Before I speculate about the consequences of this revelation, let me fill in the story with some background information.
After Dan Markingson killed himself in the CAFÉ study on May 8, 2004, Steven Olson, the site investigator, filed a Serious Adverse Event report with the University of Minnesota Institutional Review Board (IRB). (This is standard practice; it is done whenever a subject dies or is seriously injured in a study, regardless of the cause.) On May 13, 2004, the IRB wrote back to Olson and asked for more information. Specifically, the IRB wanted to know: “Was this subject considered competent to provide consent? How was consent obtained?” It was in response to this letter that Olson replied. Olson told the IRB that yes, the subject was fully competent to consent, and as evidence, he submitted the “evaluation to consent” form.
Why is this form important? Well, it is important because in the weeks leading up to his enrollment in the CAFÉ study, Dan Markingson had repeatedly been judged incompetent to consent to medical treatment. Every clinician who had seen him, including Olson, had decided that his thinking was so disordered that he could not fully understand and appreciate information well enough to make an informed choice about his medical care. Ordinarily, this would mean that Dan could not be enrolled in the CAFÉ study without the authorization of a surrogate decision-maker. That decision-maker should have been his mother, Mary Weiss. But Mary Weiss had made it clear that she was opposed to Dan’s enrollment in the CAFÉ study. So to get Dan into the study, Olson needed to show that Dan was competent. The “evaluation to consent” form was intended to demonstrate that Dan was, in fact, thinking clearly enough to understand the risks and benefits of the CAFÉ study, and thus fully competent to consent. (I have written more about this here. I should also point out that this "evaluation to consent" is very poorly constructed and not at all an adequate gauge of competence to consent.)
This morning, Mike Howard pointed out to me that there was not just a single “evaluation to consent” form in Dan’s medical records, but rather two of them, and that the two versions appeared to be slightly different in odd ways. I posted the two forms this morning, and right away, the family members of other research subjects in the Department of Psychiatry recognized the forms. Which raises a disturbing question: what could possibly explain the presence of identical forms in the charts of different subjects?
I don’t want to make any accusations, especially without seeing the documents firsthand. But if someone in the Department of Psychiatry were using a photocopied form with identical, pre-determined answers as evidence that mentally ill research subjects were competent to consent to research, it would be a very serious matter. Ordinarily, I would think that it would merit an investigation into the protection of human subjects at the university. Unfortunately, however, there does not seem to be anyone at the University of Minnesota willing to look into such complaints.