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FDA Waives Informed Consent? – Intercessors for America



I Prayed

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Father, we’re concerned about the inability of federal agencies to protect us from medical harm. Show us how to pray about this, and reveal what we should know.

Certain medical trials with “minimal risk” no longer require informed consent from patients. But what is minimal risk, and who will determine it? 

From The Epoch Times. 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.

Talk about issues like these on The Community.

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. …

A Road Toward Eroded Trust?

Much of the pushback against the new rule suggested the changes would allow IRBs to compromise on standards more and more, adding that the term “minimal risk” is too vague and could be misinterpreted or abused. The result would be decreased public trust in research and health care providers. …

Minimal risk, as defined by the FDA, means the likelihood of experiencing harm or discomfort is not greater for a subject during a study than for them during everyday tasks. In other words, there’s minimal risk in nearly every activity, from walking to putting away the dishes to picking the kids up from school; the study’s risk cannot exceed the risk one experiences daily. …

What do you think? Share this article to raise awareness of this new rule.

(Excerpt from The Epoch Times. Photo Credit: fotostorm/Getty Images Signature via Canva Pro)

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