BACKGROUND: Each year in California, hundreds of thousands of newborn screenings are performed to detect genetic conditions. The blood specimen and information obtained during the testing process become the property of the state. California indefinitely stores the residual blood samples and makes them available to third party researchers without the consent of parents. Approximately 350,000 pregnant women are also screened each year for risk of certain birth defects and some women opt to allow the residual blood specimen to be stored and used for research.
PROBLEM: The genetic material of mothers and children is being stored in the California Biobank and used for research for public health purposes, but there is no transparency into what research is being conducted, what entities are utilizing the residual blood samples, or what specific public health benefits have been achieved.
SOLUTION: SB 1099 Newborn screening: genetic diseases: blood samples collected. This bill would ensure that the public has access to information about the activities of the California Biobank by requiring CDPH to annually prepare a report, deliver a copy of the report to the Legislature, and post the report on their website. The report would be required to contain information such as:
- The total number of any residual screening specimens stored at the California Biobank.
- The number of inheritable conditions identified by the original screening tests the previous calendar year.
- The number of projects utilizing specimens from the California Biobank and the number of specimens each project is using.
- The number of published research studies that used or referenced biospecimens from the Biobank and the potentially substantial public health benefit from the research.
CURRENT STATUS: Signed into law on September 25, 2024.
