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Dr. Mark S. Dacey, a clinical investigator in Denver, Colorado, failed to obtain informed consent from human research subjects in accordance with 21 CFR Part 50 during the conduct of at least two investigational drug trials. An FDA inspection of his clinical site conducted between October 23 and November 8, 2024, identified violations of the Federal Food, Drug, and Cosmetic Act and regulations governing clinical investigations and human subject protection. The investigator did not adhere to the informed consent requirements mandated by 21 CFR 50.20, which requires that no human subject may participate in FDA-regulated research without legally effective informed consent from the subject or their authorized representative.