# Admin. Supplement to: Ensuring Patients' Informed Access to Noninvasive Prenatal Testing

> **NIH NIH R01** · CLEVELAND CLINIC LERNER COM-CWRU · 2020 · $223,677

## Abstract

PROJECT ABSTRACT
Prenatal genetic screening tests and diagnostic tests (referred to as prenatal genetic tests) are a fundamental
component of the delivery of high-quality, evidence-based prenatal care. Current guidelines recommend that
prenatal genetic tests should be offered to all pregnant patients to optimize obstetric outcomes, ideally offered
early in pregnancy so that patients can make formative decisions about their prenatal care. Delay in access
and utilization of prenatal genetic tests can have significant implications for pregnancy outcomes. The COVID-
19 pandemic is an urgent clinical problem that has emerged with the potential to jeopardize women's access to
genetic tests. Currently, it is not known how COVID-19 may impact pregnant women's access to and utilization
of these critical tests. This includes concern not just for those pregnant women who become severely ill with
COVID-19 but also those who fear exposure to SARS-CoV-2 by presenting to a healthcare facility have genetic
testing by means of a blood draw or ultrasound-based procedure. The goal of this study is to study the effect
of COVID-19 on prenatal healthcare delivery, specifically patients' ability to access prenatal genetic screen-
ing and diagnostic tests in an informed and evidence-based fashion. By doing so, we will identify serious
short term health issues for women, children, and families resulting from this pandemic and readily-
deployable and scalable solutions to ensure women's informed access to high-quality prenatal care during
future public health crises. This study is significant as its findings will lead to system-level improvements to
support pregnant patients' informed access to prenatal genetic tests for the duration of the pandemic and fu-
ture public health emergencies of similar magnitude. Additionally, this study will increase the impact of the
NEST R01, providing an in-depth understanding of how COVID-19 affects shared decision-making, informed
consent, and patient satisfaction regarding prenatal genetic testing decisions. In doing so, this proposal dove-
tails with the objectives of the parent R01 to ensure that patients have informed access to advances in prenatal
genetic technologies as crucial metrics of prenatal healthcare safety, access, and quality.

## Key facts

- **NIH application ID:** 10165356
- **Project number:** 3R01HG010092-04S1
- **Recipient organization:** CLEVELAND CLINIC LERNER COM-CWRU
- **Principal Investigator:** Ruth Farrell
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $223,677
- **Award type:** 3
- **Project period:** 2017-09-15 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10165356

## Citation

> US National Institutes of Health, RePORTER application 10165356, Admin. Supplement to: Ensuring Patients' Informed Access to Noninvasive Prenatal Testing (3R01HG010092-04S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10165356. Licensed CC0.

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