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(US) Federal Agencies Must Investigate Serious Regulatory, Ethical Lapses in Reckless Epilepsy Clinical Trial Funded by NIH – Public Citizen (June 2021)

Posted by Dr Gary Allen in Human Research Ethics on July 24, 2021
Keywords: Beneficence, Clinical trial, Ethical review, Human research ethics, Institutional responsibilities, International, Justice, Medical research, Protection for participants, Respect for persons

The Linked Original Item was Posted On June 8, 2021

A hand carefully removing a block, with the word "ETHICS" printed along it, from a pile of bricks

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.

For the Established Status Epilepticus Treatment Trial (ESETT), researchers in emergency departments at 58 hospitals across the U.S. enrolled 462 children and adults suffering an episode of status epilepticus — a seizure lasting longer than five minutes — that had not resolved after standard initial treatment with a benzodiazepine and randomly assigned them to receive one of three FDA-approved seizure medications intravenously: levetiracetam, fosphenytoin, or valproate. The goal was to determine which of the three drugs would result in better seizure resolution and responsiveness within 60 minutes after initiation of the assigned drug.

“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.”

Federal Agencies Must Investigate Serious Regulatory, Ethical Lapses in Reckless Epilepsy Clinical Trial Funded by NIH - Public Citizen
WASHINGTON, D.C. — A National Institute of Health (NIH)-funded clinical trial involving patients with life-threatening prolonged seizures was deeply flawed and…

Related Reading

(US) Participants In Rogue Herpes Vaccine Research Take Legal Action – KHN (Marisa Taylor | March 2018)

The Dying Scientist and his Rogue Vaccine Trial – Wired (Amanda Schaffer | May 2018)

(US) FDA Launches Criminal Investigation Into Unauthorized Herpes Vaccine Research – KHN (Marisa Taylor | April 2018)

University Under Fire For Off-The-Grid Herpes Vaccine Experiments – Kaiser Health News (Marisa Taylor | January 2018)

Years before Heading Offshore, Herpes Researcher Experimented on People in U.S. – Scientific American (Marisa Taylor | November 2017)

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