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FDA’s New Rule Allows for Medical Research Without Informed Consent
The Epoch Times ^ | 1/23/2024 | Amie Dahnke

Posted on 01/23/2024 7:17:41 PM PST by 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.

(Excerpt) Read more at theepochtimes.com ...


TOPICS: Constitution/Conservatism; Crime/Corruption; Front Page News; Government; Politics/Elections
KEYWORDS: bigpharma; civilrights; consent; donatedonaldtrump; donatefreerepublic; fda; getnoticed; healthcare; informed; informedconsent; mengelization
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To: All

When did they exchange the Hippocratic Oath for Hypocritical Oafs?

FdFDA


21 posted on 01/23/2024 8:20:36 PM PST by LegendHasIt
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To: sevlex

Satan will have plenty of fun with these people when they get to hell.


22 posted on 01/23/2024 8:23:06 PM PST by No name given (Anonymous is who you’ll know me as)
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To: E. Pluribus Unum

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...


23 posted on 01/23/2024 8:23:17 PM PST by SuperLuminal (Where is the next Sam Adams when we so desperately need him)
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To: E. Pluribus Unum

“”The study cannot pose more than minimal risk to humans””

So......sub-humans at the FDA get to decide just what constitutes a ‘minimal’ risk. If the ‘uninformed’ person just happens to be a MAGA supporter, or just believes in the Bill of Rights, then I’m sure the risk parameters are much higher. If one, or 10, or 100,000 happen to die....oh,well. It was done for science, dontcha know.


24 posted on 01/23/2024 8:28:08 PM PST by Ronaldus Magnus III (Do, or do not, there is no try)
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To: All

Damn butchers.

They align completely with Yuval Harrare (WEF’s main policy maker) in his speech today (or maybe yesterday) where he says we peasants have no rights, that our rights and our very lives are fantasies under the control of the elite.

https://www.youtube.com/watch?v=apikNPiZGLM


25 posted on 01/23/2024 8:30:00 PM PST by LegendHasIt
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To: null and void; aragorn; EnigmaticAnomaly; kalee; Kale; AZ .44 MAG; Baynative; bgill; bitt; ...

p


26 posted on 01/23/2024 8:50:20 PM PST by bitt (<img src=' 'width=30%>)
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To: rlmorel; ransomnote; mewzilla; SeekAndFind; Jane Long; metmom

Here is the link to the FDA blog:

https://www.fda.gov/news-events/fda-voices/increasing-options-clinical-research-facilitate-medical-product-development

There was another blog by Califf, on randomized controlled trials (RTCs).

I cant find it (hopefully some has it bookmarked), but there was a story about “scientists” trying to take down randomized controlled trials (RCTs) as the Gold Standard for research, in favor of “real world data.” The reason, per the story, was that for (I think it was) masks, RCTs revealed masks to be useless. But, by using RWD or real world evidence(?), “scientists” could rig the results, erm, have a clearer picture.


27 posted on 01/23/2024 8:50:38 PM PST by DoodleBob (Gravity's waiting period is about 9.8 m/s²)
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To: null and void; aragorn; EnigmaticAnomaly; kalee; Kale; AZ .44 MAG; Baynative; bgill; bitt; ...

p


28 posted on 01/23/2024 8:51:31 PM PST by bitt (<img src=' 'width=30%>)
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To: sevlex

✅✅✅✅✅


29 posted on 01/23/2024 8:56:33 PM PST by mabarker1 ( (Congress- the opposite of PROGRESS!!! A fraud, a hypocrite, a liar. I'm a member of Congress!!!)
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To: E. Pluribus Unum

The patients MUST know if they are being experimented on. It absolutely must be informed consent under all circumstances. Period.


30 posted on 01/23/2024 8:58:32 PM PST by metmom (He who testifies to these things says, “Surely I am coming soon.” Amen. Come, Lord Jesus…)
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To: E. Pluribus Unum

And we’re supposed to trust them to follow the rules.


31 posted on 01/23/2024 9:50:54 PM PST by roving (Deplorable Listless Vessel Trumpist With Trumpitis and a Rainbow Bully)
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To: E. Pluribus Unum
https://www.jdsupra.com/legalnews/fda-issues-final-rule-permitting-irb-9116244/

4. The waiver or alteration will not adversely affect the rights and welfare of the subjects. In the preamble, FDA explicitly declines to provide a definition of the “rights” or “welfare” of subjects and places reliance on the familiarity of IRBs with these concepts.

5. Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation. FDA does not provide clear examples of what such pertinent information might entail.

32 posted on 01/23/2024 9:57:36 PM PST by yelostar (Spook codes 33 and 13. See them often in headlines and news stories. )
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To: E. Pluribus Unum

And how do they define “minimal harm”? Can such a thing actually be quantified? What’s “minimal harm” to one person might not be so to another.


33 posted on 01/23/2024 10:05:05 PM PST by EinNYC
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To: E. Pluribus Unum
Don’t people in clinical trials have a right to be compensated?

How can they be compensated if they don’t know they’re involved in a clinical trial?

34 posted on 01/23/2024 10:19:01 PM PST by yelostar (Spook codes 33 and 13. See them often in headlines and news stories. )
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Any other way to throttle Leftism without killing it?


35 posted on 01/23/2024 10:30:36 PM PST by Gene Eric (Don't be a statist! )
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To: packagingguy

I noticed that too. Nobody can be forced to participate in experimental medical trials without informed consent. Nor can anyone be coerced or threatened, loss of employment. That is completely illegal, it’s in Title 18, USC.

“Rules”.


36 posted on 01/23/2024 10:46:20 PM PST by Freedom4US
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To: E. Pluribus Unum

Government would contend the experimental COVID vaccines were minimal risk. The people were not supplied information sufficient to give informed consent, and they were coerced into getting the shots. Our government is attempting to justify by regulation what it has already done.


37 posted on 01/23/2024 11:01:57 PM PST by csn vinnie
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To: metmom

Unfortunately, it’s not always done. I cannot say what happened but I will say it is not always done. I think some doctors are on something.


38 posted on 01/23/2024 11:19:33 PM PST by BipolarBob (My investment choice for 2024 is pre-ban menthol cigarettes. )
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To: All

This will excuse companies to introduce mRna nasties into what were otherwise normal and accepted vaxs. That is what this is all about. Expect stuff in your food supply as well. We must get everybody prepared for Disease X. Too many survived Covid 19 (it was just a trial run).


39 posted on 01/23/2024 11:22:22 PM PST by BipolarBob (My investment choice for 2024 is pre-ban menthol cigarettes. )
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To: packagingguy

Yeah, we’ll see it in court in a few years if Chevron isn’t shot down. If SCOTUS kills it, then this rule is pretty much null and void.


40 posted on 01/23/2024 11:36:04 PM PST by Tacrolimus1mg (Do no harm, but take no sh!t.)
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