Tuesday, May 13, 2014

Rubber-stamp research accreditation: what's it worth?

There's a new wrinkle in the ongoing University of Minnesota propaganda concerning the Markingson case: "accreditation."  You can read about it in yesterday's statement from Brian Lucas, in response to former Governor Arne Carlson's letter to the Board of Regents.

Evidence of our commitment to ethical human subject research can be seen in the fact that we have received Association for the Accreditation of Human Research Protection Programs (AAHRPP) re-accreditation twice in the last ten years.  We are currently preparing for a third re-accreditation.  This is an extremely rigorous process that is “best in class” nationally.

What exactly is AAHRPP and what is accreditation worth?

The first thing to know is that AAHRPP operates on a fee-for-service model.  AAHRPP charges institutions as much as $82,800 for a single accreditation application.

The second thing to know is that felony convictions, corruption and research deaths do not preclude accreditation.  For instance, the pharmaceutical company Pfizer, a three-time felon responsible for one of the most notorious research scandals of the past two decades, was accredited in 2009.

The third thing to know is that AAHRPP does not investigate research wrongdoing and considers its accreditation process confidential.  Here is the response I received from the CEO of AAHRPP, Elyse Summers, when I asked AAHRPP to look into evidence of wrongdoing by the University of Minnesota's Institutional Review Board.

Dear Professor Elliott: 

I am writing in response to your correspondence with AAHRPP concerning allegations regarding human subjects’ protection at the University of Minnesota. We share your commitment to ensuring the safety of human subjects and promoting ethical human subjects research and we take your concerns very seriously. As you know, AAHRPP is not an investigative body but rather, a non-governmental organization that accredits high quality human research protection programs. As such, our role is limited to evaluating whether an applicant or accredited organization complies with our Standards and Procedures. AAHRPP publishes our Standards and Procedures, as well as the accreditation status of accredited organizations, on our website. Should an organization’s status change, that information would be provided on our website in accordance with our Procedures. Our Procedures do not provide for the disclosure of any other information about an Organization, and we are thus obligated to maintain the confidentiality of Organization-specific information. 

My best, 

Elyse I. Summers, J.D. President and CEO 

What is accreditation worth?  For the research institutions who pay for it, it's a bargain. But for research subjects themselves: absolutely nothing.

1 comment:

  1. I hope Governor Carlson feels insulted by the fact that the U-MN thinks so highly of his letter and concerns that they have their paid-mouthpiece Lucas respond. You know, the guy with a BA in blabber-mouthing, and couldn't determine whether a respected clinical investigator who has conducted clinical trials for probably longer than he's been out of diapers, was a "wacko" or not. One can only dream of a better world where all the "chickens" at the U-MN can cross the road without having their motives questioned.

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