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New US regulations on disclosure of genetic risk in drug trials by Dec 31, 2025?
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Resolution / Starting Odds
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Official announcements from the FDA or US government
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Alzheimer's Drugmakers Withheld Genetic Risk Information from Trial Participants and Families
Oct 24, 2024, 01:44 AM
Alzheimer's drugmakers did not inform trial participants and their families that genetic tests showed they were at high risk for brain bleeds. Participants were required to sign consent forms acknowledging the risk of brain injuries due to certain genetic profiles and that they would be tested, but the results were not disclosed to them. This has raised ethical concerns and questions about the role of private-equity backed IRB boards in the trials. One observer noted, 'It’s not even a matter of ethics, it’s a matter of common sense.'
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Warning issued • 25%
Recall issued • 25%
Investigation initiated • 25%
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Centers for Medicare & Medicaid Services (CMS) • 25%
Food and Drug Administration (FDA) • 25%
Department of Health and Human Services (HHS) • 25%
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