In a concerning development, informed consent has been quietly revoked, marking a blow to patient autonomy. This change comes just 77 years after informed consent was codified in the Nuremberg Code.
On 22 January 2024, a ruling by the US HHS and FDA came into effect. It allows for an exception from obtaining informed consent in clinical investigations deemed “minimal risk.”
It raises questions about state-sanctioned medical experimentation and what constitutes “minimal risk” and paves the way for potentially dangerous experimental programmes without patient consent.
The implementation of this ruling by corrupt scientists and health regulators is a step toward a dystopian future.
The Era of Informed Consent is Over
The following was originally published by Brownstone Institute.
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 … [Emphasis added]
This ruling went into effect on 22 January 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 Centres 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.”