The Era of Informed Consent is Over

E. Rowell:  This article focuses on one piece of legislation that is part of a corpus of federal laws passed by Congress without the knowledge or consent of the American people and which make quasi-legal the transfer of power from the President to the HHS Secretary and thence to the Joint Chiefs of Staff (US DoD) in a declared “public health emergency.”  For a fuller appreciation of the degree to which laws have been put in place to support the US bioterrorism program, please see:

By Victor Dalziel, BROWNSTONE                                                 24 March 2024

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 vaccinesmRNA 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.

Victor Dalziel is an Australian content creator, academic researcher, and writer. Victor has a master’s degree in international relations and a PhD in Philosophy and has worked, studied, and presented across the globe.


March 31, 2024 | 5 Comments »

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  1. Tennessee legislators have passed a bill to require any food that contains a vaccine or vaccine material to be classified as a drug and labeled as such.

    The measure now heads to Gov. Bill Lee’s desk

    Leading Reports

  2. The despotic control with which the Deep State has authorized itself to hold over the average citizen will have to pass two levels of review to survive being struck down, albeit at some point in the future.

    Whereas the permanent bureaucracy in the US likely feels itself emboldened by the authority it derives from having participated in the overthrow of a sitting president, its authority and interpretations are not without review. First, there is a strong consensus of opinion which supports the view that the Chevron doctrine form which the Deep State draws its authority will likely be struck down, yet there are previous legal opinions and standards which are clearly at odds with the dismemberment and disposal of informed consent. I most recently wrote about the legal standing of the Nurember Code, such as it is, a little over a year ago. Hence we can expect a legal challenge to the Deep State interpretation of the Cares Act in curbing the primacy of informed consent at some point in our future, even if the Chevron doctrine survives, which I would suggest is not likely to be the case.

    This will of course come to place the matter before the US Supreme Court, something which should be far more encouraging than anyone could find in making this statement today. What is truly needed is an America First president with an American first congress to restore such liberties as informed consent to the American people. Til then, the Rogues in Black Robes will provide the only potential to halt this extension of medical tyranny over the people.

  3. Words like “misguided” and “potentially corrupt” conceal the objective of the waiver. The informed consent waiver is designed to legalize tyranny and establish totalitarian control through political medicine. There is absolutely nothing morally acceptable about waiving informed consent. It removes any individual agency and control over one’s own body. The malevolence of this waiver is staggering.