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Polygenic and Integrated Genomic Risk Assessment for Healthier U.S. Families

Award Number: U01HG011172
ORGANIZATION: NATIONAL HUMAN GENOME RESEARCH INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2020
PERIOD OF PERFORMANCE END DATE: 04/30/2027

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Polygenic and Integrated Genomic Risk Assessment for Healthier U.S. Families - Abstract eMERGE is a national network organized and funded by the National Human Genome Research Institute (NHGRI) that combines DNA biorepositories with electronic health record (EHR) systems for large scale, high-throughput genetic research in support of implementing genomic medicine. In 2020, eMERGE IV embarked on a study of genomic risk assessment and management in 5,000 children and 20,000 adults of diverse ancestry, beginning with efforts to identify and validate published PRSs in ten common diseases with complex genetic etiologies. The study recruited and returned results to nearly 25,000 individuals (aged 3–75 years) from general healthcare system populations. Enrollment was not targeted to individuals with specific conditions, although individuals with prevalent conditions were included. For this prospective, cohort study, the primary outcome being measured is the number of new healthcare actions after return of the genome- informed risk assessment. Cincinnati Children’s has been an active and engaged site in eMERGE IV. We enrolled participants, completed GIRA returns to participants and their EHRs, surveyed providers, implemented 6-month participant post return of results surveys, and reconsented pediatric participants who turned 18 and. In partnership with another site, we conducted a qualitative study to understand parents’ responses to their children’s PRS-based genomic risk results. Our site has provided Network leadership, and we have been deeply engaged with the other sites and network leadership throughout the study. In this proposal we request a one year extension of funding. During this time, we will perform 6- and 12-month EHR data pulls. We will engage in participant retention strategies as permitted by sIRB protocol. We will complete 6-month participant post-return of result surveys. As needed, we will contribute CCHMC/UC data to existing R4 instruments (and likely new R4 instruments) to assure needed CDP data is available for Network manuscripts. Moreover, we will lead and publish network wide manuscripts as described in the approach. Altogether, we intend to work with the NHGRI leadership and other sites to continue to discover and publish the learnings from the eMERGE IV prospective, pragmatic study following the plans for an extension year that we collaboratively designed as a network.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $438,114 )
2026	2026	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Human Genome Research	003	5	5/20/2026	SUPPLEMENT FOR EXPANSION	$438,114
2026	2025	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Human Genome Research	004	5	5/29/2026	SUPPLEMENT FOR EXPANSION	$0
2026	2025	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Human Genome Research	001	5	1/28/2026	SUPPLEMENT FOR EXPANSION	$0
2026	2024	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Human Genome Research	002	5	5/15/2026	NON-COMPETING CONTINUATION	$0
2026	2024	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Human Genome Research	000	5	1/28/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $438,114

Issue Date FY: 2025 ( Subtotal = $843,187 )
2025	2025	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Human Genome Research	001	5	7/15/2025	SUPPLEMENT FOR EXPANSION	$843,187
2025	2024	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Human Genome Research	000	5	7/14/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $843,187

Issue Date FY: 2024 ( Subtotal = $821,352 )
2024	2024	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Human Genome Research	002	5	6/18/2024	NON-COMPETING CONTINUATION	$67,050
2024	2024	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Human Genome Research	001	5	4/25/2024	NON-COMPETING CONTINUATION	$754,302
2024	2023	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Human Genome Research	000	4	2/23/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $821,352

Issue Date FY: 2023 ( Subtotal = $475,567 )
2023	2023	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Human Genome Research	000	4	9/14/2023	NON-COMPETING CONTINUATION	$475,567
														Subtotal = $475,567

Issue Date FY: 2022 ( Subtotal = $1,645,879 )
2022	2022	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Human Genome Research	001	3	8/17/2022	NON-COMPETING CONTINUATION	$1,645,879
2022	2021	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Human Genome Research	000	2	1/11/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,645,879

Issue Date FY: 2021 ( Subtotal = $1,669,753 )
2021	2021	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Human Genome Research	002	2	8/19/2021	NON-COMPETING CONTINUATION	$1,669,753
2021	2020	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Human Genome Research	000	1	3/12/2021	NEW	$0
2021	2020	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Human Genome Research	001	1	3/26/2021	NEW	$0
														Subtotal = $1,669,753

Issue Date FY: 2020 ( Subtotal = $1,338,768 )
2020	2020	CHILDREN'S HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Human Genome Research	000	1	7/1/2020	NEW	$1,338,768
														Subtotal = $1,338,768

Grand Total All Awards = $7,232,620

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Polygenic and Integrated Genomic Risk Assessment for Healthier U.S. Families

Award Number: U01HG011172

ORGANIZATION: NATIONAL HUMAN GENOME RESEARCH INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/01/2020

PERIOD OF PERFORMANCE END DATE: 04/30/2027

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