State Regulation of Biomedical Citizen Science

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.

Biohacking COVID-19: Sharing Is Not Always Caring

“…However, the impure, or egoistic, element of principlism as an avowed motivation has been found in some messages regarding human challenge trials, a type of medical research in which volunteers share their bodies to be infected (or hacked) to accelerate the development of therapeutics (Zettler 2022). Alastair's post illustrates this element:I got infected with COVID-19 as part of a trial and am donating the €5000 I received for participating.…”

“…Biohackers have an ethos rooted in rebellious hacker culture (Delfanti 2013); they question the proprietary structure of scientific information and urge ultimate freedom when it comes to sharing knowledge and material resources. This stance can be seen in the many cases of biohackers’ resistance to private (e.g., YouTube) and governmental (e.g., Food and Drug Administration) regulatory efforts (Zettler 2022). For biohackers, there is a commitment to promote open science as it goes against freedom of thought to prohibit individuals from engaging in scientific practices.…”