Self-experimentation, ethics, and regulation of vaccines

Guerrini, Christi J.; Sherkow, Jacob S.; Meyer, Michelle N.; Zettler, Patricia J.

doi:10.1126/science.abe1963

Cited by 13 publications

(12 citation statements)

References 5 publications

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“…(1) top-down activities that are designed and controlled by institution-based scientists with minimal to no input from citizen scientists; (2) collaborative activities that are designed and controlled by institution-based scientists with robust input from citizen scientists, who also help to execute the research; and (3) bottom-up activities that are designed, controlled, and executed by citizen scientists with minimal to no input from institution-based scientists (Aungst, Fishman, and McGowan 2017;Fiske et al 2019). Some examples of bottom-up biomedical citizen science projects include an online platform for individuals to publicly share their genotyping results and phenotypic information for personal exploration and research use; a community laboratory project to sequence the genome of a cuttlefish; a three-person effort to reverse engineer a gene-therapy drug; a collaboration involving multiple community laboratories to develop a process for generic manufacture of insulin; and a citizen science collaborative involving individuals self-manufacturing and self-injecting putative vaccines (bioCURIOUS n.d.; Greshake et al 2014;Gallegos et al 2018;Guerrini et al 2020a;Talbot 2020).…”

Section: Introductionmentioning

confidence: 99%

“A Cohort of Pirate Ships”: Biomedical Citizen Scientists’ Attitudes Toward Ethical Oversight

Trejo

Canfield

Brooks

et al. 2021

CSTP

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As biomedical citizen science initiatives become more prevalent, the unique ethical issues that they raise are attracting policy attention. One issue identified as a significant concern is the ethical oversight of bottom-up biomedical citizen science projects that are designed and executed primarily or solely by members of the public. That is because the federal rules that require ethical oversight of research by institutional review boards generally do not apply to such projects, creating what has been called an ethics gap.Working to close this gap, practitioners and scholars have considered new mechanisms of ethical oversight for biomedical citizen science. To date, however, participants' attitudes about ethics and oversight preferences have not been systematically examined. This information is useful to efforts to develop ethical oversight mechanisms because it provides a basis for evaluating the likely effectiveness of specific features of such mechanisms and their acceptability from the perspective of biomedical citizen scientists.Here, we report data from qualitative interviews with 35 stakeholders in bottom-up biomedical citizen science about their general ethics attitudes and preferences regarding ethical oversight. Interviewees described ten ethical priorities and endorsed oversight mechanisms that are voluntary, community-driven, and offer guidance. Conversely, interviewees rejected mechanisms that are mandatory, hierarchical, and inflexible. Applying these findings, we conclude that expert consultation and community review models appear to align well with ethical priorities and oversight preferences of many biomedical citizen scientists, although local conditions should guide the development and use of mechanisms in specific communities.

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Section: Introductionmentioning

confidence: 99%

“A Cohort of Pirate Ships”: Biomedical Citizen Scientists’ Attitudes Toward Ethical Oversight

Trejo

Canfield

Brooks

et al. 2021

CSTP

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“…There may also be a reduction of patient populations available to participate in other potentially more promising types of COVID-19 trials. Overexuberance may lead to patients opting to take risks on unpromising cellular therapies for COVID-19 in the direct-to-consumer clinic market space or via self-experimentation, which also has been a concern in the ‘do-it-yourself’ COVID-19 vaccine area [ 16 ]. It is crucial for the cellular medicine and stem cell research fields to do everything possible to avoid even the appearance of weak science or pseudoscience, both related to COVID-19 and more generally, which is a real risk [ 17 ].…”

Section: Discussionmentioning

confidence: 99%

Anticipated Impact of Stem Cell and Other Cellular Medicine Clinical Trials for COVID-19

Kim

Knoepfler

2021

Regen. Med.

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Aim: There is a critical need for safe and effective treatments for COVID-19. One possible type of treatment is cellular medicine such as stem cell therapy, but its potential is unclear. Here, our aim was to assess the potential impact of the many cellular medicine trials for COVID-19. Materials & methods: We collected and analyzed data for defined criteria from trial registries. Results: Our data suggest that relatively few of these COVID-19 trials will produce high-level evidence, but that on average they may be somewhat more rigorous than typical cell therapy trials unrelated to COVID-19. Conclusion: Most COVID-19 cellular medicine trials have relatively low potential for rapid, concrete impact. We discuss the findings in the context of the cellular medicine field overall.

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“…Interest in biomedical citizen science-also known as biohacking, open science, do-it-yourself (DIY) science, community biology, independent science, non-traditional biology, and non-establishment science (Guerrini et al 2019)-is growing. This growth may have accelerated in response to the COVID-19 pandemic (Caplan and Bateman-House 2020;Evans 2020;Guerrini et al 2020;Shah and Jamrozik 2020). For instance, Just One Giant Lab (JOGL), a nonprofit web platform that provides a virtual "laboratory," launched its OpenCOVID-19 initiative in March 2020 that includes projects ranging from efforts to validate mask effectiveness to building ventilators to developing testing (Rasmussen et al 2020).…”

Section: Introductionmentioning

confidence: 99%

State Regulation of Biomedical Citizen Science

Zettler

2022

Citizen Science: Theory and Practice

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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.

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Self-experimentation, ethics, and regulation of vaccines

Abstract: DIY COVID-19 vaccines raise legal and ethical questions.

Cited by 13 publications

References 5 publications

“A Cohort of Pirate Ships”: Biomedical Citizen Scientists’ Attitudes Toward Ethical Oversight

“A Cohort of Pirate Ships”: Biomedical Citizen Scientists’ Attitudes Toward Ethical Oversight

Anticipated Impact of Stem Cell and Other Cellular Medicine Clinical Trials for COVID-19

State Regulation of Biomedical Citizen Science

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