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Letter to the NIH Regarding Serious Regulatory and Ethical Lapses in a Reckless Seizure Clinical Trial Funded by the Agency

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Public Citizen shared with the National Institutes of Health (NIH) its request to the Office for Human Research Protections and Food and Drug Administration for immediate investigations into the serious regulatory and ethical lapses in the design and conduct of the NIH-funded Established Status Epilepticus Treatment Trial (ESETT), which involved subjects with status epilepticus (life-threatening prolonged seizures) and was conducted without the informed consent of the subjects. We urged the NIH to promptly conduct an audit of all ongoing or soon-to-be-initiated NIH-funded clinical trials involving critically ill subjects and assess whether usual care clinical practices were rigorously characterized and appropriately incorporated into the design of these trials.

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