Panel: U of M needs more protections for research subjects

Updated 7:10 p.m. | Posted: 2:12 p.m.

A University of Minnesota advisory panel has recommended dozens of reforms to better protect human subjects in university research studies.

The draft plan released Monday comes after months of strong criticism over the way the university handles research patients who are mentally ill or otherwise vulnerable.

It would strengthen protections for patients by adding personnel, boosting training and increasing oversight. The changes would cost the university $5.5 million in one-time costs and an additional $2.2 million a year.

University bioethicist Steven Miles, a member of the panel, said he hopes the plan could become a national model.

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"Having taught medical ethics now for 34 years, I think ... this is possibly the most robust policy I've ever seen," he said.

Monday's report endorses recommendations made in February by the Association for the Accreditation of Human Research, which found weaknesses in the university's efforts to protect research subjects.

The report follows several reviews this year criticizing the university for lax protections and for enabling a culture in which some researchers have cut ethical corners. Previous reports have noted tension among some university psychiatry researchers as well as between some university psychiatrists and some Fairview Health Services caregivers at the university hospital where they practice.

Much of the scrutiny stems from the case of Dan Markingson, a mentally ill man who in 2004 killed himself while enrolled in a corporate-sponsored drug trial at the U. Critics, including prominent bioethicists, have suspected that researchers coerced Markingson into the experiment and ignored his mother's warnings that he might hurt himself.

A state legislative audit in March criticized the university's handling of the case. It also noted multiple potential conflicts of interest. Monday's report divides recommended steps into more than a dozen areas, but they focus on some main ones:

Oversight. The U wants to strengthen its oversight panels to ensure researchers are carrying out their experiments properly. The panels often have had a hard time finding enough people to serve on them, and have often lacked expertise they need to review experiments. And the U wants to boost membership by compensating members and making service on the boards "a valued activity." The report also suggests making sure the workload is low enough to ensure panelists can focus on the biggest concerns.

Consent. University leaders say a tougher consent process would help researchers understand how to deal with patients with mental illness and ensure they can better judge whether patients are capable of agreeing to enroll in a study. The report would also have researchers keep monitoring their patients to make sure they're still willing and able to participate. Whether researchers had properly obtained consent was a major question in the Markingson case.

Conflicts of interest. The report also takes steps to curb conflicts of interest that were a big concern in the Markingson case. It calls for more stringent reporting of income from sources such as drug companies. And with a rare exceptions, it prohibits researchers from receiving personal compensation from such companies while they're conducting research for them.

"That is clearly way above what's done in the United States," said Medical School Dean Brooks Jackson.

Culture. University leaders say the reforms also try to end the much-cited "culture of fear" in the Department of Psychiatry that has stifled attempts to improve protections. They say the plan addresses the problem not in one big change but in several different areas.

They say the system injects more checks and balances into the system of power. They also have proposals they say will enable nonphysicians — such as caregivers, family members and community representatives — to have more say in the research process. And the U will be offering physicians more education and training in ethics and the new standards.

Jackson said he is reviewing personnel changes as part of some "clinical transitions," but already leadership of the psychiatry department has changed.

Dr. Charles Schulz, a central figure in the Markingson case, recently stepped down as both head of psychiatry and executive medical director.

State legislative auditor Jim Nobles, whose March report on the Markingson caused a stir among some legislators, said the U's reform plan looked "very encouraging."

"I thought it was thorough," he said. "I thought it was deep. And I think they certainly show they understand the challenges and the problems."

Nobles said he hopes the university carries it through properly. He said he'll visit the U in the fall to see how things are going and wants to follow up in coming years.

But university bioethicist and critic Leigh Turner was more skeptical. Although university leaders such as Miles said the U's plan is tougher than its peers', Turner said he saw little that wasn't already done nationally. Many of the improvements, he said, were just common-sense moves.

He said the plan "has some potential to address some problems," and said "any signs of improvement are, in some respects at least, modest indications of progress."

But Turner said the plan doesn't solve enough, and that because of that, "I don't think this is going to bring concerns about oversight of human subjects research to a close."

The university hasn't released a timeline for the plan yet, but Jackson said he hopes to have most reforms in place in six to nine months.

The public can view the plan on the university's website and email comments through June 1. The Board of Regents is scheduled to vote on it at its regular meeting next month.

The panel drafted the reforms under the leadership of Dr. William Tremaine, a professor of medicine at Mayo Clinic College of Medicine. It included a dozen representatives of faculty, university administration and health care organizations.