Clinical Trial Exposed Some Subjects to Substandard Care for Life-Threatening Prolonged Seizures Without Informed Consent
WASHINGTON, D.C. — A National Institute of Health (NIH)-funded clinical trial involving patients with life-threatening prolonged seizures was deeply flawed and must be immediately investigated, Public Citizen said today in a letter to the U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP) and the U.S. Food and Drug Administration (FDA) following an analysis of the trial.
A troubling account from the US that appears to illustrate that egregious ethical lapses are not confined to the past, the product of biases of the past or addressed by tough research ethics review arrangements.
“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,” said Michael Carome, director of Public Citizen’s Health Research Group and author of the letter. “These lapses are even more disturbing in light of the fact that subjects were enrolled without providing informed consent.”