Do-it-yourself vaccine for COVID-19-Scientific American

In response to the COVID-19 pandemic, members of the Rapid Deployment Vaccine Collaborative (or RaDVaC), a group of scientists and their friends or colleagues, Self-administered SARS-CoV-2 untested vaccine (Virus that causes COVID-19). RaDVaC scientists said their project was “Until at least one effective commercial vaccine is widely available to minimize the risk of harm from SARS-CoV-2.. Although the project white paper contains terms and conditions designed to protect authors from legal liability, RaDVaC’s self-experiment raises significant legal and ethical issues.

Self-experiment has a fascinating history. In the early 1900s, Walter Reed conducted an experiment in Cuba, deliberately exposing individuals to yellow fever, including members of the research team, as participants. These have had great public health benefits in ensuring that yellow fever is transmitted by mosquitoes, Death of multiple participants.. Some of the Nobel Prize-winning works by scientists are based on self-experiments that initially seemed crazy. For example, in 1984, Barry Marshall Swallowed bacteria To prove that they caused gastritis and peptic ulcer. Many heart surgery 1929 experiment According to a German doctor who inserted a catheter into his heart.

Perhaps surprisingly, self-experiment was once considered an ethical safeguard. Nuremberg CodeEstablished in response to significantly unethical experiments during the Second World War, allowing researchers to engage in higher-risk studies if they offered to participate, as well as early yellow fever research. .. However, the idea that self-experimentation can justify higher research risks has been abandoned Later Code of Ethics.. Not only is it legally and ethically complicated, but protection like independent reviews and informed consent is now available. Research regulation, May be a better way to protect study participants.

Existing regulations for research are not designed to address self-experimentation. The laws applicable to research generally define research as activities designed to produce generalizable knowledge. Not designed for improperly designed experimentsIt rarely produces useful data and is merely intended to protect a small number of people.

In addition, the US Common Rules apply to federally funded research and RaDVaC does not use federal funding. However, HarvardFederal guarantee“The institution agrees that all studies it conducts (regardless of funding source) comply with regulations. As reported, an immune response with self-experimentation in the George Church lab in Harvard This will definitely require approval by the Institutional Review Board to provide oversight of this self-experiment, if studies are planned for. Further, if not all, if results are published in a peer-reviewed journal But in most cases, journal Requires regulatory review and oversight.

US Food and Drug Administration has similar powers Regulate research, And perhaps more relevant to our purpose,Drug“(Including human biological materials and biologics)-even if they are not distributed for benefit. The RaDVaC project uses biological material, specifically a small chain of amino acids from the major SARS-CoV-2 protein, and therefore may be under FDA jurisdiction. Although the FDA has traditionally exercised this mandate to regulate similar biohacking practices for small do-it-yourselfers, Retain the power to do so in the future.. Finally, they can also sue RaDVaC if people are harmed by taking this vaccine, but the white paper’s disclaimer is carefully designed to avoid liability.

Even if the law does not adequately address this behavior, it can still be ethical, including the potential to waste scientific expertise and research efforts. When RaDVaC is intended to generate generalizable knowledge about this vaccine, unsystematic self-experiments rarely yield useful information. For example, self-experimentation can lead to biased results if researchers overestimate the likelihood that the vaccine will work, or if they fail to report side effects. Randomized controlled trials, by contrast, are usually designed for people who have had an intervention or who are blind to placebo.

Beyond self-experimentation, friends, staff, and families of the scientists involved take this vaccine based on the recommendations of these experts, and there are two potential misconceptions. First, those taking the vaccine may overestimate their protection from SARS-CoV-2 and change their behavior. Some individuals misunderstand that they are protected and may take dangerous actions that could harm themselves or others.

The second misconception is that this is a study that can benefit others. The same data analyst seemed to believe this when he added, “My survival with this outbreak will be a useful dataset.” Yet, the RaDVaC project failed to generate as useful data as a standard well-designed vaccine trial. For example, it is unclear if the vaccinated individual is fully evaluated or monitored, and there seems to be no control group. ..

However, even though everyone involved in this project has a complete understanding of what they are doing, there are questions about expertise and privileges. Senior scientists benefit from many privileged groups, including investment in education, expertise in their field of expertise, and access to information and resources. Without a doubt, these privileges responsibility Use expertise for the benefit of society. If the RaDVaC vaccine is potentially beneficial, not testing it in a rigorously designed study is tragic.

Indeed, uncontrolled self-experimentation is part of a larger problem in the COVID-19 pandemic. The virus panic has led to widespread use of interventions other than well-designed clinical trials. Without such trials, We remain dim about which interventions bring a net benefit or harm. As long as the scientists involved have vaccine research expertise, they need to reform the RaDVaC project or lend it to serious projects.

On the other hand, their overconfidence in their ability to work outside the wheelhouse can be detrimental if scientists do not have the relevant expertise. Earlier this week, computational biologist Stephen Salzburg called for the introduction of the COVID-19 vaccine before the results of the Phase III trial were available. Ah Editorial condemning his misunderstood views Will be released the next day, Salzberg immediately reversed position.. Similarly, some of the nominated members of the RaDVaC project have expertise in genetics, neuroscience and anti-aging research. Their time may be better spent on projects in these areas, but it is still important When this pandemic is finally over..

Instead of trying everything other than a kitchen sink against COVID-19, our collective efforts Prioritize the most promising interventions And test them Rigorous research, As was done for some COVID-19 treatment.. RaDVaC scientists should be encouraged to cooperate with systematic COVID-19 vaccine testing with relevant expertise and otherwise do other valuable things over time.