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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.
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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.”
This ruling also allows researchers and their misguided evangelical billionaire backers to potentially pursue dangerous experimental programmes such as Bill Gates’ mosquito vaccines, mRNA vaccines in livestock, and vaccines in aerosols. This Act encourages these novel and high-risk programmes, 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.
About the Author
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.
Featured image: Defendants in their dock at the Nuremberg Trials November 1945 – October 1946. Source: The Guardian
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Categories: Breaking News, World News
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:
This ruling went into effect on 22 January 2024, which means it’s already standard practice across America.
*
It is highly likely Americans whose loved ones are those included in grim VAERS statistics recording deaths and severe injuries dues to “safe and effective” mRNA “vaccines” (gene-editing biological weapons) will be absolutely infuriated after hearing of this outrageous development.
This Brownstone Institute report confirms the very serious allegation of Sasha Latypova, Katherine Watt, Dr. David Martin, biological weapons legal expert Frances Boyle, and increasingly accepted by others: The (ongoing) COVID/mRNA bioweapons mass murder nightmare has been under the total command of the United States Department of Defense (de facto Nazi Fourth Reich) since before “Two weeks to flatten the curve” – now, more than 4 extremely long years ago.
Why being British living in the US I now consider taking US citizenship a liability. Also I now reject all interactions with the medical establishment in all forms not even for testing. Poop in a box DNA grab colon test – binned it.
In 2 years I know 4 people that have died from pancreatic cancer … way, way way too many and that confirms my concept.
If I refuse all medical treatment no matter what then chances are being 60 I will live a hell of a lot longer than allowing doctors access to treat me.
How was that even allowed to occur??? The HHS and FDA are NOT legislative bodies… They do NOT have the authority to make such decisions, let alone have them codified in law… Where’s the damned lawsuit against them for this???
ChemtrailPoision pollutes the sky
While the Vatican’s Eugenicist Royal Elites Blackmail Politicians of Pedophilia Corruption
Ancient Institutionalized Pedophilia
Descends From Pagan Rome’s Deities.
Zeus and Jupiter’s Abduction of Ganymede Continues into the Vatican’s Corruption of Christianity.
Clear the Sky of: ChemtrailPoision by Striking the Achilles’s Heel of Pedophile Corruption.
BERGOGLIO: POPE FRANCIS IS THE ANTICHRIST – Fighting Monarch
Hitler LED GERMANY OFF A CLIFF, with the Molotov-Ribbentrop pact with Stalin’s Soviet Bolsheviks the people who committed the HOLODOMOR.
and ignited WW2 an Aryan cataclysm by invading Poland.
Reveal this truth to prevent it from happening again.
Why go-to war in the first place?
Peacefully evacuate the annexed Germans in Poland and leave the WW1 borders as they are, least you trigger WW2, which he did.
And lost more territory of Germany, the supposed reason to invade Poland in the first place.
Hitler brought Ruination, Devastation and Desecration to Germany.
And some brainwashed people still think he did good?
Simply Search for: Rape of German Woman after WW2, to see what Hitler brought to Germany.
Using wokery for my own means I refuse to identify as a subject 😉
I gave up my citizenship and became an American which everyone should have done after the civil war in 1869, take the TASA course at https://states.americanstatenationals.org
Then its time for another Nuremberg trial
But the assumption is that the body makes antibodies, but it does not and therefore the vaccines become disease input injections which cause the deaths of many, as has been the caser with Covid. WHO started the Covid Pandemic and with our Government’s, were behind the push to get everyone vaccinated but the vaccines only made illnesses more prevalent, Kate is a fine example with a Turbo Cancer from her Covid injection in 2021. My free salt water cure does what no vaccine will ever be able to do. It kills any viral virus in the nasal passages of the head, so no Covid in the body can occur and it costs zero to make and use, unlike BionTech’s vaccine which delivers Spike Proteins throughout the body in 12 hours from injection, stays in the body for 6 months, each injection, changes the bodies Natural DNA to ModRNA DNA in 6 hours and makes the Host, no longer Human and all Human Rights are lost, but now a new species “Transforming from Human” with zero Human Rights and targets the Dentric Cells in the Lymph Nodes, not a nasal Covid disease in the head, so what then, is the real purpose of BionTech’s/Pfizer’s vaccine, you tell me?
Seems to me that very wealthy people are playing games with poor people’s lives with vaccines which can’t and don’t work and are not tested on animals. over a period up to 10 years, as was the case once, before they ever got to be injected into any Human as “safe”.
Why don’t these super rich people inject themselves with their vaccines, before they try them out on us, after all, if they die first, they are making the World cooler and a better less populated planet, by result, so win/win.
what? Kate getting the actual bioweapon? i don’t think so… LOL
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I do expect all branches of the US politicians to take any medical treatment first without exception if they intent to pump the toxic stuff into my wife. She just had a fantastic treatment to rebuild a knee my only proviso was all fluids had to come from her to used which is what they did. Plasma, blood and t-cells so you do not get this genetic manipulation or rejection.
Good this cartilage rebuild in a joint.
Can’t very well be an effective tyrant with all those rules and regulations protecting people…
They’re cordially invited to pound salt.
define “minimal risk” since one size fits all is impossible in medication .
Sounds like it is past time to remind them that they do not grant rights, and that their authority is derived from the consent of the governed.
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