Funding for this research was provided by:
National Institute of Environmental Health Sciences (R01 ES016669)
IMHRO/Staglin Family Professorship
Text and Data Mining valid from 2018-08-22
Received: 2 April 2018
Accepted: 3 August 2018
First Online: 22 August 2018
Ethics approval and consent to participate
: All study procedures were approved by the institutional review boards of the California Health and Human Services Agency and Kaiser Permanente Northern California. Study activities were also approved by the CA State Committee for the Protection of Human Subjects. It was determined at the CDC that the agency was not engaged in human subject research. It was also determined at UCSF Committee on Human Research that the institution was not engaged in human subject research. Samples used in this study were coded, no one at the CDC or UCSF has access to identifiable information, and there are IRB-approved policies prohibiting the release of the key. The study conforms to the Declaration of Helsinki.Consent forms for the California’s prenatal expanded alpha-fetoprotein (XAFP) screening program were obtained at the time of the maternal sampling and included privacy notifications, which stipulated that specimens and data from prenatal testing could be used for legitimate research purposes given appropriate institutional review board (IRB) approval. Newborn bloodspot specimens were obtained from the archives of the Genetic Disease Screening Program (GDSP), which distributes a ‘Notice of Information Practices’ describing how personal and medical information from newborn screening may be used without additional consent for legitimate research purposes, given appropriate institutional review board (IRB) and GDSP approval.
: Not applicable.
: The authors declare that they have no competing interests.
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