Group of U faculty voices concern over drug review

Got this over the weekend from University of Minnesota political-science professor Teri Caraway, who says the team conducting the U's ordered review of clinical research practices will soon be on campus.

In June, the U hired the Association for the Accreditation of Human Research Protection Programs to run the review, which involves a team of independent investigators.

It did so after the Faculty Senate called for a review in December. Scholars had been raising questions over the 2004 suicide of patient Dan Markingson in a university drug trial, and how the U had handled his involvement in the trial.

Since then, some critics -- both outside and inside -- have questioned how thorough and unbiased the inquiry will be.

Caraway says the letter -- signed by about a dozen faculty members -- went to Brian Herman, the U's vice president for research, and former Senate Consultative Committee Chairman Will Durfee, about the group's concerns with the review:

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

 

***

LINKS TO BACKGROUND DOCUMENTATION

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

http://www1.umn.edu/usenate/fsenate/docs/131205toronto_letter.pdf

 

List of signatures from October 2013 letter:

http://www1.umn.edu/usenate/fsenate/docs/131205toronoto_signatures.pdf

 

November 2013 letter from faculty senators to the FCC:

http://www1.umn.edu/usenate/fsenate/docs/131205letter_to_fcc.pdf

 

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):

http://conservancy.umn.edu/bitstream/11299/163110/1/Senate_Minutes_13_12_05.pdf

 

The RFP:

http://www.scribd.com/doc/210823892/RFP-for-Clinical-Research-Review-at-UMN

 

The AAHRPP's proposal:

http://www.research.umn.edu/news/documents/AAHRPP_Proposal.pdf

 

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

http://www.law.utoronto.ca/sites/default/files/users/lemmenst/Untitled_20140424_011928.PDF

 

Public Citizen's letter expressing concerns about the investigation:

http://www.citizen.org/documents/2205.pdf

 

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

http://www.scribd.com/doc/230006617/Markingson-Letter-From-Lemmens-Et-Al-June-13A-2014

 

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

http://www.scribd.com/doc/234260005/AAHRPP-s-Undisclosed-Conflicts-Of-Interest

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