U of M's human research re-accreditation on hold

University of Minnesota's Human Research Protection Program has been placed under pending accreditation status following a report on the university's research policies on human subjects.

The decision on the re-accreditation comes seven months after an external review panel commissioned by the university found "many weaknesses" in the U's efforts to protect people who participate in research experiments.

"This is not going to change anything in and by itself," said Dan Gilchrist, communications director for the U of M's office of the vice president for research. "We're already engaged in a larger plan to strengthen and improve our human research participant protections program at the university."

The university's human research program has come under scrutiny over the death of Dan Markingson, a mentally ill man who committed suicide in 2004 while participating in a university study of an anti-psychotic drug made by the pharmaceutical company AstraZeneca.

The U of M's Human Research Protection Program was accredited in April 2004, a few days before Markingson killed himself.

For the university to move to full accreditation, it must implement several changes to its policies, such as responding to the concerns of research subjects. Gilchrist said the U will send four quarterly reports on the standards that the university has not yet met to the independent accreditor.

"We have had and continue to have pretty rigorous protocol around these things," he said. "Because some of the attention that has come to our program over the past few years, we want to create a program that is a national model. We want to go above and beyond, even what our accreditors are asking us for, to become a model for this kind of work across the country."

The university also provides a monthly progress report to the Legislature that notes how the university is implementing changes on its policies, Gilchrist said. In its October report, the university's plan includes establishing a community oversight board and updating its policy on conflicts of interest.

Correction: An earlier version of this story said the Association for the Accreditation of Human Research Protection Programs released a report critical of the university. The university released the report of an external review panel, whose work was managed by the AHRPP.