Posted on 01/23/2024 7:17:41 PM PST by E. Pluribus Unum
Studies cannot pose more than minimal risk to humans and must include appropriate safeguards to protect the rights, safety, and welfare of those involved.
In an effort to encourage the discovery of more treatment and diagnostic options in the medical field, the U.S. Food and Drug Administration (FDA) has finalized a rule allowing certain clinical trials to operate without obtaining informed consent from participants.
The hitch? The study cannot pose more than minimal risk to humans and must include appropriate safeguards to protect the rights, safety, and welfare of those involved.
The rule was issued in late December 2023 and went into effect on Jan. 22, 2024.
“We anticipate this new rule will enable minimal risk research that would not be practicable to conduct otherwise,” Dr. Robert M. Califf, serving commissioner of Food and Drugs for the FDA, wrote on his FDA blog, “Catching Up With Califf.“ ”This could include studies comparing the effectiveness of approved products to determine which option works best for certain patients.” The FDA initially proposed the rule in November 2018, permitting an institutional review board to waive the requirement for informed consent under certain conditions. The agency received fewer than 50 comment letters on the proposed rule from academia, institutional review boards (IRBs), public advocacy groups, industry, trade organizations, public health organizations, and citizens.
Most of the comments favored the agency’s efforts, supporting the rule because it reduced administrative burdens on both IRBs and researchers while encouraging valuable research on important health issues affecting the public without putting trial participants at risk, according to the FDA.
(Excerpt) Read more at theepochtimes.com ...
When did they exchange the Hippocratic Oath for Hypocritical Oafs?
FdFDA
Satan will have plenty of fun with these people when they get to hell.
Right out of Mao’s & Stalin’s game plans...
That our ruling communists would even dare publicly propose this is a clear indicator of their power, of the serfs subservience, and of the long-term permanent future of this dark tyranny...
Nowhere is there am American spokesperson willing to derail this freight train of tyranny...
There are about 60-million migrant invaders, a DEI trained military, and powerful communist politicians who are prepared, willing, and enthusiastic for the chance to start killing all Americans who disagree...
“”The study cannot pose more than minimal risk to humans””
So......sub-humans at the FDA get to decide just what constitutes a ‘minimal’ risk. If the ‘uninformed’ person just happens to be a MAGA supporter, or just believes in the Bill of Rights, then I’m sure the risk parameters are much higher. If one, or 10, or 100,000 happen to die....oh,well. It was done for science, dontcha know.
Damn butchers.
They align completely with Yuval Harrare (WEF’s main policy maker) in his speech today (or maybe yesterday) where he says we peasants have no rights, that our rights and our very lives are fantasies under the control of the elite.
https://www.youtube.com/watch?v=apikNPiZGLM
p
Here is the link to the FDA blog:
There was another blog by Califf, on randomized controlled trials (RTCs).
I cant find it (hopefully some has it bookmarked), but there was a story about “scientists” trying to take down randomized controlled trials (RCTs) as the Gold Standard for research, in favor of “real world data.” The reason, per the story, was that for (I think it was) masks, RCTs revealed masks to be useless. But, by using RWD or real world evidence(?), “scientists” could rig the results, erm, have a clearer picture.
p
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The patients MUST know if they are being experimented on. It absolutely must be informed consent under all circumstances. Period.
And we’re supposed to trust them to follow the rules.
4. The waiver or alteration will not adversely affect the rights and welfare of the subjects. In the preamble, FDA explicitly declines to provide a definition of the “rights” or “welfare” of subjects and places reliance on the familiarity of IRBs with these concepts.
5. Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation. FDA does not provide clear examples of what such pertinent information might entail.
And how do they define “minimal harm”? Can such a thing actually be quantified? What’s “minimal harm” to one person might not be so to another.
How can they be compensated if they don’t know they’re involved in a clinical trial?
Any other way to throttle Leftism without killing it?
I noticed that too. Nobody can be forced to participate in experimental medical trials without informed consent. Nor can anyone be coerced or threatened, loss of employment. That is completely illegal, it’s in Title 18, USC.
“Rules”.
Government would contend the experimental COVID vaccines were minimal risk. The people were not supplied information sufficient to give informed consent, and they were coerced into getting the shots. Our government is attempting to justify by regulation what it has already done.
Unfortunately, it’s not always done. I cannot say what happened but I will say it is not always done. I think some doctors are on something.
This will excuse companies to introduce mRna nasties into what were otherwise normal and accepted vaxs. That is what this is all about. Expect stuff in your food supply as well. We must get everybody prepared for Disease X. Too many survived Covid 19 (it was just a trial run).
Yeah, we’ll see it in court in a few years if Chevron isn’t shot down. If SCOTUS kills it, then this rule is pretty much null and void.
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