Thursday, March 5, 2015

"Damning" external review of U's research protection program to be presented to Faculty Senate


Two of the panel members from the AAHRPP external review of the U's Human Research Protection Program will be presenting their findings to the Faculty Senate tomorrow (Friday) afternoon.  The Senate meeting will be in the Coffman Union auditorium from 1-3 pm.

Turner to feds: "Investigate us! Please!"

Leigh Turner, my colleague in the Center for Bioethics, has asked the federal Office of Human Research Protections to investigate the University of Minnesota's Human Research Protection Program.

His request was prompted not just by last week's damning external review, but by President Kaler's claim that the review "found no legal or compliance problems."  In fact, the review points to a number of instances in which the University appears to have violated federal research guidelines.

You can read his full request to OHRP on the Health in the Global Village blog.

Monday, March 2, 2015

Science: "Human Subjects Protection Under Fire at the University of Minnesota"

"A damning report on how the University of Minnesota (UM) protects volunteers in its clinical trials concludes that researchers inadequately reviewed research studies across the university and need more training to better protect the most vulnerable subjects. It also found that a 'climate of fear' existed in the Department of Psychiatry, where concerns about clinical trials first surfaced."

Read more in Science.

Friday, February 27, 2015

“I am particularly gratified—but not surprised—that the panel found no legal or compliance violations, affirming numerous previous reviews and accreditations of our program”

So says The Ministry of Truth.  Apparently, this is how you spin a report that actually says:

"For example, faculty and staff in Psychiatry repeatedly characterized the climate of work as a 'culture of fear.'  They provided stories of intimidation by researchers and fear of retaliation should staff voice opposition to practices that were of concern."

"The review team found little evidence that the University’s IRB engaged in a meaningful process of evaluating research risk."

"Investigators have failed to address issues of vulnerability to coercion or undue influence."

“It was clear to the external review team that the membership of the Medical IRBs did not include sufficient members with the scientific expertise necessary to adequately address the research being reviewed at corresponding meetings.”

“The failure to have either adequate number of IRB members, or adequate expertise, during IRB deliberations raises profound questions about the IRB’s ability to conduct a robust and reliable protocol review.”

“Of the 30 protocols examined for scientific review, five cases were identified where the scientific review was completed by a subordinate faculty member for research in which a department chair was the principal investigator.  In these cases, a conflict of interest exists and the risk of bias in the review is significant.”

“Accordingly, the minutes did not completely or accurately appear to represent what occurred during the IRB meetings. “

“The review process, as documented in the minutes, does not reflect a meaningful discussion of the risks and benefits of research protocols and the necessary steps taken to protect human subjects in the face of scientific or ethical concerns. “

Wednesday, February 25, 2015

Faculty Senators demand explanation for secret draft of external research review

February 25, 2015

Dear Vice President Herman and Professor Durfee,

We are writing to you to express our grave concerns regarding the status of the AAHRPP’s review of clinical trials at the University of Minnesota. We have been informed that the AAHRPP has submitted a draft report to the administration prior to the release of the final report, which is due to be released no later than Friday, February 27, 2015.

Vice President Herman assured the public (and directly told some of us) that the administration would have no involvement in what was specifically meant to be an independent report. Yet the submission of a draft report to the administration prior to the release of a final draft opens the door to accusations that the administration exercised inappropriate influence on the content of the final report and hence jeopardizes the integrity of the independent review. The appearance of impropriety is reinforced by the lack of transparency regarding the administration’s access to a draft prior to the release of a final report. This unfortunate development undermines the central purpose of the report: to restore trust in the University.

To restore faith in the integrity and independence of the review, the administration should do the following:

1. Publicly release every draft of the report that was shown to anyone in the administration

 2. Provide a public explanation for any changes that were made between the initial and subsequent drafts that were sent to the administration.

The administration’s handling of this process threatens to undermine further the institution’s credibility with the legislature and the public. Full transparency is essential to address these concerns and ensure the credibility of the review.

Sincerely,

Teri L. Caraway, Associate Professor, Political Science
Francis Harvey, Associate Professor, Geography, Environment, & Society
Amy Kaminsky, Professor, Gender, Women, & Sexuality Studies
Rick McCormick, Professor, German, Scandinavian, & Dutch
William Messing, Professor, School of Mathematics
David Pellow, Professor, Sociology
Riv-Ellen Prell, Professor, American Studies
Naomi Scheman, Professor, Philosophy
JB Shank, Associate Professor, History
Karen-Sue Taussig, Associate Professor, Anthropology