‘Informed Consent’ officially nixed as long as there is only ‘minimal risk’ to the patient

 You might have missed it, because I almost did, but “informed consent” has been quietly erased, just as long as there is “minimal risk” to the medical subject. Here’s the story, from a report by Victor Dalziel and published by Brownstone Institute on Sunday:

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.

For context, the 21st Century Cures Act was a bill introduced by a Democrat, passed by a Republican House and Republican Senate, and signed into law by Obama, in late 2016, about a month before President Trump took office; Dalziel notes the legislation was “controversial” and had “strong support” from Big Pharma.

Now, that final FDA ruling took effect… about two months ago, on January 22, 2024; as Dalziel notes, this “means it’s already standard practice across America.”

Here is the text of the “summary” of the rule, from the Federal Register:

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This final rule allows an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The final rule permits an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations.

In perfect legalese, the language of the rule uses the perfectly subjective “minimal risk” term… which is defined by… whom? Per Dalziel:

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’....

The rule delegates these agencies with the task of implementing “appropriate safeguards” to (ostensibly) “protect” the “human subjects.” Huh, almost sounds like we’re lab rats, not people, or individuals, patients, or participants. How did this go for the “subjects” of the Tuskegee Experiment?

The same bureaucracies full of deep state operatives who are largely responsible for bringing the clot shot to market; who censored and sabotaged the spread of legitimate medical information like the efficacy of ivermectin and other alternative therapies to treat the viruses and bugs spreading around during the “pandemic” era; who tell us that glyphosate-covered grains and seed oils are healthier than grass-fed beef and butter; who criminalize raw milk over yet shove synthetic cross-sex hormones down our children’s throats, are going to be determining what is “risky” and what’s not? (This list could go on ad nauseam.) How comforting.

Dalziel also highlights another, equally-distressing aspect:

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.

While all of this is extremely disturbing, as a colleague noted, “informed consent” was largely an illusion, and more of a mafia-style coercive “sign this or else” approach. So, suffice it to say, that if the comforting fiction of “informed consent” is out the door, there’s a silver lining, and that is that the people may wake up to what was already happening anyway.

https://www.americanthinker.com/blog/2024/03/informed_consent_officially_nixed_as_long_as_there_is_only_minimal_risk_to_the_patient.html