# Supporting Just-in-Time Consent for Prenatal Screening in Diverse Populations > **NIH NIH R01** · MAYO CLINIC JACKSONVILLE · 2024 · $812,285 ## Abstract PROJECT SUMMARY/ABSTRACT Prenatal screening for genetic conditions (PGS) has changed the landscape of prenatal care by offering noninvasive indication of some fetal genetic conditions. PGS should be clearly distinguished from prenatal diagnostic testing using microarray analysis of amniotic fluid, which is considered the gold standard for fetal genetic assessment. While other routine screens are not held to the standard of fully informed consent, the ethics literature on PGS, from maternal serum screening to cell-free DNA and other technologies, has argued that PGS requires higher levels of consent based on the exceptional nature of its informational impacts, including potential abortion decisions based on fetal characteristics. Multiple studies examining the patient experience have described or proactively expressed concern at the routinization of PGS, including insufficient pre-test counseling and ethical reflection on whether PGS was the right approach for the patient and family, consistent with their values on disability and abortion. However, our own research on the implementation of PGS in low-resource settings in the U.S. has found that there are few resources to attempt, let alone achieve, fully informed consent prior to screening. Furthermore, for the great majority of pregnancies that do not receive a high-probability PGS screen, attempting fully informed consent introduces mental and psychological stress on pregnant individuals that may be unnecessary and undesirable. Patients who receive screen-positive results do require extensive information and support for pregnancy and parenting decision-making, but they represent a tiny minority of all those screened. Thus, we argue that a model of just-in-time consent (JITC) for PGS, incorporating simple consent with shared decision-making, better fulfills the goals of prenatal screening and locates intense moral decision-making in a more appropriate place in the pregnancy journey. JITC acknowledges the increased moral weight that prenatal screening may have over other routine screens without burdening pregnant individuals and health systems with unnecessary consent procedures. We propose a clinical trial over three demographically and geographically diverse sites that serve a large pregnant population from historically underserved communities to compare a novel JITC mechanism to current care. Our Aims are: (1a) Conduct community engaged research with patients and providers to understand the necessary components of JITC for PGS; (1b) Design and pilot a mobile-based intervention to deliver knowledge elements necessary for JITC for cfDNA; (2) Using a stepped-wedge design, implement the mobile-based intervention at three diverse sites and evaluate outcomes of feasibility and decisional satisfaction; and (3) Develop data-based, ethically informed recommendations regarding implementation of a just-in-time consent model for patients receiving high risk PGS screening test results. ## Key facts - **NIH application ID:** 10941749 - **Project number:** 1R01HG013718-01 - **Recipient organization:** MAYO CLINIC JACKSONVILLE - **Principal Investigator:** Megan A. Allyse - **Activity code:** R01 (R01, R21, SBIR, etc.) - **Funding institute:** NIH - **Fiscal year:** 2024 - **Award amount:** $812,285 - **Award type:** 1 - **Project period:** 2024-09-18 → 2025-06-30 ## Primary source NIH RePORTER: https://reporter.nih.gov/project-details/10941749 ## Citation > US National Institutes of Health, RePORTER application 10941749, Supporting Just-in-Time Consent for Prenatal Screening in Diverse Populations (1R01HG013718-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10941749. Licensed CC0. --- *[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*