Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Heart, Lung, and Blood Institute (NHLBI)

Funding Opportunity Title
Hybrid Effectiveness-Implementation Trials for Heart, Lung, Blood, and Sleep Diseases in the Inpatient Setting (U01 - Clinical Trials Required)
Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices
  • September 24, 2020 - NHLBI Announces Availability of Frequently Asked Questions (FAQs) for RFA-HL-21-001 . See Notice NOT-HL-20-817.
  • Funding Opportunity Announcement (FOA) Number
    RFA-HL-21-001
    Companion Funding Opportunity

    RFA-HL-18-018 - Preparing for Hybrid Effectiveness-Implementation Trials for Heart, Lung, Blood, and Sleep Diseases in the Inpatient Setting (U01)

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

    93.838, 93.837, 93.839, 93.840, 93.233

    Funding Opportunity Purpose

    The purpose of this Funding Opportunity Announcement (FOA) is to support type 2 and 3 hybrid effectiveness-implementation trials for heart, lung, blood, and sleep (HLBS) diseases in the inpatient setting. NHLBI is seeking applications that propose a trial testing an implementation strategy (or strategies) that was developed utilizing an implementation research framework and that aims to increase implementation of an evidence-based practice(s). This FOA intends to support applications that propose a multidisciplinary research team that includes expertise in inpatient clinical research, implementation research, and analytical methods. Any applicant proposing a trial that meets the requirements of this FOA is eligible to apply, regardless of participation in Preparing for Hybrid Effectiveness-Implementation Trials for Heart, Lung, Blood, and Sleep Diseases in the Inpatient Setting (U01) (RFA-HL-18-018).

    Key Dates

    Posted Date
    June 15, 2020
    Open Date (Earliest Submission Date)
    November 09, 2020
    Letter of Intent Due Date(s)

    November 9, 2020

    Application Due Date(s)

    December 9, 2020, 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.

    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)
    December 9, 2020, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related 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.

    Scientific Merit Review

    April 2021

    Advisory Council Review

    May 2021

    Earliest Start Date

    July 2021

    Expiration Date
    December 10, 2020
    Due Dates for E.O. 12372

    Not Applicable

    Required Application Instructions

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

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

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

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

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

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


    4. Table of Contents

    Part 2. Full Text of Announcement

    Section I. Funding Opportunity Description

    Purpose

    Implementation research in health care focuses on the translation of evidence-based health interventions into clinical settings to improve patient outcomes and benefit population health. To date, most NHLBI-funded implementation research has focused on clinical care in the community and outpatient setting. However, many evidence-based practices shown to improve patient outcomes for heart, lung, blood, and sleep (HLBS) diseases in the inpatient setting are not being implemented in clinical practice.

    The purpose of this FOA is to support type 2 and 3 hybrid effectiveness-implementation trials for HLBS diseases in the inpatient setting. Hybrid effectiveness-implementation trials are clinical trials designed to assess the impact of an intervention on clinical effectiveness and implementation. This initiative will support trials that will examine both clinical and implementation outcomes, with a main focus on implementation outcomes such as adoption, fidelity, and sustainability. Additional examples of implementation outcomes include, but are not limited to, those described in Proctor E et al Adm Policy Ment Health 2011. This FOA encourages trial designs that are as rigorous as possible; randomized trial designs (including cluster randomized and stepped wedge cluster randomized designs) are encouraged. The use of electronic medical records is also encouraged.

    This FOA seeks applications for hybrid effectiveness-implementation trials that will test an implementation strategy(ies) that was developed utilizing an implementation research framework. Implementation strategies are methods or techniques used to enhance implementation of a clinical practice, and may include multiple components such as staff education, audit and feedback, or communication tools. Additional examples of implementation strategies include, but are not limited to, those described in Powell BJ et al Implement Sci 2015. Implementation research frameworks are models which may be used to systematically develop and evaluate implementation research strategies, and examples include RE-AIM and the Consolidated Framework for Implementation Research (CFIR). Additional examples of implementation research frameworks include, but are not limited to, those described in Tabak et al Am J Prev Med 2012.

    The implementation strategy(ies) to be tested in the trial is expected to address a gap in implementation of an evidence-based practice(s) for inpatients with HLBS diseases. This FOA encourages testing of strategies aimed at increasing implementation of an evidence-based practice(s) for which the practice’s efficacy is supported by phase III clinical trials and/or clinical practice guidelines.

    This program will foster collaborative research projects. Multidisciplinary research teams that include expertise in inpatient clinical research, implementation research, and analytical methods (e.g., biostatistics, informatics), in addition to other relevant expertise specific to the project, are encouraged.

    Investigators do not need to have been a participant in RFA-HL-18-018, Preparing for Hybrid Effectiveness-Implementation Trials for Heart, Lung, Blood, and Sleep Diseases in the Inpatient Setting (U01) to apply.

    Supported Research Activities

    This FOA is intended to support type 2 and 3 hybrid effectiveness-implementation trials aimed at increasing implementation of an evidence-based practice(s) for HLBS diseases in the inpatient setting. It is expected that the trial will test an implementation strategy(ies) that was developed utilizing an implementation research framework. Trials evaluating implementation strategies targeting evidence-based practice(s) for patients with HLBS diseases in the emergency department, acute care hospital ward, and/or intensive care unit would be considered responsive to this FOA.

    Project Director(s)/Principal Investigator(s) (PD(s)/PI(s)) are expected to use up to one year of the U01 project period to complete all activities needed to enroll the first subject in the hybrid effectiveness-implementation trial. This may include the finalization of study partnerships and Institutional Review Board/Data and Safety Monitoring Board approval of the trial protocol. Years 2-5 of the U01 project period are expected to be used to support the conduct and analysis of the trial.

    Investigators are expected to delineate a project timeline with performance-based milestones to achieve completion of the trial on time and on budget. NHLBI staff, in collaboration with the awardee, will closely monitor progress throughout the project period, including milestones and accrual.

    Milestones must address timing of overall trial and budget goals, including accrual goals for women, minorities, and individuals of all ages including children and older adults, as appropriate. It is expected that performance of milestones will be shared on a regular basis through eConnect, an NHLBI platform that will facilitate transfer of electronic information to NHLBI. Continuation of the award is conditional upon satisfactory progress in meeting milestones and accrual goals, and is subject to the availability of funds.

    Examples of Research Programs

    Selected examples of possible hybrid effectiveness-implementation trials include, but are not limited to, those aiming to:

    • Increase delivery of low tidal volume ventilation in patients with acute respiratory distress syndrome;
    • Increase daily spontaneous breathing trials among eligible mechanically ventilated patients;
    • Increase appropriate utilization of non-invasive ventilation among patients with a chronic obstructive pulmonary disease (COPD) exacerbation or cardiogenic pulmonary edema;
    • Increase early cardiac catheterization in selected unstable angina and non-ST segment elevation myocardial infarction patients per American College of Cardiology/American Heart Association guidelines;
    • Increase delivery of Get with the Guidelines-Heart Failure;
    • Implement guideline recommendations on the use of recombinant activated Factor VII;
    • Increase provider adoption of guidelines established for antithrombotic therapy for venous thromboembolic disease.

    Examples of research that will not be considered responsive to this FOA include:

    • A trial of an implementation strategy targeting evidence-based practice(s) for patients in the outpatient setting or recently transitioned from the inpatient to outpatient setting;
    • Trials other than inpatient HLBS type 2 and 3 hybrid effectiveness-implementation trials. Applicants proposing phase II or above clinical trials may consider applying to NHLBI's multi-center or single center clinical trial FOAs.

    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?
    Required: Only accepting applications that propose clinical trial(s)

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NHLBI intends to commit total costs of $2,512,000 in FY 2021.

    Award Budget

    Application budgets are limited to $400,000 in direct costs in FY 2021, and $675,000 per year in FY 2022 through FY 2025. Applications budgets should reflect the actual needs of the proposed project.

    Award Project Period

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

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

    Section III. Eligibility Information

    1. Eligible Applicants

    Eligible Organizations

    Higher Education Institutions

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

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

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

    Nonprofits Other Than Institutions of Higher Education

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

    For-Profit Organizations

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

    Local Governments

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

    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 if based in Canada. Non-Canadian foreign components 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) – 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:

    Director, Office of Scientific Review
    National Heart, Lung, and Blood Institute
    Telephone: 301-435-0270
    Email: NHLBIChiefReviewBranch@nhlbi.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.

    Facilities and Other Resources: Describe how the available infrastructure and performance site will be leveraged to facilitate the efficient operation of the proposed hybrid effectiveness-implementation trial. Address the appropriateness of the environment including the appropriate infrastructure for the study, access to the appropriate patient population, and engagement of providers, hospital(s), hospital unit(s), and health system(s).

    SF424(R&R) Senior/Key Person Profile

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

    The application should propose a multidisciplinary team with the necessary expertise to design and implement the proposed hybrid effectiveness-implementation clinical trial. Team members should include investigators with inpatient clinical research expertise, implementation research expertise, and analytic methods expertise, in addition to other relevant expertise specific to the application. Evidence demonstrating that the PDs/PIs and Key Personnel have the experience and capability to conduct the proposed trial and meet the milestones and timelines should be provided.

     

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

    If parts of the costs of the trial are to be provided by sources other than NHLBI, these contributions must be presented in detail in the budget justification. Third Party support of the proposed research activity (if approved) will be incorporated as a specific term and condition in the Notice of Award. If the Third Party support ceases and the trial is no longer tenable without the Third Party support, a close-out plan may be requested. Applicants are reminded that although Cost Share is not required, if these types of costs are included in the research application and peer reviewed, it is expected that these costs will not be covered by NHLBI.

    Include budget support for at least two investigators to travel to an in-person meeting to be held in the Washington, D.C. area during years 2 and 5.

    Include budget support for all costs associated with DSMB activities. This includes the costs for preparing reports for the DSMB and meeting reimbursement for the DSMB members. The investigators should assess the need for liability insurance for DSMB members and provide a plan commensurate with the risk of the trial. The budget should include provision for executing the plan proposed. The investigators should also include a plan for assessing DSMB member conflict of interest, and put associated costs in the budget. Additionally, if the DSMB is convened by NHLBI, the investigators should include in their budget coordination of support for at least one DSMB meeting per year in Bethesda, MD and coordinate regular DSMB calls as needed (by teleconference or videoconference).

    Include budget support for publication, data sharing, and dissemination of results.

    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 must describe each of the following elements:

    • The Research Strategy must present an overview of the evidence-based practice(s), the evidence for the efficacy of the evidence-based practice(s), data supporting the presence of an implementation gap in the proposed study population, and the clinical importance of addressing this gap for inpatients with HLBS diseases.
    • The implementation strategy(ies) to address the implementation gap that will be tested in the trial must be clearly described. Include a description of the implementation research framework(s) used to develop the implementation strategy(ies). The framework should be appropriate to the implementation strategy(ies) and outcomes proposed.
    • How stakeholders will be engaged throughout the conduct of the trial.
    • Provide an overview of the hybrid effectiveness-implementation trial to evaluate the implementation strategy(ies). This should include details of the study population, study design, and outcome measures. Both implementation outcomes and clinical outcomes are required, with the main focus on implementation outcomes. Additional details will be in the required in the PHS Human Subjects and Clinical Trials Information Form.
    • Plan for dissemination of the implementation strategy if evidence to support its use is generated through this trial. The plans for dissemination must include methods for dissemination that are not limited to publications and presentations.
    • Propose and justify milestones that will be subject to peer-review. A milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. Milestones must be relevant, measurable, results-focused, and time-bound, and should address timing of overall recruitment/enrollment and retention goals. The milestones should address accrual goals for women, minorities, and individuals of all ages, including children and older adults, and any other identified requirements for completion of the approved research. Describe the milestones that will be met to address the specific aims and ensure the successful completion of the clinical trial and dissemination of its results. Milestones of particular interest include, but are not limited to:
      • Complete finalized study protocol;
      • Final informed consent(s) and assent forms (if applicable);
      • DSMB review and approval of final protocol, template consent(s) and/or assent(s), and data and safety monitoring plan;
      • IRB approval of final protocol and consent and/or assent;
      • Enrollment of first participant;
      • Enrollment of 25%, 50%, 75% and 100% of the projected recruitment for all study participants, including women, minorities and children (as appropriate);
      • Collection of data related to primary and secondary endpoints and database lock;
      • Submission of primary manuscript to peer-reviewed scientific journal(s) and dissemination of results.

    Letters of Support: Letters of support from clinicians, hospitals, hospital units, and/or health systems whose support are necessary to the successful conduct of the trial should be provided. If partial funding is to be provided by sources other than NHLBI, provide Letter(s) of Support signed by an authorized organization representative (AOR).

    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.
    • Awardees are expected to comply with the NHLBI Data Sharing Policy.
    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.

    Section 2 - Study Population Characteristics

    2.5 Recruitment and Retention Plan

    The Recruitment and Retention Plan should address: 1) the expertise of the individual(s) responsible for screening, approaching and consenting potential participants, if applicable; 2) the process for identification and screening of study participants; 3) primary and back-up recruitment strategies (e.g., use of electronic health records); 4) participant retention and adherence strategies; 5) engagement of stakeholders.

    For multi-center studies, provide a table of the recruiting sites and site PD/PIs showing enrollment goals and number of potential participants available at each site.

    2.7 Study Timeline

    Include a table or graph of the overall study timeline. This is expected to be a visual representation (such as a Gantt Chart) of core milestones and key project management activities. A narrative is not expected in this section. The study timeline should include core milestones that need to be met throughout the lifecycle of the clinical trial to ensure its success, and the subtasks that will be used to reach the milestones. The period of time for the study duration is expected to be displayed in months and must include, but is not limited to, the following:

    • Complete finalized study protocol;
    • Final informed consent(s) and assent forms (if applicable);
    • Agreements in place for product supply (if applicable);
    • Training of study staff/sites;
    • DSMB review and approval of final protocol, template consent(s) and/or assent(s), and data and safety monitoring plan;
    • IRB approval of final protocol and consent and/or assent;
    • Enrollment of first participant;
    • Enrollment of 25%, 50%, 75% and 100% of the projected recruitment for all study participants, including women, minorities and children (as appropriate);
    • Collection of data related to primary and secondary endpoints and database lock;
    • Final data analyses to occur;
    • Submission of primary manuscript to peer-reviewed scientific journal;
    • Submission of study results to ClinicalTrials.gov within 12 months of the primary completion date.

    Section 3 - Protection and Monitoring Plans

    3.5 Overall Structure of the Study Team

    Include a description of the multi-disciplinary research team and how they will work together, including plans for collaboration among investigators with inpatient clinical research expertise, implementation research expertise, and analytic methods expertise. Include a description of how stakeholders will be engaged throughout the conduct of the hybrid effectiveness-implementation trial.

    Section 4 - Protocol Synopsis

    4.1.a. Detailed Description

    Include a description of the study design (e.g., single center, multi-center, cluster randomized, stepped wedge) and provide a narrative of the hybrid effectiveness-implementation trial to evaluate the implementation strategy(ies). Both implementation outcomes and clinical outcomes are required, with the main focus on implementation outcomes.

    4.3Statistical Design and Power

    Justify the proposed sample size based on appropriate study assumptions, event rates, effect size, and power calculations. The calculations must be linked to the study endpoints and to the hypothesis(es) being tested. Explain how the outcome(s) will address the hypothesis(es) being tested. Provide details of the randomization scheme, if applicable. Describe plans for interim and final analyses; methods of bias control; and methods for handling missing data (as applicable).

    Include a description of the approach to data management and validation, including data management systems, methods of data entry and cleaning, event tracking and logistics, case report forms, and methods for monitoring the quality and consistency of the intervention(s) and data collection; data confidentiality and subject privacy; adjudication of events (as needed); and data reports.

    Delayed Onset Study

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

    PHS Assignment Request Form

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

    Foreign Institutions

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

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

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

    4. Submission Dates and Times

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

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

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

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

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

    7. Other Submission Requirements and Information

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

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

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

    Important reminders:

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

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

    See more tips for avoiding common errors.

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

    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.

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

    Overall Impact

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

    Scored Review Criteria

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

     

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

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

    Specific to this FOA:

    What is the strength of evidence supporting the evidence-based practice(s)? If the trial is successful at achieving its endpoints, how much will this research improve outcomes for inpatients with HLBS diseases?

     

    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?

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

    Specific to this FOA:

    Does the application include appropriate plans for multidisciplinary collaboration including investigators with inpatient clinical research expertise, implementation research expertise, and analytic methods expertise? How strong is the application in demonstrating that the PDs/PIs and Key Personnel have the experience and capability to conduct the proposed trial and meet the milestones and timelines?

     

    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?

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

     

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

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

    Does the application adequately address the following, if applicable

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

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

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

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

    Specific to this FOA:

    Was an implementation research framework(s) effectively used to develop the implementation strategy(ies)? How feasible are the proposed project and implementation strategy? Is the study design appropriate to answer the research question and collect the necessary data? What strengths and weaknesses are there in the study design? Are the endpoints clearly defined? Is the study timeline appropriate to complete the goals, meet the milestones, and address the scientific question(s)?

     

    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?

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

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

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

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

    Specific to this FOA:

    How likely is the proposed environment to provide the appropriate infrastructure for the study, access to the appropriate patient population, and engagement of providers, hospital(s), hospital unit(s), and health system(s)?

    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.

    Study Timeline

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

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

    Core Milestones

    Are the listed milestones for each phase appropriate for the goals of the project? To what extent are the Core Milestones relevant, measurable, achievable, result-focused and time-bound?

     

    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.

     

    Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

     

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

     

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

     

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

     

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

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NHLBI, 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 on the basis of established PHS referral guidelines 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 Heart, Lung, and Blood 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.

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

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

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

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

    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 Parts 75, and other HHS, PHS, and NIH grant administration policies.

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

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

    The PD(s)/PI(s) will have the primary responsibility for all aspects of the study, including the research design and protocol development, participant recruitment and follow-up, data collection, quality control, data and safety monitoring, final data analysis and interpretation, and preparation of publications. The PD(s)/PI(s) will be responsible for reporting on study conduct, safety measures, data collection, and analysis to the DSMB.

    The PD(s)/PI(s) will be responsible for organizing regular Steering Committee calls with the study team and NHLBI Project Scientist to discuss study goals, progress, and challenges. At least two investigators from each study team are expected to attend and participate in meetings among awardees of this RFA during years 2 and 5 in the Washington, D.C. area.

    Upon completion of the project, awardees are expected to put their data into the public domain and/or make them available to other investigators, according to the approved plan for making data and materials available to the scientific community.

    Support or other involvement of industry or any other third party may be advantageous and appropriate. Awardees must follow NHLBI policy concerning third party agreements.

    Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

    An NHLBI Project Scientist will be substantially involved in this project above and beyond the normal stewardship of an NIH IC Program Official.

    The Project Scientist will:

    • have regular contact with awardees via teleconferences to discuss how the project addresses the purpose of this FOA;
    • serve on the Steering Committee and other study committees, when appropriate, as a non-voting member;
    • will assist with development of the research protocol, monitor patient recruitment and study progress, and ensure adherence to NHLBI policies;
    • may work with awardees on issues coming before the Steering Committee such as recruitment, protocol development, follow-up, quality control, adherence to protocol, possible changes to the protocol, final data analysis and interpretation, preparation of publications, and development of solutions to major problems such as insufficient participant enrollment.

    The Project Scientist will organize a meeting among awardees of this FOA during years 2 and 5 in which awardees will share information about their study goals, progress, and challenges with other awardees in order to promote shared learning among awardees.

    In addition to the Project Scientist, a separate NHLBI Program Official will be responsible for the normal programmatic stewardship of the award and will be named in the Notice of Award. However, NHLBI may elect to have a dual-role approach where a single individual may act as the NHLBI Project Scientist and Program Officer. Final decision-making authority on matters of budgetary and funding actions, grants management actions, and management of intellectual property issues is assigned to NHLBI staff other than the Project Scientist. The responsibility for final decision making may reside with Senior Institute management, separate organizational components and/or oversight committees. Because it is anticipated that the Project Scientist/Program Official will participate in activities that rise to a level of involvement that results in conflicts of interest, for example, co-publication, other staff members such as direct line supervisors and/or other Senior NHLBI Program management staff will serve as agency Program Officials and will be responsible for the normal scientific and programmatic stewardship of the award.

    The NHLBI reserves the right to phase-out or curtail the award in the event of (a) failure to develop or implement a mutually agreeable protocol, (b) substantial shortfall in milestones mutually agreed upon by the recipient organization and PD/PI and the NHLBI, (c) substantive changes in the agreed-upon methodologies and tools with which NIH cannot concur, (d) human subject ethical issues that may dictate a premature termination, or (e) results that substantially diminish the scientific value of study continuation.

    Areas of Joint Responsibility include:

    The NHLBI Project Scientist and PD(s)/PI(s) will participate on regular Steering Committee calls to discuss study goals, progress, and challenges. All other responsibilities are divided between awardees and NIH staff as described above.

    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 grantee, an NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

    3. Reporting

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

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

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative 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)

    Lora Reineck, M.D., M.S.
    Division of Lung Diseases
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-435-0222
    Email: lora.reineck@mail.nih.gov

    Lawton Cooper, M.D., M.P.H.
    Division of Cardiovascular Sciences
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-435-0419
    Email: cooperls@nih.gov

    Cheryl Boyce, Ph.D.
    Center for Translation Research and Implementation Science
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-496-1051
    Email: cheryl.boyce@nih.gov

    Andrei Kindzelski, M.D., Ph.D.
    Division of Blood Diseases and Resources
    National Heart, Lung and Blood Institute (NHLBI)
    Telephone: 301-435-0050
    Email: kindzelskial@nhlbi.nih.gov

    Peer Review Contact(s)

    Director, Office of Scientific Review
    National Heart, Lung, and Blood Institute (NHLBI)
    Telephone: 301-435-0270
    Email: NHLBIChiefReviewBranch@mail.nih.gov

    Financial/Grants Management Contact(s)

    Taryn Cobb
    National Heart, Lung, and Blood Institute (NHLBI
    Telephone: 301-435-0222
    Email: cobbt@nhlbi.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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