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Questioning the Need for Informed Consent: A Case Study of California's Experience with a Pilot Newborn Screening
Lisa Feuchtbaum1, George Cunningham, Stan Sciortino
1California Department of Health Services, Genetic Disease Branch, Richmond, CA (USA).
Insights
Waiving parental consent for newborn screening pilot studies ensures all infants receive vital early detection. This approach prioritizes public health and infant well-being over limited parental autonomy in research settings.
Area of Science:
- Medical Genetics
- Public Health Policy
- Neonatal Screening
Background:
- California mandates newborn screening for severe, irreversible genetic disorders.
- Early detection and treatment are critical for preventing lifelong disabilities.
- A pilot study aimed to test new screening technologies on existing blood specimens.
Purpose of the Study:
- To evaluate the impact of informed consent on participation in a newborn screening technology pilot study.
- To examine the ethical and practical implications of parental consent in newborn screening research.
- To determine if waiving informed consent would improve access to new screening technologies.
Main Methods:
- Analysis of data from a pilot study on new newborn screening technologies in California.
- Comparison of participation rates between mandatory screening and a study requiring informed consent.
- Examination of missed cases and testing denials due to consent procedures.
Main Results:
- Informed consent was obtained for only 47% of births during the study.
- Hospitals' inability to consistently obtain consent led to missed screening opportunities.
- Waiving informed consent would have allowed all newborns to be tested.
Conclusions:
- The needs of society and newborns outweigh the autonomy interests of a few parents in research contexts.
- Waiving parental consent for evaluating new screening technologies is recommended for future studies.
- This approach ensures broader public health benefits and equitable access to potentially life-saving diagnostics.
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.
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