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The FDA has finalized a rule allowing certain clinical trials to operate WITHOUT obtaining informed consent from participants.
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.
Pushback against the new rule suggested the changes would allow institutional review boards (IRBs) to compromise on standards more and more, adding that the term “minimal risk” is far too vague and could be misinterpreted or abused.
Eliminating informed consent puts EVERYONE at risk.
Source: RogerHodkinson
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Author: Lioness of Judah Ministry
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