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September 23, 2020 / Bio Valley BIOON / — Based on an article entitled “Self-experimentation, ethics and regulation of vaccines” published online on September 17, 2020 in the journal Science, developed a The “citizen scientists” well COVID-19 vaccine stakeholders may think they are getting vaccinated to fight the ongoing pandemic, but this do-it-yourself approach to medical innovation is fraught with significant legal, ethical, and public health issues. One of the authors of this article is Professor Jacob S. Sherkow, a legal expert at the University of Illinois at Urbana-Champaign, who studies the impact of advanced biotechnology policies.
The image is from the electron micrograph of SARS-CoV-2, and the image is from NIAID / NIH.
As the novel coronavirus pandemic continues to ravage the world, various citizen science groups outside of the pharmaceutical industry have been working to develop and self-evaluate unproven medical interventions to combat COVID-19. Sherkow said that while people’s interest in DIY (do-it-yourself) methods stems from the idea that the U.S. Food and Drug Administration (FDA) and other public health agencies cannot regulate self-experiments, This idea is legal and de facto. It is incorrect.
“Citizen science” broadly describes activities that have the scientific purpose of inviting public participation. Sherkow said that while citizen science is very important and has a strong tradition in the United States, “homemade COVID-19 vaccines can be more dangerous than people would like to believe.”
He said: “We all sympathize with the idea that people want to fight this virus through self-vaccinations. But people need to understand that all home remedies are not necessarily helpful and some are likely to be fatal.”
People’s interest in doing it yourself stems from the false belief that self-experimentation will not be subject to cumbersome ethics committee review or federal oversight. But Sherkow said this misunderstanding has potentially serious effects on public health.
He said: “People must realize that just because they conduct experiments on themselves does not mean they are legal without approval. According to laws or institutional policies, some self-experiments can be identified as human experiments that require ethical review.” The fact that it is a self-experiment does not give him discretion. “
Similarly, the posting of medical information on the Internet is generally not regulated by the FDA. Sherkow said the FDA is likely to regulate the use of typical equipment, chemicals and reagents to develop a potential therapeutic product.
He said: “Using the information you find in a dark corner of the internet, develop your own materials and need to transport materials or reagents across states, this is an interstate trade and will trigger FDA regulation. At this point the FDA you can stop it. “
Household interventions are in stark contrast to traditional vaccine development methods, which require randomized controlled trials with clear endpoints such as confirmed immune responses and protocols for data retention and use. Sherkow said that the development and self-administration of medical interventions not approved and verified by biohackers (Biohacker, editor’s note: Refers to people experimenting with their own bodies) not only threatens public health, but also undermines public health. The confidence of all vaccines.
He said: “We live in an age of vaccine misinformation. This is one of the reasons we are conducting phased clinical trials for vaccine and drug development. It is not just about finding out if something is effective or not. “. Question: It is also necessary to find out the general toxicity of this treatment and whether its method of production is harmless to the human body.
Characterizing or positioning research as a self-experiment does not eliminate the risk of infringing the interests of viewers or groups. Sherkow said that citizen scientists, especially professional scientists who are part-time, self-made vaccine manufacturers, “should take them seriously when promoting DIY interventions or treatments, especially those with potentially serious public health and social impacts. High moral responsibility. “
He said: “Although many citizen scientists seem to take seriously the ethical responsibilities associated with their activities, it is important to recognize that these responsibilities will expand when public health is threatened, such as the development of a COVID-19 vaccine. However, just because there is a list of instructions created by many respected and well-trained scientists on the Internet, it does not mean that certain things cannot go wrong. (Bioon.com)
Reference materials:
1. Christi J. Guerrini et al. Self-experimentation, ethics and regulation of vaccines. Science, 2020, doi: 10.1126 / science.abe1963.
DIY COVID-19 vaccines are plagued with public health problems
https://medicalxpress.com/news/2020-09-do-it-yourself-covid-vaccines-fraught-health.html
