According to an article in STAT https://www.statnews.com/2018/10/29/er-patients-given-ketamine-powerful-drugs-without-consent/?utm_source=STAT+Newsletters&utm_campaign=56d4d18dfb-Daily_Recap&utm_medium=email&utm_term=0_8cab1d7961-56d4d18dfb-118516237, a Minnesota hospital tested powerful antipsychotics and potent anesthetic on emergency room patients without their knowledge or consent. This is a violation of law say federal inspectors have determined.
According to FDA inspectors, the hospital’s Institutional Review Board contended that researchers did not need consent to make patients part of a clinical trial in which they were given antipsychotic drugs that they might not receive as part of usual care. A public citizen group responded that the hospital IRB, “appears to lack even a basic understanding of federal regulations for the protection of human subjects and is clearly incapable of fulfilling its obligation” to do so.
In August, FDA sent inspectors to the hospital. The FDA report, says STAT, examined additional clinical trials beyond those initially flagged. It found that in four, the hospital IRB “did not determine that informed consent would be sought from each prospective subject” as required by law, while in another five, the IRB granted fast-track review to studies that didn’t qualify for it.