Letter to the OHRP and FDA Calling for Investigations into Serious Regulatory and Ethical Lapses in a Reckless Seizure Clinical Trial Funded by NIH
View list of hospitals that enrolled subjects in ESETT
Public Citizen called on the Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA) to immediately investigate the National Institute of Health (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. The troubling flaws in ESETT’s design exposed some of the subjects to unacceptable and avoidable risks and thus violated regulatory and ethical norms for human research.
June 8, 2021, OHRP acknowledgment email.
July 7, 2021, FDA acknowledgment email.
December 6, 2021, FDA final response letter.
See Public Citizen’s other work on ethics and clinical trials.