The Briefing Room

General Category => Health/Education => Topic started by: mountaineer on January 25, 2024, 01:27:31 pm

Title: FDA Final Rule: IRB Waiver of Informed Consent for Minimal-Risk Investigations
Post by: mountaineer on January 25, 2024, 01:27:31 pm

January 24, 2024
FDA Final Rule: IRB Waiver of Informed Consent for Minimal-Risk Investigations
Jones Day (https://www.jdsupra.com/legalnews/fda-final-rule-irb-waiver-of-informed-4444762/)

Quote

The Food and Drug Administration ("FDA") expands informed consent exceptions with a final rule permitting institutional review board ("IRB") waiver or alteration of elements for certain FDA-regulated minimal-risk clinical investigations.

On December 21, 2023, FDA issued a final rule providing an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. This rule permits an IRB to approve an informed consent procedure that waives or alters certain informed consent elements or waives the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal-risk clinical investigations—provided the IRB has found and documented five criteria consistent with the revised Federal Policy for the Protection of Human Subjects ("Common Rule"). ...

The final rule requires an IRB to find and document five Common Rule criteria in order to permit a waiver or alteration of the informed consent requirements: 

    The clinical investigation involves no more than minimal risk to subjects;
    It could not practicably be carried out without the requested waiver or alteration;
    If the clinical investigation involves identifiable private information or identifiable biospecimens, it could not practicably be carried out without using such information or biospecimens in an identifiable format;
    The waiver or alteration will not adversely affect subject rights and welfare; and
    Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation. 

The final rule takes effect on January 22, 2024.

Title: Re: FDA Final Rule: IRB Waiver of Informed Consent for Minimal-Risk Investigations
Post by: mountaineer on January 25, 2024, 01:28:51 pm

Champagne Joshi
@JoshWalkos
Just so you know the FDA and HHS made it so that “informed consent” could be waived by IRB’s. The new rule went into effect two days ago.
(https://pbs.twimg.com/media/GEpdw0PW4AAZIoc?format=jpg&name=900x900)
7:27 PM · Jan 24, 2024

You should really take the time to read the convoluted reasoning they employ in response to the critical comments submitted. Basically they say that in certain situations informed consent could f**k up our plans so we have to be able waive it.
https://twitter.com/JoshWalkos/status/1750314508692726200

Title: Re: FDA Final Rule: IRB Waiver of Informed Consent for Minimal-Risk Investigations
Post by: mountaineer on January 26, 2024, 07:01:27 pm

While Everyone Has Been Focused On Texas The FDA Has Just Removed Informed Consent From Anything They Deem “Minimum Risk”
Without Any Politician Voting On It, The FDA Just Forced All Americans To Be Big Pharma Lab Rats
https://twitter.com/WallStreetApes/status/1750749039845576987

Title: Re: FDA Final Rule: IRB Waiver of Informed Consent for Minimal-Risk Investigations
Post by: Smokin Joe on January 27, 2024, 03:05:03 am

This violates the Nuremberg Code.

Now, anyone can be a Tuskegee lab rat.