Audit: Slow Reports Of Health Issues In University Research
ST. PAUL, Minn. (AP) — University of Minnesota researchers should report more quickly patients' serious medical issues during clinical trials, according to findings released Thursday by the state's legislative auditor that gives just the latest look at issues in the school's research practices.
The Office of the Legislative Auditors' report examined the school's last decade of industry-sponsored studies and found some researchers took as long as six months to report patient hospitalizations and, in some cases, submitted little information on adverse events during clinical trials.
Thursday's audit follows a scathing report earlier this year that found serious ethical lapses leading up to the 2004 suicide of a man enrolled in a university drug trial. The March report surrounding Dan Markingson's death triggered some major changes: The school temporarily halted its psychiatric drug trials, the longtime chair of the psychiatry department stepped down and, just this month, the university's governing board endorsed a wide-ranging new research ethics plan that bans scientists from accepting consulting fees from companies who sponsor their research.
In response to the legislative auditor's most recent concerns, Dr. Brian Herman, the university's vice president for research, pointed to the new ethics roadmap as a sign it's committed to improving.
Thursday's report notes that Markingson's suicide was the only death of a research subject while that person was participating in a research study that auditors discovered while reviewing 65 industry-sponsored studies between 2004 and 2014.
But the audit found researchers have too much leeway to decide what incidents should be quickly reported to an Institutional Review Board, a critical entity to protect human subjects during studies. For instance, the report notes a scientist could conclude a patient's hospitalization for suicidal thoughts was triggered by his or her condition — not the medication being studied — and therefore avoid reporting the issue immediately.
And the timing and thoroughness of those reports was a major issue for the legislative auditor. It found scant details on many medical issue reports, and 17 percent of the cases it reviewed didn't list a date of a medical incident. In one case, a patient's hospitalization for deteriorating schizophrenia symptoms wasn't reported for 10 months.
"In our view, some of these events should be reported to the board in a more timely manner and with more information," the auditor concluded.
Herman said some changes in the works will ensure that more information is collected sooner, but warned against "a different set of reporting requirements" that could be cumbersome for the university.
(© Copyright 2015 The Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten or redistributed.)
