Notice of Intent to Publish a Notice of Funding Opportunity for Network of Genomics-Enabled Learning Health Systems (gLHS) – Clinical Sites (U01 Clinical Trial Required)

Key Dates

None

National Human Genome Research Institute (NHGRI)

The NHGRI intends to promote a new initiative by publishing a Notice of Funding Opportunity (NOFO) to solicit applications to support a network of genomic-enabled learning health systems (gLHS). These health systems will identify and improve approaches for clinical integration of genomic information in a virtuous cycle of implementation, assessment, refinement, and re-implementation. Specifically, this initiative would: 1) support 4-6 established or emerging gLHS clinical sites to share their genomic medicine implementation practices and identify those most suitable for cross-network implementation; 2) use these practices to conduct 2-4 network-wide pilot implementation projects and evaluate their impact; and 3) develop and refine successful gLHS implementation strategies as resources that can be broadly shared and adopted, including in resource-limited settings.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects, and to allow potential applicants with relevant expertise and insights to consider applying for this new NOFO.

The NOFO is expected to be published in late summer 2023 with an expected application due date in fall 2023.

This NOFO will utilize the U01 activity code; clinical trial is required. Details of the planned NOFO are provided below.

A learning health system (LHS), also called a “rapid-learning health system,” is one in which internal data and experience are systematically integrated with external evidence and the resulting knowledge is put into practice. In an effective LHS, generalizable knowledge can potentially be captured from every patient encounter and delivered to clinicians to modify their practice, ideally allowing them to “learn from what they do and do what they learn.” Ultimately, the goal of an LHS is to enable health systems to rapidly fill evidence gaps and refine them as needed to improve the quality of care delivered in a virtuous cycle of continuous quality improvement.

Genomic information can be integrated at any step in this process to produce genomic-enabled learning health systems (gLHS), which can facilitate rapid incorporation and evaluation of genomic-informed care. A few examples include genomic identification of actionable genetic conditions, EHR integration of genomic information for genetics-care delivery, EHR-identification of monogenic disorders, genome sequencing in critically ill infants, and targeted pharmacogenetic testing. Interoperability of integrated genomic data across health systems is also necessary, and significant strides have been made, as exemplified by the successful deployment of the “Genetic Cancer Risk Detector (GARDE)” program.

The potential for gLHS to move genomic discoveries rapidly into clinical care through systemic implementation was highlighted in the NHGRI 2020 Strategic Vision, particularly the possibility of extending gLHS studies across multiple health systems to reveal common challenges and solutions. To explore successful implementation models and possibilities for collaboration among them, NHGRI convened Genomic Medicine XIV – Genomic Learning Healthcare Systems in August 2022. Establishing a network to promote sharing and collaboration across gLHS was a key recommendation of that meeting.

Objectives and Scope

This NOFO will establish 4-6 gLHS clinical sites (CS) that will work with a coordinating center (CC) to form a gLHS Network that will share and develop current best practices for implementing, evaluating, refining, and re-implementing genomic medicine interventions. The Network will identify 2-4 pilot implementation projects in the first year and implement and evaluate these projects in years 2-4. The Network will assess the impact of integration and implementation, using lessons learned to refine tools and resources for wider dissemination, in year 5. CS will be responsible for identifying and sharing within (and eventually beyond) the Network their best practices for genomic medicine integration.

Pilot implementation projects

 Network-wide genomic medicine interventions will be selected and designed to demonstrate and enhance the ability to exchange genomic results, recommendations, and workflows across CS. They should have significant evidence supporting the value of or need for broader implementation from existing programs at the CC, CS, and/or from similar systems. Other criteria for selecting projects will be defined by the Network, but key aspects include interoperability and assessment of the ability for a patient’s genomic information to follow them across multiple providers.

Evaluation and best practices

Assessment metrics for selected projects should include outcomes of value to patients, communities, health systems, payers, clinicians, and other stakeholders. The evaluation and findings will be used to refine approaches and develop gLHS implementation resources, which should include approaches for: integrating genomic results in the EHR, real-time monitoring of or dashboarding the status of implementation, and tracking the outcomes of interventions.

Broadening participation in gLHS

gLHS products should be feasible across a range of health systems, including low-resource settings and genetically diverse populations. Implementation resources produced by the Network will be designed to help other providers adopt gLHS approaches and potentially facilitate their participation in this and similar networks.

This Notice encourages investigators with expertise and insights into LHS and gLHS to consider applying to this new NOFO. CS applicants will be expected to:

• Demonstrate willingness to share and improve upon their existing gLHS approaches.
• Demonstrate readiness for change and ability to work with peers in a network setting.
• Have the capacity for their EHR to interact with other systems to enhance interoperability within and outside of their health system.
• Demonstrate a track record of using LHS approaches in their health system, including in underserved and diverse communities and settings, and willingness to apply genomic interventions in their LHS.
• Have experience integrating, or have the capability to integrate, genomic information into their EHRs and into the primary care setting.
• Have expertise in community and stakeholder engagement, implementation science, change management, and health services research.
• Demonstrate evidence of their ability to extend their approaches to low-resource settings and diverse U.S. populations.
• Identify and include in their sites champions from resource-limited settings who will provide their unique expertise and perspectives to broaden the applicability of Network products.
• Have the ability and commit to implementing agreed-upon, Network-wide approaches to conduct 2-4 pilot genomic medicine implementation projects.

This RFA will be NHGRI’s first initiative focused on exploring and developing gLHS. Other NHGRI efforts focus on implementation and evidence generation without the iterative virtuous cycle of LHS.

Funding Information

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Robb Rowley, M.D.

National Human Genome Research Institute (NHGRI)

Telephone: (301) 827-9126

Email: [email protected]