No more research recruits from medical hold

Officials made the change after discussions around recruiting from 72-hour involuntary holds.

by Christopher Aadland

As part of the University of Minnesota’s research ethics overhaul, the University has banned the recruitment of patients confined under involuntary medical holds.
The change, which took effect in August and appeared in the University’s required September update to the state Legislature on its progress updating human subject protections, prohibits researchers from recruiting patients held in 72-hour medical holds into psychiatric studies. 
The move comes amid an additional 60 changes scheduled for implementation by June to better protect human research subjects.
Though the new policy wasn’t originally part of the 60 changes, continued discussions around the issue prompted it, said Dan Gilchrist, communications director for the University’s Office of the Vice President for Research.
He said the policy change is meant to protect vulnerable patients in 72-hour hospital holds from coercion or the appearance of coercion to enroll in a drug study — issues that multiple reports raised earlier this year. 
“Some people would say that it doesn’t look like a person in that state, being held, can consent,” Gilchrist said. “We decided that we want to create an [Institutional Review Board] and human research protection program that is going to be above and beyond,” adding that the change will impact a small number of researchers.
Still, Leigh Turner, an associate bioethics professor and longtime critic of the University’s reaction to research ethics concerns, said the school should answer additional questions about its recruiting practices. 
In a letter to state legislators last month, he said the University should disclose the number of patients who were recruited when in an emergency or involuntary hold and whether the school’s IRB was aware of the practice. 
“Universities are supposed to have mechanisms to conduct these kinds of investigations,” Turner said. “I’ve been here long enough to worry about the integrity of any investigation actually conducted by the University.”
At least one human subject whom researchers recruited from an involuntary hold participated in a University study. 
In 2009, legislators outlawed enrolling patients in studies who are under a stay of commitment. The move followed the 2004 suicide of Dan Markingson, a man who was enrolled in a University drug trial at the time of his death and recruited while in a stay of commitment. 
The University launched the revamp of its Human Research Protection Program after more than a decade of scrutiny and a series of critical reports released earlier this year raised questions about its research ethics and revealed flaws in how it protects research subjects.
The University’s required September report to the state Legislature listed the 72-hour medical hold policy change.