The University of Minnesota has hired an outside organization to conduct a six-month review of its clinical research practices.
The Association for the Accreditation of Human Research Protection Programs, a nonprofit accrediting body, will run the inquiry on a proposed budget of $142,000.
University officials say it will manage a team of independent investigators that includes experts from Harvard Medical School and Johns Hopkins University.
The announcement today comes after a December resolution by the U’s faculty senate calling for a review of how the U treats its human patients in clinical trials. The resolution came amid lingering questions over the 2004 suicide of a patient, Dan Markingson, who was involved in a university drug trial.
Vice President for Research Brian Herman called the organization “the Good Housekeeping Seal of Approval,” and said the reviewers were among the world’s leading experts in the appropriate use of humans in clinical research.
“I think they’re an outstanding group to look at the questions we’ve asked them to look at,” he said.
But U of M bioethicist Leigh Turner said the questions are the heart of the problem for critics such as him.
He said the U doesn’t need a bland review of current practices, but a genuine investigation into cases such as Markingson’s. He and other academic critics from other universities have said previous inquiries have been weak.
Turner said an investigation “needs to look at particular allegations of research misconduct.”
Trudo Lemmens, a University of Toronto professor of health law and policy — who has been critical of the U’s handling of the Markingson case — echoed Turner’s concern in an email.
“People familiar with accreditation programs will agree that these are focused on paper work and procedures, not on what is happening on the ground,” he wrote. “What I find particularly troubling for an organization that states it aims to protect research subjects, is that it accepts in these circumstances to conduct an inquiry which excludes any reference to serious concerns that have been raised in specific cases. A credible organization should put its conditions on the table, and explicitly request a wider mandate that includes the elephant in the room.”
Lemmens also questioned the association’s independence, saying it already accredits the U and so has a “client-provider relationship.”
“It is clearly not in the organization’s interest to admit that its accreditation has done little to prevent serious problems, or that its accreditation procedures may have overlooked serious problems,” he wrote.
Hermann said that to his knowledge no one involved in the review has a conflict of interest.
The U says the panel will issue a public report, and it will recommend any necessary improvements to university practices. A university spokeswoman could not say when it will issue the report.