…”Nurses on the psych unit did not even know if a patient was participating in a clinical trial”…
“Shockingly, experimental medicines were not documented on the MAR (med administration record) or inpatient chart. One staff nurse suspects that either the physicians administered the investigational meds when they rounded or the patients received the investigational meds when they were taken to an adjacent ambulatory center. This is unheard of in any trial I did, where drug accountability for investigational meds was akin to tracking narcotics. I’ve never worked in a unit where medicines weren’t charted. Again, it also makes monitoring for adverse events, critical to any study, impossible.
Possible HIPAA violations reportedly occurred—intake people at Fairview Hospital gave the psychiatry department information about admitting diagnoses without the patients’ consent, allowing coordinators to then approach the patient about clinical trials.”…
“Dr. Judy Stone writes about the serious problems at the University of Minnesota that the AAHRPP external reviewers ignored.”