In a significant blow to patient autonomy, informed consent has been quietly revoked just 77 years after it was 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) 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 went into effect on January 22nd, 2024, which means it’s already standard practice across America.
So, what is the 21st Century Cures Act? It is a controversial Law enacted by the 114th United States Congress in January 2016 with strong support from the pharmaceutical industry. The Act was designed to
…accelerate the discovery, development, and delivery of 21st-century cures, and for other purposes [?]…[emphasis added]
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].
This Act granted the National Institutes of Health (NIH) legal protection to pursue high-risk, novel vaccine research. A strong case could be made that these provisions capture all the necessary architecture required for much of the evil that transpired over the past four years.
Overturning patient-informed consent was another 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. 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.
According to this amendment, the state alone, acting through the NIH, the FDA, and the Centers for Disease Control and Prevention (CDC), will decide what is considered a “minimal risk” and, most concerning, will determine:
…appropriate safeguards to protect the rights, safety, and welfare of human subjects.
Notice the term subjects, not patients, persons, individuals, or citizens…but subjects. In asymmetrical power relationships such as clinician/patient, it is understood that the passive subject will comply with the rulings and mandates of their medical masters. The use of the term subjects also serves to dehumanise. The dehumanisation of populations was a critical component of Nazi human experimentation and, as Hannah Arendt argued, is an essential step toward denying citizens “…the right to have rights.”
This ruling also allows researchers and their misguided evangelical billionaire backers to potentially pursue dangerous experimental programs such as Bill Gates’ mosquito vaccines, mRNA vaccines in livestock, and vaccines in aerosols. This Act encourages these novel and high-risk programs, with medical studies approved as ‘minimal risk’ by the regulators no longer requiring researchers and pharmaceutical companies to obtain patient consent. 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 but went on to cause immeasurable pain, suffering, and death.
This amendment represents merely a first tentative step as the US government tests the waters to see what it can get away with. Given the lack of attention this ruling received in both the corporate press and independent media, the government is likely to feel emboldened to widen its scope. Thus, this decision represents the beginning of a chilling revisionism in Western medical history, as patient autonomy is again forsaken.
This ruling, to be actioned by potentially corrupt scientists, health bureaucrats, and captured health and drug regulators, is another step toward a dystopian future unimaginable just five years ago. No doubt the infrastructure to implement this decree is already being constructed by the same groupthink cultists responsible for the nightmarish pandemic lockdowns, continuing to place the pursuit of profit and the greater good above individual choice, bodily autonomy, and informed consent.
Only offering total nonviolent noncompliance to the illegitimate Federal government and its unconstitutional agencies waging a full spectrum soft war against We the People will put an end to these color of law “rulings.” Stripping informed consent law as per the above “ruling” for strictly democidal “Safe and Effective” purposes is a direct subversion of natural rights.
No power was given to Congress, the Federal government, or any of the criminal agencies like the CIA, FBI, NIH, FDA, etc. to infringe on anyone’s natural rights; to wit:
Which is precisely why everyone must take their health into their own hands, from avoiding all processed foods to sourcing local non-GMO farm fare to stocking up on supplements and lifesaving products that the powers that be do not want you to have access to.
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They want you dead.
Do NOT comply.
Mass resistance / non-compliance or you will live on your knees in perpetuity.
When a country falls into rule of men rather than rule of law, the first thing it does as a matter of lawmaking is to strip the natural rights of people, such as defined in our Bill of Rights, in order that abuses of individual sovereignty can take place under cover of “law.” Thus laws become arbitrary and capricious and the natural checks on power, found primarily in the right to speak freely and the right to informed consent, give way to unabridged power and the subjugation of the people. The sovereignty of the individual should be inviolate and never subject to emergency decrees; this is a point in government we haven’t fully grasped.