How did the FDA get around the laws mandating informed consent? From Robert W. Malone, MD, MS, at rwmalonemd.substack.com:
US Government political appointees and career employees knew very early, withheld the information, and blocked the minimal informed consent required by EUA
Some assert that the Cures Act is what enabled the US Federal Government to bypass informed consent regarding the gene therapy-based COVID vaccines.
Read that again.
“Except where it is not feasible, it is contrary to the best interests of such human beings, or the proposed clinical testing poses no more than minimal risk to such human beings and includes appropriate safeguards as prescribed to protect the rights, safety, and welfare of such human beings”
How does the FDA define minimal risk?
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
