource with high quality exposure assessment services for biological and environmental samples (https://hhearprogram.org/). HHEAR will advise the Consortium on targeted and untargeted analyses of environmental exposures and guide the FES and SDCC on methods for sample collection, shipment, and storage. Potential targeted analyses (https://hhearprogram.org/sample-matrix-table) may include markers of exposure to polycyclic aromatic hydrocarbons, inflammation, trace elements, nutrients, pesticides, pharmaceuticals, or other analytes. Untargeted analyses may be used to examine large sets of analytes through hypothesis-free approaches. HHEAR will also work with the SDCC to integrate environmental data with other Consortium data and provide statistical consultation for environmental data analysis.

Steering Committee

The CURE Steering Committee (SC) will consist of Program Directors/Principal Investigators (PDs/PIs) from each FES, RSC, SDCC, HHEAR, and the NIH project scientists. The SC will hold regular meetings as determined by needs of the Consortium. It will designate subgroups and working groups and all PDs/PIs are expected to participate actively in these groups. The Steering Committee will serve as the governing body of the Consortium and will vote to accept the final protocol and other actions pertaining to the governance, design and implementations of matters pertaining to the Consortium and the successful achievement of the goals of the FOA (see section VI, #2, Cooperative Agreement Terms and Conditions of Award—Areas of Joint responsibility).

It is anticipated that the research plans for the CURE Consortium may be both hypothesis-driven and discovery-based. In seeking to understand potential causative and modifying factors of CKDu, as well as characterizing its long-term course, more than one epidemiology study design is expected, including both case-control and longitudinal cohort approaches.

Field Epidemiology Site (FES)

The FES should propose epidemiologic studies to understand the cause or causes of CKDu, the course of disease progression, and episodes of acute kidney injury, using both baseline and longitudinal assessments of participants affected by CKDu and control participants. FES activities must be based in CKDu-endemic regions. FES activities may be proposed in more than one location but should be clearly justified. Demonstration of the feasibility of carrying out the proposed epidemiologic research in each location is required. Applicants should propose studies examining a range of potential etiologies including, but not limited to: examining family history or disease clustering; examining occupational or residential exposures; examining environmental exposures or xenobiotic exposures; and evaluating lifestyle factors or pharmaceutical use. Studies designed to look at a single hypothesis are discouraged. Applicants should propose recruitment of affected subjects and appropriate controls consistent with the goals of the studies they devise.

Applicants proposing to establish a FES should have previous experience with epidemiologic research in resource-limited settings. Applicants from the U.S. should incorporate local investigators and local staff in CKDu-endemic areas who have relevant health research experience within the communities where they propose to work, even if prior research activities were not directed to kidney disease. The FES should include expertise in epidemiology, kidney disease, project management, assessment of work practices and collection of biological samples. Multi-PI applications are encouraged.

If a FES proposes to collect kidney biopsies, it should have local, on-site experienced kidney biopsy operators, support staff and pathology infrastructure that is sufficient to ensure participant safety and to follow centralized protocols for tissue handling, processing, and storage (nephropathology expertise is not required).

Research Objectives

Each FES will enroll at least 400 participants who are affected by CKDu (cases, as defined above in Background section) and 400 or more control participants, depending upon study design which will be finalized by the Consortium Steering Committee. There will likely be more than one control group to permit evaluation of different modifying factors or exposures. The total study population for the Consortium across the three FES is expected to include at least 1200 cases and 1200 or more controls.

The FES will:

  • Work with the SDCC and the Consortium Steering Committee to incorporate proposed study designs from the FES, RSC and SDCC into harmonized overall designs, which include both cross-sectional (cases and controls) and longitudinal approaches.
  • Develop and implement a strategy to identify, recruit, enroll and follow-up participants with CKDu and unaffected control participants in the location identified as CKDu-endemic. The FES will also develop backup strategies which anticipate potential challenges to meet recruitment and retention targets.
  • Perform clinical assessments, data collection, and biological and environmental sample collection following common protocols and utilizing data collection tools developed by the SDCC and finalized by the Consortium Steering Committee.
  • Determine the safety and feasibility of performing percutaneous kidney biopsies in a subset of participants with CKDu, including following protocols for sample collection, if experienced kidney biopsy operators, support staff and sufficient pathology infrastructure exist in the location.
  • Engage with and maintain relationships with community leaders, local and/or central health ministries, local and/or central governments, and local health care providers, as needed, to permit successful completion of study activities. This will include working with ethics review boards and privacy boards and anticipating concerns for data and sample sharing.

In furthering the work of the Consortium:

  • The FES will work collaboratively with SDCC, the RSC and HHEAR to develop biological and environmental sampling strategies and to share samples which may include blood, urine, hair, nails or other specimens.
  • The FES must agree that the final design of the study, including selection of cases and controls, selection of outcomes, clinical variables, environmental exposure measurements, and all other factors pertaining to the design and implementation of the study will be determined by the CURE Consortium Steering Committee. This will be based on input and deliberations by all members of the Consortium.
  • The FES will accept the overall governance, common protocols, publication policies, collaborative procedures, confidentiality policies and data sharing plans to be developed by the Consortium.
  • The Consortium will have its first steering committee as a face-to-face meeting on the NIH campus in the first year of award on September 20-21, 2021 and awardees must commit to attending this meeting. The Consortium will meet semi-annually in the Bethesda, MD area and awardees must attend and must budget for travel to steering committee meetings.

This FOA will not support intervention trials to prevent or treat CKDu.

This FOA is intended to support only human studies and applications that include animal or model systems are not responsive.

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

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, NIEHS and FIC intend to commit up to $4,000,000 in Fiscal Year 2021 to support the three related funding opportunities RFA-DK-20-017, RFA-DK-20-018, and RFA-DK-20-019. We anticipate awarding 1 Scientific Data Coordinating Center, 1 Renal Science Core and 3-4 Field Epidemiology Sites.

Award Budget

The direct costs for this award are anticipated to be no more than $400,000 in direct costs for each award in Year 1 and Year 2. Application budgets are anticipated to be no more than $300,000 in direct costs in Years 3-5. Application budgets need to reflect the actual needs of the proposed project. Award budgets will vary each year depending upon the scientific needs and opportunities of the Consortium.

Award 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

  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are 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.

Applicants must have experience with field research in resource-limited settings. The investigators should have expertise in epidemiology, kidney disease, project management, assessment of work practices and collection of biological samples.

2. Cost Sharing

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

3. Additional Information on Eligibility

 

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.

, with the following exceptions or additional requirements:

For this specific FOA, the Research Strategy section is limited to 30 pages.

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.

SF424(R&R) Senior/Key Person Profile

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

 

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

Applicants must budget for PI/PD(s) and co-PI(s) to travel to semi-annual face-to-face steering committee meetings in the Bethesda, MD area.

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:

Research Strategy

  • Study design: Describe the proposed epidemiology study designs to elucidate the cause or causes of CKDu, the exacerbating and protective factors, sex differences, as well as the long-term course of CKDu. The application should describe baseline assessments of cases and controls and longitudinal assessments, that can define progressive loss of kidney function, episodes of acute kidney injury and periods of disease stabilization.
  • Risk factors: Describe exposures and covariates that will be measured including, but not limited to, occupational conditions, biological or household family characteristics, environmental exposures, pharmaceutical use, lifestyle factors, etc. Studies designed to look at a single hypothesis are discouraged.
  • Location: Describe how the location chosen for Field Epidemiology Site (FES) activities is considered CKDu-endemic. If more than one location is proposed, provide justification for the proposed study populations and locations.
  • Feasibility: Describe a feasible strategy to identify, recruit, and enroll study participants with CKDu (as defined in Part 2, Section I, Background) and control participants (unaffected) in the location that has been identified as CKDu-endemic, consistent with the proposed study design. Describe backup strategies which anticipate potential challenges to meet recruitment targets. Describe a feasible strategy to retain study participants. Describe backup strategies which anticipate potential loss-to follow up and methods to maintain contact with enrolled participants.
  • FES Team: Clearly describe the formal organizational structure of the FES team, which should include expertise in epidemiology, kidney disease, project management, and ethical conduct of international research in resource-limited settings.
    • Describe how the FES team will contribute to the design and successful execution of study protocols including participant recruitment and retention.
    • If the applicant is U.S.-based, describe the involvement of local investigators and local staff with relevant health research experience on the FES team.
    • Describe the capability of the FES team to follow common protocols in performing clinical assessments, data collection, biological and environmental sample collections.
    • Describe the capability of the FES team to track recruitment, retention, study assessments and sample collection.
    • Describe the capability of the FES team to adapt to unanticipated events that may require changes in the study protocol or structure.
  • Research infrastructure: Describe how the currently available infrastructure for performing study visits, obtaining biological and environmental samples, processing and storing samples is sufficient to carry out the final study protocol.
  • Sample collection and transport: Describe the capability of the FES team to collect and arrange transport of all biological and environmental specimens for analysis to the SDCC, RSC or HHEAR. (The cost of specimen shipping will be covered by the SDCC. The cost of sample collection kits will be covered by the RSC.) Describe potential challenges in specimen transport from low resource settings to laboratories based in the U.S. or other foreign sites and how these challenges will be resolved.
  • Local partnerships: Describe how the FES team will engage with and maintain consistent relationships with community leaders, local health care providers, local and/or central health ministries, and local and/or central governments to permit successful completion of study activities.
  • Ethical conduct of research: Describe how the team will work with ethics review boards and privacy boards within the locations and countries with CKDu. Describe how the FES will anticipate and resolve local concerns for data and sample sharing.
  • Biopsies: If the FES applicant plans to perform percutaneous kidney biopsies on subset of participants with CKDu, describe the safety and feasibility of the biopsy procedure in the location where activities will occur. Describe the availability of experienced kidney biopsy operators. Describe the available infrastructure for tissue handling and fixation through local pathology laboratory (nephropathology expertise is not required).
  • Consortium collaboration: Document willingness to participate in the development and execution of common protocols for the field epidemiology components of the Consortium and relevant research collaborations with other members of the Consortium.

Letters of Support:

Applicants should provide a letter of support from all involved health ministries and other relevant oversight bodies in which they agree to work collaboratively with the Consortium, as outlined in the FOA terms and conditions, including following common research protocols, shipping biological and environmental samples, and sharing research data.

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.

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.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

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.

 

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 to this FOA: Have the applicants shown that the research proposed will advance our understanding of the cause or causes of CKDu, the exacerbating and protective factors, and the long-term course of the disease?

 

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 to this FOA:

How clearly have the applicants demonstrated that their experience in epidemiology and field research in resource-limited settings is sufficient to carry out the proposed work including recruitment, and retention of study participants, clinical assessment, data and sample collection? How effectively does the Field Epidemiology Site (FES) team incorporate expertise in project management, kidney disease, assessment of work practices and collection of biological samples? Have the applicants shown that the organizational structure of the FES team is appropriate for the studies they have proposed? If the applicant site is U.S.-based, how effectively have local researchers been incorporated into the FES team? ?

 

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 to this FOA: How innovative are the applicants' plans to overcome the challenges of conducting research activities in resource-limited locations?

 

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?

Specific to this FOA: How well do the proposed study designs address the potential causes of CKDu, avoiding a narrow focus or single hypothesis? Do the study designs assess the exacerbating and protective factors, the sex differences in incidence and outcome and the long-term course of CKDu? How appropriate is the proposed selection of cases and controls? How appropriate are the proposed risk factors?

How well have the applicants demonstrated they can operate and follow study protocols in the location they have proposed? How well have they anticipated the potential challenges of performing research activities in the proposed location? How well have the applicants shown the feasibility of the proposed study activities including multiple study visits and biological and environmental sampling in the planned location(s)? How clear and feasible are the plans to identify a cohort of participants affected by CKDu? How robust and redundant are the plans for recruitment and retention of study participants? How well thought out is the strategy to engage community leaders, health ministries, and local and central governments which will be needed for successful completion of study activities? How well have the applicants anticipated the complexities of obtaining study approval from local ethics review boards and privacy boards to ensure the study can be completed and samples can be transported to SDCC, RSC and HHEAR laboratories?

If kidney biopsies are proposed, how appropriate are the plans for performing the procedure safely?

Have the applicants clearly described their willingness to contribute to and participate in Consortium collaborations?

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?

 

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 to this FOA: How well have the PI(s)/PD(s) justified that the site chosen for FES activities is actually CKDu-endemic? Is the infrastructure at the proposed study locations sufficient to permit study activities including clinical assessments, data collection, and sample collection, processing, storage and transport?

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.

 

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.

 

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.

 

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.

 

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.

 

Not applicable.

 

Not applicable.

 

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.

 

How effective is the applicant's strategy to work with community leaders, local healthcare providers, local and or central health ministries and local and/or central governments to permit successful completion of study activities? How clearly do the letters of support from health ministries and local governments demonstrate evidence of strong commitment to cooperate with the research endeavor proposed? Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

 

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).

 

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).

 

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.

 

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 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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

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

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 grantee’s business official.

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

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

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

 

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC and by local ethics review boards in the location where study activities occur. 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

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

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

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

1. Developing the research design and study protocol, including definition of objectives and approaches, sample size and power calculations, and establishing procedures for participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results.

2. Establishing a Steering Committee to implement, coordinate and manage the project(s). Awardee(s) will name investigators to serve as members on a Steering Committee and other subcommittees, as appropriate, meeting periodically. Awardees will be required to accept and implement the common protocol(s) and procedures approved by the Steering Committee.

3. Designating Protocol Chairs. The Program Directors/Principal Investigators (for studies involving multiple protocols) shall designate a single Protocol Chairperson (if the Program Director/Principal Investigator does not assume this role) for each protocol to be carried out by the study group. The Protocol Chairperson shall function as the scientific coordinator for the protocol and shall assume responsibility for obtaining approval to implement the protocol from the Steering Committee and for developing and monitoring the protocol. Significant modifications to approved protocols must be approved by the Steering Committee.

4. Implementing collection of data specified by the study protocol. For a multi-center study, each awardee/site is required to ensure that data will be submitted expeditiously to the Scientific Data Coordinating Center. Additionally, individual investigators/sites must demonstrate the ability to implement the strategy specifically designed for their individual study population.

5. Establishing 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 Steering Committee.

6. Submitting interim progress reports, when requested or agreed upon by both parties, to the NIDDK Program Official including as a minimum, summary data on protocol performance. For coordinated multiple awards or a multi-site single award, the NIDDK Program Official may require additional information from individual awardees/sites. Such reports are in addition to the required annual noncompeting continuation progress report.

7. Reporting of 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.

8. Any third-party (including industry, academia, and foundations) collaboration should be governed by a research collaboration agreement (e.g. Clinical Trial Agreement, Research Collaborative Agreement, etc.) or any third-party contract mechanism(s) 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.”

9. Any involvement of a third-party (including industry, academia, and foundations) in the study and network activities that includes access to any network study data and biosamples, or study results that are not publicly available, or using the name of the network or study or the name of the NIH or NIDDK, is permitted only after written permission by the NIDDK Program staff who will consult with others at NIH and NIDDK Technology Advancement Office.

10. 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 steering committee policies on publications.

11. Maintaining confidentiality of information: The awardee(s) will maintain the confidentiality of the information developed by the investigators (i.e., protocols, data analysis, conclusions, etc.) as well as proprietary information of an individual company or other entity collaborating with the study. Any exception requires written approval from NIDDK Program staff.

12. The NIDDK has established Central Biosample, Genetic, and Data Repositories for the archiving and storage of data and biosamples collected in large, multi-site studies funded by NIDDK. Prior to enrolling participants, the PI or his/her designee will coordinate with the NIDDK Central Repository to develop a Data Sharing Plan and prepare the collected data for eventual archiving and distribution. In addition, if applicable, the PI or his/her designee will work with the NIDDK Biosample Repository to coordinate procedures for coding, shipping, processing, receipt, storage, and sharing of study samples that are to be maintained in the Repository. All samples and data transferred to the Repositories will be under the custodianship of the NIDDK, although the study’s leadership will have proprietary control of and exclusive access to the samples and data for an agreed-upon period of time. Subsequently samples and data 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 data sharing in multi-center and large single-center clinical studies https://www.niddk.nih.gov/-/media/Files/Research-Funding/Process/PublicversionNIDDKdatasharingpolicy2013July2013.pdf.

13. Study investigators are required to comply with NIH Policy on the Dissemination of NIH Funded Clinical Trial Information as stated at https://grants.nih.gov/policy/clinical-trials/reporting/understanding/nih-policy.htm. Per policy, the awardee is responsible for meeting the expectations of this policy. Refer to additional information at https://grants.nih.gov/policy/clinical-trials/reporting/index.htm.

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

An NIDDK Project Scientist with substantial involvement will:

1. Serve as the contact point for all facets of the scientific interaction with the awardee (s). As required for the coordination of activities and to expedite progress, NIDDK may designate additional NIDDK staff to provide advice to the awardee on specific scientific and/or analytic issues. Such staff may include another Project Scientist or Project Coordinator, who will provide direct technical assistance to the awardees to optimize the conduct and/or analysis of the study; or who may assist in the coordination of activities across multiple sites.

2. For multi-center studies, participate in the Steering Committee that oversees study conduct. The NIDDK Project Scientist or Project Coordinator will be a full participant and voting member of the Steering Committee and, if applicable, subcommittees.

3. Serve as a resource to study investigators with respect to other ongoing NIDDK activities that may be relevant to the study to facilitate compatibility with the NIDDK missions and avoid unnecessary duplication of effort.

4. Have substantial involvement assisting in the design and coordination of research activities for awardees as elaborated below:

a. Assisting by providing advice in the management and technical performance of the investigations, coordinating required regulatory clearances for investigational agents used in the study, which are held by NIDDK. The NIDDK may reserve the right to cross file or independently file an Investigational New Drug Application or an Investigational Device Exemption form with the FDA.

b. The NIDDK Project Scientist or Project Coordinator may coordinate activities among awardees by assisting in the design, development, and coordination of a common research or clinical protocol and statistical evaluations of data; in the preparation of questionnaires and other data recording forms; and in the publication of results.

c. Reviewing procedures for assessing data quality and study performance monitoring.

d. The NIDDK Project Scientist or Project Coordinator may be co-authors on study publications. In general, to warrant co-authorship, 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.

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

  1. 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 Steering Committee, 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.
  1. Review and approve protocols prior to implementation to insure they are within the scope of peer review, for safety considerations, as required by Federal regulations.
  1. The NIDDK Program Official will monitor protocol progress, and may request that a protocol study be closed to accrual for reasons including: (a) accrual rate insufficient to complete study in a timely fashion; (b) accrual goals met early; (c) poor protocol performance; (d) patient safety and regulatory concerns; (e) study results that are already conclusive; (f) low likelihood of showing a benefit of the intervention (futility); and (g) emergence of new information that diminishes the scientific importance of the study question. The NIDDK will not permit further expenditures of NIDDK funds for a study after requesting closure except as specifically approved by the NIDDK.
  1. Make recommendations for continued funding based on: a) overall study progress, including sufficient patient and/or data accrual; b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high quality of research, which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements.
  1. Appoint an independent Data and Safety Monitoring Board (DSMB) as appropriate for Phase III clinical trials or other high-risk studies, or an Observational Study Monitoring Board (OSMB) for observational/epidemiologic studies; these Boards will review study progress, safety data, and interim results, as appropriate, and provide guidance to the NIDDK. The NIDDK Program Official or their Project Coordinator will serve as the Executive Secretary and/or NIDDK program representative on the DSMB/OSMB.


 

Areas of Joint Responsibility include:

In addition to the interactions defined above, NIDDK Project Scientist and Awardees shall share responsibility for the following activities:

Steering Committee

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

The Steering Committee has primary responsibility to design research activities, establish priorities, develop common protocols and manuals, questionnaires and other data recording forms, establish and maintain quality control among awardees, review progress, monitor patient accrual, coordinate and standardize data management, and cooperate on the publication of results. Major scientific decisions regarding the core data will be determined by the Steering Committee. The Steering Committee will document progress in written reports to the NIDDK Program Official, and will provide periodic supplementary reports upon request.

The Steering Committee will be composed of all Program Director(s)/Principal Investigator(s), (including those of data coordinating /statistical centers, if any) and co-investigators as deemed necessary, and the NIDDK Project Scientist. The final structure of the Steering Committee and voting procedures will be established at the first meeting. The NIDDK Project Scientist will have voting membership on the Steering Committee, and as appropriate, its subcommittees. The frequency of Steering Committee meetings will be dictated by a vote of the members of the Steering Committee.

A Chairperson of the Steering Committee, other than the NIDDK Project Scientist, will be selected by the NIDDK, in consultation with the Steering Committee. The Chairperson provides leadership to the Committee by conducting the Steering Committee meetings, representing the study group to the External Oversight Committee established by the NIDDK and by interacting closely with the awardees during protocol development and implementation.

Dispute Resolution

Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NIDDK may be brought to dispute resolution. A dispute resolution panel will be composed of three members --one selected by the awardee (or the Steering Committee, with the NIDDK member not voting), a second member selected by NIDDK, and the third member elected by the two prior selected members. These special dispute resolution procedures in no way affect the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 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)

Susan R. Mendley, MD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-827-1861
Email: susan.mendley@nih.gov
 

Bonnie R. Joubert, MPH, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3276
Email: bonnie.joubert@nih.gov
 

Kathleen Michels, PhD
Fogarty International Center (FIC)
Telephone: 301-435-6031
Email: Michelsk@nih.gov

Peer Review Contact(s)

Ann A. Jerkins, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-2242
Email: Ann.Jerkins@nih.gov

Financial/Grants Management Contact(s)

Helen Hunter Cox, MHS
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-496-7274
Email: Helen.Cox@nih.gov

Jenny Greer
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3332
Email: jenny.greer@nih.gov

Bruce R. Butrum
Fogarty International Center (FIC)
Telephone: 301-496-1670
Email: butrumb@mail.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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