Tag: body integrity

The Era of Informed Consent is Over

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.  

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Hospital Pays Job Applicant Who Refused Mandated Flu Shot

A hospital in Grand Rapids, Mich., has agreed to pay a settlement to a job applicant who had been offered a position, but then was arbitrarily rejected because he declined to take a flu shot hospital officials demanded.

News of the settlement comes from Liberty Counsel.

The fight involved Trinity Health Grand Rapids, which previously was known as Mercy Health St. Mary’s. The resolution includes a consent decree that allows paying of some $50,000 to the worker who was rejected.

The case originally was filed by the U.S. Equal Employment Opportunity Commission and charged the hospital improperly denied a job applicant’s request for a religious exemption to the flu shot.

The requirement for such shots later was dropped by the hospital, which agreed to train leaders on religious rights in addition to paying the settlement.

“According to the EEOC’s lawsuit, even though the hospital’s former flu shot policy allowed for a religious exemption, the hospital determined the applicant’s articulated religious beliefs were ‘insufficient’ to grant the exemption and denied it without an explanation. Trinity Health, which had made a conditional job offer to the applicant, then rescinded that job offer and did not give the applicant an opportunity to address the concerns with his request.”

The EEOC accused the corporation of violating Title VII of the Civil Rights Act of 1964.

The report explained federal law insists that employers make reasonable accommodations for religious employees – unless those accommodations create an “undue hardship” on the company.

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New Jersey Bill Would Force Drivers Suspected Of Being High On Marijuana To Provide A Blood Sample To Police

Cannabis experts are concerned about a lawmaker’s attempt to require motorists suspected of driving under the influence of marijuana to provide a blood sample to police.

Critics of the recently introduced bill say it would not only give police more power that would likely be wielded disproportionately against people of color, but they also argue the testing methods called for in the bill don’t even work.

Joshua Bachner, a cannabis attorney at law firm Mandelbaum Barrett, criticized the move as an example of government overreach.

“The state should develop—and there’s many of us in the state happy to coordinate with them—a comprehensive, reliable method for determining impairment,” he said. “But these piecemeal approaches are only going to cause a lot of victimization, frankly, for those who are falsely accused.”

Under current law, anyone in New Jersey who drives is consenting to provide a breath sample if police believe they are driving drunk—it’s called “implied consent.” The new bill would expand that to include a blood test and apply to any narcotic, hallucinogenic or other drug. Someone would be deemed under the influence of marijuana if they test positive for 3 nanograms or more of THC—the chemical that gets cannabis users high.

The push to expand implied consent laws to apply to drivers suspected of marijuana use comes two years after New Jersey’s recreational marijuana market launched, and as legal cannabis becomes more prevalent nationwide.

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CDC’s 2024 Child Vax Schedule: All Risks, No Liability

Childhood vaccines stand as a unique consumer product, enjoying unparalleled liability protection from the government. Given the corruption of the healthcare apparatus, it is no wonder that the U.S. Centers for Disease Control and Prevention (CDC) keeps expanding the list of recommended childhood vaccines, as happened in early 2024, says attorney Aaron Siri.

In his interview with The New American, Siri explains how the number of vaccine doses recommended for children under one year, including in-utero, surged from three to ninety over thirty-seven years, now including three doses of Covid-19 genetic therapy. This increase stems directly from the National Childhood Vaccine Injury Act of 1986, which granted legal immunity to vaccine manufacturers for injuries and deaths caused by CDC-recommended childhood vaccines.

Despite the CDC’s claims of rigorous safety trials, the truth is starkly different, according to the openly available information provided by the vaccine makers to the U.S. Food and Drug Administration (FDA). Shockingly, most safety trials last for only several days, in contrast to the several years spent on drugs that are liable to lawsuits. Furthermore, trials for childhood vaccines are conducted against other vaccines, not placebos, raising questions about the reliability of the results. Thus, a complete safety profile for these products is unknown, as highlighted by the attorney.

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The Loosening of Rules on Informed Consent

On January 22, 2024, amendments to the Food and Drug Administration (FDA) regulations (21 CFR 50) covering Institutional Review Boards (IRBs) were finalized and implemented. The amendments added a new section 50.22 that allows for exceptions to informed consent requirements for minimal risk research. 

While the addition of section 50.22 harmonizes FDA IRB regulations with the Dept of Health and Human Services (DHHS) IRB regulations (known as the Common Rule: 45 CFR 46) that are administered by the Office for Human Research Protections (OHRP), the handling of the Covid shots over the past 3-4 years should raise red flags. 

Currently, I am chair of an IRB at a private-not-for-profit outpatient healthcare agency that does research in which vulnerable populations are recruited. As such, I’m well aware that the foundational documents from which the OHRP developed the regulatory framework under which IRBs operate are the Nuremberg Code and the Belmont Report. 

Back in October 2023, my first Brownstone post, Where is the Office for Human Research Protections, asked the question as to how the approval of a Phase 3 research pharmaceutical product (mRNA vaccines) could be done without the formal involvement of IRBs. Specifically, the Nuremberg Code, covering informed consent, and the Belmont Report, covering among other elements, bodily autonomy, which are foundational to oversight of human subject research, and the requirement for a data and safety monitoring plan were completely discarded. Was the OHRP consulted for its input, and if not, did anyone from OHRP express concern? Given that these protections were put in place in response to medical atrocities (the Holocaust and the Tuskegee experiments), you’d think that they’d be sacrosanct. Think again!

While not providing a direct answer to the question I posed, Debbie Lerman’s posts, Covid mRNA Vaccines Required No Safety Oversight and Covid mRNA Vaccines Required No Safety Oversight: Part Two, and Sasha Latypova’s post, EUA Countermeasures Are Neither Investigational nor Experimental, provided a detailed roadmap as to the actions that were actually taken in implementing Emergency Use Authorization (EUA) for the Covid shot. To me, the most significant finding was that the legality of using EUA in civilian populations is rather tenuous, at best. 

With the foregoing as a backdrop, let’s get into the nuts and bolts of the new FDA regulations, noting that in addition to being chair of an IRB, I am also a retired physician, who has been in the healthcare field for 50 years. This includes 19 years of direct patient care in a rural setting as a Board Certified Internist, 17 years of clinical research at a private-not-for-profit outpatient healthcare agency, and over 35 years of involvement in public health, and health systems infrastructure and administration. As such, I bring a breadth of training, knowledge, and experience to this matter that is fairly unique.

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CRIMINAL FDA DECLARES INFORMED CONSENT NULL AND VOID

If we’ve learned one thing over the last three years, it’s that abiding by centuries-old medical ethics, like asking questions, is what White Supremacists™ and domestic terrorists do.

Via the soon-to-be-memory-holed American Medical Association webpage on informed consent:

“Informed consent to medical treatment is fundamental in both ethics and law. Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care. Successful communication in the patient-physician relationship fosters trust and supports shared decision making.

The process of informed consent occurs when communication between a patient and physician results in the patient’s authorization or agreement to undergo a specific medical intervention.”

That was then.

This is now, when respecting the Science™ requires that you shut your filthy masked mouth and do whatever corporate media news actors and Public Health™ technocrats tell you to do.

Via 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.”

Branch COVIDians surely don’t care about any of this, as they gave up long ago exercising their former right to be fully informed of medical experimentation risks anyway. In fact, they brag about their ignorance and apathy and doglike obedience as if they are virtues.

Listen to the New York NAACP lady explain:

“We must take the vaccine. Now, I’m going to tell you a personal story off script. So, today right after this I am going to have an infusion, and I’m going to have an infusion because I want to make sure that the cancer that was in my body does not return. I’m not asking what’s in the infusion, I’m not looking up all of the ingredients in the infusion, I am sticking out my arm and I am taking the infusion, and that’s what we have to do.” [seal-like clapping from the masked retards behind her]

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No, Trading Flesh for Prison Time Is Not “Bodily Autonomy”

YOUR LIVER OR your liberty? Choose one.

This is the proposition that a bill in the Massachusetts House of Representatives puts to people locked up in the commonwealth: Donate bone marrow or an organ or two, says HD 3822, and the Department of Correction will cut 60 to 365 days off your sentence. The bill is sponsored by four Democrats.

Everything is wrong with this proposal except its intentions: to shorten transplant waiting lists and reduce state prison populations. Or so I assume. The 370-word text does little more than establish a Bone Marrow and Organ Donation Program within the Department of Correction and a committee to work out the details. There is not even a perfunctory assurance of informed consent. With any luck, the bill will flutter to the bottom of some committee’s docket.

But HD 3822 is more than a piece of legislative slapdashery. It hints at the ways policymakers think about people and bodies and the calculus that determines which bodies deserve respect and care and which do not.

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“My Body, My Choice” Activists Malfunction When Asked About Vaccine Mandates

A video shows pro-abortion activists who embrace the concept of “my body, my choice” having brain malfunctions when asked about vaccine mandates.

The past few days have seen infinite instances of the same people who called those skeptical of mandatory vaccines every slur in the book suddenly do a 180 and claim the government has no right to have a say over their bodily autonomy.

That made for some interesting responses when Alex Stein confronted Roe vs Wade demonstrators with the hypocrisy of their own rhetoric.

“Are you in favor of my body, my choice?” Stein asked protesters, all of whom agreed.

“What about vaccine mandates?” he countered.

One man responded by engaging in a deluge of verbal diarrhea, while another simply said, “Get the fuck out of here, man.”

Vaccine mandates were “better for the community,” said another woman, before refusing to accept that a baby was a baby.

“That isn’t a baby,” said another woman who was pro-vaccine mandates.

“I’ll throw your phone on the floor if you don’t stop,” another man angrily responded.

“This is not going where we want it to go,” said another older woman who could not compute the dichotomy while her husband held a sign saying “sick of the hypocrisy.”

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