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)
Office of Behavioral and Social Sciences Research (OBSSR)

Funding Opportunity Title

Psychological, Behavioral, and Neurocognitive-Focused Ancillary Studies to the Molecular Transducers of Physical Activity in Humans Consortium (MoTrPAC) (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DK-17-009

Companion Funding Opportunity

None

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

93.847 

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support an ancillary study grant application(s) to add psychological, behavioral, and/or neurocognitive assessments to the data collection in adults (> 18 years of age) enrolled at the clinical sites in the Molecular Transducers of Physical Activity in Humans Consortium (MoTrPAC) supported by the NIH Common Fund. This ancillary study FOA complements the parent MoTrPAC study by supporting research to elucidate the individual level psychological, behavioral, and neurocognitive characteristics that explain variation in individual response and adherence to a program of physical activity. The ultimate goal of the research supported by this FOA is to characterize individual differences in response to exercise over the course of the MoTrPAC protocol in order to identify novel treatment targets and inform personalized physical activity intervention approaches in the future.      

Key Dates
Posted Date

May 15, 2017

Open Date (Earliest Submission Date)

September 24, 2017

Letter of Intent Due Date(s)

September 24, 2017

Application Due Date(s)

October 24, 2017, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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 2018

Advisory Council Review

May 2018

Earliest Start Date

July 2018

Expiration Date

October 25, 2017

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


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. Go to Grants.gov to download an application package to complete the application forms offline or create a Workspace to complete the forms online; submit your application to Grants.gov; and track your application in eRA Commons.
Learn more about the various submission options.

Table of Contents

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

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

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

Despite the well-established benefits of regular physical activity for health, well-being, and weight maintenance, few Americans meet established guidelines for physical activity, and decades of health promotion efforts have not led to significant population-level changes in physical activity. To close this gap between knowledge and behavior, we need to understand the drivers of physical activity initiation and maintenance at multiple levels. To date, there has been relatively little research elucidating individual psychological, behavioral, and/or neurocognitive characteristics that underlie individual variability in response to moderate to vigorous physical activity. Even less research has examined how the biological responses to physical activity relate to the psychological, behavioral, and neurocognitive determinants of physical activity initiation and maintenance. 

The NIH Common Fund initiative, Molecular Transducers of Physical Activity in Humans Consortium (MoTrPAC) will allow a much deeper understanding of the biological responses to physical activity. This ancillary study FOA complements the parent study by supporting research to elucidate the individual level psychological, behavioral, and neurocognitive characteristics that explain variation in individual response and adherence to physical activity programs. Examples of measurement domains that may be supported through this ancillary study include, but are not limited to, sensorimotor, perceptual, learning and memory, cognitive control and executive functions, motivation and effort, affective and stress responses, reward and decision-making processes, exercise-specific phenomena (e.g., exercise tolerance), and interpersonal processes. The extensive biological data (molecular, physiological, metabolic, etc.) collected in the parent study will also allow researchers to examine hypotheses about how biological variables interact with psychological, behavioral, and neurocognitive characteristics to explain response to initiation and short-term maintenance of physical activity in the context of the MoTrPAC exercise protocol. Although some exploratory data collection is allowed, well-justified mechanistic hypotheses about the psychological, behavioral, and/or neurocognitive data collected are required in a rigorously designed and adequately powered study.

Understanding individual differences at baseline and in response to moderate-to-vigorous physical activity is expected to help in the development of more potent and personalized approaches to increase and maintain physical activity across the lifespan. As such, measurements and hypotheses that are clinically meaningful and have potential to inform future intervention research are encouraged. Grant applications including additional intervention components or approaches, beyond the MoTrPAC protocol, are not appropriate for this FOA. Rather, the goal of this ancillary study FOA is to identify meaningful behavioral, psychosocial or neurocognitive targets that will inform future development and testing of more efficacious physical activity interventions to enhance or maintain weight loss and to improve outcomes in obesity, diabetes, and other chronic metabolic diseases.

Research in response to this FOA must include hypothesis-driven measurement of psychological, behavioral, and/or neurocognitive assessments in adults (> 18 years of age) at baseline and at the post-intervention follow-up visit in the MoTrPAC protocol. Hypothesis driven measurements over the course of the MoTrPAC exercise protocol and between the baseline and post-intervention follow-up visit are encouraged. Measurement related to specific bouts of exercise might include psychological, behavioral, and/or neurocognitive factors prior to initiation of exercise, during exercise, and post exercise. Additional information regarding the MoTrPAC protocol and relevant contacts can be found on the MoTrPAC website.

Research to understand the interaction between individual psychological, behavioral, and/or neurocognitive characteristics and biological factors in response to initiation and maintenance of the MoTrPAC physical activity protocol is also encouraged when scientifically appropriate. This includes research to understand the potential mediating role of biological response to exercise on psychological, behavioral and/or neurocognitive factors as well as the mediating role of psychological, behavioral, and/or neurocognitive factors in the biological response to exercise.

Although research to understand the effects of exercise on psychological, behavioral, and/or neurocognitive factors is allowed, the primary intent of this FOA it to understand phenotypic variability in approach to and experience of exercise, including understanding sub-group differences and trajectories of these factors from baseline to post protocol assessment in order to inform targets for future intervention development.

Examples of psychological, behavioral, and/or neurocognitive assessment domains might include but are not limited to:

  • Affective and/or emotional characteristics such as positive and negative valence or measures of stress and stress response;
  • Cognitive and/or behavioral processes such as attitudes, predictions, and appraisals or patterns of approach and avoidance;
  • Reward and motivational factors such as sensitivity to the rewarding and aversive aspects of exercise, incentive salience of exercise reward, patterns of goal setting and goal striving related to exercise, basic motivation(s) or drive to exercise, or choice behavior involving preferences and valuation of risks related to reward and punishment in the context of exercise;
  • Social and interpersonal processes influencing exercise response such as social relationships, identity, shaping, or cultural norms; and
  • Neurocognitive mechanisms such as how sensorimotor and perceptual processes; simple and complex attention; learning and memory; reward learning and habit formation; working memory and executive function and the neural circuits that support these functions contribute to the experience of and effort toward exercise.

Although applicants can include measurements outlined in the examples above, there is no expectation that the ancillary assessments proposed will include all or any of the above examples.  Rather, the expectation is that the focus of the proposed ancillary assessments be psychological, behavioral, and/or neurocognitive factors selected based on mechanistic hypotheses about the relationship between these factors and response to exercise initiation and maintenance over the duration of the MoTrPAC exercise protocol.

Assessments and measures included in the grant application should have demonstrated validity and reliability. Exploratory or new measures are allowed but should not be the exclusive focus of the research proposed.

Ancillary studies are not required to propose data collection at all of the clinical sites in MoTrPAC.  The sites proposed should be based on scientific hypotheses, power estimates, and feasibility. Although the parent MoTrPAC study will recruit and enroll the participants, ancillary study investigators should describe and justify the expected study population, group/intervention assignment, and sample sizes necessary to answer the ancillary study’s major research questions. 

The ultimate goal of the research supported by this funding opportunity announcement is to inform future physical activity interventions, particularly interventions to prevent excess weight gain or enhance or maintain weight loss. As such, applicants must include a range of Body Mass Index (BMI) categories (https://www.cdc.gov/obesity/adult/defining.html), and are encouraged to oversample for obesity in the sample they propose to the degree possible given the enrollment plan for the MoTrAPAC parent study. Other aspects of diversity in the sample proposed are also highly encouraged as a means to better understand variation by key subgroup characteristics such as age, sex, and/or racial/ethnic minority populations vs non-Hispanic White differences. Research proposed in response to this funding opportunity announcement is limited to adults (> 18 years old) recruited to participate in the MoTrPAC exercise protocol. Ancillary studies may not enroll the sub-group of highly-fit/elite athletes that will be recruited in MoTrPAC.

Quantifiable metrics to measure achievement of milestones should support the project including concrete milestones, for producing data that will be used to address the objectives in the application. Additional milestones may be negotiated before awards are made. 

Applicants are expected to collaborate with the MoTrPAC study group to ensure that the proposed measurements are feasible within the context of the parent protocol and that the measurements proposed will not interfere with the parent study recruitment and retention.  Awardees must work collaboratively with the MoTrPAC clinical centers and Clinical Coordinating Center (CCC), the MoTrPAC Steering Committee, and the NIH throughout the award period. Any changes would retain the primary scope and scientific focus of the peer-reviewed application but, as with any cooperative agreement, investigators need to be prepared to work collaboratively to assure that the ancillary study remains complementary with the parent study, does not hinder recruitment or retention, or otherwise interfere with the conduct of the parent study.

Research Management

Applicants must adequately support all necessary research coordination and management activities, including support for personnel and resources necessary to plan, implement, and oversee the ancillary study, such that the ancillary study doesn't burden, interfere with, or otherwise redirect or utilize resources for the parent study. Applicants are expected to coordinate with the MoTrPAC parent study team (clinical centers and Clinical Coordination Center) throughout the design, implementation, and data analysis stages. Study management also includes assistance with communication among the participating ancillary study sites/institutions in collaboration with NIDDK and the MoTrPAC study group.

Expectations for research management include but are not limited to:

  • Development and maintenance of the ancillary study protocol, manual of procedures, data and safety monitoring plan, informed consent, and other additional study documentation; Oversight and assurance of appropriate implementation of the study protocol;
  • Training and certification of study staff;
  • Coordination and communication with the MoTrPAC study and components;
  • Maintenance and oversight of subject confidentiality and safety;
  • Collation, management, and analysis of the data produced by this ancillary study;
  • Development of reports for the MoTrPAC Ancillary Study Committee and NIDDK-convened Observational Study Monitoring Board;
  • Interaction with NIDDK to address questions and requests relevant to OSMB oversight of the study protocol, implementation and management procedures, and data quality/completeness; and
  • Planning and management of relevant ancillary study meetings, including assisting NIDDK and NIH with the logistics of Observational Study Monitoring Board (OSMB) meetings and webinars.

Research applications including animal research are not appropriate for this FOA.

Observational Study Monitoring Board (OSMB)

An OSMB will be appointed by the NIDDK to review ancillary study protocols and monitor study performance in collaboration with the MoTrPAC parent study and study guidelines. In general, OSMBs meet twice per year with additional meetings and/or reporting as needed. As a part of its responsibilities, the OSMB will submit recommendations to the NIDDK regarding the continuation of the ancillary study(ies). All protocols or changes to protocols must be approved by the relevant Institutional Review Board(s), the MoTrPAC Steering Committee and other oversight bodies, the ancillary study OSMB, and the NIDDK before initiation.

Other Special Performance Requirements

Applicants are expected to collaborate with the MoTrPAC Steering Committee and sub-committees and with the NIDDK. Applicants are expected to:

  • Cooperate with the MoTrPAC Steering Committee and awardees in the development, modification, and performance of the study protocol(s);
  • Comply with all study policies and quality assurance measures approved by the MoTrPAC Steering Committee;
  • Agree to oversight of the study by an OSMB convened by NIDDK, which may include responses to questions; requests for changes to the study protocol(s), procedures, and management; and/or additional monitoring as requested by the OSMB and NIDDK;
  • Transmit study data to the MoTrPAC Clinical Coordinating Center at the end of the project and as needed during the project period;
  • Report all adverse events or alerts in accordance with procedures, as necessary, in collaboration with the MoTrPAC Steering Committee and NIDDK;
  • Cooperate with other awardees in the publication of study results and the eventual release to the scientific community of study procedures and other resources;
  • Accept the “Cooperative Agreement Terms and Conditions of Award” in Section VI.2.A “Award".

Applicants must have advanced, written approval from the appropriate MoTrPAC representative to submit an ancillary study application.

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.

Funds Available and Anticipated Number of Awards

NIDDK and OBSSR intend to commit a total of $4,500,000 to fund 1-2 awards in Fiscal Year 2018.

Award Budget

Application budgets are limited to $3,000,000 Direct Costs per year. This limit is exclusive of any Facilities and Administrative costs associated with consortium or subcontract agreements. Budgets are expected to reflect the actual needs of the proposed project

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 in response to 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:

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not 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) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • o    NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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

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

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

Buttons to access the online ASSIST system or to download application forms 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 Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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, preferably electronically, should be sent to:

John Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Blvd, Room 7005, MSC 5452
Bethesda, MD 20892-5452
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. The following items must be included as attachments under "Other Attachments."

1. Clinical Protocol Synopsis

The file name “Clinical Protocol Synopsis.pdf” should be used and will be reflected in the final image bookmarking for easy access for reviewers. Applications that lack the Clinical Protocol Synopsis will be deemed incomplete and will not be peer reviewed. The clinical protocol synopsis must include the following information:

  • Description of study objectives, scientific rationale, and overall study design;
  • Description of participant eligibility and inclusion/exclusion criteria;
  • Description of the assessments including implementation procedures, timeline, and monitoring plans;
  • Participant recruitment, enrollment, and retention plans, including a discussion of the availability of participants by study group assignment and plans to coordinate with the parent study;
  • Detailed description of the assessments including implementation procedures, timeline, and monitoring plans;
  • Description of collaboration and integration of assessments into the parent study protocol;
  • Methods to monitor and assure data/assessment completion;
  • Details on the availability and expertise of personnel, devices or equipment necessary to administer assessments, and facilities required for assessments;
  • Details on additional data that will be requested from the parent study to enable the primary research questions to be addressed, including demographic, anthropometric, laboratory, physiological, and/or other data;
  • Description of the study oversight, data management, and quality control plan, including methods for monitoring the quality and consistency of the data collection, and data entry as well as policies and methods for ensuring blinding of relevant investigators and staff.

2. Statistical Analysis Plan

The file name “Statistical Analysis Plan.pdf” should be used and will be reflected in the final image bookmarking for reviewers' easy access. Applications that lack the Statistical Analysis Plan(s) will be deemed incomplete and will not be peer reviewed.

The applicant(s) should describe the statistical methods planned for each specific aim, including the sample size and power calculations and plans for the primary and secondary analyses. This plan is critical for judging whether applicants have the appropriate sample size based on suitable power calculations and/or are using the most appropriate methods to analyze the resulting data, have made appropriate statistical assumptions for the chosen analyses, and will make correct conclusions at the end of the study. Analysis plans that target mediating effects should account for the time-ordered yet interdependent nature of such variables. Applications should include plans to account for participant drop-out and missing data.

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

The application must include funds for the U01 PDs/PI(s), key personnel and/or staff to travel and attend the following meetings:

  • Steering Committee meetings in the Washington, DC area;
  • Central or other on-going training sessions;
  • One in-person and one remote (webinar) meeting per year of the OSMB (including all meeting room and travel expenses for up to 7 OSMB members) to be held in the Washington, DC 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: Applicants should provide the following information:

  • A concise description of the overall strategy, methodology, and analyses to be used to accomplish the goals and specific aims of the study;
  • A description of and rationale for the proposed assessments and measures including the type, frequency, feasibility, reliability, and validity;
  • A discussion of studies and preliminary data that led to the proposed psychological, behavioral, and/or neurocognitive assessments that would be used in this ancillary study;
  • A description of the anticipated sample, including sample size overall and by MoTrPAC group assignment, relevant study subject inclusion and exclusion criteria, and study site location(s);
  • An overview of the recruitment and retention strategy;
  • A discussion of the feasibility of conducting the proposed study, including the track record of the investigative team and specific competence and previous experience of the technical and administrative staff who will be integral to the operation of the proposed project;
  • A description and rationale for the biological and clinical data that will be requested from the MoTrPAC study;
  • A description of the statistical methods and power for the study design;
  • Description of how the proposed team will work together and in collaboration with the MoTrPAC study investigators and staff to accomplish the goals of the ancillary study; and
  • A brief acknowledgement of responsibilities and previous experience as part of a multi-center, collaborative project.

In this section, there should be sufficient description of the items listed above to permit thorough evaluation of the proposed study. Technical details contained in the Clinical Protocol Synopsis, Statistical Analysis Plan, and Data and Safety Monitoring Plan can be referenced from within the Research Strategy section in order to avoid duplicating text.

Preliminary Data: Sufficient preliminary data should be provided to permit evaluation of the relevance and feasibility of the proposed research strategy to be implemented in the context of the MoTrPAC study protocol.

Milestones and Timeline: Applicants should provide specific achievable goals and milestones, including approximate timelines for the proposed project. These will include goals for recruitment, retention, collection of study data, and study closeout.  

Collaboration: Applicants should visit the MoTrPAC website for information related to the parent study. Applications to this FOA must include a letter in the Letters of Support (see below) from the appropriate committee (e.g., Ancillary Study Committee) or person (e.g., Chair of the Steering Committee) representing MoTrPAC indicating that the parent study is willing to provide the ancillary study investigators with access to participants and data, as needed. Applicants should communicate with the appropriate MoTrPAC representative, as specified by the MoTrPAC ancillary studies policy to determine the ancillary studies review process and timeline. Applicants should see the MoTrPAC ancillary study policy website for application guidelines and procedures.

Applicants must describe, including a description of the organizational structure, how this ancillary study team will collaborate and work together with the identified Clinical Centers, other components of the MoTrPAC Consortium, and the NIH team to plan and conduct the study; including making measurement and protocol changes to maximize scientific benefit and minimize burden on participants. Applications which lack this information will be deemed incomplete and will not be peer-reviewed.

Data Safety and Monitoring Plan: A DSMP is required for all applications submitted to this FOA. The DSMP should be commensurate with the risk level of the proposed clinical research in a manner consistent with NIDDK Human Subjects Research: https://www.niddk.nih.gov/research-funding/human-subjects-research/policies-clinical-researchers/data-safety-monitoring-plans.

Letter of Support: Applicants must demonstrate that they have the approval and cooperation of the parent study and identified Clinical Centers for the activities proposed for the ancillary research in response to this funding opportunity announcement. Applicants must agree to submit all data to the MoTrPAC Clinical Coordinating Center at the appropriate timepoint for submission to the designated NIH repository. A letter from the appropriate MoTrPAC representative  indicating that the parent study is willing to provide access to participants, samples and data as needed must be submitted  as part of  the application.

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, with the following modification:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
  • All data are expected to be provided to the relevant NIH Data Repository for MoTrPAC in accordance with Institute guidelines, consistent with achieving the goals of the program.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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.

Post Submission Materials

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

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?  

Investigator(s)

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

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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: Have the applicants demonstrated the feasibility of their recruitment and measurement plan; including MoTrPAC site/s support for the ancillary protocol? Have the investigators justified that the site/s proposed will yield the appropriate sample size to test their hypotheses?

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 children, justified in terms of the scientific goals and research strategy proposed?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

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.

Burden

Has the burden of the proposed ancillary study on the parent study and its participants been adequately described?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six 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 six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

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 children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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

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

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

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

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

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

Section VI. Award Administration Information
1. Award Notices

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

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

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 law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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, by the Steering Committee. 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 awards, 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. The awardee(s) will retain custody of and have primary rights to the data developed under these awards, subject to the Government rights of access consistent with current HHS, 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 involvement of a third party in the study, including access to any study data; study results; using the name of the study; or the name of the NIH or NIDDK, is permitted only after concurrence by the NIDDK Program Official who may consult with others at NIH including the NIDDK Technology Advancement Office.

9. Study investigators are encouraged 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.

10. 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 a company collaborating with the study.

11. 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. The PI or his/her designee will coordinate with the NIDDK Data Repository to 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, and storage 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 Steering Committee 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 (https://grants.nih.gov/grants/policy/data_sharing/ and, https://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm#goals, and https://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

12. The Food and Drug Administration Amendments Act of 2007 (FDAAA or US Public Law 110-85) was passed on September 27, 2007. The law requires mandatory registration and results reporting for certain clinical trials of drugs, biologics, and devices. If trials conducted under this grant are applicable clinical trials subject to FDAAA, the sponsor or his/her designee will perform the mandatory study registration and reporting of study results to ClinicalTrials.gov. For more information about this law and requirements for sponsors and/or investigators, visit the PRS and U.S. Public Law 110-85 Information Page at http://prsinfo.clinicaltrials.gov/fdaaa.html. In addition, grantees should be aware that clinical trials not covered by FDAAA may still require registration in an approved registry in order to be published, according to the guidelines issued by the International Committee of Medical Journal Editors (http://icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html).

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 Analyst, 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, participation in the Steering Committee that oversees study conduct. The NIDDK Project Scientist or designee will be a full participant and voting member of the Steering Committee and, if applicable, subcommittees.

3. Serving 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. 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 designee 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 designee 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) participate 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.

2. 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.

3. 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.

4. 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.

5. 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:

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 disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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 progress report, 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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

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

Scientific/Research Contact(s)

Luke E. Stoeckel, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-741-9223
Email: luke.stoeckel@nih.gov

Dana Wolff-Hughes, Ph.D.
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-496-0979
Email: dana.wolff@nih.gov  

Peer Review Contact(s)

Michele L. Barnard, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8898
Email: barnardm@niddk.nih.gov

Financial/Grants Management Contact(s)

Todd Le
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7794
Email: toddle@niddk.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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