Culminating a turbulent saga that began with the suicide of a research subject more than a decade ago, Minnesota Gov. Mark Dayton has signed into law a bill that gives the state unprecedented control and oversight of psychiatric drug research at the University of Minnesota.

The new law grants broad powers to the state Office of the Ombudsman for Mental Health and Developmental Disabilities to monitor the treatment of research subjects participating in drug trials at the university’s department of psychiatry.

“The ombudsman shall monitor the treatment of individuals participating in a University of Minnesota Department of Psychiatry clinical drug trial and ensure that all protections for human subjects required by federal law and the institutional review board are provided,” the law states.

According to the law, matters appropriate for review include unusual deaths or injuries of a research subject, reports of emergency use of manual restraint, and situations which may be unreasonable and unfair. It also empowers the ombudsman office to check into situations that are “unclear or inadequately explained, when reasons should have been revealed.”

Investigations and inquiries can be triggered by confidential complaints from any source about a research subject or a clinical drug trial.

“The university shall not retaliate or take adverse action against any person who in good faith makes a complaint or assists in an investigation,” the law states.

If an investigation finds lax compliance with federal protections of human subjects or with the requirements of the university IRB, the ombudsman may recommend corrective action be taken by the university and the state Board of Regents.

It is not clear whether there is another such arrangement in the country, and in responding to IRB Advisor the university called it “new and quite novel.” Having unsuccessfully fought the law, the university issued the following statement in response to our request for comment:

“The University of Minnesota is committed to upholding the highest ethical standards in research practices involving human participants. We continue to report monthly to the legislature on the progress in implementing our work plan to improve research with human participants across the entire university. An early review of our progress by the Office of the Legislative Auditor issued in May [2016]1 said our reform plan is ‘ambitious and far reaching,’ and that ‘we think it will significantly strengthen protections for human subjects research’ if fully implemented and sustained. We look forward to sharing our progress with the Ombudsman for Mental Health and will provide them with the information they may request on pharmaceutical trials in the Department of Psychiatry. Although the arrangement under the law is new and quite novel, we have no reason to anticipate disruption to ongoing or future research projects.”

The state ombudsman office had no comment on the development, but Carl Elliott, PhD, a professor in the Center for Bioethics at the university, welcomed the news after having previously testified in state hearings that the oversight was needed.

“It’s happening and I’m glad it is,” he tells IRB Advisor. “I went over there and testified and pushed as hard as I could to get it passed.”

Arguing that the university was reluctant to enact reforms, Elliot and other university critics called for oversight by an outside agency to finally resolve continuing questions about the safety of research in the psychiatry program.

To that end, the resulting language of the law indicates the oversight will be far from cursory, with the onus on the university to report the death of a research subject to the ombudsman office within 24 hours.

We will never know if having the full provisions of this new law in place in May 2004 could have prevented the suicide of Dan Markingson, a 27-year-old aspiring screenwriter who had a mental breakdown and was enrolled in a University of Minnesota psychiatric drug trial under somewhat dubious circumstances. He faced commitment to a state psychiatric facility if he declined to participate in the drug trial, according to a state auditor’s report.2 In 2009, the Minnesota legislature passed a law restricting the enrollment into drug trials of persons under a stay of commitment.

Markingson was extremely vulnerable when recruited into the study, his mother expressed strong concerns about it, and later warned after he was enrolled that he was not improving, according to the report. His subsequent suicide occurred in the bathroom of a state-licensed group home for people with mental illness. A spate of lawsuits, investigations, and reports of university progress or lack thereof took on a life of their own in the aftermath, as the suicide metastasized into an indictment of leadership at the university and the state Board of Regents.

Will this new oversight arrangement finally free the university from the long shadow of the Markingson incident? One thing is clear: The powers now granted to the state suggest that no research incident of any significance could be shielded from full scrutiny for very long.

Within the scope of the law’s intention, the ombudsman office has the power to gather records related to psychiatric clinical drug trials at the university and issue subpoenas to move investigations forward.

“If the records are private and the client is capable of providing consent, the ombudsman shall first obtain the client’s consent,” the law states. “The ombudsman is not required to obtain consent for access to private data on clients with developmental disabilities. The ombudsman is not required to obtain consent for access to private data on decedents who were receiving services for mental illness, developmental disabilities, or emotional disturbance.”

The subpoena power means in the wake of an adverse incident, ombudsman investigators can demand the appearance and compel testimony by those involved in psychiatric drug research.

However, with appropriate political acumen, the law secures a potential loose cannon securely to the deck by requiring the ombudsman to report all findings to the governor before any release of information.

The law also calls for a “Medical Review Subcommittee” — which already exists at the ombudsman office, but may be appointed separately as described in this law — to determine whether the death of a research subject is “unusual” and warrants investigation.

If so, the medical review panel can review the causes of the death and request an autopsy. They would then submit a report regarding the death to the ombudsman, the client’s next of kin, the facility where the death occurred and, if appropriate, make recommendations to prevent recurrence of similar deaths to all appropriate parties.

REFERENCES

  1. Nobles, J. Office of the Legislative Auditor. Protections for Human Subjects in Research Studies at the University of Minnesota Department of Psychiatry: A Preliminary Assessment of Reforms. May 16, 2016: http://bit.ly/1YbaxHe.
  2. Nobles, J. Office of the Legislative Auditor, State of Minnesota. A Clinical Drug Study at the University of Minnesota Department of Psychiatry: The Dan Markingson Case. Special Review: March 19, 2015: http://bit.ly/1xjI5IB.