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-25-016.

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 limited competition awards 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 applicants sufficient time to develop meaningful applications that align with the objectives of this NOFO. The NOFO is expected to be published in February 2025with an expected application due date in April 2025. The NOFO will utilize the U01 activity code.

At this time there are ten organizations that possess the 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 applicants will conduct the research (patient retention and implementation of all study procedures) and disseminate research findings in collaboration with the coordinating center (CC) and NHGRI. In conjunction with the CC and NHGRI, applicants will be responsible for assessing uptake of risk reduction recommendations and other process and health outcomes, and analyzing and interpreting research results. Each applicant will participate in a cooperative and interactive manner with all other clinical sites (CS) and the CC in all aspects of the eMERGE Network, including developing Network procedures and working groups, performing quality assessments of data, and assessing clinical uptake and outcomes. Continued patient involvement is a key aspect of this project. The applicants will work collaboratively with each other and the CC to establish a plan for patient engagement and retention across the eMERGE Network, including patients who are typically more challenging to keep engaged in biomedical research. Applicants will also work with the CC to track and obtain follow-up information from patients who are no longer receiving care at one of the funded CSs. The CSs will also work collaboratively with each other and the CC for timely and efficient transmission, in as automated a fashion as possible, of data needed for the CC to continue to monitor retention, data quality, and study outcomes across the entire 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)