The Loosening Of Rules On Informed Consent

On January 22, 2024, amendments to the Food and Drug Administration (FDA) regulations (21 CFR 50) covering Institutional Review Boards (IRBs) were finalized and implemented. The amendments added a new section 50.22 that allows for exceptions to informed consent requirements for minimal risk research. 

While the addition of section 50.22 harmonizes FDA IRB regulations with the Dept of Health and Human Services IRB regulations that are administered by the Office for Human Research Protections, the handling of the Covid shots over the past 3-4 years should raise red flags.

Back in October 2023, my first Brownstone post, Where is the Office for Human Research Protections, asked the question as to how the approval of a Phase 3 research pharmaceutical product could be done without the formal involvement of IRBs.

Specifically, the Nuremberg Code, covering informed consent, and the Belmont Report, covering among other elements, bodily autonomy, which are foundational to oversight of human subject research, and the requirement for a data and safety monitoring plan were completely discarded.

A) Research involving human subjects conducted or supported by the Department of Health and Human Services, or other federal departments or agencies that apply the Federal Policy for the Protection of Human Subjects to such research; and/or.

Not one of the comments mentioned exceptions to informed consent in the context of research involving a pharmaceutical product.

All it takes is for IRBs to insist that any research project involving a pharmaceutical product must include informed consent; with no exceptions. 

https://brownstone.org/articles/the-loosening-of-rules-on-informed-consent/