Last week, in response to Arne Carlson's broadside to the state legislature, the U's communications office added two new supposed exonerations to its usual mix. The strangest of the two is the Minnesota Board of Social Work's damning report on Jean Kenney, the study coordinator for the CAFE study, which found problems ranging from incompetence to falsification of a physician's initials on study records.
The second is a report from the Office of the Ombudsman for Mental Health and Mental Retardation -- a state office with no disciplinary power that was nonetheless very critical of the university. Have a look at its report, which concludes with this recommendation to the IRB. Does this sound like an exoneration to you?
8) Recommendation for the Institutional Review Board:
People under a stay of commitment for mental illness may require special protection to ensure that their voluntary informed consent is indeed voluntary and not intentionally or unintentionally coerced.
The client signed the "Adult Consent Form" for the CAFE study on 11/21/2003, the day after the hearing that resulted in the client's stay of commitment. The client's stay of commitment included eleven "terms and conditions" enumerated by the judge, including ''that the Respondent remain hospitalized, cooperate with the treatment plan at [the hospital] until medically discharged, and follow all of the aftercare recommendations of the treatment team."
The client's treating psychiatrist, who was also the study's Principal Investigator, and the client's hospital social worker, who was also a research staff member, were the two witnesses to the client's signature on the consent form.
The IRB's own web-based tutorial "lnforned Consent Overview - Selecting Participants" states,
Doctor-patient relationships between the investigator and participants should be avoided, when possible, to eliminate any power-based coercion. Patients can say no to someone they do not expect to see in thefuture, but it is very difficult for people to say no when they rely on someone for ongoing medical care.
Participants often depend on physicians to make treatment recommendations, and then they defer to the physician's professional knowledge and judgment. They may not read the consent document fully because the physician has already explained the procedure orally, and they consider the doctor the primary source for information.