Notes
The FDA simplifies experimentation on children without parental consent. By Sasha Latypova (09/18/24)
sashalatypova.substack.com/p/the-fda-si…
An FDA rule titled “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations” removing informed consent went into effect on January 22, 2024.
federalregister.gov/documents/2023/12/2…
Summary
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.
Removing or limiting informed consent is especially troubling for any age group, but it’s especially troubling when parents cannot make informed decisions for their own children to be experimented on by government.
Latypova rightly asks: “Who determines if the risk is “minimal”? The institutional review boards are just as captured and brainwashed as all other academia, government and healthcare. This is a very troubling development.”
She then explains that “The FDA has removed parental informed consent, making it easier to experiment on children without informing the parents.”
Parents should be warned that their kids basically could become experimental subjects:
The government can experiment on children receiving a public benefit or who are part of a state/local assistance program — without informing parents. For example, children participating in school lunch programs could be fair game.
The government can use data even after the children are no longer part of any government assistance program.
This is a very dangerous development!
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