If proper data and safety monitoring had been done, the vaccine would very likely have been removed from the market by the late spring of 2021, prior to being considered for children under the age of 18. While Dr. Nass informs us that EUA swept aside OHRP, I believe we need much more detail as to how that happened, and how other elements of OHRP/IRB policies and practices developed over decades were swept aside.
I'm referring to the Office for Human Research Protections and Institutional Review Boards, and the way these entities interact.
I'm well aware that the foundational documents from which the Office for Human Research Protections developed the regulatory framework under which IRBs operate are the Nuremberg Code and the Belmont Report.
Under Emergency Use Authorization; the American people, in effect, became Phase III research subjects when it came to the mRNA vaccine.
EUAs were invented in 2005, possibly in order to force anthrax vaccines immediately after my group got the anthrax vaccine license revoked.
Something to keep in mind regarding the last paragraph above is that the mandates have historically been for vaccines that have completed all phases of the research process, and have been approved and licensed for use.
So the vaccines are not vaccines, they are "Countermeasures." Informed consent is not needed when you tell a soldier to go to the front and fight, and this was run the same way.
In addition to sweeping aside bedrock IRB principles regarding informed consent and bodily autonomy, the COVID vaccine pushers either never developed a Data & Safety Monitoring Plan, a standard practice when doing this type of research or did so, but never released the findings.
https://brownstone.org/articles/where-is-the-office-for-human-research-protections/
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