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Letter to the HHS Acting Assistant Secretary for Health Regarding the Unethical iCOMPARE Trial

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Public Citizen and the American Medical Student Association request an urgent meeting with the Department of Health and Human Services’ (HHS) Acting Assistant Secretary for Health and the Director of the Office for Human Research Protections to discuss OHRP’s failures to suspend the unethical iCOMPARE trial and to launch an investigation into the research. In light of the increasingly overwhelming evidence of widespread, serious ethical and regulatory violations involving the trial, a decision by OHRP to not initiate a formal for-cause compliance oversight evaluation of all institutions participating in this unethical trial would constitute an unacceptable abuse of the agency’s discretion and an abrogation of its fundamental responsibility to protect human subjects.