1 Boring Old Man

March 16, 2015

WASHINGTON, D.C. – Public Citizen today called on the U.S. Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) to launch an investigation after a recent report revealed the University of Minnesota’s (UM) apparent failure to adequately protect human research subjects. In light of these findings, Public Citizen also calls on the Association for the Accreditation of Human Research Protection Programs (AAHRPP) to immediately rescind its accreditation of the human subjects protection program at UM.

The report was commissioned by UM through a contract with AAHRPP and prepared by an external review team comprising six experts.

“The alarming findings by the external review team echo some of the most serious instances of systemic failures of human subjects protections uncovered at major academic institutions over the past two decades,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group and formerly a senior official at OHRP. “These finding also appear to represent a clear danger to the rights and welfare of human subjects enrolled in medical research studies at UM.”

Among the findings, two things were most troubling.

First, the UM medical institutional review board (IRB) appears to lack appropriate expertise among its members for the research that it reviews. Under HHS regulations, when reviewing research protocol applications, there must be sufficient expertise among the members present at the meeting to make the determinations required for research approval.

The external review team documented that from October 1, 2013, through September 30, 2014, more than 300 research protocols were reviewed from departments including adult hematology, oncology and transplant, cardiology, surgery and neurology. However, there were no individuals on the IRB during this time period with expertise in any of these medical disciplines. Also, for 85 psychiatry research protocols reviewed during the same one-year period, the single IRB member who was a psychiatrist was absent from most meetings. When an IRB lacks a member with relevant expertise in a given area, it is allowed to invite an expert in that area to assist the IRB in the review of research. But the external review team was told that the IRB rarely brought in experts for consultations.

“As the expert external review team noted, failing to have members with adequate expertise during IRB deliberations ‘raises profound questions about the IRB’s ability to conduct a robust and reliable review,’” said Carome.

The second troubling finding was that when reviewing and approving research, the UM medical IRB appears to have failed to adequately assess the risk and benefits of the research. Under HHS regulations, the assessment of the risks-to-benefit ratio is one of the most important duties of an IRB. The external review team found that according to the majority of the minutes from meetings, there was little discussion of the risks and benefits to subjects.

“If the documented meeting minutes are correct, it would be very difficult to believe that there could have been a meaningful discussion of the risks and benefits and the steps that needed to be taken to protect human subjects,” said Carome.

The expert committee also found that the UM medical IRB gave inadequate attention to the process for informed consent, particularly with respect to the consent of individuals who were likely to have impaired decision-making capacity.

These findings not only raise the obvious question about human subjects’ safety but also raise serious doubts about the quality, reliability and meaningfulness of AAHRPP’s accreditation program.

“AAHRPP accreditation is supposed to indicate that a research organization follows rigorous standards for ethics, quality and protections for human research,” said Carome. “However, this is not the case at the University of Minnesota. The public deserves to know how AAHRPP failed to detect the serious problems at UM before accrediting it, and AAHRPP should act quickly to suspend the accreditation of UM’s human subjects protection program.”