Review: U of M policies protecting human research subjects are weak

A long-awaited external review of University of Minnesota research policies has found "many weaknesses" in the university's efforts to protect human subjects of its experiments.

The report by the Association for the Accreditation of Human Research Protection Programs, released today, concludes that although the university is strong in many areas, its policies and practices "do not consistently reflect 'best practices,' and are not 'beyond reproach.'"

"The University has not taken an appropriately aggressive and informed approach to protecting subjects and regaining lost trust," the report states.

The review grew out of faculty concern that the university's reputation has been "under a cloud" internationally because of lingering questions over the 2004 suicide of university drug-trial patient Dan Markingson.

President Eric Kaler agreed to the review in December 2013 after university faculty passed a resolution calling for a review of U of M's practices.

Among the main report's findings was that the association "found evidence of weak and often inadequately expert review of research." The reviewers said that leaves the university vulnerable to criticism and its research subjects "potentially susceptible to [avoidable] risks."

U of M researchers paid "inadequate and inconsistent attention to the process of consent" by patients with impaired decision-making ability, the researchers said.

The report notes that ethics training for the university's researchers "fulfill minimal standards but represent a missed opportunity" for a more sophisticated approach to the matter.

Reviewers also said that the university has paid "inadequate attention" to research with vulnerable or impaired patients. The report suggests that to better protect human subjects, the U should involve non-research staff in the recruitment of patients.

Most striking, the reviewers said, was the "commonly conveyed sense of doubt in leadership's commitment to human subject protection" on the U of M campus.

According to the report, a major concern of reviewers was a "widespread characterization by university personnel of a few researchers in the Department of Psychiatry as 'untrustworthy' and as creating a 'culture of fear' in relation to efforts to enhance the protection of research."

The report offers a series of recommendations for improving training and procedures for research involving human subjects, including development of standards that "protect against real or perceived coercion in psychiatric treatment settings in which individuals may fear involuntary court proceedings."

In a written response to the review, Kaler and U of M Vice President for Research Brian Herman called the report "thorough," and said the university is acting on several of the recommendations. They said a special team will put forth a plan of action within 60 days.

"We will be accountable for taking action," they wrote.

In the months leading up to the report, U of M bioethicist Leigh Turner had said the association had too many financial and personnel ties to the university and pharmaceutical companies to conduct a fair assessment.

But he now says he's pleasantly surprised by the thoroughness of the report, and calls it "an important document" that "gets at a lot of really serious problems."

Both Turner and fellow U of M bioethicist Carl Elliott have long criticized the U's handling of the Markingson case. They say the university has refused to admit that the flawed research culture that contributed to his death still exists.

"It's astonishing that here we are after a decade of all of this, and this is being described as a contemporary problem — not a problem from 2004, but a problem today," Turner said.

Turner said the report "is opening up a very large can of worms."

Senate higher-education committee Chairwoman Terri Bonoff said she found the report's main findings "disturbing," but said she would withhold final judgment until the state legislative auditor released his report next month.

The review is one of two that address U of M's clinical drug trial practices.

Next month, state Legislative Auditor Jim Nobles is expected to release the results of his investigation of the Markingson case. Nobles said his inquiry will take the external review into consideration.

Nobles said he also is considering a follow-up investigation of the university psychiatric drug studies since the Markingson case.