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 ...
How did the Nuremberg Tribunals view this?
You’re now a guinea pig.
I don’t think I will agree on big pharma/govt’s definition of “minimal risk”.
We’re Fauci’s beagles now.
They’re already experimenting on us without consent
Another Nuremberg trial chapter waiting to be written.
That was exactly what I zeroed in on as well.
If you give these bastards a nanometer of space thinking they will practice goodwill, they will open it up to a channel ten miles wide.
None of them, not one, can be trusted.
All part of the plan to destroy the people’s faith in the US Government, or what very very little they have left.
It's been going on for a long time, but especially since the garbage Covid shots, they called "vaccines".
Now they can legally give you a known placebo utterly worthless to treat your condition, make you pay for it resulting in no effective treatment.
We can be lied to legally and made to pay for drugs known to not work but told they do work.
This is beyond insane. What legal recourse would one even have now in such morally and ethically bankrupt polices.
End result for this is poor people are used as unkowning lab rats while the elite benefit from the testing and actual drugs that work.
They have a planet to save.
We are the carbon they want to eliminate.
WE All Are....
If they haven’t done so All Ready.
.
Wait——do Clot shots count?
Nazis. Paging Dr Mengele!
I wonder how they’d feel being ammunition test subjects without giving consent.
Peace, Love and the Nuremberg Code!
My how Mengele of them.
“new rule”
Informed consent is a law, not some agency’s “rule”.
No avenue for abuse there, uh uh.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.