UMN Administrators Withhold AAHRPP Draft Report

The credibility of AAHRPP’s “independent review” of clinical research practices and policies at the University of Minnesota is once again being questioned. Faculty senators – who asked to receive a copy of the report at the same time as university administrators – yesterday learned that AAHRPP, more formally known as the Association for the Accreditation of Human Research Protection Programs, has already provided the university’s senior administration with a draft version of its report. Ten faculty senators are expressing “grave concerns” regarding the status of the AAHRPP review.

Noting that faculty senators were assured by Vice President for Research Brian Herman that “the administration would have no involvement in what was specifically meant to be an independent report,” the ten faculty senators warned Herman that “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.” The faculty senators state that withholding the draft report from faculty senators “jeopardizes the integrity of the independent review.” The likely quality and integrity of the AAHRPP review has been questioned since this organization was selected to review the university’s research protections program.

The faculty senators have asked the university’s administration to disclose all draft versions AAHRPP has provided to anyone in the university’s administration and explain any changes made to the text after an initial draft version of the report was provided to administration.

The AAHRPP report was commissioned after faculty senators passed a “Resolution on the matter of the Markingson case.” Dan Markingson committed suicide while he was a research subject in the now notorious CAFÉ study. According to the resolution, “a panel external to and independent from the University of Minnesota” was to be charged with “conducting an inquiry examining current policies, practices, and oversight of clinical research on human subjects at the University, in particular clinical research involving adult participants with diminished functional abilities.” Shortly after the resolution was passed, University of Minnesota President Eric Kaler stated that the inquiry would not address the Markingson case.

The AAHRPP review has been dogged by criticism and controversy. Following the awarding of a contract to AAHRPP, one of the reviewers, Jeremy Sugarman, was discovered to have been a paid consultant for Quintiles, the contract research organization hired by AstraZeneca to manage the CAFÉ study. At the time of her selection, a second reviewer, Melissa Frumin, was a defendant in a medical malpractice lawsuit brought by an alleged victim of research misconduct. AAHRPP itself has numerous ties to the pharmaceutical industry as well as employees of the “research protection programs” it accredits. The choice of AAHRPP to conduct an inquiry was also controversial because AAHRPP’s CEO, Elyse Summers, has publicly acknowledged that AAHRPP does not investigate allegations of research misconduct. AAHRPP has also been in a longstanding client-provider relationship with the University of Minnesota as a result of being paid for its accreditation of the university’s research protection program. Despite the identification of numerous financial and professional conflicts-of-interest, University of Minnesota administrators continue to defend their selection of AAHRPP.

The faculty senators’ letter is below.

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
  1. 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

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