Thursday, the Senate Higher Education and Workforce Development Committee heard two reports on research practices at the U of M. The reports, one of which was requested by Higher Education leaders in the legislature and the other requested by the U of M, went into specific detail around the case of Dan Markingson and his unfortunate death. The reports provided information about where the University had fallen short in its oversight and responsibilities for ethical human research and provided a series of recommendations for the U of M to explore going forward.
The case mentioned involved a man suffering from mental health issues, who was given the choice to participate in a drug study or to be placed in a psychiatric hospital. While taking part in the study, Markingson’s mental health deteriorated, and in the course of the study he committed suicide. The case brought much scrutiny around the research practices at the U of M, especially those studies involving human subjects. An initial round of reviews and investigations largely found the U of M’s practices were thorough.
The OLA report found that the U of M ignored serious ethical issues in its handling of the case. These findings include that Markingson was extraordinarily vulnerable when recruited into the initial study; numerous instances of conflict of interest were cited; Markingson’s mother’s concerns were not considered; he did not have an advocate with him when he agreed to participate in the study; the Institutional Review Board’s (IRB) review was superficial; the coordinator of the study was found to make significant errors; both administrators and regents responded to the case by dismissing the need for further review and ignored serious ethical issues; and a panel of experts who recently reviewed the U of M’s current human subjects protection program found significant and troubling problems.
The second report, the result of an independent investigation committed by the U of M, was intended to be forward looking. They identified opportunities to enhance components of the Human Research Protection Program (HRPP) with special attention to research that includes subjects at-risk for impaired decision‐making or who are otherwise vulnerable to coercion or undue influence. They also made recommendations to strengthen IRB review. The report also asserted that efforts to rethink organizational structure and lines of reporting will assist the IRB in its educational and compliance functions. These recommendations would require an appropriate investment in effort and resources will be required by the University and Medical School.
In response to the report, further legislation may arise to continue to strengthen the U of M’s research practices.