RW 7/8.) EUA Removal of Informed Consent

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This section covers the United States Solution to EUA Removal of Informed Consent

EUA Removal of Informed Consent

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The rules and regulations that I have gone through and taken you through in the United States really show the legal framework in America and how it has been set up.

So, let’s sum it up.

The United States went through a complete conversion militarily, between our individual liberties under the Patriot Act. The legal standards of scrutiny for people changed under the Patriot Act with their national security letters, with your cell phone records, your bank accounts. All of these things I’ve discussed before.

But in tandem with that and at the same time, there was a massive amount of public health laws that gave both the Department of Defense and the Department of Health and Human Services the extra powers, in the case of either wartime or public health emergencies, to bypass standard medical protocols of releasing biological, chemical, radiological, and neurological agents, weapons, or products to the general human population.

The EUA ends efficacy requirements

Within the framework of CBRN elements and Defensive medical countermeasures, end the need for safety testing, as all government contractors can be contracted to develop prototypes. This is an argument that the federal government is making right now in federal court in East Texas. It has nullified the requirements to get informed consent. It is not required. You do not have to give informed consent to take a completely experimental biological agent. And it also established all of these laws, established, similar to the vaccine injury compensation fund that was established in 1986 which routed all injury claims to the countermeasures injury compensation program.

So, in other words, we had to have this 1986 to get these manufacturers to develop these therapies that we need for our children. And likewise, we now have this fund that says, hey, if you’re injured, you don’t get to go to civil court and sue. No, no, no. You’re going to be routed to a countermeasures injury compensation fund, and this is why you’re not going to be able to go to court over these things.

The other thing that all of these laws really did is they put a lot of guidance documents out to state, local governments, municipalities, to let them know that the federal government was in charge during public health emergencies and that they actually pre-empt basically state law, which really is a problem, and that is, in fact, the problem.

Wyoming right now, their legislature is in the midst of discussing passing laws that will basically nullify the legal authority in reach of the WHO and also the federal government in the area of health, and this makes sense because we are what we call a republic, and we have the 10th Amendment. The 10th amendment says that anything that is not really police powers are reserved specifically to the federal government, which healthcare was not. If it was not specifically reserved to the federal government, it under the Constitution belongs to the states.

This is exactly what the states need to do to fight back against this massive, “we can just do whatever we want, there’s no liability anywhere, we don’t have to follow medical testing protocols that you’re used to. We don’t have to give you informed consent. We don’t have to even tell you what we’re doing. And, by the way, state, we can come in and quarantine these people, even if we suspect that they have these things because that is our authority under the new militarization of healthcare in the world, and there’s nothing that you can do to take us to court, except for this. You can go to this.”

That is completely not true. At the end of the day, the Constitution is the defining document, along with its amendments. We have states’ rights; we are a republic, and we do have federalism in this country, and that is, if states will actually take their authority back and do something with it, then we could see some changes here.

So, I finally got my answer to my question of how can I resolve informed consent required with EUA when it clearly wasn’t being delivered, and this is basically 21 US Code 360bbb-3: Authorization for Medical Products for Use in Emergencies. (01)

It talks about how the Public Health Services Act, can produce and put these things, these agents, into the stream of commerce even if, basically, it has not gone through the traditional medical approval protocol process. And so, we know that EUA ends the medical protocols that we’re used to.

But then we have 21 CFR. This is our Federal Regulation; this is not a statute, but this is what has been written as a Federal Regulation from the statute, and you can see 21 CFR 50.24: Exemption from Informed Consent Requirements for Emergency Research. (02)

This is saying that the RRB responsible for your approval and continuing review of clinical investigation describing this section may approve that investigation without requiring that informed consent of all research subjects to be obtained if the IRB, with the concurrence of the licensed physician who is a member of the consultant of the IRB, and who is not participating, finds and documents the following:

  • (1) that human subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific data, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness of particular interventions

In other words, that the subjects are in a life-threatening situation and we don’t have enough proven medical collected data, and it we don’t have the basically an actual investigation to determine the safety and efficacy of these things

  • (2) obtaining informed consent is not feasible because (i) the subjects will not be able to give their informed consent as a result of their medical condition, or (ii) the intervention under investigation must be administered before the consent of the subject’s legally authorized representative is feasible, or (iii) there is no reasonable way to identify prospectively the individual who is likely to be eligible or to participate in clinical investigations.

Basically, they have exempted out informed consent.

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Penny... on Health
Penny... on Health

Truth-seeker, ever-questioning, ever-learning, ever-researching, ever delving further and deeper, ever trying to 'figure it out'. This site is a legacy of sorts, a place to collect thoughts, notes, book summaries, & random points of interests.

DISCLAIMER: The information on this website is not medical science or medical advice. I do not have any medical training aside from my own research and interest in this area. The information I publish is not intended to diagnose, treat, cure or prevent any disease, disorder, pain, injury, deformity, or physical or mental condition. I just report my own results, understanding & research.