New rule may allow Covid shot given w/o patient knowledge / approval

[Infolurker]

Found this gem on another board. Transferring over for review

ht tps: // ww w. federal register. gov/documents/2023/12/21/2023-27935/institutional-review-board-waiver-or-alteration-of-informed-consent-for-minimal-risk-clinical

(fair use applies) DELIBERATELY BROKEN LINK

EXCERPT (I only posted the summary - the entire piece is at the link)


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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.


Publication Date:

12/21/2023


AGENCY:

[b]Food and Drug Administration, HHS.[/b]

ACTION:

[b]Final rule.[/b]

SUMMARY:

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).[b] 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.[/b]

DATES:

[b]This rule is effective January 22, 2024.[/b]

https://www.govinfo.gov/content/pkg/FR-2...-27935.pdf

[Michigan Swamp Buck]

I'd like to know what an "FDA-regulated minimal risk clinical investigation" is. I bet it's not good, in fact I bet it's evil.

[Ninurta]

From the wording, this appears to affect clinical trials. It doesn't create a waiver for informed consent, but it does add one more criterion for waiver to the original 4 from 1991. The fifth, or new, criterion is for data or samples that are personally identifiable. It creates a potential for waiver of informed consent even if the subject's data or samples are personally identifiable.



It looks like they expect to be able to save corporations about 9 million dollars a year by alleviating them of the need to print informed consent forms.




It doesn't cover clinical treatment per se, only if that treatment is part of a study on human test subjects.... i.e. "human guinea pigs".




It does not mention covid shots at all, but neither does it exclude research on covid shots. I think the headline of the article is misleading on that account, because the scope is so much wider than just covid. It covers ANY clinical investigations. The article title is misleading because it is too narrow, and focuses only on the fear du jour. of covid.



The phrase "Minimal risk" in the legislation is also misleading. It's entirely subjective rather than objective because it does not specify the cutoff for what constitutes "minimal risk".



The rule is internally inconsistent. Since you have a right to be informed of and consent to any willful alterations to your own body or bodily chemistry, it is logically impossible to both waive informed consent  under any circumstances AND  " include appropriate safeguards to protect the rights, safety, and welfare of the human subject."




Personally, I think the main target of the new rule is genetic data, since it specifies "personally identifiable data or biospecimens". There is no such thing as a biospecimen that cannot be traced to a specific individual, thus identifying him or her, through the genetic data it contains. Even stool samples for a colon cancer screening can be traced to the individual, because it will contain some of their cells. Matter of fact, it's those cells they test for the presence of cancer.




That leads me to believe it is being tailored to testing for genetic treatments, like DNA/RNA gene therapy... like the recent covid "vaccines", but in no way limited to them. It could also include "clinical investigations" into new bioweapons that are tailored to kill people with a specific genetic marker - specific species, races, cultures, or populations. Chilling thought, no?




And it goes way beyond covid shots, although it IS limited to "clinical investigations", i.e. clinical trials on humans or investigations into new diseases among humans.


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