Vulnerable patients confined on 72-hour emergency holds at the University of Minnesota hospital can no longer be recruited into research studies, an ethics panel has decided.
The change, which took effect this month, is part of a broader effort to improve ethics oversight and patient protections at the U, which has been criticized following the recruitment of a schizophrenia patient named Dan Markingson who died by suicide while enrolled in a drug trial in 2004.
Excluding patients on 72-hour hospital holds eliminates the potential for coercion — or even the appearance of coercion — of research subjects, said Dr. Brian Herman, the university’s vice president for research.
Such patients “are in a situation where they are highly emotional because they have been brought in and they are restricted in their ability to do things,” Herman said. “It could be viewed by some … that they weren’t necessarily completely of free will to make a decision about whether to participate” in research.
The university launched a research ethics overhaul in March and suspended patient recruiting for 17 psychiatric studies following two reports that criticized its Department of Psychiatry — an external review ordered by the U’s Faculty Senate and a preliminary investigation by the state legislative auditor of the Markingson case.
Markingson was diagnosed with schizophrenia in 2003 and died by suicide in 2004 while participating in a university study of three antipsychotic drugs.
He was recruited, while under court commitment order, by a university psychiatrist who was running a study, treating Markingson and advising a judge on the terms of Markingson’s commitment. State legislation has since prevented such a potentially coercive arrangement.
Herman said university leaders generally agreed to go a step further and also ban enrollment of patients under involuntary 72-hour holds. The policy also prevents recruitment of hospitalized patients during the 12 hours after their initial involuntary holds are lifted.
The new rules apply to 10 psychiatric studies whose patient recruitment was suspended but that have since received approval to continue, following a safety review by a private agency, Quorum Review IRB, which the university had hired.
“This was painful, but actually not as bad as I had feared,” said Dr. Kathryn Cullen, a child psychiatrist whose study of the drug ketamine for treatment-resistant depression had patient recruiting delayed by three months.
Six of the suspended studies weren’t reviewed, because the researchers were no longer seeking patients and had moved on to analyzing data or publishing the results, Herman said.
Quorum did raise concerns about a seventh study, and indicated that it would not approve it to resume patient recruitment. The study, which involved a drug that might reduce marijuana use in schizophrenia patients, was led by Dr. Charles Schulz, the Psychiatry Department chairman who stepped down in April.
Herman said that the concerns were manageable but that the study was withdrawn anyway because Schulz is retiring in December and no other researcher has stepped in to take it over.
An end to recruiting of patients under 72-hour holds — who are mostly psychiatric patients but could include others whom doctors believe will be at risk if they aren’t confined for treatment — is one of several changes underway.
The university is also broadening the number and composition of institutional review boards, which assess whether research protocols present any threats to patient safety. Herman said those steps are expected to take place next month.