May-September, 2014: Letters and Blog Posts Challenging the Integrity, Legitimacy, and Transparency of the AAHRPP Review

The University of Minnesota’s choice of AAHRPP to review research practices and policies generated generated swift and sustained criticism. By the time AAHRPP was selected, its CEO, Elyse Summers, was already on record stating that the organization is not an investigative body and does not address specific allegations of research misconduct. AAHRPP’s “independence” from the University was also challenged due to the organization’s longstanding client-provider relationship to the University of Minnesota. On a fee-for-service basis, AAHRPP first accredited the University’s research protection program in 2004. It reaccredited the University in 2007 and 2010. Critics, myself included, questioned why an organization that had already accredited the university’s research protection program for a decade was now being given responsibility for reviewing the performance of that very program.

Problems with the three reviewers publicly disclosed by AAHRPP were also addressed. As noted, one reviewer, Dr. Jeremy Sugarman, was identified as a consultant for Quintiles, the Contract Research Organization that managed the CAFÉ study in which Dan Markingson committed suicide. Sugarman had also served as a consultant for Genentech, another company that had funded clinical trials conducted by faculty members in the Department of Psychiatry. Another reviewer was discovered to have been in the process of being sued for negligence by an alleged victim of research misconduct at the time of her selection. A third reviewer was identified as a personal friend and mentor to Summers and an important figure in the establishment of Summers’ employer, AAHRPP. Identification of these concerns and conflicts-of-interests highlighted the absurdity of AAHRPP’s claims that it had identified “world-renowned expertsto conduct the review.

An organization that had previously attracted little scrutiny from journalists and academics, AAHRPP was found to have numerous ties to the pharmaceutical industry. One member of AAHRPP’s Board of Directors is currently a senior executive at Novartis. Three board members are former Pfizer executives. Pfizer has funded three AAHRPP conferences and an AAHRPP guidebook.   It also became apparent that Pfizer had accepted funding from Pfizer after being paid for accrediting Pfizer and then benefited from the services of a Pfizer employee who prepared a business expansion plan to help AAHRPP expand its market share providing accreditation services in China. A member of AAHRPP’s Council on Accreditation was also found to be a recipient of funding from Pfizer. AAHRPP’s various connections to the pharmaceutical industry put into question AAHRPP’s claim that it provides independent, transparent, and unbiased accreditation of research protections programs.

Personal and professional links between AAHRPP and senior officials connected to the University’s research protection program were also detected. Dr. Susan Berry, current Chair of the University of Minnesota’s IRB Executive Committee, was found to be serving as one of AAHRPP’s site visitors. Moira Keane, the former Executive Director of the University of Minnesota’s Human Research Protections Program, was also found to be acting as an AAHRPP site visitor. She had previously served as Chair of AAHRPP’s Council on Accreditation. Discovery that past and present members of the University’s research protection program were acting as site visitors for AAHRPP again prompted skepticism toward the University’s decision to hire AAHRPP as the “manager” for a review of the University’s research protection program.

Requests that AAHRPP disclose possible additional financial conflicts-of-interest went unanswered as AAHRPP’s CEO refused to release conflict-of-interest disclosure statements of directors, members of the Council on Accreditation, staff members, and site visitors.

Carl Elliott, “Rubber-stamp research accreditation: what’s it worth?” Fear and Loathing in Bioethics, May 13, 2014.

Leigh Turner, “Re: How the University of Minnesota is Misusing AAHRPP Accreditation to Deflect Calls for an Investigation of Psychiatric Research Misconduct,” May 14, 2014.

Carl Elliott, “CEO: ‘AAHRPP is not an investigative body’,” Fear and Loathing in Bioethics, June 6, 2014.

Trudo Lemmens, Raymond De Vries, Alice Dreger, Lois Shepherd, Susan M. Reverby. “Re: Markingson Case and Review AAHRPP,” June 12, 2014.

Michael A. Carome and Sidney Wolfe, Letter to President Kaler, June 16, 2014.

Leigh Turner, “Re: AAHRPP’s Undisclosed Conflicts-of-Interest and its Compromised ‘Review’ of the University of Minnesota’s Research Protections Programs,” July 16, 2014.

Leigh Turner, “Dr. Melissa Frumin and the AAHRPP Review of the University of Minnesota’s Research Protections Programs,” Health in the Global Village, July 16, 2014

Leigh Turner, “Re: Request for Public Disclosure of Documents Related to Conflicts-of-Interest at AAHRPP,” July 21, 2014.

Robbie Feinberg, “U of M professor bashes review of university’s drug research program,” City Pages, July 21, 2014.

Leigh Turner, “Re: Additional Conflicts-of-Interest Involving AAHRPP and Pfizer,” July 24, 2014.

Leigh Turner, “AAHRPP’s Sham Review and Conflicts-of-Interests,” September 7, 2014.

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