In a Feb. 10 editorial entitled “Regents play innocent,” the Minnesota Daily criticized the Board of Regents for deciding not to launch yet another investigation into the tragic suicide of a young man who had participated in a research study at the University of Minnesota nearly seven years ago.
The editorial board accused the regents of undermining the University’s mission “to … search for the truth.” Ironically, the search for the truth suffered most at the hands of the Daily’s editorial.
The regents’ decision was based on a thorough review of the findings of previous investigations of this case. The editorial board’s position, in contrast, appears to be based on misinformation and questionable opinions. So as to restore some factual accuracy to the record I offer the following clarifications:
The Daily stated that “the University seems to think that because it was not liable in court for Markingson’s death, it did nothing wrong.” What the piece failed to mention were the other separate reviews of the Markingson case by non-University psychiatrists, the FDA and the Minnesota Board of Medical Practice. Not only did all conclude that no laws were violated, they also determined that proper care was provided and that there was no evidence of misconduct on the part of the University researchers.
The editorial states that “… the University made $327,000 from the study ... $15,000 of which came from recruiting … Markingson,” implying that a profit motive contributed to the University’s actions in this case. For the record it should be noted that the $327,000 paid to the University represents total reimbursement to cover the legitimate cost of conducting this particular clinical study. Contrary to the implication in the editorial, the University did not profit financially from participation or from patient recruitment.
Readers might also be interested to know that the protocol was designed by investigators at the University of North Carolina-Chapel Hill and that UNC served as the study coordinating center for more than 20 participating study sites across the country. The study protocol was reviewed and approved by each institution’s human subjects review board.
I also refute the assertion “that corporate research cash is more important to the University than patient safety and transparency.”
The University is steadfast in its commitment to the protection of all research subjects. The U’s Human Research Protection Program has been continuously accredited by the Association for the Accreditation of Human Research Protection Programs since this voluntary, national accreditation program was initiated. Following its most recent inspection, AAHRPP commended the program, again awarding it full accreditation.
The director of the HRPP, the Institutional Review Board chairmen and chairwomen, many IRB committee members and program staff are acknowledged leaders in the area of human subject protections. The University’s human research protection program is recognized as one of the best in the country, and its record speaks for itself.
There is one indisputable fact in this case — Markingson’s suicide was tragic.
There is also a common recognition that industry-sponsored clinical research often involves complex ethical and medical issues that deserve thoughtful consideration and management.
This is well articulated in the regents’ letter. In announcing their decision the regents encouraged the University community to “engage in a rigorous, open and honest exploration of these opportunities and challenges.” Rather than undermine the “search for truth,” the board’s letter reminds us of this core scholarly mission and directs us to it. The gravity of the Markingson tragedy deserves nothing less.
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