Ombudsman for Mental Health implements oversight of Psych Department drug trials

Complaints can now be filed directly with the state.

Kevin Beckman

Participants in psychiatric drug trials at the University of Minnesota that have complaints now have a direct line to the state ombudsman for mental health and developmental disabilities.

A law passed last year authorizes the state’s ombudsman to monitor individuals enrolled in clinical drug trials in the University’s Department of Psychiatry, which was marred by the death of a clinical trial participant more than a decade ago. Legislators and experts praised the law as a way to alleviate concerns that clinical trial participants may have.

“People are glad that it’s there,” said co-author of the bill, Rep. Connie Bernardy, DFL-New Brighton. “People who don’t have a voice have a voice now and an advocate for them to help themselves or their family member.”

Under the statute’s provisions, the ombudsman will gather records related to clinical drug trials and ensure that the psychiatry department is complying with federal law and Institutional Review Board mandates with regards to protecting human subjects.

The legislation also requires the University’s Board of Regents to reimburse the ombudsman for any oversight costs.

Psychiatry department head Sophia Vinogradov said she and Vice President for Research Brian Herman met with Ombudsman Roberta Opheim earlier in the fall to set up an oversight plan and that the three assessed the best ways of going forward.

“Our role is going to be … to receive any kind of complaints that an individual who’s enrolled in a drug trial might have so they have access to somebody not attached to the University,” Opheim said. “That doesn’t mean we wouldn’t hope that they don’t first try to work through their grievance or problem with the University, but it’s not required that they do that if they feel very strongly that they need to report it outside the University system or they feel they’ll be retaliated against.”

Opheim said the ombudsman’s office will distribute information to each research participant to make sure they know they can contact the office with a complaint.

“They have a right to make a confidential report to us,” she said. “And then, based on the program, we would make an effort to resolve that between the study participant and the lead investigator or … whomever the grievance is about.”

Based on the type of complaint the office receives, actions might include a mediated discussion between the researchers and the participant, more education for the participant or increased education on the research program in the future, Opheim said.

“The very last resort would be more of a whistle-blower role if we feel we can’t get any satisfaction,” she said. “But I don’t anticipate that being [the case]. There’s been open cooperation between our agency and the University trying to get this off on the right track.”

Psychiatric drug studies were halted in the spring of 2015 following harsh reports from the state legislative auditor and an externally managed review. Opheim said the oversight plan will develop more when research starts again.

“It’s really in the early stages until they get up and running with their research programs again,” she said.

Current and former members of the University’s IRB said the law was necessary and a step in the right direction towards adequate protection of human research subjects.

“I’m hopeful that having them in there as oversight that the investigators are doing what they’re supposed to do to protect patients and research participants,” said Niki Gjere, an IRB member. “It’s the first time that we’ve actually had somebody have the authority to go in there and actually oversee what’s happening.”

University bioethics professor and former IRB member Carl Elliot expressed similar hopes that the ombudsman’s office will help keep the psychiatry department on track.

“I think that [the office of the ombudsman] will have the trust of patients in a way that University authorities won’t,” Elliot said. “I think the U still has a long way to go. I don’t think that these things are going to by any stretch fix things, but they’re at least small, positive steps in the right direction.”

Opheim said the oversight will continue until the legislature says it isn’t necessary anymore, but there is no end date in the statute.