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Petition to the FDA to Initiate Disqualification Procedures Against Hennepin County Medical Center Researchers and IRB for Unethical High-Risk Clinical Trials

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Public Citizen petitioned the Food and Drug Administration (FDA) to initiate disqualification proceedings against two researchers at Hennepin County Medical Center (HCMC) in Minneapolis, Minn., for repeatedly and deliberately violating agency regulations intended to protect human subjects when they conducted a series of high-risk clinical trials without obtaining the consent of the subjects. The petition also asked the FDA to take similar action against the HCMC institutional review board (IRB) for violating federal human subjects protection regulations by approving these trials without ensuring that informed consent requirements for such experiments were implemented.

November 17, 2021, FDA acknowledgment letter.

April 18, 2022, FDA final response letter.

See Public Citizen’s other work on ethics and clinical trials.