As the coronavirus disease 2019 (COVID-19) pandemic continues to sweep the globe, several groups have been working to develop and self-administer unapproved, unproven interventions that they describe as vaccines for COVID-19 (1–4). Some of the interest in these do-it-yourself (DIY) approaches apparently stems from a belief that self-experimentation is never subject to time-consuming ethics board review or regulation, such as by the U.S. Food and Drug Administration (FDA). This belief is legally and factually incorrect, and the misunderstanding has potentially important public health implications. Any failure by the FDA to regulate DIY vaccines would permit vaccines of dubious safety and effectiveness to endanger public health and would signal a lowering of standards that—in an age blighted by vaccine skepticism and during a highly politicized pandemic—could undermine public trust in all vaccines, however developed (5). Further, some self-experimentation can qualify as human subjects research that is required to undergo ethics review, by law or institutional policy. Even when ethics review is not required, citizen scientists must take seriously their heightened ethical responsibilities when promoting DIY interventions, especially those with potentially serious public health and societal effects, such as COVID-19 vaccines. Given the proliferation of citizen science efforts to fight COVID-19 and the general c onfusion (even among sophisticated scientists) that surrounds the regulation of DIY research, regulatory leadership is badly needed.
“The FDA Can't Stop You”
In July 2020, six months after the first case of COVID-19 was confirmed in the United States, scientists associated with the Rapid Deployment Vaccine Collaborative (RaDVaC) reported administering to themselves a product of their own making that was intended to be a vaccine against the disease. As described in the group's white paper, the putative intranasal vaccine consists of synthetic peptides that mimic those of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, and is designed to elicit only a local immune response (6).
By its own account, RaDVaC is engaged in “citizen science,” which broadly describes activities having a scientific aim that invite public participation. RaDVaC's chosen research path—which involves a homemade intervention, an evolving protocol, and unclear plans for collecting and analyzing outcomes data—is in contrast to traditional paths to vaccine development, which require randomized controlled trials (RCTs) with well-defined endpoints, such as demonstrated immune responses, and protocols concerning the retention and use of data.
Although some citizen scientists have antiregulatory leanings, RaDVaC has explained that it is not anti-FDA. Rather, its stated mission is a humanitarian one, animated by a belief that open, crowdsourced vaccine efforts will hasten the widespread availability of a potentially life-saving vaccine through development activities that it believes are not subject to FDA regulation (6). To that end, RaDVaC published on the internet instructions on how to self-manufacture and self-administer its DIY vaccine. RaDVaC also has provided materials for those activities, reporting as of several weeks ago the delivery of vaccine materials to 70 individuals (1). RaDVaC has made clear to potential users that its vaccine has not been reviewed or approved by the FDA. It also believes, as one of its leading scientists stated, “If you are just making it and taking it yourself, the FDA can't stop you” (1)…
Although many citizen scientists appear to take seriously the ethical responsibilities associated with their activities, it is important to recognize that those responsibilities expand when public health is at stake, such as with COVID-19 vaccine development. Characterizing or positioning research as self-experimentation does not eliminate risks to bystanders or the collective good. Given those potential risks, citizen scientists who are involved in open vaccine development and testing efforts outside of traditional scientific institutions should seek review by an independent IRB. The cost is not necessarily prohibitive for all projects and should be prioritized the same as critical safety equipment. Ethical and efficient development of a vaccine shown to be safe and effective against COVID-19, and broad dissemination of such a vaccine, are goals we all share and should be able to work together to achieve.
WASHINGTON — As a teenager, Keoni Gandall already was operating a cutting-edge research laboratory in his bedroom in Huntington Beach, Calif. While his friends were buying video games, he acquired more than a dozen pieces of equipment — a transilluminator, a centrifuge, two thermocyclers — in pursuit of a hobby that once was the province of white-coated Ph.D.’s in institutional labs.
“I just wanted to clone DNA using my automated lab robot and feasibly make full genomes at home,” he said.
Mr. Gandall was far from alone. In the past few years, so-called biohackers across the country have taken gene editing into their own hands. As the equipment becomes cheaper and the expertise in gene-editing techniques, mostly Crispr-Cas9, more widely shared, citizen-scientists are attempting to re-engineer DNA in surprising ways.
Until now, the work has amounted to little more than D.I.Y. misfires. A year ago, a biohacker famously injected himself at a conference with modified DNA that he hoped would make him more muscular. (It did not.)
Earlier this year, at Body Hacking Con in Austin, Tex., a biotech executive injected himself with what he hoped would be a herpes treatment. (Verdict: No.) His company already had live-streamed a man injecting himself with a home-brewed treatment for H.I.V. (His viral load increased.)…
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