Monday, September 8, 2014

For the Record: Univ. of Minnesota faculty concerns about investigation into clinical trials



Sep 7, 2014

Last fall 14 faculty senators at the University of Minnesota called for the Faculty Senate to take action to address ethical concerns arising from the tragic death of Dan Markingson in a clinical trial conducted at the University of Minnesota. The Faculty Senate passed a resolution last December calling for an independent investigation, and President Kaler agreed to conduct such an investigation. Unfortunately, events since then have led some of the senators who called for a review to have serious concerns about both the scope of the review and the impartiality of the team conducting it. The letter appended below, which we have sent to Vice President for Research Brian Herman and Professor Will Durfee, expresses some of our concerns. 

The team conducting the investigation will be on campus this week (Tuesday and Wednesday).

Two of the signatories of the letter, Naomi Scheman  have agreed to serve as our media contacts.

In addition, at the end of the email, you will find useful links that provide background information about the independent investigation.

Sincerely,

Teri L. Caraway
Associate Professor and Faculty Senator
Department of Political Science
University of Minnesota, Twin Cities

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Dear Vice President Herman and Professor Durfee 

As members of the University of Minnesota Faculty Senate who called for an investigation into human subject research at the University in the wake of the Markingson case (as detailed in the "whereas" sections of the resolution), we would like to express our concerns with the process as it is unfolding so far. Although the resolution passed by the Senate and supported by President Kaler called for a review of present policies and practices, it has been clear to us that a review can serve the stated purpose of clearing the cloud of suspicion about the treatment of vulnerable human subjects only if it also looks at relevant aspects of the past. In particular, an investigation of "present practices" needs to include how the University has dealt and is dealing with--including learning from--serious allegations concerning past practices. 

Our intention of communicating that conviction to the review team has, however, come up against concerns regarding conflicts of interest on the part both of members of the review team and of AAHRPP, which selected the team and is supervising the review. Put simply: we are convinced that a credible review would need to investigate the Markingson case, but that such an investigation would itself need to be credible, especially in light of the history of the University's appealing to clearly noncredible reviews as supposedly exonerating; and the conflicts of interest raise serious questions about the credibility of the present review. 

We do not want to prejudge the work of the review team or to impugn the integrity of its members. We do, however, want to put on the record our sense that the review is not proceeding in a way that seems likely to satisfy the principal requirements behind the resolution we brought to the Senate: for a genuinely credible, independent review that takes a hard look at how the University dealt--and continues to deal--with activities that are widely perceived as profound breaches of ethical responsibility.

Signed:

Teri L. Caraway, Associate Professor, Political Science
Cesare Casarino, Professor, Cultural Studies & Comparative Literature
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
Kevin P. Murphy, Associate Professor, History and American Studies
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 

cc: Eric Kaler, Eva von Dassow, and Rebecca Ropers-Huilman

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LINKS TO BACKGROUND DOCUMENTATION

October 2013 letter from 170+ scholars calling for an investigation:

List of signatures from October 2013 letter:

November 2013 letter from faculty senators to the FCC:

Minutes from the Faculty Senate meeting that passed the resolution calling for an investigation (starts on page 16; the resolution was amended as described in the minutes):

The RFP:

The AAHRPP's proposal:

Professor Trudo Lemmens's et al April 2014 letter to President Kaler regarding the RFP:

Public Citizen's letter expressing concerns about the investigation:

Professor Trudo Lemmens's et al June 2014 letter to President Kaler:

Professor Leigh Turner's July 16, 2014, letter to the AAHRPP regarding conflicts of interest:

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