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FDA’s New Rule Allows for Medical Research Without Informed Consent

re: The Epoch Times
re: statins

Real science is never settled, and anyone who has certainty on such things is not qualified to discuss it.

Maybe it’s a good thing but...

What could go wrong?

FDA’s New Rule Allows for Medical Research Without Informed Consent

2024-01-22

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.

...many researchers noted in their support that certain minimal-risk trials are nearly impossible to conduct if consent is required. One example includes the analysis of a retrospective records review; before the new rule, such a study required informed consent from the patients whose data were being studied. By being able to dig into such information, these researchers and the FDA argue they may be able to make medical advancements without sacrificing patient safety or rights.

...

WIND: who decides what is “minimal risk”? Isn’t that what was claimed about the COIVD Jab, which harmed so many? IMO, no one who got the COVID Jab ever had informed consent, because it was never tested properly let alone risks/benefits explained without grotesque viewpoint bias. That Rubicon has been crossed.

BTW, anyone who thinks data can be anonymized is either lying or uninformed or stupid. De-anonymization is a thing, and not hard to do. And the idea that it’s OK for anyone to have access to personal medical data without consent is outrageous, claimed anonymization or not.

In other words, at the very least, it’s a trust issue. And I don’t trust the ethically-challenged medical industry farther than I can shit.

The bought-and-paid-for follow the money schmucks at the FDA are not working for us; they’re working for Big Pharma and Big Food.

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