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FDA Informed Consent Waiver Allows Your Blood, Genetic Data, and Personal Health Information to Be Taken Without Your Knowledge
Rule has been effective since January 2024.
In a move that raises significant ethical and privacy concerns, the U.S. Food and Drug Administration (FDA) in January 2024 finalized a rule permitting Institutional Review Boards (IRBs) to waive or alter informed consent requirements for clinical investigations deemed “minimal risk.” ...
Effective since January 22, 2024 and buried in regulatory jargon, the FDA’s waiver rule effectively grants pharmaceutical companies, government agencies, and other organizations the ability to access and use Americans’ private health data, including blood and genetic material, without their consent or knowledge.
The implications are staggering.
Under this waiver, any person’s health data, biospecimens (such as blood or tissue samples), or medical records can be accessed and used for FDA-regulated research if it meets vague and highly subjective criteria.
https://www.cchfreedom.org/hipaa-the-deliberate-deception/