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 (DHHS) IRB regulations (known as the Common Rule: 45 CFR 46) that are administered by the Office for Human Research Protections (OHRP), the handling of the Covid shots over the past 3-4 years should raise red flags.
Currently, I am chair of an IRB at a private-not-for-profit outpatient healthcare agency that does research in which vulnerable populations are recruited. As such, I’m well aware that the foundational documents from which the OHRP developed the regulatory framework under which IRBs operate are the Nuremberg Code and the Belmont Report.
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 (mRNA vaccines) 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. Was the OHRP consulted for its input, and if not, did anyone from OHRP express concern? Given that these protections were put in place in response to medical atrocities (the Holocaust and the Tuskegee experiments), you’d think that they’d be sacrosanct. Think again!
While not providing a direct answer to the question I posed, Debbie Lerman’s posts, Covid mRNA Vaccines Required No Safety Oversight and Covid mRNA Vaccines Required No Safety Oversight: Part Two, and Sasha Latypova’s post, EUA Countermeasures Are Neither Investigational nor Experimental, provided a detailed roadmap as to the actions that were actually taken in implementing Emergency Use Authorization (EUA) for the Covid shot. To me, the most significant finding was that the legality of using EUA in civilian populations is rather tenuous, at best.
With the foregoing as a backdrop, let’s get into the nuts and bolts of the new FDA regulations, noting that in addition to being chair of an IRB, I am also a retired physician, who has been in the healthcare field for 50 years. This includes 19 years of direct patient care in a rural setting as a Board Certified Internist, 17 years of clinical research at a private-not-for-profit outpatient healthcare agency, and over 35 years of involvement in public health, and health systems infrastructure and administration. As such, I bring a breadth of training, knowledge, and experience to this matter that is fairly unique.
Hellbound and Down 