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"Informed consent to medical treatment is fundamental in both ethics and law. Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care. Successful communication in the patient-physician relationship fosters trust and supports shared decision making.That was then.
The process of informed consent occurs when communication between a patient and physician results in the patient's authorization or agreement to undergo a specific medical intervention."
"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This final rule allows 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. The final rule permits an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations."Branch COVIDians surely don't care about any of this, as they gave up long ago exercising their former right to be fully informed of medical experimentation risks anyway. In fact, they brag about their ignorance and apathy and doglike obedience as if they are virtues.
Peter Marks, the FDA's vaccines lead, told STAT the agency reached its decision after a recent review of the data on the vaccine revealed another person in this country had died after receiving it — the ninth such death — in the first quarter of the year.Nine deaths.
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"If we see deaths and there is an alternative vaccine that is not associated with deaths but is associated with similar efficacy...we felt it was time at this point to make a statement on the [product's] fact sheet that this was not a first-line vaccine," said Marks.
With one death for every 2 million doses given in this country, the FDA decided that is a risk most people don't need to take, Marks said.
Comment: See also: