Questioning the Need for Informed Consent: A Case Study of California's Experience with a Pilot Newborn Screening Research Project

Abstract

California provides mandatory newborn screening for disorders that cause irreversible, severe disabilities if not identified and treated early in life. Parental consent is not required. In 2001, the Genetic Disease Branch was mandated to pilot test a new technology that could identify many additional disorders using the same blood specimen already collected. Study participation required informed consent, which was obtained for 47% of births during the study timeframe. The inability of hospitals to carry out the consent procedure for all newborns resulted in denial of testing and missed cases. If informed consent were waived, all newborns could have been tested. Several empirical questions are posed and each is examined from the perspective of society, the parents and the newborn. It is concluded that the legitimate needs of society and the interests of newborns should not be sacrificed to respond to the autonomy interests of the few parents who did not wish their infant to participate in the study, and that in the future, parental consent should be waived for projects evaluating new screening technologies.

Keywords

newborn screening informed consent ethics population research evaluation autonomy pilot study

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