Key Dates

• January 3, 2025 - Notice of Intent to Publish a Funding Opportunity Announcement for Limited Competition: Outcomes of Electronic Medical Records and Genomics (eMERGE) Genomic Risk Assessment and Management Network - Clinical Sites (U01, Clinical Trial Required).  See Notice NOT-HG-25-015.

National Human Genome Research Institute (NHGRI)

The National Human Genome Research Institute (NHGRI), a component of the National Institutes of Health (NIH), intends to issue a sole source award to promote a continuation of an initiative by publishing a Notice of Funding Opportunity (NOFO) to solicit applications for researchers to participate in the Outcomes of Electronic Medical Records and Genomics (eMERGE) Genomic Risk Assessment and Management Network. The Network will extend through April 2030 the follow-up and collection of outcome data on the roughly 25,000 patients receiving genomically informed risk assessment (GIRA) and management recommendations. The objective of the extended follow-up provided by the Outcomes of Electronic Medical Records and Genomics (eMERGE) Genomic Risk Assessment and Management Network is to determine whether appropriate uptake and sustainability of interventions persist beyond the initial return of the GIRA.

This Notice is being provided to allow potential applicant sufficient time to develop meaningful applications that align with the objectives of this NOFO. The NOFO is expected to be published in February 2025 with an expected application due date in April 2025. The NOFO will utilize the U01 activity code.

At this time only one organization possesses the necessary expertise, technical infrastructure, and agreements to perform the multidisciplinary research and scholarship to 1) extend follow-up of eMERGE patients from a minimum 1 year to a minimum of 4 years; 2) assess longer-term adherence to and outcomes of GIRA-based preventative recommendations among clinicians and patients; and 3) identify correlates of adherence by condition, patient age and other demographics, and social determinants of health. NHGRI intends to continue supporting the single, Network-wide, combined risk assessment and management protocol that has been implemented across the various populations represented in the 25,000 patients recruited in the current phase of eMERGE (RFA-HG-19-013, RFA-HG-19-014, RFA-HG-19-015).

The applicant will play a major research role in preparation and distribution of Network-wide datasets for distributed analysis, joint analyses of Network-wide data including analysis of clinical and cost-effectiveness outcomes and subgroup effects, and coordination of protocol updates and implementation among the sites. The applicant will ensure that robust and efficient informatics tools are established at the clinical sites (CS) and coordinating center (CC) to continue to collect, store, transmit, and analyze the data as required by the current GIRA protocol. The applicant should describe how they plan to facilitate the capture of the necessary outcome data from within and outside the clinical sites' health systems. The CC will design and implement a detailed quality assessment and control plan to ensure a high-quality data set is captured and shared among the sites. The CC will also be responsible for ensuring data generated by the eMERGE Network are deposited into a publicly accessible data repository such as AnVIL and ClinVar.

The applicant will coordinate all activities of the Outcomes of Electronic Medical Records and Genomics (eMERGE) Genomic Risk Assessment and Management Network. This includes capturing research and clinical data from disparate data systems and coordinating research analyses across multiple groups. The applicant will need to include plans for coordinating, facilitating, and supporting the activities of eMERGE in collaboration with CSs and NHGRI, including archiving and tracking all materials relevant to the development and implementation of the eMERGE Network. 

Funding Information

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Robb Rowley, MD
Division of Genomic Medicine
National Human Genome Research Institute
6700B Rockledge Drive, Room 3120, MSC 6908
Bethesda, MD 20892
Robb.Rowley@nih.gov
(301) 827-9126 (office)
(301) 480-5159 (fax)