Monday, December 3, 2012

How to file a federal complaint about research subject protection at the U

In the weeks since the “corrective action” against Jean Kenney was issued by the Minnesota Board of Social Work, I have been contacted by the families of several patients who were harmed or mistreated in psychiatric studies at the University of Minnesota.  Some of them plan to file their own complaints to the Board of Social Work.  This is an excellent idea, which is why I posted Mike Howard’s complaint  to the Board about Kenney, so that others can use it as a model.

But the Board of Social Work is not the only place to file a complaint.  If a person has evidence that wrongdoing has occurred in a federally funded study, he or she has another avenue: the federal Office of Human Research Protections (OHRP).  OHRP has jurisdiction over research funded by federal bodies such as the National Institutes of Health, and it has genuine power.  In fact, in 1990s, its predecessor office, the Office for Protection of Research Risks, temporarily suspended medical research at major medical centers such as Duke and Johns Hopkins after serious ethical wrongdoing was revealed.

Judging from the alarming problems outlined in the “corrective action” against Kenney, I believe there are grounds for complaints to OHRP about the CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness) study.  The University of Minnesota was a site for the CATIE study as well as the CAFÉ study, and Kenney was the study coordinator for both.  The principal investigator, Stephen Olson, was recruiting subjects for both studies in 2003.

I would be glad to help anyone interested in filing a complaint.  I am ashamed of the way that my university has handled the egregious ethical violations in the CAFÉ study, and I am willing to do whatever I can to make sure that justice is done. You can find me here, and I can be reached at my gmail address, ellio023.

Carl Elliott

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