The Era of Informed Consent is Over

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In a significant blow to patient autonomy, the death knell of informed consent has silently been rung just 77 years after being codified in the Nuremberg Code.

On the 21st of December 2023, as we were frantically preparing for the festive season, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) quietly issued a final ruling to amend a provision of the 21st Century Cures Act. This allowed,

…an exception from the requirement to obtain informed consent when a clinical investigation poses no more than a minimal risk to the human subject…

This ruling came into effect on January 22nd, 2024, which means it’s already standard practice across America. And as Australia and many smaller American vassal states are passive policy-takers rather than autonomous policymakers, it is only a matter of time before this chilling precedent arrives on our shores.

So, what is the 21st Century Cures Act? It is a Law enacted by the 114th United States Congress in January 2016. The Act was designed to…

…accelerate the discovery, development, and delivery of 21st-century cures, and for other purposes [?]…[1]

This Act was passed under the guise of a strong state response to The Opioid Crisis sweeping across America at the time; however, most of the $6.3 billion in funding was allocated directly to the National Institutes of Health (NIH). Some of the provisions within this Act make for uncomfortable reading. For example, the Act supported,

High-risk, high-reward research [Sec. 2036].
Novel clinical trial designs [Sec. 3021]
Encouraging vaccine innovation [Sec. 3093].

So, under the guise of responding to the Opioid Crisis, which would claim over 100,000 American lives in 2021, five years after this Act was passed, the NIH was granted legal protection to pursue high-risk, novel vaccine research. A strong case could be made that this Act captures all the necessary architecture required for much of the evil that transpired over the past four years. One hitch in their plan was the legal provision that citizens technically had a legal right to refuse medical investigations; that obstacle has now been removed. 

Indeed, overturning patient informed consent was a stated goal of the original Act, buried under Section 3024 was the provision to develop an,

Informed consent waiver or alteration for clinical investigation.

Scholars of medical history understand that the concept of informed consent, something we all take for granted today, is a relatively new phenomenon codified in its modern understanding as one of the critical principles of the Nuremberg Code in 1947. While much of the Nuremberg trials focused on involuntary human participation in scientific experiments, they also addressed informed consent and its central role in allowing patients to participate actively in their treatment. It is inconceivable that just 77 years after Nuremberg, the door has once again opened for state-sanctioned medical experimentation on potentially uninformed and unwilling citizens.  

Informed consent is not just a legal argument but also an ethical one. Previously, it was accepted that legal and ethical protections are required when large power imbalances exist, for example, between researcher and citizen. These ethical considerations are ensconced in four little-known medical ethics principles supposedly guiding all of the NIH’s actions. 

1. Beneficence (the pursuit of good).
2. Nonmaleficence (do no harm).
3. Autonomy (the freedom of patients to choose).
4. Justice (ensuring fairness).

By removing informed consent, every one of these ethical considerations is disregarded. 

According to this amendment, the state alone, acting through its proxies such as the NIH, the FDA, and the Center for Disease Control and Prevention (CDC), will decide what is considered a “minimal risk” and, most concerning, will determine what:

…appropriate safeguards [are required] to protect the rights, safety, and welfare of human subjects.

Notice the use of the plural human subjects, not patient/s, person/s, individual/s, or citizen/s but subjects. I understand that this is standard practice in documents such as these. However, in this asymmetrical relationship, it is understood that the passive subject must comply with all rulings and edicts commanded by their health bureaucrat masters. The use of the term subjects also serves to dehumanise. The dehumanisation of populations was a critical component of both Nazi human experimentation and numerous eugenics movements across the ages. As Hannah Arendt argued, dehumanisation is an essential step toward denying citizens “…the right to have rights”.  

This ruling also allows researchers and their misguided evangelical billionaire backers to pursue potentially dangerous experimental programs such as Bill Gates’ mosquito vaccines, mRNA vaccines in livestock and vaccines in aerosols. These novel and high-risk programs can now hypothetically be trialled without the people’s consent. Indeed, big pharma and health authorities are no longer required to inform the public of their medical investigations as long as they prove they pose minimal risk. Yet, the histories of pharmacology and medicine are plagued with clinical investigations and interventions that were thought to pose no more than minimal risk to humans that went on to cause immeasurable pain, suffering and death.

This amendment represents an alarming first step as the US government tests the waters to see what they can get away with. Given the lack of attention this ruling received in both the corporate press and independent media, they are likely to feel encouraged to widen the scope of this amendment. Thus, this ruling represents the beginning of a chilling revisionism in Western medical history as patient autonomy is again forsaken. This ruling, to be enforced by potentially corrupt health bureaucrats and captured health and drug regulators, is a recipe for a dystopian future unimaginable just five years ago. No doubt the infrastructure to implement this decision is already being constructed behind the scenes by the same groupthink cultists responsible for the most nightmarish elements of the COVID-19 lockdowns, obediently placing the pursuit of profit and the greater good above the principles of individual choice, bodily autonomy, and informed consent.   

[1] my emphasis

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  • Victor Dalziel

    Victor Dalziel, is a self-taught content creator, academic researcher, stylist, and amateur DJ, embodying a critical disposition. Victor has lived, worked, and studied across the world, from China and South Korea to the United Kingdom. With a master's degree in international relations and a PhD in Philosophy [Sociology of Education], Victor's journey has been an unconventional one. Victor's superpower is remaining humble, softly spoken, and affable while maintaining a belly full of fire, passion, and rage! Surviving on less than a shoestring, in early 2023 Victor embarked on a passionate pursuit of his creative vision on YouTube. In a matter of weeks, Victor's content struck a chord with viewers, amassing over 5000+ views and garnering a rapidly growing audience. His unique blend of expertise and creativity, combined with a dry sense of humour connected with viewers from diverse backgrounds. However, it was at this early stage that Victor received a strike, coinciding with his channel temporarily disappearing from the platform. After a period of reflection, Victor has returned and found a new home on free-speech alternative Rumble.

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