Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Minority Health and Health Disparities (NIMHD)

Funding Opportunity Title
Limited Competition: Research Centers in Minority Institutions (RCMI) Clinical Research Network for Health Equity (UG3/UH3 - Clinical Trial Optional)
Activity Code

UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement

Announcement Type
New
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-MD-22-006
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.307
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites applications from current Research Centers in Minority Institutions (RCMI) awardees to participate in the RCMI Clinical Research Network for Health Equity (RCMI-CRNHE), a newly established clinical research network that will transform the development, delivery, and sustainability of evidence-based health care practices and services by providing the infrastructure to leverage community-based clinicians and/or health care delivery systems to conduct research addressing health care for populations that experience health disparities including the diverse clinicians providing health services.

The UG3/UH3 Cooperative Agreement involves 2 phases. The UG3 phase, for up to 2 years, is designed to support a project with specific milestones to be accomplished by the end of the first project period. The UH3 phase is to provide funding for up to 3 additional years following successful completion of the UG3. UG3 projects that meet their milestones will be administratively considered by NIMHD and prioritized for transition to the UH3 phase. Investigators submitting to this FOA must describe both UG3 and UH3 phases.

Key Dates

Posted Date
April 06, 2022
Open Date (Earliest Submission Date)
May 01, 2022
Letter of Intent Due Date(s)

May 1, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
May 31, 2022 Not Applicable Not Applicable July 2022 August 2022 September 2022

All applications are due by 5:00 PM local time of applicant organization. 

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.

Expiration Date
June 01, 2022
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

Background

A clinical research network (CRN) is a consortium of research institutions with affiliated or collaborating ambulatory care clinical practices that collaborate to investigate research questions related to improving the quality of primary care and chronic ambulatory health care, including implementation of best practices and use of multi-level approaches to address health care delivery challenges, and answer questions relevant to the clinicians in this setting. A CRN also usually has one or more coordinating or administrative centers that support the research activities of the consortia CRNs are uniquely positioned for efficacy studies, dissemination and implementation research and comparative effectiveness research. CRNs are ideal for conducting a wide variety of physician and patient studies and are a rich source of medical data.

The Research Centers in Minority Institutions-Clinical Research Network for Health Equity (RCMI-CRNHE) is intended to provide research infrastructure that allows for systematic inquiry to improve the health care and health outcomes for NIH-designated United States populations that experience health disparities defined as racial and ethnic minority populations, sexual and gender minority groups, underserved rural populations, and socioeconomically disadvantaged populations (See https://www.nimhd.nih.gov/about/overview/). The RCMI-CRNHE will also support a network of clinicians with representation from backgrounds that are underrepresented in the clinical and health-related sciences workforce on a national basis (http://www.nsf.gov/statistics/wmpd/). In the RCMI-CRNHE, the goal is to develop infrastructure to establish local or regional consortia of ambulatory primary care settings that serve patients from populations that experience health disparities. Of priority are primary care and chronic ambulatory health care settings linked to RCMI academic health centers, Federally Qualified Health Centers (FQHCs), and health centers that serve a high proportion of patients with public insurance (Medicare, Medicaid, CHIP) or no insurance. Further, the RCMI-CRNHE will support consortia of health care centers comprised of clinicians with representation from groups underrepresented in the clinical and health-related sciences to examine important research questions about the patient-clinician communication and relationship as well as key constructs such as conscious and unconscious bias, trust, cultural competency, and shared decision-making.

The goal of the RCMI-CRNHE is to draw on the experience and insight of practicing clinicians and local communities to identify and frame research questions that can improve health care and address health disparities. Thus, the RCMI-CRNHE will enable practices that serve populations that experience health disparities to be involved in all aspects of clinical research, including developing research questions, and translating findings into practice. For example, the health care systems and clinicians can help drive the research questions based on urgent practice priorities, including addressing disparities in access, quality, and outcomes of treatment and services. By linking the insights of local clinicians with rigorous research methods and community engagement practices, the RCMI-CRNHE will produce research findings that are immediately relevant to the clinician and more easily translated into everyday practice and integrated into health care systems.

Once the RCMI-CRNHE has been fully established, NIMHD envisions the network to be able to conduct research that will inform, develop, and test clinical and behavioral interventions and service delivery strategies that are feasible, scalable, and sustainable, and will ultimately improve routine health care services for populations that experience health disparities. This research will include observational studies based on clinical care, clinical trials, natural experiments, comparative effectiveness and translational research, and implementation research.

Overall Structure of the RCMI-CRNHE

Coordinating Center

An existing RCMI Coordinating Center funded under RFA-MD-20-007 will centralize and harmonize study operations, coordinate data management, and provide biostatistical support to facilitate rapid development and implementation of minority health and health disparity studies conducted in the RCMI-CRNHE. The Coordinating Center will also manage a Network Steering Committee.

Research Consortia

The Research Consortia will be funded via a two-phase, milestone-driven cooperative agreement (UG3/UH3) mechanism consisting of a start-up/planning phase of one to two years (UG3) and a pragmatic or implementation execution phase (UH3) of three to four years for a total project period of up to five years.

Each Research Consortium will consist of one or more RCMIs that have created a network of local and/or regional health care delivery systems and/or health care practices. The consortia will operate independently, although they will be required to work collaboratively with the Coordinating Center to ensure centralized and harmonized study operations, use of common data elements where applicable, and data management. Each Consortium has a representative in the Network Steering Committee. As the RCMI-CRNHE is operationalized, it is envisioned there will be opportunity for collaboration across consortia.

General Requirements

Projects awarded through this FOA are intended to support capacity at local RCMIs so they can provide scientific, administrative, and logistical infrastructure. This will enable regional and local consortia of health care practices and health care systems to participate in clinical and health services research.

Eligible CRN health care sites are those that provide ambulatory primary care, including family medicine, general internal medicine, and general pediatrics, as well as medical subspecialties with a component of chronic care such as rheumatology, endocrinology (especially diabetes), general cardiology (noninvasive), asthma/chronic lung disease, geriatrics, and general gynecology. Of particular interest, are practices and health care systems that serve populations that experience health disparities, for example, FQHCs and the ambulatory care settings of academic institutions.

Research Objectives

In the RCMI-CRNHE, each consortium is required to function as a resource to be able to support the conduct of research through robust infrastructures that can be leveraged to (1) efficiently and rapidly identify, recruit and enroll clinicians that serve diverse patient populations into health services and clinical research; (2) harmonize electronic health record (EHR) data across multiple integrated systems for common analyses, using common data elements and adhering to principles of data storage; (3) develop, test, and deploy interventions, workflows, and decision support systems; (4) develop and test strategies to address health care disparities within ambulatory primary care settings; and (5) facilitate research that addresses emergent health conditions and risk or protective factors that are relevant for minority health and for populations that experience health disparities, such as long term sequelae of COVID-19, as well as chronic diseases such as diabetes mellitus, asthma, osteoarthritis, heart failure, chronic lung disease, chronic liver disease, and depression.

The consortium is required to have the capacity and infrastructure to enable local or regional primary care clinicians and health care systems to participate within the consortium, provide support for two pilot studies, and demonstrate the ability to work with the Coordinating Center to implement appropriate data management practices.

These requirements include capacity and infrastructure to:

  • Build and maintain established relationships with relevant constituent groups (e.g., patients, clinicians, administrators, payors, relevant federal and state agencies, patient advisory boards) to inform research questions, gain input about the feasibility and clinical interest of research topics, and attend to front-end infrastructure to secure stakeholder commitment to adopt, implement and sustain successful practices and products developed within this consortium, including developing a plan for equitable practitioner and patient compensation system.
  • Maintain accessibility to relevant patient, clinician, and health system data, including the capacity for study-specific data management systems that allow for electronic data capture in practices and utilize flexible and innovative technologies to capture research data, including the capability to accomplish research participant follow-up independent of in-office visits, and enabling collection of common data elements (https://nexus.od.nih.gov/all/2021/06/24/common-data-elements-increasing-fair-data-sharing/) and data sharing (https://grants.nih.gov/grants/policy/data_sharing/).
  • Coordinate and facilitate the conduct of research within their consortium of primary care clinicians and health care systems, such as infrastructure for human subjects protections including processes to execute single IRB oversight of protocols, provide practitioners and office/clinic staff with responsible research conduct training required by NIH and IRBs; provide study-specific training to clinicians and office/clinic staff, enabling them to recruit, enroll, and collect data on their patients in their offices/clinics; developing systems to assist clinicians in maintaining high rates of patient enrollment and retention; and performing quality management activities and monitoring study execution by clinicians and office/clinic staff.
  • Develop and test strategies (using implementation science) to encourage adoption, quality, scale-up, and sustainability of new innovations and existing best practices, including processes for recruiting practices and providers and systems for managing study development/implementation progress.

Additional Requirements:

NIMHD is requiring data sharing for all projects, where it is not prohibited (i.e., Tribal data sovereignty). NIMHD requires and supports the timely release and sharing of appropriate final research data from NIH-supported studies for use by other researchers to expedite the translation of research results into knowledge, products, and procedures to improve human health https://grants.nih.gov/grants/policy/data_sharing/.

  • The grant recipients are required to work with the Coordinating Center to submit common data elements (CDEs). Recipients should identify staff responsible for these data coordination and reporting activities.
  • Recipients are required to use guidance provided by the Coordinating Center for data acquisition, collection, and curation, including consent for data sharing and implementation of methods to enable data collected to be shared.

Required Elements

Community Engagement Activities

Community engagement activities are designed to establish long-term relationships with communities and community based organizations (e.g., Tribal governments and agencies, academic, private, safety-net health systems, grassroots organizations, public health departments, and community and faith-based organizations) in order to address their health-related concerns within the consortium, to promote participation in research and recruitment and retention of study participants, and to disseminate findings from research projects. Activities must include the formation of a Patient/Community Advisory Board that ensures adequate representation of the patients seen in the Consortia sites.

Methods and Design Activities

In collaboration with the Coordinating Center, methods and design activities will support the consortium informatics infrastructure, including a data warehouse, and develop and implement improvements in data collection methods and capacity. The unit should apply state-of-the-art approaches from the fields of data science, machine learning, artificial intelligence, health services research, community-engaged research, and implementation science. In collaboration with the Coordinating Center, the unit should facilitate the development and implementation of the consortium’s Pilot Projects and the consortium-affiliated research.

Research Activities

Applicants must conduct two (2) Pilot Projects (described below) of high importance to consortium stakeholders (including local clinicians) that will allow consortium and external investigators to develop competitive applications to support larger-scale research projects in the future.

The Pilot studies should seek to optimize and improve care for a diverse population of patients within defined health care systems of the consortium; examples of pilot projects include but are not limited to developing and/or testing new IT platforms, risk algorithms, decision support systems, and preventive, or services interventions; creating efficiencies in all aspects of the conduct of research, dissemination of findings, and producing study results that can directly inform practice change; reducing health disparities by engaging intervention targets; and/or improving methodologies in systems research, and/or seeking strategies to continuously improve the accessibility, quality, continuity, equity and value of services delivered within the consortium.

Projects must examine NIH-designated United States populations that experience health disparities, i.e., racial and ethnic minority populations, sexual and gender minority groups, underserved rural populations, and socioeconomically disadvantaged populations (https://www.nimhd.nih.gov/about/overview/).

Milestones and UG3/UH3 Transition

The UG3/UH3 Cooperative Agreement involves 2 phases. This FOA will support a start-up/planning UG3 phase for up to 2 years with specific milestones to be accomplished by the end of the period and a pragmatic or implementation UH3 phase for 3-4 years. The total project period is up to five years. UG3 projects that meet their milestones will be administratively considered by NIMHD and prioritized for transition to the UH3 phase. Milestones are key for this initiative. A milestone is defined as a scheduled event in the project timeline, signifying the completion of a major project stage or activity.

. Projects should include well-defined milestones for the planning phase (UG3) and annual milestones for the execution phase (UH3). It is understood that the proposed milestones for the UH3 phase will be revised as activities in the UG3 phase progress. In the event of an award, the PD/PI and NIH staff will negotiate a final list of milestones for each year of support.

The UG3 phase will support the development of forms and other resources necessary to the performance of the pilots; further development and finalization of study partnerships including signed contracts with performing clinical sites; single Institutional Review Board (IRB) approval of the study; Data and Safety Monitoring Plans; and finalization of the informed consent form(s), manual of operations, and pilot project management plans. Applications are required to provide a pilot project management plan that delineates how the study will monitor and evaluate critical processes impacting feasibility of launch, conduct, and completion, coupled with on-time and on-budget performance milestones. All regulatory approvals should be obtained prior to the end of the UG3 award.

Project Trial Conduct Phase (UH3): The objective of the three-to-four-year UH3 trial that will be fully described in the phase II application is to conduct two pilot projects in accordance with activities planned in the UG3 phase. Activities will depend upon the study, but in general the following goals should be achieved: Complete enrollment and follow-up of all study participants, and provision of a complete, cleaned, and de-identified dataset and any supporting documentation (including, but not limited to the study protocol, statistical analysis plan and algorithms, and data dictionary) required for the data analyses within 12 months of completion of the proposed examination and study visits.

At the completion of the UG3 planning phase, the applicant will be required to submit a detailed transition request for the UH3 Project trial conduct phase. UH3 transition requests will undergo an administrative review to determine whether the Project will be awarded for the pilot conduct phase (UH3). All regulatory approvals should be obtained prior to the end of the UG3 award. Training of clinicians, research teams, or other human resources should be planned at the start of the UH3 award to allow for the successful launch and execution of the proposed execution phase in the UH3 phase. Prospective applicants should note that initial funding of the UG3/UH3 Phase Innovation cooperative agreement does not guarantee support of the UH3 Project execution phase. Applicants should understand that transition to the UH3 phase of the project will occur only if an administrative review process recommends that the UG3 planning milestones have been successfully met, that the UH3 phase can proceed with confidence of success, and availability of funds. It is recommended that the milestones for the UG3 phase be objectively defined to ensure clear demonstration that the proposed milestones were met at the time of the transition request. Appeals of the transition decision will not be accepted. Continuation of the award is conditional upon satisfactory progress and subject to availability of funds. If, at any time, recruitment falls significantly below the projected milestones for recruitment, the NIH will consider ending support and negotiating an orderly phase-out of the award and retains, as an option, periodic external peer review of progress. NIH staff will closely monitor progress of milestones, accrual, and safety.

Applications Not Responsive to the FOA

The following studies will be considered non-responsive will not be reviewed:

  • Centers without a focus on one or more NIH-designated populations that experience health disparities.
  • Centers that do not include all required Components.

Technical Assistance Webinar

A technical assistance webinar for prospective applicants will be held by NIMHD staff members involved in this FOA. The webinar will provide orientation and technical assistance to potential applicants by explaining the goals and objectives of the Research Centers in Minority Institutions -Clinical Research Network for Health Equity initiative and answering questions from attendees. Date and time of the webinar will be posted on the NIMHD website at www.nimhd.nih.gov. Prospective applicants are encouraged to send questions, preferably at least 24 hours prior to the webinar, to the Scientific/Research Contact,

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?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Funds Available and Anticipated Number of Awards

NIMHD intends to commit $3,000,000 in FY 2022 to fund 2 awards.

Award Budget

Application budgets are limited to $1,000,000 in direct costs annually.

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)

Eligibility Criteria

  • Only active Research Centers in Minority Institutions (RCMI) U54 awards supported under RFA-MD-17-003, RFA-MD-17-006, RFA-MD-18-012, or RFA-MD-20-006 are eligible.
  • To be eligible, the parent award must be active when the application is submitted (i.e., within five years of the start date of the originally reviewed and approved project period of the existing parent RCMI’s competitive segment; or if applicable, within the originally reviewed and approved project period of a competitive revision).
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • 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.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, 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.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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 SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Yujing Liu, MD, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-7815
Email: liuyujin@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

For the initial UG3/UH3 application, a complete detailed budget is required for both the UG3 phase and the UH3 phase. The applicant should estimate the costs for the UH3 implementation phase based on the scope of work described in the application for the UH3 phase. Budget justifications must be included. The length of the project period should reflect the actual needs of the project.

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:

Specific Aims: Specific aims should be scientifically appropriate for the distinct phases of the project. Include separate aims, for both the UG3 and UH3 phase, and clearly label them as UG3 specific aims and UH3 specific aims.

Research Strategy: Within the Research Strategy, applicants should first describe the UG3 Phase and then the UH3 Phase. The Research Strategy section should have a clear demarcation of the UG3 and UH3 phases of the application. It is not necessary to repeat background information or details of methods in the UH3 portion that were provided in the UG3 portion. The UH3 Phase must be described in sufficient detail to permit reviewers to assess significance and innovation of the proposed work.

Describe the organizational plan and management structure for providing leadership and administrative support for the CNHE. Delineate the roles and responsibilities among key personnel at participating organizations. Include plans for ensuring accountability for achieving program objectives. Describe how the Steering Committee will be used to ensure successful completion of the stated aims. Applicants should propose the formation of a Patient/Community Advisory Board that ensures adequate representation of the patients seen in the Consortia sites. Applicants should avoid naming potential members of an advisory group.

Describe the approach to build the scientific and logistical capacity and infrastructure requirements to enable local or regional primary care clinicians and health care systems to participate within the consortium, provide support for two pilot studies, and demonstrate the ability to work with the Coordinating Center to implement appropriate data management practices.

Describe the process to solicit ideas, review applications, and select the pilot projects to be implemented in the UH3 phase.

Applicants should describe the methods and design activities to support the consortium pilot projects and collaboration with the Coordinating Center.

Describe the approach to develop collaborative agreements or memoranda of understanding, identifying capacity needs within each participating practice and health care system to enable research capacity and collaboration across systems, and strategies to inform research questions, recruit practices, implement studies, and disseminate successful practices and products developed through consortium studies.

For each practice and health care system identified as potential member of the consortium, provide data about patients cared for including the geographic service areas; key demographic characteristics of patients including race/ethnicity, age distribution, and insurance status; characteristics of practice settings (e.g., urban, rural, suburban, in-hospital, or ambulatory); and the demographic characteristics including race/ethnicity and gender of the clinicians providing care (MDs/DOs, PAs, or NPs).

Describe the approach the consortium will take to develop a disease-agnostic research agenda of observational studies, pragmatic clinical trials, efficacy trials, translational research, comparative effectiveness, and implementation science that will inform, develop, and test interventions and service delivery strategies that are feasible, scalable, and sustainable, and will ultimately improve health and health care services for populations that experience health disparities, including racial and ethnic minorities.

Describe activities designed to establish long-term relationships with communities and community organizations (e.g., Tribal governments and agencies, academic, private, safety-net health systems, grassroots organizations, public health departments, and community and faith-based organizations).

Projects should include well-defined milestones for the planning phase (UG3) and annual milestones for the implementation phase (UH3). The milestones should be robust and associated with clear, quantitative criteria for success that allow go/no-go decisions at the UG3/UH3 transition point. Transition from the UG3 to the UH3 phase is contingent upon the successful completion of proposed milestones. .

Letters of Support:

Letters of support are required from practices that are potential members of the consortium.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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 fieldof the Senior/Key Person Profile form. 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 unique entity identifier (DUNS number or UEI as required) provided 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 NIMHD, 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?

In addition, for applications involving clinical trials

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?

To what extent are the activities proposed by the consortium to develop a disease-agnostic research agenda of observational studies, pragmatic clinical trials, efficacy trials, translational research, comparative effectiveness, and implementation science that will inform, develop, and test interventions and service delivery strategies that are feasible, scalable, and sustainable likely to improve health and health care services for populations that experience health disparities, including racial and ethnic minorities?

 

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?

In addition, for applications involving clinical trials

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 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?

In addition, for applications involving clinical trials

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?

In addition, for applications involving clinical trials

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: Are

Does the organizational plan and management structure for provide appropriate leadership and administrative support for the RCMI-CRNHE?

Are the roles and responsibilities among key personnel at participating organizations well delineated and include appropriate plans for ensuring accountability for achieving program objectives?

Does the plan for Steering Committee activities ensure successful completion of the stated aims?

Does the plan for the formation of a Patient/Community Advisory Board ensure adequate representation of the patients seen in the Consortia sites?

Is the approach to solicit ideas, review applications, and select the pilot projects to be implemented in the UH3 phase logical and reasonable?

To what extent are the activities

Are the and appropriate?

To what extent are the

 

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?

In addition, for applications involving clinical trials

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: To what extent do To what extent do the letters of support indicate full commitment to the proposed RCMI-CRNHE?

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.

 

Specific to applications involving clinical trials

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)?

 

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

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

 

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

 

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

 

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

 

Not Applicable

 

Not Applicable

 

Not Applicable

Additional Review Considerations

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

 

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.

Not Applicable

 

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

 

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

 

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

 

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIMHD, 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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. 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 and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient 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, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, 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 (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR Part 200, 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 agency (NIH,) programmatic involvement with the recipients 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

  • Coordinating project activities technically, scientifically, and administratively at the recipient institution.
  • Defining objectives and approaches; collecting and analyzing data; and publishing results, interpretations, and conclusions of studies conducted under the terms and conditions of the award.
  • Ensuring that appropriate Institutional Review Board approvals and certifications for research involving human subjects for all participating sites, collaborators or partners are obtained.
  • Consulting with NIMHD to ensure compliance with relevant grant policies and regulations.
  • Prior to the end of the UG3, recipients are responsible for submitting the transition package, which includes the UG3 progress report, progress toward agreed-upon UG3 milestones, and a description of readiness to implement the UH3 research.
  • Cooperating with the Coordinating Center, including supporting work groups and committees as needed, and participating in sharing data, resources and software according to the Coordinating Center’s data sharing policies
  • Recipients 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 NIH policies and achieving the goals of this program.

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

NIMHD will assign a Program Official and Project Scientist(s) to the award.

The Project Scientist(s) will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination. Project Scientists(s) will:

  • The Project Scientist will provide input, expert advice, and suggestions in the design, development, and coordination of the infrastructure development, implementation efforts, the research projects, and collaboration with the coordinating center.
  • Additional NIH staff may participate in all Work Groups, implementation teams and committees, as appropriate. Participation by staff from other federal agencies may also be appropriate and advantageous to facilitate the activities of the program.
  • The NIH reserves the right to terminate or curtail the award (or an individual component of the award) in the event of inadequate progress or data reporting.
  • The Program Official will 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 their staff, periodic site visits for discussion with the recipients’ research team, observation of field data collection and management techniques, fiscal reviews, and other relevant stewardship matters.
  • The Program Official will be responsible for the normal programmatic stewardship of the award.

Areas of Joint Responsibility include:

  • The PD(s)/PI(s) provide, in concert with the NIH staff, support necessary to ensure that sites and investigators and NIH and other research partners fully comply with federal regulatory requirements, including but not limited to those relating to human subjects protections, informed consent, and reporting of adverse events.
  • Recipients and NIH will jointly develop procedures for data collection, processing, storage and analysis to ensure the confidentiality of data on individual health care provider organization patients, health care providers and other institutions involved in any consortium research projects and a data structure that results in findable, accessible, interoperable and reliable shared dataset.
  • Recipients and NIH Staff will participate with other UG3/UH3 award recipients, and the coordination center staff to facilitate shared goals, enhance resource sharing and foster collaborations.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient'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, recipients 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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 the threshold.  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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Rada K. Dagher, PhD, MPH.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-451-2187
Email:rada.dagher@nih.gov

Nancy L. Jones, PhD, MS
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8945
Email:nancy.jones@nih.gov

Peer Review Contact(s)

Yujing Liu, MD, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-7815
Email: liuyujin@mail.nih.gov

Financial/Grants Management Contact(s)

Priscilla Grant, J.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email:pg38h@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 and 2 CFR Part 200.

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