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ELSI of epigenetic NIPT: Patient, provider, and community input on clinical implementation

Award Number: R01HD119556
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/11/2026
PERIOD OF PERFORMANCE END DATE: 04/30/2030

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ELSI of epigenetic NIPT: Patient, provider, and community input on clinical implementation - Modified Project Summary/Abstract Section Non-invasive prenatal testing (NIPT), which uses a maternal blood sample to screen for fetal chromosomal aneuploidies through cell free fetal DNA (cffDNA), has become a common test during pregnancy. NIPT has raised ethical concerns about the routinization of screening for aneuploidies and potential impact on social views of disability, and these concerns have been elevated by the offering of tests that expand the types of genetic conditions that are included. Recent efforts have shown promise for extended use of NIPT by identifying epigenomic signatures of cffDNA (eNIPT) predicting pregnancy complications, such as pre-eclampsia (PE). PE is associated with significant maternal morbidity and mortality, and PE rates are generally higher in the United States compared to many European countries. The use of eNIPT to predict pregnancy risks offers hope for early intervention to prevent complications for impacted pregnancies and improve pregnancy outcomes. Yet eNIPT would significantly alter the information available from this common test sample in pregnancy. eNIPT would further amplify concerns about routinization of the test and create challenges to informed consent and decision making. eNIPT could also allow incidental detection of stigmatized exposures in pregnancy, such as alcohol and tobacco use, which have well-validated epigenomic signatures. The potential to detect environmental exposures creates an additional risk of linking exposures to biological changes that can lead to stigmatization and generalizations. These risks may deter use of eNIPT by individuals who stand to benefit from early intervention for pregnancy risks based on eNIPT. Shaping practice and policies in a way to bolster the potential benefits of eNIPT while mitigating potential harms requires input from stakeholders, especially those who will be most impacted by the testing. This study will explore patient, community, and obstetric provider attitudes about eNIPT. Focus groups with people who are pregnant or have experienced being pregnant in the past five years and the community members who support them will assess interest in and acceptability of eNIPT, perceived benefits and risks, and desired actions to support informed decision making and lower risks of harms. Interviews with obstetrics providers in traditional and community healthcare settings will explore perceptions of eNIPT, ELSI factors supporting eNIPT utility, and needs for effective clinical implementation. These findings will feed into a Delphi process to identify recommended and prioritized points-to-consider for ethical and socially responsible clinical implementation of eNIPT guided by patient, provider, and community input.


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 = $465,146 )
2026	2026	CHILDRENS MERCY HOSPITAL	2401 GILLHAM RD	KANSAS CITY	MO	64108	JACKSON	USA	Child Health and Human Development Extramural Research	001	1	9/22/2026	NEW	$0
2026	2026	CHILDRENS MERCY HOSPITAL	2401 GILLHAM RD	KANSAS CITY	MO	64108	JACKSON	USA	Child Health and Human Development Extramural Research	000	1	9/16/2026	NEW	$465,146
														Subtotal = $465,146

Grand Total All Awards = $465,146

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ELSI of epigenetic NIPT: Patient, provider, and community input on clinical implementation

Award Number: R01HD119556

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/11/2026

PERIOD OF PERFORMANCE END DATE: 04/30/2030

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