FDA’s New Rule Allows for Medical Research Without Informed Consent

The Epoch Times ^ | 1/23/2024 | Amie Dahnke

[E. Pluribus Unum]

Studies cannot pose more than minimal risk to humans and must include appropriate safeguards to protect the rights, safety, and welfare of those involved.

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.

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.

“We anticipate this new rule will enable minimal risk research that would not be practicable to conduct otherwise,” Dr. Robert M. Califf, serving commissioner of Food and Drugs for the FDA, wrote on his FDA blog, “Catching Up With Califf.“ ”This could include studies comparing the effectiveness of approved products to determine which option works best for certain patients.” 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 fewer than 50 comment letters on the proposed rule from academia, institutional review boards (IRBs), public advocacy groups, industry, trade organizations, public health organizations, and citizens.

Most of the comments favored the agency’s efforts, supporting the rule because it reduced administrative burdens on both IRBs and researchers while encouraging valuable research on important health issues affecting the public without putting trial participants at risk, according to the FDA.

[nuke_road_warrior]

I don't think I will agree on big pharma/govt’s definition of “minimal risk”.

They're regulating clinical trials. How do you know there is "minimal risk" until the trials are over?

Paging Dr. Mengele.

[jeffc]

"This could include studies comparing the effectiveness of approved products to determine which option works best for certain patients.”

And how, exactly, does 'informed consent' prevent this?

Fedgov is not our friend, and they are not here to help...

[Elsie]

Yeah!

Even the UN doesn’t allow this!

[Elsie]

Do it to Julia!!

[Sirius Lee]

Freedom: When laws exist to protect a people from a corrupt government.

Tyranny: When laws protect a corrupt government from the people.

[Liaison]

With this new rule you may never know if the death of your loved one is from natural causes or some experiment they should never been apart of.

[mewzilla]

And Japan’s Unit 731.

But Big Med makes them all look like pikers.

[New Perspective]

Now they can legally give you a known placebo utterly worthless to treat your condition, make you pay for it resulting in no effective treatment.

These people are mentally deranged. All of them.

[momincombatboots]

Trump gave him the presidential commendation. Iowa is clear, lockdowns and big pharma experiments are exactly what they want. So the fda is just echoing what Trump gave the globalists.

[New Perspective]

Right out of Mao’s & Stalin’s game plans... That our ruling communists would even dare publicly propose this is a clear indicator of their power, of the serfs subservience, and of the long-term permanent future of this dark tyranny... Nowhere is there am American spokesperson willing to derail this freight train of tyranny... There are about 60-million migrant invaders, a DEI trained military, and powerful communist politicians who are prepared, willing, and enthusiastic for the chance to start killing all Americans who disagree...

Very well summed up, sad, but true.

[Elsie]

There are about 60-million migrant invaders; replacements - for the unborn that America CHOICED to death.

---

https://youtu.be/JA9PKK6NkG4

[PGalt]

Thanks for posting.

[grey_whiskers]

Obama’s “Life of Julia” or Orwell?

[G Larry]

The headline states the "new rule" allows them to violate that law.

I'm saying the violation is nothing new.

[grey_whiskers]

Get stuffed, neverTrumper.

[SecondAmendment]

Abortion = you are chattel.

[E. Pluribus Unum]

Abortion = Self-Inflicted Genocide

[Elsie]

I’m an old guy.

Don’t read much output from Dems or Libs.

Life’s too short.

[stylin19a]

The rule was issued in late December 2023 and went into effect on Jan. 22, 2024.

does that mean, when getting a transfusion, they don't have to tell you it comes from an HIV positive person ?

[E. Pluribus Unum]

As long as it is an experiment.