Just a quick refresher course here. In 2009, over five years after Dan Markingson was recruited into a drug study at the U while under a civil commitment order, the state legislature passed "Dan's Law." That rationale behind the law was this: it is very difficult, if not impossible, for psychiatric patients to give truly voluntary consent for a research study if they are involuntarily confined to a locked psychiatric unit. The same goes for patients under a "stay of commitment," which would return them to a locked unit if they disobeyed their psychiatrist. Dan's Law made it very hard for Minnesota psychiatrists to recruit patients into drug studies while they are under civil commitment orders.
But Dan's Law had a loophole. It said nothing about patients under a 72-hour hold. These patients are also confined to locked units, often for psychiatric reasons, but they are not under civil commitment orders. A psychiatrist hold a patient for 72 hours without getting a commitment order.
This is what happened to Robert Huber in 2007. Stephen Olson recruited Mr. Huber into the disastrous bifeprunox study while he was confined to a locked unit at Fairview under a 72-hour hold. Yet the U has repeatedly refused to concede there was anything wrong with this.
Which brings up today's development. The governor has just signed legislation that prohibits the recruitment of psychiatric patients under a 72-hour hold. You can see a summary of the bill on this page, under number 120.
The amendment reads in full as follows:
(d) A patient must not be allowed or required to consent to nor participate in a clinical drug trial during an emergency admission or hold under this subdivision or subdivision 2. A consent given during a period of an emergency admission or hold is void and unenforceable. This paragraph does not prohibit a patient from continuing participation in a clinical drug trial if the patient was participating in the drug trial at the time of the emergency admission or hold.
There was some preliminary news coverage of the issue two weeks ago when the bill passed the Senate.