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
Biomarkers of Dietary Intake and Exposure Coordinating Center (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices
None
Funding Opportunity Announcement (FOA) Number
RFA-DK-20-007
Companion Funding Opportunity

RFA-DK-20-005 U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements

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

93.847

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites cooperative agreement applications under the U24 mechanism, for a Data Coordinating Center (DCC) to participate in a consortium and coordinate the activities of Dietary Biomarker Development Centers program (DBDC). A companion FOA (RFA-DK-20-005), (U2C Clinical Trial Required) invites applications from multidisciplinary teams, for establishing Dietary Biomarkers Development Centers (DBDCs), to discover, develop, and validate dietary biomarkers of intake and exposure.

Key Dates

Posted Date
July 02, 2020
Open Date (Earliest Submission Date)
September 21, 2020
Letter of Intent Due Date(s)

September 21, 2020

Application Due Date(s)

October 21, 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
October 22, 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

This Funding Opportunity Announcement (FOA) invites U24 cooperative agreement applications for a Data Coordination Center (DCC) to participate in and coordinate the activities of Dietary Biomarkers Development Centers (DBDC) for dietary intervention trials focused on the development of dietary biomarkers of intake and exposure. A companion FOA (RFA-DK-20-005), the Development of Biomarkers of Dietary Intake and Exposure (U2C Clinical Trial Required) will invite applications for the Dietary Biomarkers Development Centers (DBDC) to recruit and conduct dietary intervention studies, including controlled feeding studies for discovering and developing metabolomics-based biomarkers of dietary intake and exposure.

Background

Adoption of sustained healthy dietary habits and dietary patterns are critical for preventing and delaying the onset of a variety of chronic diseases including obesity, diabetes, cardiovascular disease, and cancer. Nutritional epidemiological studies explore the role of dietary constituents in human health and disease. Dietary exposure information, which is crucial for establishing such associations, is often derived from self-reported 24-hour dietary recalls, Food Frequency Questionnaires (FFQ), food diaries, and other similar dietary intake assessment instruments. However, these instruments are often subject to a variety of systematic and random measurement errors. In addition, these measurements are further limited by incomplete food composition databases that are used for converting the intake information to examine the associations. There is a critical need for objective biomarkers of dietary intake that can serve as independent markers of dietary intake and complement current dietary intake assessment methods. While nutrient biomarkers have been extensively explored, their utility in the clinical research is limited, and non-nutrient dietary constituents are not well integrated into the dietary biomarker discovery pipeline. Moreover, metabolic transformation of dietary constituents, especially the non-nutrients by host and microbial metabolism havenot been efficiently harnessed into this pursuit. Unbiased metabolomics platforms especially Liquid Chromatography-Mass Spectrometry (LCMS) based approaches, present an unprecedented opportunity for measuring both nutrient and non-nutrient metabolites, based on their chemical composition, giving a larger chemical space to explore. A recent workshop convened by the NIH has explored the potential of omics approaches especially metabolomics for dietary biomarker development. The workshop report can be found here: https://academic.oup.com/advances/article/11/2/200/5544358.

Research Objectives

This FOA invites applications for a Data Coordinating Center (DCC) to participate in a consortium for the development of dietary biomarkers program. A separate FOA (RFA-DK-20-005) will provide support for Dietary Biomarker Development Centers (DBDCs) using a phased U2C award mechanism. The DBDCs comprised of multidisciplinary teams carry out exploration of metabolomics-based dietary biomarkers of intake and exposure. The DCC will coordinate the activities of the consortium and provide scientific leadership and oversight for the dietary biomarker development program. In order to facilitate the planning and implementation of dietary biomarkers development project, the following consortium structure is proposed.

Consortium Organization:

The Awardees of the DBDCs and the DCC will form a Steering Committee (SC) along with NIDDK and United States Department of Agriculture-National Institute of Food Administration (USDA-NIFA)staff. The first six months of the award will be devoted to planning the study and developing strategies for dietary biomarker development. It is anticipated that there will be substantial involvement of NIDDK and USDA-NIFA staff in the planning phase of the study. The information provided by the awardees in the applications will serve as the initial basis for these discussions in the planning phase. It is expected that DBDCs will deliberate and decide on common strategies for biomarker discovery, evaluation, validation and analytical methods. Some of the biomarker strategies are likely to be site-specific, particularly related to some of the dietary interventions. The DCC will lead and coordinate the discussions on study design, protocol development, implementation, and data analysis. They will also engage in regular teleconferences and other interactive discussions driven by science and consensus of the consortium. It is anticipated the PD(s)/PI(s) of the DBDCs and DCCs will actively engage in all the consortiumrelated activities during the entire duration of the study.

1. Dietary Biomarker Development Centers (DBDCs)

Dietary Biomarker Development Centers (DBDCs) supported by RFA DK-20-005 (U2C Clinical Trial Required) will explore and develop biomarkers of dietary intake and exposure, employing untargeted LCMS based metabolomics. Specifically, the applicants will be responsible for generating an initial set of metabolite signatures for major food groups or specific food types as described by the USDA (https://www.usda.gov/media/blog/2017/09/26/back-basics-all-about-myplate-food-groups), in response to controlled feeding to a small group of study volunteers. They will also characterize initial biomarker properties and performance such as dynamic range by analyzing the biospecimens (e.g., blood and urine) collected before and after intervention, and/or half-life of the dietary metabolites, during this phase. In a follow up study, these markers will be evaluated for predicting recent and habitual consumption using multiple dietary recalls and food diaries and other dietary assessment methodologies as appropriate. The DBDCs will recruit participants, conduct the dietary intervention(s), and collect data and biospecimens and carry out analyses. Data generated by the DBDCs will be curated by the sites and submitted to the DCC along with the metadata as appropriate and specified by the study protocol.

The DCC will conduct independent analyses of the data in addition to the analyses conducted by study teams at the DBDCs will conduct data analyses, while the DCC will carry out independent analysis of the data. The study group will have exclusive access to data from the study population for a defined period, according to NIDDK and NIH data sharing policies. All study data analyzed for publication of the primary and secondary study outcome(s) and completed ancillary studies are expected to be provided to the NIDDK Repository (https://repository.niddk.nih.gov/home/) or to a national data repository such as National Metabolomics Data, Repository (NMDR) hosted at University of California-San Diego (https://www.metabolomicsworkbench.org/) so that it can be shared as appropriate per NIH policy and consistent with achieving the goals of the program. The Steering Committee (see below) will also establish policies for conducting ancillary studies and other appropriate guidance for running the consortium.

2. Data Coordinating Center (DCC)

A single DCC will coordinate and provide scientific oversight to the consortium. NIDDK specific guidance for DCC management of clinical cooperative agreements can be found at https://www.niddk.nih.gov/research-funding/human-subjects-research/policies-clinical-researchers.The overall goal of the DCC is to provide leadership, in collaboration with the DBDCs, organize and facilitate the activities of the NIDDK/USDA Dietary Biomarkers Development Centers Program under the direction of the Steering Committee. It is expected that the awardees will participate in a planning phase for the first six months of the project to plan and decide on the common strategies for the study designs, biospecimen analysis and data analysis that can be employed across the DBDCs for the dietary biomarkers development project. These decisions are largely driven by the expertise and experience of the consortiummembers and the resources and infrastructure available to them.

The DCC study team will be expected to oversee and perform the consortium activities in the planning phase, including but not limited to:

  • Establishment and participation in a Steering Committee made of the key personnel from DBDCs and DCC and NIH and USDA staff, and initiation of any needed subcommittees to work together as a consortium;
  • Establishment of any necessary consortium policies, such as policies for data sharing and safety or publication of data;
  • Finalization of the common elements of the study protocol(s), including bio-specimen collection, processing, and analysis and protocols for data analysis;
  • Development of consent form(s);
  • Development of manuals of operations which would include, but is not limited to, procedures, validation, and quality control for any laboratory analysis;
  • Development of a data and safety monitoring plan. NIDDK will appoint a Data and Safety Monitoring Board (DSMB) to conduct oversight of the clinical trials. It is expected that DBDCs will obtain local IRB approvals from their parent institutions;
  • Development of training materials and training/certification plans for study staff, if appropriate;
  • Other elements as necessary.

During the implementation phase the DCC will be expected to oversee the following functions, including but not limited to:

  • Createand maintaina functional web-infrastructure to support the submission and access of dietary biomarker data. This system should be easy to use, harmonized to different databases, and designed for direct submission of data;
  • Establish secure and user-friendly interactive tools for facilitating effective communication and exchange of information among the consortiummembers;
  • Provide administrative and logistical support services for the Steering Committee and DSMB, (two semi-annual meetings for the Steering Committee in the planning phase and one annual meeting thereafter and one annual meeting for the DSMB);
  • Provide administrative and logistical support for the regular conference calls and meetings and generation of meeting minutes;
  • Take responsibilityfor the receipt, protection and management of dietary biomarker data obtained from the DBDCs, checking for missing data elements, performing quality oversight of the analyses and conducting independent data analysis;
  • Establish a database of the dietary biomarker data into a user-friendly database as per Findable, Accessible, Interoperable, and Reusable (FAIR) policies https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4792175/ ;
  • Oversee all aspects of the consortia performance, including timeliness and completeness of data, ensuring quality of data and sample submission;
  • Generate and present semi-annual data and safety monitoring board (DSMB) reports, Steering Committee monthly meeting minutesas well as monthly site performance reports;
  • Provide independent biostatistical analysis support for evaluating dietary biomarker performance that uses innovative and creative methods for carrying out independent analysis of the data across the consortium;
  • Prepare major consortium-wide publications for the scientific literature and reports for the Steering Committee and the Data and Safety Monitoring Board (DSMB);
  • Oversee ancillary study proposal reviews and collaboration (data/specimen sharing) with approved and funded ancillary study projects, as needed;
  • Facilitate, createand support of various task driven working groups for coordinating consortiumwide activities and developing consensus.

3. Steering Committee:

The Steering Committee (SC) is comprised of investigators of the DBDCs, DCC, and the program staff from NIH and USDA-NIFA and serves as the main governing body for the study. The SC is primarily responsible for the general planning, developing study protocols, metabolomics analysis and data analysis plans and other study related procedures and manual of operations. Investigators of the individual DBDCs, the DCC, the project scientists from NIDDK and the USDA will hold one vote each for any action item that requires voting. The SC will initiate appropriate working groups for efficient management of the consortium. In addition, the SC will develop various policies for the consortium for the implementation strategies. The SC will conduct regular phone calls for accomplishing consortia tasks and meeting the milestones. It is expected that the Steering Committee will meet a minimum of two times in person, in Bethesda, MD region during the planning phase, one time soon after the award of the grants and another time at the end of first six months for finalizing the dietary intervention strategies. The SC will also meet once annually during the implementation of the project. They will also engage in regular teleconferences and other interactive discussions driven by science and consensus of the consortium. It is anticipated the PD/PIs of the DBDCs and DCCs are actively engaged in all the consortia related activities during the entire duration of the study.

In accordance with NIDDK data sharing policies, all dietary biomarker data produced by the consortium will be made publicly available, following current best practices regarding data safety and privacy policies. It is also expected that data will be stored in standardized formats in appropriate data repositories.

While eligible applicant institutions may apply for both the DBDCs and DCC components of this program, the PD(s)/PI(s) cannot be the same individual(s).

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 intends to commit $580,000 in FY 2021 to fund one award.

Award Budget

Application budgets cannot exceed $350,000 direct costs per year.

Award Project Period

The maximum project period is five 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)

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

 

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 Guideexcept 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.

Other Attachments:

Statement of Willingness: The filename "Willingness to Participate" should be used. The statement of willingness should include, but is not limited to:

  • Participate collaboratively in the DBDC consortium;
  • Work collaboratively with the NIDDK and USDA-NIFA staff andthe DBDC to participate in the initial and annual meetings thereafter during the grant award;
  • Cooperatively interact with the NIDDK and USDA-NIFA staff, and the DBDCs and provide expert opinions during the planning activities to come up with best strategies for the project and collectively come up with common strategies to be implemented across the consortium;
  • Efficiently carry out the project during the implementation phase to produce quality data on dietary biomarkers, share and work with other DBDCs to analyze the data and identify candidate dietary biomarkers, and evaluate dietary biomarker performance;
  • Facilitate data deposition in a timely fashion by providing appropriate templates and other data formats and troubleshooting any issues related to data deposition;
  • Actively interact with DBDCsand provide guidance on the needs of the dietary biomarkers project that may arise during the performance of the project;
  • Organize regular conference calls and other meetings prepare meeting notes and, attend planning and annual meetings;
  • Organize DSMB meetings in communication with NIDDK program staff and facilitate the meeting reports.

Data and Safety Monitoring Plan (DSMP): The filename "Data and Safety Monitoring Plan.pdf" should be used. A Data and Safety Monitoring Plan shouldbe submitted.

NIDDK will appoint a Data and Safety Monitoring Board (DSMB). While the final details of the DSMP will depend on the final study protocol, this attachment should address processes likely based on the scientific thrust of the study. Information about DSMPs is available on the NIDDK website: https://www.niddk.nih.gov/research-funding/human-subjects-research/policies-clinical-researchers/data-safety-monitoring-plans.

All applications should include a general description of the monitoring plan, policies, procedures, responsible entities, and approaches to identifying, managing and reporting reportable events (adverse events and unanticipated problems), to the applicable regulatory agencies (e.g., Institutional Review Board (IRB)), the Office of Biotechnology Activities (as appropriate), the Office for Human Research Protections, and the NIDDK and DSMB.

The DSMP must address the following areas:

  • Who will manage and conduct the monitoring;
  • What will be monitored;
  • Proposed monitoring time points;
  • Where the monitoring will occur;
  • How the reportable events will be managed and reported; and
  • How sites/centers, and participating facilities will be monitored.
SF424(R&R) Senior/Key Person Profile

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

The DCC Director is required to have an established record of external funding and research accomplishment and demonstrated skills in managing and coordinating consortiumactivities and managingdatabases and likely have a background in dietary biomarkers research.

 

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

The minimum level of effort for the DCC Director is 1.2 person months (10% effort). S/he may be supported by an associate director, but the total, combined Directorship efforts may not exceed 2.4 person months. The DCC may also include an administrative assistant(s) or a meeting coordinator) that must be fully justified.

The budget to support the DCC, including personnel, travel, consortium meeting expenses and supplies, cannot exceed $100,000 direct costs per year. The travel and meeting budget must include support for the annual NIDDK/USDA Dietary Biomarkers development Centers Program's face-to-face meeting, DSMB meetings and other related consortium activities. The remaining funds should be allocated for the database and consortium coordination needs and for the development of bioinformatic tools needed for the consortium.

Budget Justification: Describe the specific functions of all key personnel, consultants, collaborators, and support staff.

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:

The DCC should provide a plan for administrative coordination of the program activities both in the planning phase and during the project implementation period, that will be executed in partnership with the DBDCs. Specifically, the DCC should describe a plan to:

  • Organize and facilitate the DBDCs activities in the planning and implementation phases related to developing common study designs for dietary feeding studies, protocols, bio-specimen analytical strategies, and data analysis plans;
  • Devise an innovative and multi-pronged communication strategy to ensure that the activities of the DBDCs can be effectively managed;
  • Establish a dietary biomarkers database for the data that emanates from the DBDCs andthe available infrastructure for this effort;
  • Develop data pipelines and various types of formats and templates for accepting data from the DBDCs;
  • Conduct independent analysis of the data generated by the DBDCs;
  • Develop an easily navigated website to facilitate activities across the DBDCs and facilitate data deposition from the DBDCs;
  • Provide a plan to organize and support an annual face-to-face meeting of the Dietary Biomarkers Development Centers consortium;
  • Provide plans to organize the monthly, web-based conference calls of the Steering Committee and Executive Committee and prepare the meeting minutes for these meetings.

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-definedclinical 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" (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 proposed DCC address the needs of the Dietary Biomarkers Development Centers consortium that it will coordinate? Is the scope of activities proposed for the DCC appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the Dietary Biomarkers Development Centers consortium?

 

Are the PD(s)/PI(s) and other personnel well suited to their roles in the DCC? Do they have appropriate experience and training, and havethey demonstrated experience and an ongoing record of accomplishments in managing dietary intervention or similar research? Do the investigators demonstrate significant experience with coordinating collaborative clinical research?Does the investigator's team show willingness to participate in a consortium? If the DCC is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the DCC? Does the applicant have experience overseeing selection and management of sub-awards, if needed?

Specific to this FOA:

Do the PD(s)/PI(s) have experience managing dietary intervention studies orsimilar research consortia?

 

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research Dietary Biomarkers Development Centers consortium the DCCwill serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?

 

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

Specific to this FOA:

Does the application propose a user-friendly andappropriate infrastructure for collecting, storing and analyzing research data? Are policies and methods for ensuring data quality and confidentiality, and participant privacy, addressed and appropriate? Are the strategies presented appropriate for developing data sharing plans and other policies and procedures for efficient operation of the Dietary Biomarkers Development Centers consortium?

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

Specific to this FOA:

Are resources available within the scientific environment to support electronic information handling?

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.

Data and Safety Monitoring Plan

Is the DSMP appropriate for the DCC?

 

For research that involves human subjects but does not involve one of thecategories 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.

 

Not applicable.

 

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

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

3. Anticipated Announcement and Award Dates

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

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

Section 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. 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 and USDA 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. USDA-NIFA's purpose is to provide a consulting and supportive role for the success of the project(s). 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 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 and USDA-NIFA Program Officials, where indicated, including as a minimum, summary data on protocol performance. For coordinated multiple awards or a multi-site single award, the NIDDK and USDA-NIFA Program Officials 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, NIH and USDA policies. The awardee must also be adherent to Study Publication and Presentation Policy. The NIDDK and USDA-NIFA will have access to and may periodically review all data generated under an award. NIDDK and USDA-NIFA staff may co-author publications of findings with awardees consistent with NIH and USDA 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) 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 and USDA-NIFA 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 and USDA-NIFA 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 biospecimens, 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 or USDA-NIFA, is permitted only after written permission by the NIDDK or USDA-NIFA 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 (e,g., protocols, data analysis, conclusions) as well as proprietary information of an individual company or other entity collaborating with the study. Any exception requires written approval from NIDDK and/or USDA-NIFA 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 PD/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 PD/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/research-funding/human-subjects-research/policies-clinical-researchers.

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:

NIDDK and USDA-NIFA Project Scientists 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/USDA-NIFA 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 and USDA-NIFA 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 and USDA-NIFA activities that may be relevant to the study to facilitate compatibility with the NIDDK/USDA-NIFA 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 and USDA-NIFA. The NIDDK and USDA-NIFA 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 and USDA-NIFA Project Scientists or Project Coordinators 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 and USDA-NIFA Project Scientists or Project Coordinators 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 and USDA-NIFA Program Officials identified in the Notice of Award 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 Steering Committee, Data Safety and Monitoring Board (DSMB), and related meetings. The NIDDK retains, as an option, periodic review of progress by researchers not involved with the study.

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.

The NIDDK/USDA-NIFA 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 and USDA-NIFA.

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.

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 and USDA-NIFA 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 and USDA-NIFA Project Scientists. The final structure of the Steering Committee and voting procedures will be established at the first meeting. The NIDDK and USDA-NIFA Project Scientists 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 and USDA-NIFA Project Scientists, 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 and USDA-NIFA 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 agreementsare required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threatensubmission 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)

Padma Maruvada, Ph.D.

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

Telephone: 301-594-8884

Email: maruvadp@mail.nih.gov

Peer Review Contact(s)

Lan Tian, Ph.D.

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

Telephone: 301-496-7050

Email: tianl@nih.gov

Financial/Grants Management Contact(s)

Sharon Bourque

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

Telephone: 301-594-8846

Email: bourques@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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