Research Opportunity Announcement: Integrating Clinical Research into Primary Care Settings through Network Research Hubs – A Pilot (OT2)

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Research Opportunity Announcement Overview

Background

Purpose and Scope

Objectives

Phased Approach

Definitions

Eligibility

Application Responsiveness

Application Requirements

Objective Review

Special Award Terms

Research Opportunity Announcement Overview #announcementoverview

ROA Number: OTA-24-016

Dates:

• ROA Posting: May 6, 2024
• Technical Webinar 1: 12pm EDT on May 14, 2024
• Technical Webinar 2: 12pm EDT on May 22, 2024
• Submission Deadline: Complete applications must be submitted under OTA-24-016 via NIH eRA Commons ASSIST no later than 5:00pm EDT on June 14, 2024. Late applications submitted to this ROA will not be accepted.

Brief Overview of the Research Opportunity: The purpose of this limited competition research opportunity announcement (ROA) is to invite applications by organizations currently affiliated with and participating in specific existing clinical research networks --to serve as “Network Research Hubs” and establish the infrastructure to conduct clinical research in primary care settings. This opportunity is limited to organizations that focus on serving rural communities and are part of or funded by: NIH Institutional Development Award Clinical and Translational Research (IDeA-CTR) awards, the NIH Clinical and Translational Science Award (CTSA) Program, and/or the Patient-Centered Outcomes Research Institute’s (PCORI) Patient-Centered Clinical Research Network (PCORnet).

Award Mechanism: This funding opportunity will use the Other Transactions Authority (OTA) governed by 42 U.S. Code § 282 (n)(1)(b) to issue Other Transaction (OT) awards. OT awards are not grants, cooperative agreements, or contracts and use an OTA, provided by law. Policies and terms for individual OTs may vary between awards. Each award is therefore issued with a specific agreement which is negotiated with the recipient, and which may be expanded, modified, partnered, not supported, or later discontinued based on program needs, changing research landscape, performance and or availability of funds.

Anticipated Awards and Budget: NIH anticipates 2-5 awards will be issued through this ROA in FY24. NIH intends to allocate a total of approximately $5M in FY24 and approximately $20M in FY25 to fund Network Research Hubs during the two-year pilot phase, contingent on programmatic objectives, performance and availability of funds. After the two-year pilot phase, individual awards may be terminated, extended, or curtailed based on programmatic objectives, performance, and availability of funds.

Contact Information: [email protected] 
 

Background #background

In recent years, the U.S. has experienced trending declines in health that are disproportionately occurring in medically underserved and disadvantaged populations. Many of these sectors are also often underrepresented in clinical research. When study demographics don’t match the demographics of those impacted by the illness or condition under investigation, the results may have limited generalizability, leading to evidence gaps and further compounding health disparities. A major barrier to participating in clinical research is lack of access to or availability of clinical studies. In addition, the majority of Americans have never talked to their doctor about participating in research. There is a critical need to extend research participation opportunities to communities often underrepresented in clinical research, and to integrate those opportunities into settings where people seek care.

Therefore, the National Institutes of Health (NIH) is planning to establish a coordinated infrastructure that integrates innovative research into routine clinical care in primary care settings. Through this effort, NIH will:

• Pilot and implement infrastructure to support primary care-based clinical research in mission areas across all NIH Institutes and Centers (ICs) spanning prevention and treatment and with a focus on health equity and whole person health;
• Establish a foundation for sustained engagement with communities underrepresented in clinical research (e.g., individuals who live in rural environments, racial and ethnic minority groups, older adults, persons experiencing challenging social determinants of health and related experiences);
• Implement innovative study designs that address common health issues, including disease prevention; and  
• Utilize a full range of clinical research designs as appropriate, including dissemination and implementation research, to inform clinical practice 

NIH envisions this infrastructure will facilitate and accelerate research advances for adoption and implementation into everyday clinical care, improving health outcomes, and advancing health equity for all Americans.

The infrastructure NIH will pilot and implement is anticipated to include the following components:

• Clinical Science Center 
  • Providing oversight of the studies/protocols and site and study selection 
  • Providing statistical and data management support  
  • Developing innovative clinical study designs and implementation strategies to minimize burden on participants and providers in primary care settings  
• Operations Center – conducting site feasibility assessments, site agreements/contracting, and coordination of study operations (protocol development; compliance with Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP) regulatory and participant protection requirements; communications; training; auditing; quality assurance; and data monitoring)  
• Independent Review and Monitoring Boards - including Data and Safety Monitoring Board (DSMB), Observational Study Monitoring Board (OSMB), and the Central Institutional Review Board (IRB)  
• Network Research Hubs – leveraging existing research networks and partnerships with Clinical Sites to conduct clinical research in primary care settings   
• Community Engagement– providing support, advice, and resources, in part through partnerships with existing entities, to facilitate sustained participant and community engagement, community-driven research, and integration of studies in primary and community care settings 
• Industry Partnerships – engaging for-profit partners for collaborative knowledge sharing and potential participation in/use of the infrastructure

Purpose and Scope #purposeandscope

The purpose of this research opportunity announcement (ROA) is to invite applications by existing clinical research networks – as well organizations currently affiliated with and participating in specific existing clinical research networks – to serve as “Network Research Hubs” as part of a larger infrastructure (comprising the components described above) supporting research in primary care settings. These Network Research Hubs must be actively part of (i.e., active funding/award) one or more of the following: NIH Institutional Development Award Clinical and Translational Research (IDeA-CTR) awards, the NIH Clinical and Translational Science Award (CTSA) Program, and/or the Patient-Centered Outcomes Research Institute’s (PCORI) Patient-Centered Clinical Research Network (PCORnet). The Network Research Hubs will serve to expand accrual efforts of select existing NIH-funded studies and develop and conduct new studies with a focus on engaging underrepresented populations, particularly those in rural or underserved areas, and enhancing study inclusivity. Bringing clinical research studies to individuals in their own communities, informed by those communities, and improving clinical research inclusivity will facilitate the generation of a more broadly applicable evidence base that contributes to improved patient outcomes and health equity for all Americans. 

Objectives #objectives

Network Research Hubs will be responsible for:

1. Conducting Research in Primary Care Settings in collaboration with Clinical Sites on select existing NIH-funded studies and new studies as the infrastructure is established.
   • Provide clinical research leadership and oversight for clinical studies at all sites supported by and/or partnering with the Network Research Hub, including Clinical Sites.  
   • Participate in select existing studies/trials conducted by NIH-funded investigators.
     Identify and recruit primary care-providing organizations to serve as Clinical Sites for study accrual, supporting the particular needs of each site (e.g., assembling and/or mentoring local research team(s), training providers and clinical staff, assuring protocol adherence, ensuring adequacy of human subjects protections) in collaboration with the Operations Center.
   • Accurately identify, screen, recruit and enroll eligible participants for clinical research studies, meeting or exceeding demographic representation and study inclusivity targets as agreed upon with the Scientific and Medical Director and/or the Scientific Committee.
   • Implement strategies for culturally appropriate and inclusive study participation, including ensuring study interventions and measures are clinically meaningful and adapted for different populations, as appropriate.
   • Provide complete, accurate, and timely collection and entry of high-quality data and biosamples into data management system and repositories as required by the protocol, Scientific Medical Director, and/or Scientific Committee.
   • Track and report trial and performance data (e.g., recruitment, retention, adverse events) by site on a regular and frequent basis as required by the clinical studies, the Scientific and Medical Director, Scientific Committee, and/or data and safety monitoring plans.
   • If successful with enhancing accrual of an existing NIH-funded study, develop new study ideas (interventional or observational) for consideration by the Scientific and Medical Director, Scientific Committee, and Operations Center that reflect the clinical needs and priorities of the applicant’s community base. These ideas for new studies will require external funding sources to cover study costs not supported by the components of the coordinated infrastructure.
   • Respond to information requests for study feasibility assessments (e.g., accessible study population, enrollment estimates, resources available) during research planning and protocol development.
   • Identify health disparities and care disparities and needs of the local population of clinical sites for research planning and prioritization.
   • Participate in data analysis, development of results, and dissemination efforts as appropriate.
   • Ensure that aggregate research results and/or final study findings are shared with study participants through effective communications.
2. Participant and Community Engagement 
   • Work collaboratively with and through individuals and communities on a continuum of practices from outreach to shared decision making to build trust, foster meaningful bi-directional relationships, and identify and address the health needs and priorities of those individuals and communities. 
   • Increase and sustain the involvement of research participants, patients, patient advocates, and community organizations as partners in research, including research planning and prioritization.
   • Operationalize and sustain engagement from the onset of research activities and through various culturally appropriate approaches to create awareness, provide education, develop and perform targeted recruitment and enrollment activities, and mobilize knowledge of the benefits of the research.
   • Leverage existing resources and expand community partnerships (e.g., safety-net health systems, other health systems, grassroots organizations, public health departments, community and faith-based organizations, schools or childcare settings, Tribal organizations and agencies) to increase access to clinical studies.
   • Manage unintended consequences and/or breaks in community relationships.
   • Evaluate engagement efforts for continuous improvement and sustainability.
   • Share approaches and strategies for effective community engagement and build a community of practice.
3. Implementing Innovations in Clinical Study Design
   • In coordination with the Scientific Committee and Scientific and Medical Director, apply and execute innovations across the landscape of clinical research to minimize burden of research on participants and clinical staff. Innovations may include activities such as: leveraging electronic health records for recruitment, randomization, and data collection; leveraging digital health technologies to reduce research burden and facilitate incorporation of diverse precision measurements into participant monitoring and clinical outcomes assessments; aligning clinical care and research workflows; implementing point-of-care trial, pragmatic, and decentralized approaches in study designs.
   • Optimize study designs to increase research equity and accessibility in real world health care settings while maintaining scientific rigor.
   • Through alignment of research and clinical workflows, facilitate clinical sites movement towards a learning healthcare system, accelerating the adoption and implementation of evidence into clinical practice.
4. Participating as Part of a Coordinated Infrastructure Supporting Research in Primary Care Settings
   • Accept and implement policies and procedures established and/or approved by the Scientific and Medical Director, Scientific Committee, Operations Director, and/or additional governance structures established as the infrastructure is further developed.
   • Contribute to the development of policies and procedures by participating in Working Groups or Sub-Committees of the Scientific Committee and other governing bodies established as the infrastructure is further developed.
   • Actively participate and cooperate with quality assurance, study oversight, and study monitoring efforts.
   • Interact and collaborate with other federal and non-federal primary care and clinical research networks and entities (e.g., the NIH Community Engagement Alliance (CEAL), Federally Qualified Healthcare Centers (FQHCs), the NIH Collaboratory, IDeA-CTRs, CTSAs, PCORnet), to leverage existing resources and partnerships, as appropriate.
   • Work collaboratively with all other components of the coordinated infrastructure.
   • Participate in cross-site and cross-component/cross-effort meetings to foster relationship building and enhance partnerships. 
   • Identify, track, and consolidate challenges and successes and share best/promising practices to integrating research in primary care settings for scalability and sustainability.

Phased Approach to Launching Studies and Building the Infrastructure #phasedapproach

NIH is planning to launch this effort as a two-year pilot. The first year of the pilot will involve selecting and funding Network Research Hubs through this ROA to support participation in select existing NIH-funded studies that are agreed upon between the applicant and NIH (in coordination with NIH-funded investigators as needed) during negotiations of a potential award. These initial studies may be interventional or observational and are expected to be reasonably suitable for primary care settings. It is expected that the select existing NIH-funded studies will have infrastructure to support operational aspects (e.g., central IRB, data management) for new sites, but resources available and needed will be negotiated prior to award.

If the Network Research Hub is successful in enhancing participant accrual into an existing study, they may potentially expand in year two with new research in coordination with the other components of the infrastructure. In order to leverage the coordinated research infrastructure described above, these new research concepts will require approval by the Scientific and Medical Director, and Operations Director and funding from external sources for all study aspects not covered by the coordinated infrastructure described above (e.g., specific interventions, additional clinical research staff). Before ramping up to an implementation phase in year three, NIH will conduct an evaluation of the program to assess which approaches and efforts are working. NIH may expand, pivot, and/or sunset awards and/or components based on the results.

Definitions #definitions

This announcement follows the definitions for Clinical Trial-Related Terms below in addition to those in the NIH glossary for clinical trial-related terms: https://grants.nih.gov/policy/clinical-trials/glossary-ct.htm.

Additional key terms are defined below:

Central Institutional Review Board (Central IRB): A centralized approach to human subject protection through a process that streamlines IRB review of selected NIH-sponsored trials for institutions across the country by relying on national experts to ensure trials are reviewed efficiently and with the highest ethical and quality standards.

Clinical Research Network: Collaborative groups of researchers and/or clinicians and that come together in partnership with healthcare systems to identify important clinical questions and design clinical studies to answer them, with coordinated support to manage regulatory, financial, scientific, and/or operational aspects of the research.

Clinical Site: A primary care practice, community health center, hospital, or other health services institution where participants are identified, screened, recruited, and/or enrolled in research conducted by the Network Research Hub.

Federally Qualified Health Centers (FQHC): As defined by the Health Resources and Services Administration (HRSA), public and private non-profit health care organizations that meet certain criteria under the Medicare and Medicaid Programs. FQHCs include:

• Nonprofit entities that receive a grant, or funding from a grant, under section 330 of the Public Health Service Act to provide primary health services and other related services to a population that is medically underserved;
• FQHC “Look-Alikes” – nonprofit entities certified by the Secretary of the U.S. Department of Health and Human Services as meeting the requirements for receiving a grant under section 330 of the Public Health Service Act but are not grantees; and
• Outpatient health programs or facilities operated by a Tribe or Tribal organization under the Indian Self-Determination Act or by an urban Indian organization receiving funds under Title V of the Indian Health Care Improvement Act.

Medically Underserved Area/Population (MUA/P): As defined by HRSA, MUAs may be a whole county or a group of contiguous counties, a group of county or civil divisions or a group of urban census tracts in which residents have a shortage of personal health services; MUPs may include groups of persons who face economic, cultural or linguistic barriers to health care.

Milestones: Objective, measurable events that are indicative of project progress occurring as proposed in the application.

Network Research Hub: An institution/organization with an established organizational structure and scientific and statistical leadership for developing, implementing, and analyzing multi-institutional clinical studies/trials.

Other Transactions Authority (OTA): A unique type of authority that allows an agency to enter into a legal agreement with a recipient organization that is not a contract, grant, or cooperative agreement (Learn more about OTAs on the NIH website).

Partnership: An association of two or more individuals or entities with a commitment to an ongoing relationship to work toward common goals as established.

Primary Care: As defined by HRSA, the provision of integrated, accessible health services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community.

Primary Care Setting: As defined by HRSA, a setting with integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. These don’t meet the criteria:

• Emergency departments
• Inpatient hospital settings
• Ambulatory surgical centers
• Independent diagnostic testing facilities
• Skilled nursing facilities
• Inpatient rehabilitation facilities
• Hospices

Research Opportunity Announcement (ROA): Used to solicit applications for programs using Other Transactions Authority.

Rural: For the purposes of this ROA, rural areas are defined according to the Office of Management and Budget and Federal Office of Rural Health Policy (FORHP) definitions, where primary Rural-Urban Commuting Area (RUCA) codes between 4 and 10 correspond to rural areas and primary RUCA codes 1-3 correspond to urban areas.

Rural Health Clinic: An entity certified by the Centers for Medicare & Medicaid Services. A rural health clinic provides outpatient services to a non-urban area with an insufficient number of health care practitioners.

Social Determinants of Health (SDOH): As defined by the CDC, SDOH are the nonmedical factors that influence health outcomes. They are the conditions in which people are born, grow, work, live and age, and the wider set of forces and systems (e.g., economic policies and systems, development agendas, social norms, social policies, racism, climate change, and political systems) shaping the conditions of daily life.

Eligibility #eligibility

Eligible applicants are limited to organizations that are lead or funded partner organizations of one or more of the following clinical research networks: the NIH IDeA-CTRs, NIH CTSA, and/or PCORI PCORnet. For the purposes of this ROA, organizations with IDeA-CTR and CTSA awards or sub-awards in no-cost-extensions are eligible to apply. In addition, applicant organizations must be located in a state/jurisdiction where at least 25% of its census tracts are defined as rural using the Revised 2010 RUCA Codes.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Hispanic-Serving Institutions (HSIs)
• 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
• American Indian/Native American Tribal Governments (Federally Recognized)
• American Indian/Native American Tribal Governments (Other than Federally Recognized)

Other

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

Application Responsiveness #responsiveness

Applications will undergo a responsiveness screening conducted by NIH program staff. Applications that are deemed nonresponsive will be withdrawn and will no longer be in consideration for funding. Examples of projects that will be considered unresponsive to this announcement include the following:

• Applications that do not meet the “Eligibility” requirements specified above.
• Applications from organizations that are not actively participating as lead or a funded partner in one or more of the following clinical research networks: IDeA-CTRs, CTSA, and/or PCORnet in the United States,
• Applications proposing partnerships only with Clinical Sites that do not meet the definition of primary care settings.
• Applications proposing support for routine patient care unrelated to human subjects research.
• Applications proposing animal or in vitro research.

Application Requirements #applicationrequirements

All application components should be uploaded in eRA Commons in searchable PDF format with a font size of 11 or 12 point and font type of Calibri, Aptos, Arial, or Times New Roman. Margins must be 1-inch wide (top, bottom, left, and right). The components of the application should be loaded as separate attachments and should be titled as specified in each section below (title included in parentheses following each section). Guidance for OT application submission can be found on the NIH website.

Cover (“Cover.pdf”, 2 page maximum)

• Number and title of this Research Opportunity Announcement
• Application Title 
• Principal Investigator(s) (PI) first and last name, title, organization, mailing address, email address and phone number. If multiple PIs are named, the Contact PI is clearly identified. 
• Name and address of the partnering Clinical Sites with a contact for each (full name, email address)
• Recipient Business Official/Signing Official first and last name, title, organization, mailing address, email address and phone number 
• First and last name of other key personnel, their title, institutional affiliation, and email address

Abstract (“Abstract.pdf”, no more than 250 words)

A brief summary of the application.

Specific Aims (“Specific Aims.pdf”, 1 page maximum)

Provide a cogent overview, at a high level, of the capabilities and proposed plans to carry out the objectives of a Network Research Hub as part of a coordinated infrastructure supporting clinical research in primary care settings. Include how the work of the Network Research Hub will increase the accessibility of clinical research and improve health equity.

Project Plan (“Project Plan.pdf”, 16 pages maximum)

Applications must include a Project Plan that clearly and fully demonstrates the applicant’s capabilities, understanding, and experience to accomplish the objectives of the Network Research Hubs.

Technical Approach (6 pages maximum)

Section A: Overview and Organization

• Outline the overall organization of the Network Research Hub and partnering Clinical Sites, and briefly describe the collective strengths of the team. Include how the Network Research Hub is actively participating in and/ or affiliated with one of the following clinical research networks: NIH IDeA-CTRs, NIH CTSA, PCORI’s PCORnet. 
• Provide a diagram (and/or map) showing the geographical relationships between all entities included in the application. The rural participant catchment area is not limited to the applicant organization’s state. 
• List the underrepresented populations that could be served by the Network Research Hub. Define the community or communities the Network Research Hub will serve.
• Describe plans to collaborate with NIH-funded investigators, other Network Research Hubs, and the other components of the coordinated infrastructure. Share how the Network Research Hub plans to contribute to the development of policies and procedures and abide by them as they are established.

Subsection B. Developing and Implementing Studies and Use of Innovative Designs

• Identify areas of research that the Network Research Hub would like to pursue if successful with implementing expansion of an initial, existing NIH-funded study. Include a description of the criteria to be used and process by which studies will be identified that are priorities of and/or co-developed by their community.
• Explain how the Network Research Hub’s research interests and/or proposed research agenda will improve scientific knowledge, develop a more broadly applicable clinical evidence base, and improve clinical practice.
• Describe innovative/novel solutions to address challenges with integrating research into primary care settings and to minimize the burden of research on participants and clinical staff. Share the team’s expertise and experience with operationalizing these solutions. 
• Briefly describe processes the applicant will use to ensure compliance with regulations for research involving human subjects, and that study teams obtain and maintain sufficient proficiency level regarding the conduct of clinical research in coordination with the Operations Center.

Subsection C. Participant and Community Engagement

• Define a framework along the continuum of practices with plans to engage diverse participants, patient advocates, and communities early in and throughout the research process (from prioritization and planning to dissemination and implementation), and plans to sustain the engagement, especially with those from populations typically underrepresented in research. 
  • Illustrate the team’s expertise in implementing related plans through recent examples and experiences.
• Clearly describe how the Network Research Hub will solicit and understand the challenges and health needs of their community.
• Highlight flexibilities in study designs, features, and engagement plans that can be adapted to meet the needs of a variety of participant groups and community partners, including those that are underrepresented in research.
• Describe how the Network Research Hub will contribute to the development of a community of practice in community engagement.

Primary Care Research Experience (6 pages maximum)

• Provide a description of up to three current or recently completed multi-site clinical studies in primary care settings (with a priority on studies serving rural areas) that the Network Research Hub has led with one or more of the proposed Clinical Sites, highlighting:
  • Study title, type/design, research question(s) addressed, and target and actual total enrollment over time
  • Partnerships with organizations providing care in primary care settings.
  • Total enrollment by site
  • Demographic breakdown of enrolled participants by race/ethnicity, sex, age, rural vs non-rural, and at least one other measure of social determinants of health (SDOH)
  • How the data and/or results were shared and disseminated (including if shared with research participants)
• List additional previous relationships and/or partnerships with the proposed Clinical Sites to provide evidence supporting the likelihood of successful collaborations on future research.

Environment and Resources (3 pages maximum) 

List and describe the salient features of the facilities and other resources available for use by the proposed Network Research Hub. 

• Describe the resources available to facilitate carrying out the objectives of a Network Research Hub.
• Characterize the proposed Clinical Sites: describe the collective catchment area of the potential research participants through geographic boundaries, quantify the proportion of the catchment area as being rural vs urban in alignment with primary RUCA codes between 1-3 as defining urban areas and 4-10 as defining rural areas, and share any unique features to facilitate accrual of populations underrepresented in research.

Leadership Plan (1 pages maximum)

A brief leadership plan should be presented which identifies and describes the governance of the Research and Clinical Sites, chain of responsibility for decision making, and process for conflict resolution. The plan should describe how the leadership will contribute to the success of and collaboration within the infrastructure and the implementation of clinical studies with a focus on underrepresented populations. A succession plan with identification of a substitute/back-up lead investigator candidate should be included, if possible, to assure programmatic continuity.

Budget (“Budget.pdf”, no page limitations)

The Budget must demonstrate estimated baseline costs of adding a select and limited number of primary care Clinical Sites to existing studies conducting clinical research in primary care settings, where the operational aspects of the study are supported by other NIH awards. Budgets are expected to be negotiated as the initial study is selected in coordination with NIH before an award is issued. Cost sharing is allowable.

Applicants shall assume a budget period of 12 months initially, and an additional 12-month option period during the 2-year pilot of this infrastructure for research in primary care settings. Funding for core support will be reimbursable, but costs per participant is expected to be funded based on study accrual milestones. Towards the end of the initial budget period, NIH will conduct an evaluation of the program to assess which approaches and efforts are working; NIH may continue, expand, pivot, and/or sunset awards and/or award components based on the results, infrastructure needs and/or congressional appropriations.

Study budgets should include funds for the community partners to be fully engaged and successfully participate in research prioritization, design and implementation.

Provide the overall expected cost for expanding research enrollment in primary care settings including but not limited to each of the following categories: 

• Personnel 
• Equipment 
• Travel 
• Subawards/subcontracts/consultants 
• Other direct costs 
• Total cost (with indirect costs included) 
• Proposed Cost Share contribution (if applicable)

Applicants must provide a budget justification for all budget items. Subrecipients/subaward budgets must include a breakdown of costs and a budget justification. Applicants should provide one budget and budget justification per institution or organization in the application.

Additional information to include in the submission

List of Key Personnel (“Key Personnel.pdf”, 1 page maximum)

Provide a list of key personnel that will significantly contribute to the objectives of the Network Research Hub. Provide their first name, last name, title, institutional affiliation, and email address.

Biosketches of Key Personnel (“Biosketch.pdf”, 3 page maximum per individual)

Provide a biosketch of each named key individual appearing in the Key Personnel List. The information in the biosketch should include the name and position title, education/training (including institution, degree, date (or expected date) of degree, and field; list of positions and employment in chronological order (including dates); list of relevant publications, proposed level of effort and a personal statement that briefly describes the individual’s role in the project and why they are well-suited for this role. Providing successful examples from past work on similar infrastructure building projects as appropriate to illustrate the relevant experience is desired. The format used for an NIH grant application is acceptable: https://grants.nih.gov/grants/forms/biosketch.htm.  

Letters of Interest/Support (1 page maximum per institution or organization)

A letter from the applicant's current affiliated clinical research network(s) (e.g., the director of the network coordinating center, administrative core, other authorized representative) should provide assurance that the proposed Network Research Hub is active and in good standing with the affiliated clinical research network. In addition, letters of interest and support should be provided from an authorized official from each of the proposed Clinical Sites and should include references to or direct evidence of prior research partnership or relationship with the Network Research Hub.

Appendix of Data Characterizing the Research and Clinical Sites’ Catchment Area (no page limit)

Data used to characterize the catchment area as rural or non-rural may be included to verify the catchment area descriptions in the Project Plan.

Objective Review #objectivereview

The intent of the objective review is to evaluate the strengths and the weaknesses of the proposed Network Research Hub and how well they would meet the objectives of a Network Research Hub. Applications will not be evaluated against each other during the review process but rather on their own individual merit.

Objective review will involve the submission of written critiques by subject matter experts documenting the strengths and weaknesses of responsive applications against the Review Criteria described below and interactive individual discussions between those experts and NIH program staff. The subject matter experts will include NIH staff and/or other federal staff.

Applications may be triaged for review based on the proposed catchment area of potential research participants, with applications with catchment areas characterized by >50% of the population being from rural areas, as defined by primary RUCA codes between 4-10, receiving priority for review.

NIH will NOT provide feedback on applications, except as a part of follow-up on an as-needed basis as time permits. NIH will not accept an appeal of the objective review or funding decision outcomes.

Review Criteria:

Potential Contribution to the Coordinated Infrastructure for Supporting Research in Primary Care Settings

The approach of proposed Research Site has a high likelihood of meeting the objectives of a Network Research Hub. The applicant has described adequate plans for collaboration with other components of the coordinated infrastructure. The proposed activities involve engagement following a comprehensive framework, facilitating early and sustained engagement with a diverse group of individuals and communities, especially those that are underrepresented in research. Plans to engage the community they serve will successfully support a community-driven research agenda. Leadership plans, support from existing clinical research networks, and support from Clinical Site partners demonstrate a high commitment to the success of the proposed Network Research Hub.

Capabilities and Experience

The applicant has a demonstrated track record of successfully implementing research in primary care settings in the recent past. Prior experience showcases the ability to access and partner with underrepresented individuals in clinical research. Evidence of prior partnerships or relationships with proposed Clinical Sites has been provided. Key personnel have sufficient and relevant expertise to support the activities of the Network Research Hub.

Resources and Environment

The Network Research Hub is currently participating in and affiliated with one or more clinical research networks (NIH IDeA-CTRs, NIH CTSA, and/or PCORI PCORnet), that will increase site readiness to rapidly launch as a new site for existing NIH-funded studies. The catchment area of the Network Research Hub and its Clinical Sites will provide a high likelihood of facilitating engagement and study accrual of populations underrepresented in research (with a priority on individuals in rural communities).

Award Negotiation and Selection Information

Based on the identified strengths and weaknesses, NIH will determine whether an application will be selected for negotiation and/or award. NIH may select up to six viable applications to move forward in negotiations for a potential award, based on the objective review. Negotiations will involve identification of the initial study already funded by NIH to which the Network Research Hub will serve as an additional enrollment site. Coordination with the NIH-funded investigators and/or NIH program staff overseeing those studies will be required in order to understand the needs and existing support for the studies and to develop a final budget and milestone plan for the Network Research Hub. Final award selection will involve assessment of applications with successful negotiations and review and approval by NIH leadership and development of objective milestones as agreed upon by NIH and the applicant.

The level of funding for any award(s) made will depend on the negotiated studies and milestones and availability of funds.

Special Award Terms #Special Award Terms 

The complete terms and conditions of each OT award issued under this ROA are subject to negotiation and will be contained in the Agreement entered between NIH and award recipient. This Special Award Terms section is provided for informational purposes only in order to provide prospective applicants with an understanding of key expectations and terms that may differ from traditional NIH award mechanisms. All terms and conditions of award will flow down to any partners (e.g., subrecipients, collaborators) participating in the OT award.  

Lower Tier Agreements 

Award recipients will be expected to issue sub-awards to entities identified in their applications and approved by NIH under this ROA. Any changes to sub-awards must be in consultation with NIH prior to adding or removing partners.

Milestone-Based Workplan 

A milestone-based workplan will be requested and negotiated prior to award for inclusion in the OT Agreement. The workplan should include a description of operational milestones, completion criteria, and expected start and completion dates.

Enhancing Diversity, Equity, Inclusivity, and Accessibility in the Research Community

Award recipients will be encouraged to diversify their staff populations to facilitate engagement with diverse research partners and to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences, such as those defined in Notice of NIH’s Interest in Diversity (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html).

Program Governance  
The Network Research Hubs will be part of a program consisting of a coordinated infrastructure involving the following governance and components:   

• NIH Oversight Committee (OC): consists of NIH leadership from multiple Institutes and Centers (ICs) of NIH as well as the Office of the Director and is co-chaired by three Institute and Center Directors. The OC is responsible for:
  • establishing the vision, mission, strategic objectives, and goals of the coordinated infrastructure to be carried out by a Scientific and Medical Director (SMD) and Operations Director.
  • ensuring the supported work appropriately and equitably supports and prioritizes the needs of all NIH ICs. 
  • monitoring and evaluating the progress of the infrastructure, its efficiency and effectiveness, and that its outputs align with the vision and mission.
• NIH Scientific Committee: consists of leadership from multiple Institutes, Centers, and Offices (ICOs) of NIH as well as the Office of the Director. The Committee will be chaired by an NIH Scientific and Medical Director. Through the Clinical Science Center, sub-committees, and/or working groups, the Scientific Committee will be responsible for:
  • providing oversight of the studies/protocols and site and study selection, 
  • managing/coordinating the Central Institutional Review Board (IRB), 
  • providing statistical and data management support, 
  • collaborating with sites to develop innovations on clinical study design and implementation to minimize burden on participants and providers in primary care settings, 
  • facilitating sustained engagement with key partners through a community advisory board, and
  • other functions as the governance and structure of the Clinical Science Center is further developed.
• NIH Operations Center: led by an NIH Operations Director, the Operations Center will consist of NIH and contracted staff that will be responsible for:
  • conducting site feasibility assessments
  • facilitating Clinical Site agreements/contracting,
  • coordination of study operations (protocol development; compliance with Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP) regulatory and participant protection requirements,
  • training,
  • auditing,
  • quality assurance, and 
  • data monitoring.

OT Agreement Governance 

Other Transactions (OT) are a special type of legal instrument other than contracts, grants or cooperative agreements. Generally, these awarding instruments are not subject to the Federal Acquisition Regulation (FAR), nor to grant regulations unless otherwise noted for certain provisions in the terms and conditions of award. They are, however, subject to the OT authorities that govern the initiative and/or programs as well as applicable legislative mandates. NIH and its components, including the Office of Strategic Coordination (OSC), have been authorized by Congress to use them. They provide considerable flexibility to the government to establish policies for the awards, so the policies and terms for individual OT awards may vary between awards. Each award is therefore issued with a specific Agreement, which is negotiated with the recipient and details terms and conditions for that specific award. Program and administrative policies and the terms and conditions of individual awards are intended to supplement, rather than substitute for, governing statutory and regulatory requirements. Awards or a specified subset of awards also may be subject to additional requirements, such as those included in executive orders and appropriations acts (including the other transaction legislation cited in the Agreement), as well as all terms and conditions cited in the Agreement and its attachments, conditions on activities and expenditure of funds in other statutory or regulatory requirements, including any revisions in effect as of the beginning date of the next funding segment. The terms and conditions of the resulting OT awards are intended to be compliant with governing statutes.

For the awards funded under this ROA, NIH will engage in negotiations and all agreed upon terms and conditions will be incorporated into the Agreement. Either a bilateral agreement or a Notice of Award (NoA) will be used as the official Agreement. The signature of the Signing Official in the application certifies that the organization complies, or intends to comply, with all applicable terms and conditions, policies, certifications, and assurances referenced (and, in some cases, included) in the application instructions.

Award Administration Roles and Responsibilities

Other Transactions Agreements Officer (OTAO) 

• is responsible for legally committing funds on behalf of the Federal government and that OT actions taken are in the best interest of the government
• administers, manages, and closes out awards
• oversees the management of award records
• receives and acts on requests for NIH approval; the only NIH official authorized to change the funding, duration, or other terms and conditions of award

Other Transactions Agreements Specialist (OTAS) 

• serves as the first line contact for OT correspondence with applicants/recipients for administrative and financial aspects of the award

Other Transactions Program Official (OTPO) 

• provides the day-to-day programmatic oversight of individual awards 
• seeks guidance and advice as appropriate from subject matter experts for various disease areas and/or clinical trial oversight (e.g., medical monitoring)
• documents programmatic decisions related to an OT
• upholds government regulations on the appropriate use of federal funds
• conducts timely review of reports, inspection of deliverables, and other mechanisms to monitor and evaluate performance of the OT recipients
• serves on the OT Team, which includes developing ROAs and contributing to the development of OT award terms and conditions
• maintains certifications to serve as OTPO
• coordinates with other NIH Program Officers when partnering on other NIH-funded projects

Subject Matter Experts

• assist the OTPO in scientific and technical discussions with awardees
• review reports and discuss progress towards milestones and deliverables
• provide recommendations to the OTPO based on progress reviews
• attend face-to-face awardee meetings, as necessary
• attend site visits, as necessary

Reporting

The terms and conditions of each award will address this criterion as appropriate based upon the final negotiated terms and agreed upon budget.

Human Subjects Research

All applications for work that will involve engagement in Human Subjects Research (as defined in 45 CFR § 46)(https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46) must provide documentation of one or more current Assurance of Compliance with federal regulations for human subject protection, including at least a Department of Health and Human Services (HHS), Office of Human Research Protection (OHRP), Federal Wide Assurance (https://www.hhs.gov/ohrp/index.html). All research involving Human Subjects must be reviewed and approved by an Institutional Review Board
(IRB), as applicable under 45 CFR § 46 (https://www.ecfr.gov/current/title-45/subtitleA/subchapter-A/part-46) and/or 21 CFR § 56 (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56).

The entity’s Human Subjects Research protocol must include a detailed description of the research plan, study population, risks and benefits of study participation, recruitment and consent process, data collection, and data analysis. Award recipients must comply with all applicable laws, regulations, and policies for NIH-funded work. This includes, but is not limited to, laws, regulations, and policies regarding the conduct of Human Subjects research, such as the U.S. federal regulations protecting human subjects in research (e.g., 45 CFR § 46, 21 CFR § 50, § 56, § 312, § 812) and any other equivalent requirements of the applicable jurisdiction.

The informed consent document utilized in human subject research funded by NIH must comply with all applicable laws, regulations, and policies, including but not limited to U.S. federal regulations protecting human subjects in research (45 CFR§ 46 (https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46) and, as applicable, 21 CFR § 50 (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50). The protocol package submitted to the IRB must contain evidence of completion of appropriate Human Subject Research training by all investigators and key personnel who will be involved in the design or conduct of NIH funded human subject research. Funding cannot be used toward human subject research until all approvals are granted.

Intellectual Property

Specific terms with respect to intellectual property will be negotiated at the time of award; however, any negotiation will consider other laws (as relevant) that affect the government’s issue and handling of intellectual property, such as the Bayh-Dole Act (35.U.S.C. 200-212); the Trade Secrets Act (18U.S.C. 1905) the Freedom of Information Act (5 U.S.C. 552); 10 U.S.C. 130; 28 U.S.C. 1498; 35 U.S.C. 205 and 207-209; and the Lanham Act, partially codified at 15 U.S.C.1114 and 1122.

Payment  

The OT award will use the Payment Management System (PMS) operated by the DHHS Program Support Center. Payments by PMS are made on a reimbursement basis unless otherwise specified in the terms of the Agreement.

Management Systems and Procedures 

Recipient organizations are expected to have systems, policies, and procedures in place by which they manage funds and activities. Recipients may use their existing systems to manage OT award funds and activities as long as they are consistently applied regardless of the source of funds and across their business functions. To ensure that an organization is committed to compliance, recipient organizations are expected to have in use clearly delineated roles and responsibilities for their organization’s staff, both programmatic and administrative; written policies and procedures; training; management controls and other internal controls; performance assessment; administrative simplifications; and information sharing.

Financial Management System Standards 

Recipients must have in place accounting and internal control systems that provide for appropriate monitoring of other transaction accounts to ensure that obligations and expenditures are congruent with programmatic needs and are reasonable, allocable, and allowable. A list of unallowable costs will be included in the terms and conditions of the award. In addition, the systems must be able to identify unobligated balances, accelerated expenditures, inappropriate cost transfers, and other inappropriate obligation and expenditure of funds, and recipients must notify NIH when problems are identified. A recipient’s failure to establish adequate control systems constitutes a material violation of the terms of the award.

Property Management System Standards 

Recipients may use their own property management policies and procedures for property purchased, constructed, or fabricated as a direct cost using NIH OT award funds. The terms and conditions of award will address this criterion as appropriate based upon the final negotiated and agreed upon budget. Procurement System Standards and Requirements Recipients may acquire a variety of goods or services in connection with an OT award-supported project, ranging from those that are routinely purchased goods or services to those that involve substantive programmatic work. Recipients must acquire goods and services under OT awards in compliance with the organizations established policies and procedures. The terms and conditions of each award will address this criterion as appropriate based on the final negotiated and agreed upon budget.

Organizational Conflicts of Interest (OCIs)  

Applicants are required to identify and disclose all facts relevant to potential OCIs involving subrecipients, consultants, etc. Under this section, the proposer is responsible for providing this disclosure with each Detailed Plan. The disclosure must include the PI/Collaborators’, and as applicable, proposed members’ OCI mitigation plan. The OCI mitigation plan must include a description of the actions the proposer has taken, or intends to take, to prevent the existence of conflicting roles that might bias the proposer’s judgment and to prevent the proposer from having an unfair competitive advantage. The government will evaluate OCI mitigation plans to avoid, neutralize, or mitigate potential OCI issues before award issuance and to determine whether it is in the government’s interest to grant a waiver.

The government will only evaluate OCI mitigation plans for proposals that are determined selectable. The government may require applicants to provide additional information to assist the government in evaluating the proposer’s OCI mitigation plan. If the government determines that a proposer failed to fully disclose an OCI or failed to reasonably provide additional information requested by the government to assist in evaluating the proposer’s OCI mitigation plan, the government may reject the Detailed Plan and withdraw it from consideration for award.

Monitoring 

Recipients are responsible for managing the day-to-day operations of OT award-supported activities using their established controls and policies. However, to fulfill their role in regard to the stewardship of federal funds, the program team will monitor their OT awards to identify potential problems and areas where technical assistance might be necessary. This active monitoring is accomplished through review of reports and correspondence, audit reports, site visits and other information, which may be requested of the recipient. The names and contact information of the individuals responsible for monitoring the programmatic and business management aspects of awards will be provided to the recipient at the time of award.

Monitoring of a project or activity will continue for as long as NIH retains a financial interest in the project or activity as a result of property accountability, audit, and other requirements that may continue for a period of time after the OT award is administratively closed out and NIH is no longer providing active OT award support.

Audit 

NIH OT recipients for the Program are subject to the audit requirements of OMB 2 CFR 200, Subpart F- Audit Requirements, as implemented by DHHS 45 CFR Subpart F. In general, 45 CFR 75, Subpart F-Audit Requirements requires a state government, local government, or non-profit organization (including institutions of higher education).  

For-profit organizations have two options regarding the type of audit that will satisfy the audit requirements. The recipient either may have (1) a financial-related audit (as defined in, and in accordance with, the Government Auditing Standards (commonly known as the “Yellow Book”), GPO stock 020-000-00-265-4, of a particular award in accordance with Government Auditing Standards, in those cases where the recipient receives awards under only one DHHS program, or (2) an audit that meets the requirements of 45 CFR 75, Subpart F-Audit Requirements.