FDA eases informed consent requirements for minimal risk trials

[MsKreed 1,179]

I guess I recall one of my more "conspiracy-minded" acquaintances posting something about this back in December. Since the headline I recall seemed overly alarmist (something like "giving Big Pharma more freedom and removing patients' right to informed consent"), assumed it was fake news.  

I'd forgotten about it.....but lately have been seeing a flood of FB "sponsored ads" suddenly recruiting the general population for drug trials. 

So, I looked it up and it appears to be a real thing:

Quote

The US Food and Drug Administration (FDA) finalized a rule allowing Institutional Review Boards (IRBs) to waive or alter elements of informed consent for certain clinical trials that pose minimal risk to human subjects.
 
The rule, published on 21 December 2023, finalizes a proposal the agency issued in 2018 and implements provisions of the 21st Century Cures Act that gave FDA the authority to allow an informed consent exception for minimal risk clinical testing that includes human subjects safeguards and directed FDA and the US Department of Health and Human Services to harmonize their human subjects regulations (RELATED: FDA Proposes Changes to Informed Consent Rules, Regulatory Focus 13 November 2018).

Under FDA’s current regulations, informed consent exceptions are only allowed in certain cases, such as life-threatening situations, when certain emergency research requirements are met, and with a Presidential waiver for specific military operations. In 2017, the agency issued guidance advising informing and research sponsors that it would not object to waiving or altering informed consent requirements for certain minimal risk clinical trials. The FDA plans to withdraw the 2017 guidance once the final rule goes into effect in January 2024.

SOURCE

 

Considering the huge advertising push I'm seeing, the new rule must have really expanded research opportunities.....

Just in the last two days, I've seen these four: