U regents back human research protection reforms

University of Minnesota regents on Friday backed a plan to better protect human research subjects.

The plan contains dozens of changes designed to strengthen oversight of research, increase ethics training for researchers, and ensure they gain patients' full consent before enrolling them in studies.

In one of the biggest changes, university researchers are now prohibited from taking money from companies while conducting research for them. Dr. William Tremaine, who led the team that drafted the report, told regents that restriction is fair.

"I think that's going to be threatening to some individuals that [say], 'This is my career,' and 'How can I keep doing what I'm doing?'" Tremaine said. "You can keep doing it. It's just you have to decide which path you want to take in terms of the money."

The changes will cost the university $5.5 million in one-time expenses and an additional $2.3 million a year. The reforms (.pdf) were prompted by a recent review that said the U wasn't doing enough to protect vulnerable research patients.

The university has been criticized for not having done enough to protect vulnerable patients such as Dan Markingson, who killed himself during a drug trial in 2004.

• FAQ: U drug trials, patient safety and the death of Dan Markingson

But Mike Howard, a friend of Markingson's mother, says the plan doesn't properly address how to keep researchers from improperly recruiting mentally vulnerable patients being held in hospitals.

"When people are on a 72-hour hold, or another involuntary hold, I mean they are highly coercive," he said. "So hopefully the U is going to find this out on their own as they start to progress."

President Eric Kaler said the U's research oversight boards will address that potential situation and could change policy.