In 2015, the head of the University of Minnesota’s Department of Psychiatry stepped down over criticism of the treatment of human subjects in research.
This criticism came after the state of Minnesota conducted a legislative audit, finding that the University severely mishandled its treatment of a mentally ill man, Dan Markingson, who died by suicide during one of the school’s psychiatric drug trials in 2004. An outside review raised concerns about allegations of coercion during the trial.
Later, it was found that Dr. Ken Winters, a psychologist, falsified a legal document to get his study started prior to approval, which dealt another blow to human research.
These events raised serious concerns about psychiatric research with human patients, and left many wondering about ethics oversight at the University. Drawing national attention, it became imperative that the school act.
Since then, a series of actions were taken to ensure that patients’ needs during clinical trials were held as the priority and renewed focus was given to research ethics.
In a recent conference, held annually by the University after the death of Mr. Markingson, the school focused on discussing and overcoming the challenges facing human research. This conference also discussed the case of Robert Huber, a patient enrolled into the trial who also claimed to be coerced.
Though it is important for the University to hold discussions on improving human research trials, it’s imperative that they work with various bodies to ensure accountability.
Internal accountability measures within departments are subject to bias, and can sometimes result in overlooked ethics violations. We encourage the Department of Psychiatry to work formally with the Center for Bioethics and other University and national institutions to ensure that faculty conducting research are held accountable to the highest standards.
Furthermore, we also think that it’s imperative that there be a fluid platform where the Institutional Review Board, an ethical oversight committee that holds accountability and University researchers can work together. Fortunately, recent efforts at the University have also emphasized this idea.
A new system, titled the Ethical Oversight Submission System (ETHOS), will hopefully increase transparency and allow a highly fragmented and compartmentalized process to be more fluid. Northwestern University has reported important degrees of success utilizing a similar software to improve the efficiency of review and accountability procedures for ethics standards.
While ensuring ethics accountability is an ongoing process, the University’s current initiatives are a step in the right direction. The purpose of research is to help more patients — this doesn’t mean researchers can ignore the rights of patients enrolled in studies to achieve that goal. In this case, the ends don’t justify the means when dealing with patients. The University must strive to stringent ethics in order to ensure safety of all — and they must be held accountable, too.