The FDA rule concurs with the Department of Health and Human Services regulation 45 CFR 46.116(f). This waiver or alteration of informed consent extends to 'biological products' which are a class of drug that include vaccines.

"The test article may be a drug (including a biological product), medical device, or electronic device," The University of Pennsylvania Health Research Protections Program said about medical research conducted without informed consent. Note that 'biological products' can include vaccines and 'electronic devices' can include implantable microchips and nanotechnology.

"Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins," the FDA said.

The Health Research Protections Program clarified what not requiring informed consent means. The practice is broken into two groups, 'alteration' and 'waiver' of consent.

"[Alteration] Permits adjustments to the informed consent process. The most common application is the use of deception, misinformation, withholding of pertinent information, or disclosing at a later time."

"[Waiver] There is no informed consent discussion and no informed consent documentation."

The Biden-era FDA rule amended a regulation to the Cures Act, allowing the nonconsensual medical experimentation. The rule was created on December 21, 2023 and went into effect January 22, 2024.

"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)," the federal register said. "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."