Part 1. Overview Information

Key Dates

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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The National Heart, Lung, and Blood Institute invites applications for a Research Coordinating Center (RCC) to support projects from RFA-HL-20-003 Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR), to test late-stage (T4) implementation strategies for optimally and sustainably delivering proven-effective, evidence-based, multi-level interventions to reduce or eliminate cardiovascular and/or pulmonary health disparities and promote and improve population health in high-burden communities. The DECIPHeR RCC will coordinate activities across all of the DECIPHeR projects, including coordinating and managing in-person and virtual network steering committee meetings and working groups; promoting collaboration and communication among investigators and the broader research community; coordinating network outreach activities; promoting skills development in implementation science; organizing, establishing, and managing a global implementation data safety and monitoring board (DSMB); and providing clinical study and site monitoring for DECIPHeR awards. For the purpose of this FOA, T4 implementation research is defined as research to identify strategies to achieve sustainable uptake of proven-effective interventions into routine clinical and public health practice and community-based settings and maximize the positive impact on population health.

Background

Although life expectancy in the U.S. has increased significantly over the past five decades, key indicators of cardiovascular and pulmonary health outcomes continue to vary markedly by race, ethnicity, sex and/or gender, geographic location, and socioeconomic status (SES). Disparities in cardiovascular and pulmonary health are well-documented and account for a substantial proportion of preventable death and disability. In population groups defined by race/ethnicity, sex and/or gender, geography, and/or SES, disparities persist, and in some settings, are widening. Compelling evidence of persistent disparities has been observed across epidemiologic cohort studies, including the Jackson Heart Study, Hispanic Community Health Study/Study of Latinos, and CARDIA study. Other studies from linked micro map plots and small-area analyses also suggest that large state-based, county-level cardiovascular disparities persist and are likely to worsen, especially in the Southeastern and Appalachian regions of the United States.

The 1985 Report of the Secretary’s Task Force on Black and Minority Health (i.e., the Heckler Report) highlighted the paradox of phenomenal scientific achievement and steady improvement in overall health status, on the one hand, and persistent, significant health inequities that existed for individuals from underrepresented racial and ethnic backgrounds, on the other. Despite numerous U.S. Department of Health and Human Services (HHS) initiatives aimed at reducing health disparities, including Healthy People 2010, Healthy People 2020, the National Stakeholder Strategy for Achieving Healthy Equity, and the most recent HHS Action Plan to Reduce Racial and Ethnic Health Disparities), disparities persist, particularly in cardiovascular and pulmonary health.

Research is urgently needed to understand the barriers to implementation, optimize delivery strategies, identify diverse multidisciplinary stakeholders who need to be engaged, and maximize strategies for sustaining use of proven-effective interventions. Few studies have focused on the implementation, scale-up, and maintenance of intervention delivery for prevention and treatment of cardiovascular and pulmonary diseases. Even fewer studies have focused on addressing disparities in high burden communities. Community-based participatory research approaches in which researchers and communities partner as equitable peers to address locally-identified issues of greatest importance to health of the community, have the best potential to foster acceptance and adoption of interventions, and to sustain support for long-term interventions.

Scope of Activities for Research Coordinating Center

The DECIPHeR RCC will be responsible for enabling collaboration and communication among DECIPHeR investigators and the broader research community; for facilitating network outreach; and for harmonizing research projects conducted across awardees..

Specific activities of the DECIPHeR RCC will include, but are not limited to:

Organization and Management

• Coordination of administrative functions and data collection related to the DECIPHeR research projects
• Promoting collaboration and communication among all DECIPHeR investigators and the broader research community
• Planning, coordination, facilitation of in-person and virtual DECIPHeR meetings including the start up meeting, monthly steering committee meetings, webinars, conference calls, the annual meeting, and other PD/PI meetings including those with NHLBI/NIH staff, as needed; Maintenance of documentation such as meeting minutes. These meetings are intended to identify areas of collaboration among awardees and will include a focus on determining how the expertise, facilities, and other resources of the awardees and their collaborators can contribute to ongoing and/or new projects, data sharing, and identifying opportunities for research involving awardees. The meetings will serve as a platform for the PDs/PIs to present their scientific progress and future plans.
• Report preparation including, but not limited to, an annual DECIPHeR Research report for NIH and other funding or regulatory agencies
• Coordination and management of outreach and marketing for DECIPHeR activities and dissemination of research findings; organizing sessions at scientific meetings; scheduling public lectures; and managing the Network's social media presence
• Development and maintenance of a secure, 508-compliant website. The website will serve dual functions as a public-facing resource as well as a portal reserved for awardees, NIH staff, and authorized users to promote sharing of information, expertise, technology development, and/or other areas of common interest.
• Coordination of cross-disciplinary collaborations relevant to the DECIPHeR goals, including expanding the scope of the annual Network Meetings; developing and supporting meetings on specific cross-disciplinary research topics; and enhancing virtual communications and information sharing

Research Coordination and Data Analysis

• Coordination of collaboration and resource sharing within the DECIPHeR Network and dissemination of research resources (e.g., measurement instruments and procedures, protocols, statistical analysis tools, algorithms, study design resources, recruitment techniques, and study forms and templates) to the broader scientific community
• Timely submission of data, publications, or products generated by DECIPHeR
• Development of common data elements, data and metadata standards, and data collection processes
• Conduct statistical analyses and assist with the development and harmonization/standardization of data across project sites in support of DECIPHeR-wide data analyses
• Administration of a Data and Safety Monitoring Board (DSMB) to provide oversight, coordination, and support to DECIPHeR awardees and other NHLBI efforts, as appropriate. It is expected that the RCC will coordinate with NHLBI to select DSMB board members who have technical expertise in cardiac and pulmonary diseases and disorders, T4 implementation research, and health disparities.
• Ensure compliance with regulatory requirements and guidelines (i.e., clinical site and study monitoring for DECIPHeR awardees, conducting monitoring visits, developing and implementing QA/QC plans, providing regular GCP training to awardees, implementing skills development activities for all staff)
• Assist in the development of IRB applications and/or coordinating IRB approvals, as needed
• Assist individual DECIPHeR awardees and/or novel cross-awardee collaborations and activities such as support for pilot studies, multi-site projects, or other research projects. The responsibility for conduct and oversight of such projects will remain with the recipient awardee(s) consistent with NHLBI and NIH policies
• Ensure adherence to DECIPHeR Standard Operating Proceedures (SOPs), promote standardized data collection and format and monitor study data for quality and accuracy . The RCC is encouraged to utilize RWJF’s Culture of Health Action Framework to support data gathering efforts both intra- and inter-community .

Research Skills Development and Capacity Building

• Leverage resources across DECIPHeR project sites to assist with skills development and research capacity-building to cultivate a cadre of investigators with the requisite skills to bridge research and practice in a variety of real-world settings and with a focus on eliminating disparities in cardiac and pulmonary diseases and conditions and implementation science. NHLBI expects that this will include skills development for early-stage investigators or those in more established fields who are transitioning to late-stage T4 implementation research.
• Coordinate efforts to establish and maintain diverse training opportunities built upon the expertise of the entire DECIPHeR Network that will address the needs of researchers within various professions (e.g., academia, community health workers, local departments of health, county and/or state health administration, federally qualified health centers, etc.)
• In collaboration with NHLBI staff and DECIPHeR awardee investigators, organize and conduct a yearly skills development conference in conjunction with one of the annual DECIPHeR Meetings
• Serve as a clearinghouse for T4 educational opportunities including the exchange of experiences among developing investigators at all DECIPHeR sites
• Develop an online mentoring network

Structure

To complete the objectives of the DECIPHeR program, the RCC U24 will play a central role in organization, management and data analysis which will require collaboration with the DECIPHeR UG3/UH3 (RFA-HL-20-003) awardees. This FOA will utilize a resources-related cooperative agreement mechanism and will be performance-based to ensure that the RCC's contributions to the effective and efficient conduct of the DECIPHeR UG3/UH3 projects and analysis of data are on time and on budget. Applicants are strongly encouraged to employ project management principles as appropriate.

Phases of Award

While the U24 mechanism is not phased, the RCC's work is dependent on the performance of the associated DECIPHeR UG3/UH3 projects. This FOA will provide continued support to the RCC that is contingent upon the successful completion of the UG3 phase for at least two of the associated DECIPHeR UG3/UH3 projects. The decision for continuation of the RCC U24 to proceed beyond the UG3 phase (corresponding to the UH3 phase for DECIPHeR projects) will be made after administrative reviews of the progress made in the UG3 phase with particular attention paid to the extent to which agreed-upon milestones have been met and subject to the availability of funds.In the event that a sufficient number of DECIPHeR projects fail to transition to the UH3 phase, the U24 awardee will be required to submit a close-out plan as the original purpose of this award is no longer viable.

Section II. Award Information

Section III. Eligibility Information

1. Eligible Applicants

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)

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

• 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

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.
  • 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 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.

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

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

Letter of Intent

• 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

Division of Extramural Research Activities

Telephone: 301-435-0279

Email: [email protected]

Facilities and Other Resources

Describe the facilities and resources available for the RCC infrastructure to support and enable the management and oversight of the DECIPHeR program's administrative, data and research coordinating, and research skills development efforts.

All Key Personnel who are major contributors to the project must provide an NIH Biosketch, whether or not they are budgeted.

The experience of each PD/PI and all Key Personnel must be carefully documented and roles and responsibilities must be well-defined. Applications must provide evidence that Senior/Key Personnel have:

• Experience working with and/or leading multidisciplinary research team including level of expertise in coordination, tracking, logistics and administration, communications, data management (including quality control), data security and IT infrastructure (including development of public and secure study websites), regulatory support, and biostatistical/analytical support, especially regarding facilitation of activities within high-burden community settings.
• Any special expertise or unique strengths that will be brought to the RCC (e.g., experience in clinical trial management, collaborations with industry partners, patient groups, or non-government organizations, etc.).
• Experience in the planning, implementation, project coordination and administration/management and monitoring of multi-center research or clinical trials including success in meeting milestones and timelines.
• Experience and expertise in late stage T4 implementation research, community-engagement research, and cardiovascular- and/or pulmonary-related diseases and disorders.
• Expertise in coordinating collaborative, multi-site research in low-resource and/or diverse settings (e.g., rural, urban, suburban, other geographically or otherwise diverse settings across the U.S.).
• Documented experience and expertise in project management of recent research project and/or multisite consortia, with a description of the collaborative leadership structure used.

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

A detailed budget for the DECIPHeR RCC should be presented for activities related to coordinating the DECIPHeR network administration and research site supervision. The operational budget should include, but not be limited to the following items:

• Management of day-to-day operations and oversight of the professional activities of the proposed administrative, data and research coordination, and skills development program;
• Development and maintenance of DECIPHeR public-facing and secure websites;
• Planning, coordination, facilities, and facilitation of in-person and virtual DECIPHeR meetings including the start up meeting, monthly steering committee meetings, webinars, conference calls, the annual meeting (at an awardee site on a rotating basis), and other PD/PI meetings including NHLBI/NIH staff, as needed; For budgeting purposes assume approximate meeting attendance of 40 delegates in Atlanta, GA;
• Travel costs for at least two individuals from the RCC including PDs/PIs or their delegates to attend biannual meetings and to attend the DECIPHeR start-up meeting in Year 1 in the Washington, DC area;
• Coordination of a skills development/research capacity-building component among DECIPHeR awardees, not to exceed $75,000 in direct costs per year;
• Administration of the DSMB and clinical site and study monitoring;
• Associated planning activities; start-up activities; implementation activities; close-out phase activities; participation in awardee meetings, the steering committee or appropriate subcommittees, and other leadership committee functions; and communication, documentation, and reporting;
• Costs for monthly network-wide teleconferences and/or webinars;
• Costs associated with securely housing network data;
• Subcontracts as necessary

The application must include only its own budget, including any subcontract budgets associated with it. Separate itemized budgets must be prepared for each subcontract. The application must provide detailed annual budgets that will enable the RCC to meet its milestones.

Start Up Meeting

Budgets must include funds for the PD/PI and two additional key personnel to participate in a two-day start-up meeting in Bethesda, Maryland at the NIH during the first year of the award (within the UG3) phase.

Annual Meetings

Budgets must include funds for the PD/PI and two additional key personnel to attend annual 3 day meetings of key staff of each award, appropriate NHLBI staff, RCC key personnel, and selected experts in year 2 through the end of the award period and should include costs for hosting one of these annual meetings at the activity site of one of the awardee projects on a rotating basis.

Community Engagement

In order to equitably engage the community of interest in the research activities under the award, applications should budget for local community meetings or other appropriate activities.

If parts of the costs 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 Special Award Condition. 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.

DSMB

Include all costs associated with DSMB activities. This includes the costs for preparing reports for the DSMB and meeting requirements for the DSMB members. The RCC should assess the need for liability insurance for DSMB members and provide a plan commensurate with the risk of the trial(s). The budget should include provision for executing the plan proposed. The RCC 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 RCC should include in their budget coordination of support for at least one DSMB meeting per year (by teleconference or videoconference).

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

Specific Aims

Describe how the RCC will contribute to the goals of the DECIPHeR program to create a trans-disciplinary collaborative team that will undertake population health improvement in high burden communities as it relates to reducing or eliminating cardiovascular and/or pulmonary health disparities.

Research Strategy

A typical research strategy description is not expected. DECIPHeR RCC applicants should not propose a research project since projects will be proposed through RFA-HL-20-003 . Instead, the following items should be addressed by the applicant:

Significance

Present a clear statement of the way in which the RCC relates to the goals of the overall DECIPHeR program. Explain why the chosen coordinating center framework is optimal.

Approach and Innovation

Applicants must describe the following:

• The management, administration, and operations needs of the RCC; Discuss how the overall administration and coordination strategies, operational plan, is appropriate for the community-based context of DECIPHeR
• The proposed timeline and work-flow plan?
• The proposed leadership structure including plans for communication and decision making, conflict resolution and organizational structure
• How the proposed activities of the RCC will be evaluated and include plans for addressing potential challenges; Present plans to identify and solve problems, determine alternative strategies, and establish benchmarks for success.
• Plans to utilize novel organizational concepts and management strategies in coordinating the overall DECIPHeR program? Include any plans to employ unique or novel methodologies that will enhance the management or methods of data analysis
• Plans for offering T4 implementation science research skills development activities. Include a discussion of how current best practices and needs assessment(s) will be used to foster rapid uptake of the DECIPHeR evidence-based interventions at the county, state, regional or population levels.
• Detailed plans for coordinating a network of research sites across the United States that will test strategies for delivering proven-effective, evidence-based, community-level interventions for reducing or eliminating cardiovascular and/or pulmonary health disparities and which promote and improve population health in high burden communities, including research coordination and data analysis
• SOPs currently in place and planned, including how tasks will be delegated and supervised and how the management team will be directed
• Communication among the management team, the research awardees, and any proposed working groups and subcommittees (e.g., clearly describe how interactions and communications between the RCC and the awardees will be managed), and with the broader research community
• How data will be transmitted in an accurate and timely fashion, and how the RCC will establish accessible and secure methods of communication
• Plans for research site and study monitoring

Letters of Support

Include letters of resource support specific to the RCC, including support provided by the applicant institution and partner organizations that will enhance the potential for success. Examples of such support would include, but are not limited to, institution-funded staff time and effort, donated equipment and space, providing free and open access to tools, web space, databases, workflow processes, logistical resources or other resource investments. Specific and detailed descriptions of these contributions, as well as the assurances that partner organizations are committed to providing these resources to the RCC should be included in this section. Also include individual letters of commitment to the partnership specific to the RCC by all other partners and/or consultants.

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.

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.

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.

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.

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 NHLBI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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.

Significance

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

Specific to this FOA:

How will successful completion of the aims support the creation of a trans-disciplinary collaborative team that will undertake population health improvement in high burden communities as it relates to reducing or eliminating cardiovascular and/or pulmonary health disparities?

Investigator(s)

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

Specific to this FOA:

How strong is the application regarding past and/or ongoing experience with coordinating collaborative, multi-site research in diverse settings (e.g., rural, urban, suburban, other geographically or otherwise diverse settings across the U.S.)? If the RCC is multi-PD/PI, how complementary and integrated are the investigators' expertise and skills? To what extent does the applicant’s experience support the ability to generate successful collaborations or partnerships with the proposed organizations, collaborators, and/or consultants documented in the application? How strong is the project management expertise represented among the key personnel? To what extent does the documented experience of the Key Personnel support the proposed RCC functions including coordination and administration, logistics, communications, data management (including quality control), data security and IT infrastructure (including development of public and secure study websites), regulatory support, clinical study and site monitoring, and biostatistical/analytical support?

Innovation

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

Specific to this FOA:

How strong are the proposed plans to utilize novel organizational concepts and management strategies in coordinating the overall DECIPHeR program?

Approach

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

Specific to this FOA:

How well-reasoned and appropriate to the community-based context are the overall administration and coordination strategies, operational plan, and organizational structure to accomplish the goals of the DECIPHeR Program that the RCC will serve? Has the applicant discussed how the skills development activities and needs assessment activities will be used to facilitate rapid uptake of the proposed evidence-based interventions at the county, state, regional, or population levels? How well has the application described the proposed leadership structure including plans for communication and decision making, conflict resolution and organizational structure? How strong is the plan for how the proposed activities of the RCC will be evaluated and how potential challenges will be addressed? How effectively and appropriately are potential problems, challenges, problem solving, alternative strategies, and benchmarks for success presented? How appropriate and feasible are the proposed timeline and work-flow plan? How appropriate and thorough are the evaluation plans for the proposed RCC activities? How well-developed is the proposed plan to develop and sustain a public and internal website? How strong is the plan for communication and collaboration across the DECIPHeR Program and NHLBI?

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?

Environment

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

Specific to this FOA:

To what extent the application demonstrate sufficient infrastructure to implement the proposed coordinating center within the proposed setting of community-based implementation research? Are technical and information technology resources sufficient to house and securely share network resources and/or data, as well as build and manage the DECIPHeR Program's public-facing and secure websites?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Renewals

Revisions

Applications from Foreign Organizations

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

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

• Will receive a written critique.

• 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

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

Section VI. Award Administration Information

1. Award Notices

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

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.

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.

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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. 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. 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.

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

• Determining the overall function, scientific and administrative leadership, and objectives of the RCC;
• Developing and implementing a governance structure for the RCC;
• Meeting goals, timelines, and milestones;
• Collaborating with NHLBI Program Official (PO) and Project Scientist (PS) in all aspects of scientific and technical research needed for the management of the RCC;
• Developing and maintaining the DECIPHeR website;
• Administering a DSMB and providing overall clinical study and site monitoring for DECIPHeR awardees;
• Assuring compliance with applicable Federal, State, and Local regulations;
• Assuring compliance with all applicable DHHS/NIH/NHLBI policies for conduct of research and clinical trials;
• Participating in all biannual DECIPHeR network meetings, teleconferences, workshops, and working groups. The PD(s)/PI(s) of this award will be required to participate in periodic meetings and conference calls with NHLBI programmatic staff. Payment for facilities and logistical costs of bi-annual meetings will be the responsibility of the RCC.
• Ensuring that research capacity- building activities conducted under this cooperative agreement employ an approach that supports the translation and uptake of proven effective therapies to address elimination of cardiovascular and/or pulmonary disparities in high-burden communities. The PD/PI will provide a process for assessing ongoing research projects and implementation research skills development and modifying, redirecting, and/or curtailing ongoing research activities to reflect local changes/shifts based on emerging needs or changing epidemiological conditions within the participating communities of interest.
• The PD(s)/PI(s) are expected to publish and release publicly and disseminate results, tools, protocols, resources and other products, in accordance with established protocols and governance of the SC (see below). It is expected that all methods, analyses, and data (e.g., software, and algorithms) will be made available in a timely manner to the scientific community.
  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 HHS, PHS, and NIH policies. It is expected that all methods, analyses, and data (e.g., software, and algorithms) will be made available in a timely manner to the associated consortium members as well as the scientific community.
  
  NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
  The role of the NHLBI Project Scientist will be to facilitate and not to direct the activities. It is anticipated that the NHLBI Project Scientist will offer advisory input. The NHLBI Project Scientist will facilitate liaison activities for partnerships and aid with access to NIH-supported resources and services. Other appropriate NHLBI program staff assistance will be coordinated by the NHLBI Project Scientist, which may include Medical Officer(s), clinical operations and regulatory, biostatistics, and other expertise as required. The NHLBI Project Scientist, with support of the appropriate staff and expertise, may provide coordination and assistance to the awardees to meet the requirements for clinical protocol content and conduct. The NHLBI Project Scientist with substantial programmatic involvement may:

• Provide substantial scientific and programmatic involvement in conduct of the RCC through technical assistance, advice, and coordination;
• Participate in the development and prioritization of activities;
• Provide assistance in coordinating activities with other NHLBI- and NIH-supported resources;
• Participate as a voting member of the DECIPHeR steering committee and attends all steering committee and subcommittee meetings;
• Assist in the selection and convening of an NHLBI Data and Safety Monitoring Board, with coordination and management by the DECIPHeR RCC;
• Provide implementation research skills development and capacity building resources for DECIPHeR awardees, with oversight and management by the DECIPHeR RCC;
• Participate in scheduled meetings and teleconferences to discuss program coordination and/or progress;
• Coordinate and facilitate the interactions among the awardees under this initiative;
• Serve as a resource for all major transitional changes that the awardees might propose (e.g., a change in partnership organization) and advise on their appropriateness prior to implementation to assure consistency with the goals of this FOA
• Assist in avoiding unwarranted duplication of effort with other NIH efforts
• Provide technical assistance and advice to the awardees as appropriate
• Interact with the PD(s)/PI(s) on a regular basis to monitor progress. Monitoring may include regular communication with the PD(s)/PI(s) and study staff, periodic site visits for discussion with the awardee research team, observation of field data collection and management techniques, fiscal reviews, and other relevant stewardship matters.
• Make recommendations to the Program Official for continued funding based on; (a) overall research progress; (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) maintaining a high quality of coordination and administration of the RCC.enance and
• Facilitate interactions with other US Federal resources to expand research and capacity- building, as applicable.

A network Scientific Advisory Group (NSAG) may be appointed and supported by NHLBI to review the progress and provide scientific advice for the intersecting and joint activities of all grants that receive funding under this FOA. The NSAG will be comprised of no more than seven federal and non-federal experts selected by the NHLBI to participate in NSAG activities in an advisory capacity, when appropriate. When convened, the NSAG will meet at the annual meeting of awardees.

Additionally, an agency Program Official or IC Program Director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:
A steering committee (SC) will serve as the governing board for DECIPHeR awardees. All participants in the DECIPHeR program are bound by the policies and procedures developed by the SC; adoption of such policies and procedures requires a majority vote. Awardees under this FOA will be required to accept and implement policies approved by the SC. Membership on the SC will include the PI of each DECIPHeR award, or a designated representative in the case of a Multiple PI award. Each member will have one vote. The NHLBI Project Scientist will be a non-voting member of the SC . The chair will be chosen by a majority vote of the SC, with years of service as chair determined by the committee. The chair is responsible for preparing meeting agendas, for scheduling and chairing meetings, and for preparing concise minutes which will be delivered to SC members within 21 days of the meeting. Virtual meetings are appropriate. The NHLBI Project Scientist may not serve as Chair of the SC.

Steering Committee responsibilities will include:

• Evaluating, reviewing, and recommending new collaborations and resource allocations for projects across DECIPHeR awardees
• Coordinating research sharing among DECIPHeR awardees (e.g., measures, consultations with staff across awardees)
• Developing and conducting shared protocols, when appropriate
• Jointly developing appropriate confidentiality procedures for data collection, processing, storage and analysis to ensure the confidentiality of data
• Cooperating to ensure the timely and broad dissemination of lessons learned to inform researchers and health care systems engaged in delivering strategies for reducing and/or eliminating cardiovascular and/or pulmonary health disparities in high-burden communities.
• Working with NHLBI staff to organize and coordinate the Network Start- Up meeting in the first year of the award in the Washington, DC, USA area at a location determined by NHLBI staff.
• Working with NHLBI staff in planning and execution of 3-day in-person biannual meetings with DECIPHer awardees held at awardee sites each year.

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. The three members will be: 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

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

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: [email protected] (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: [email protected]

Melissa Green Parker, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-496-1051
Email: [email protected]

Director, Office of Scientific Review
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0270
Email: [email protected]

Tammi Simpson
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8051
Email: [email protected]

Section VIII. Other Information