Drudge Retort: The Other Side of the News
Saturday, March 30, 2024

On the 21st of December 2023, as we were frantically preparing for the festive season, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) issued a final ruling to amend a provision of the 21st Century Cures Act. This allowed ... an exception from the requirement to obtain informed consent when a clinical investigation poses no more than a minimal risk to the human subject ... This ruling went into effect on January 22nd, 2024, which means it's already standard practice across America.


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Wow this is authoritarian.


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Yeah, we all live in Red China.


#1 | Posted by LegallyYourDead at 2024-03-31 11:09 AM | Reply

Yeah, it would be great if Americans were assured bodily autonomy. Dobbs put an end to that pipe dream.

#2 | Posted by truthhurts at 2024-03-31 11:16 AM | Reply | Newsworthy 1

I will say having participated a study a while ago that informed consent even then was somewhat of a joke. Yes they spelled out potential side effects but included parts about some unexpected side effects. Also unless you are a medical expert you can get pretty lost in all the information on the roughly 60 pages I had to sign/initial.

I still don't agree with the ruling as informed consent should be trying to push towards making the informed part more not less accessible to patients but I also don't see where for most people in studies this will make a significant difference.

#3 | Posted by TaoWarrior at 2024-03-31 11:44 AM | Reply

"informed consent"

Latin for I break, you fix.

#4 | Posted by Danforth at 2024-03-31 11:47 AM | Reply

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