The Defender - FDA Makes It Official: Informed Consent Not Required for ‘Minimal Risk’ Studies
We should all have some questions and concerns. This new FDA rule obfuscates the detection and discovery of adverse events. And more.
Here are some distressing questions and answers about the FDA’s “minimal risk” rule. SHARE, SHARE, SHARE.
Who decides what constitutes “minimal risk”? Researchers and IRBs. This prevents human subjects from deciding for themselves whether to participate in research studies.
How can they know if a product has “minimal risk”? They cannot; It is disingenuously presumptuous to claim to know a pharmaceutical product or procedure comes with “minimal risk” prior to long-term outcomes determination.
How can people and parents know to sue a pharmaceutical company if they have been enrolled in a study without their knowledge if they cannot experience temporally linked causal association? They cannot. This rule obfuscates the detection and discovery of adverse events.
Where can I sign up for your summer course on informed consent? RIGHT HERE.
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Minimal? To who, not the enrolled patients that didn't know about it. Think of the STDs that they didn't treat. Minimal?
If informed consent is irrelevant when risk is arbitrarily deemed minimal despite no actual evidence of minimal risk, merely the opinion of the researcher/ regulator, then surely it opens the door to mandatory imposition of anything with "minimal" risks... right? I mean, informed consent was irrelevant for risks of Covid shots because of PREP and EUA so it's not much of a leap to assume that the government already has a half dozen ways to force anything on anyone at any time. It's on the horizon. They're merely releasing these ways one at a time so we get lulled into thinking we still have basic informed consent.