# Unresolved Issues in Newborn Screening: Quantifying the Harms of a False Positive Result

> **NIH NIH R01** · CHILDREN'S RESEARCH INSTITUTE · 2022 · $696,596

## Abstract

PROJECT SUMMARY
While newborn screening (NBS) programs have saved the lives of thousands of children with inherited
disorders, the future success of this vital public health program depends on the ability to accurately assess and
balance the benefits and harms of screening. The ongoing development of new testing technologies increases
the number of disorders screened, which generates more false positive NBS results. Despite decades of
research, the scope and magnitude of harms from false positive NBS results remain poorly understood. Failure
to resolve this poor understanding has significant policy, ethical, and research implications. From a policy
perspective, it undermines the requisite evaluation of benefits and harms that accompanies decisions about
whether to add a disorder to a state NBS panel. From an ethical perspective, it places children and their
families at risk for adverse outcomes from a mandatory public health program. From a research perspective, it
interferes with the design of effective interventions to mitigate these harms. Therefore, the objective of this
study is to comprehensively examine the scope, magnitude, and risk factors for harms to both children who
receive false positive NBS results and their families. This study objective will be accomplished through a
prospective multistate cohort study of children undergoing NBS and their parents with the following specific
aims: (1) To determine the scope and magnitude of harms due to false positive NBS results; (2) To identify
parental and child factors associated with harms due to false positive NBS results; and (3) To develop a
primary care provider (PCP)–parent communication aid to improve PCP communication with parents of
children who receive false positive NBS results. The proposed project will provide the most comprehensive
data to-date on post-screening harms for children with false positive NBS results. These data are critical to the
success of future efforts to improve and expand NBS in the US.

## Key facts

- **NIH application ID:** 10440414
- **Project number:** 5R01HD095068-05
- **Recipient organization:** CHILDREN'S RESEARCH INSTITUTE
- **Principal Investigator:** Beth A Tarini
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $696,596
- **Award type:** 5
- **Project period:** 2018-09-15 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10440414

## Citation

> US National Institutes of Health, RePORTER application 10440414, Unresolved Issues in Newborn Screening: Quantifying the Harms of a False Positive Result (5R01HD095068-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10440414. Licensed CC0.

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