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- W4312384839 abstract "Much of the analysis of the public health legal and regulatory mechanisms that potentially apply to biomedical citizen science activities in the United States has focused on the federal government, including US Food & Drug Administration (FDA) and human subjects research requirements. But US state governments have authorities that intersect with, and sometimes extend beyond, federal regulators’ powers—such as through state medical practice statutes—and these state authorities might reach certain biomedical citizen science activities. For example, in 2019, California both enacted a “CRISPR law” requiring sellers of gene therapy kits to inform consumers that such kits “are not for self-administration,” and through its Department of Consumer Affairs, launched an investigation of a well-known biohacker for “unlicensed practice of medicine” under existing law. Building on legal analyses of state efforts to regulate establishment science, this essay explores ways that state governments might regulate biomedical citizen science activities and associated bodily autonomy—something that states may become increasingly interested in as biomedical citizen science efforts proliferate and intersect with state efforts to regulate bodily autonomy (for example, in the context of abortion). It also explores implications for those engaged in biomedical citizen science, including the fact that even when state regulatory efforts are not enforced or are successfully challenged, they are important because they can still influence federal policy." @default.
- W4312384839 created "2023-01-04" @default.
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- W4312384839 date "2022-01-01" @default.
- W4312384839 modified "2023-10-14" @default.
- W4312384839 title "State Regulation of Biomedical Citizen Science" @default.
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- W4312384839 doi "https://doi.org/10.5334/cstp.526" @default.
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