Posted on 02/21/2024 2:48:20 PM PST by ransomnote
[H/T mewzilla]
The U.S. Food and Drug Administration (FDA) has published a final rule on “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations,” which permits 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. We have summarized this rulemaking below, which mostly mirrors the proposed form of the rule, with the notable exception of codifying the “identifiable private information or identifiable biospecimens” criterion previously laid out in FDA guidance. The final rule is effective January 22, 2024.
MORE AT LINK: https://www.jdsupra.com/legalnews/fda-permits-irb-informed-consent-8699615/FDA has finalized its November 2018 proposal to provide the agency with the authority to permit an exception from informed consent requirements when the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject. The final rule adds Section 50.22, “Exception from informed consent requirements for minimal risk clinical investigations” to CFR Part 50, which permits an additional exception from the general requirements of informed consent for certain FDA-regulated clinical investigations when:
The investigation involves no more than minimal risk to the subjects;
The investigation could not practicably be carried out without the requested waiver or alteration;
If the clinical investigation involves using identifiable private information or identifiable biospecimens, the clinical investigation could not practicably be carried out without using such information or biospecimens in an identifiable format (see discussion below);
The waiver or alteration will not adversely affect the rights and welfare of the subjects; and,
Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
Recall that the head of the CDC(Walensky) and Anthony Fauci both produced promotional videos assuring pregnant women that the Covid 'vaccine' was 'safe and effective' and they knew (they lied) of no reason why they should not be given to pregnant women.By the standards demonstrated by our medical regime, all they have to say is 'they know of no reason' and then keep the toxic, deadly reasons from the public.
Consumer protections are being disregarded. Yet they claim the republicans are all about deregulation. This is the worst sort IMO
This is wrong on so many levels. I will be talking with my daughter who happens to specialize in contract law and get a small contract drafted that I will have my provider sign stating they will never include me in any such trials.
We know where this is going. And quickly.
Does "legally authorized representative" mean their lawyer or Estate administrator after the subject dies?
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