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The War Against Human Health: The eroding medical ethics

The War Against Human

In what they say was an effort to encourage the discovery of more treatment and diagnostic options in the medical field, the US Food and Drug Administration (FDA) has finalised a few days ago, a new rule allowing certain clinical trials to operate without obtaining informed consent from participants.

They say that the mitigatory factor is that 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. Now, the FDA initially proposed the rule in November 2018, permitting an institutional review board to waive the requirement for informed consent under certain conditions.

The agency received comment letters on the proposed rule from academia, institutional review boards (or IRBs), public advocacy groups, industry, trade organisations, public health organisations, and citizens.

It appears that many see this measure as an improvement to safety of clinical trials.

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