"There stands Jackson like a stone wall..."

General Barnard Bee during the First Battle of Bull Run

From my colleague Carl Elliot's blog:  

Friday, March 1, 2013

 

Stonewalled by the University of Minnesota again

On February 20, after discovering evidence of duplicate “evaluation to consent” and HIPAA forms apparently originating in the Department of Psychiatry, I submitted a formal request for an investigation to Dr. Frances Lawrenz, the Research Integrity Officer at the university and an Associate Vice-President for Research. To be honest, I did not expect my request to get a fair hearing, given my experience with other such complaints, but I felt that it was probably a good idea to go through proper procedures anyway. In my letter, I specifically asked Lawrenz not to involve the Office of the General Counsel in her investigation, because of the possibility that the office was involved in the issues that I was asking her to investigate.

Her reply came by email on February 26.

“Dear Dr. Elliot, Thank you for your email and attachment. I have read the material. I did share the information with Barbara Shiels because she is the lawyer assigned to provide advice about research misconduct. I also carefully read our research misconduct policy to determine the fit of your information with the policy. Our research misconduct policy has a 'statute of limitations' of 7 years. (See http://policy.umn.edu/Policies/Research/ACADEMICMISCONDUCT_PROC01.html ) Since the matters covered in your letter occurred more than seven years ago, the material you present is outside the purview of the policy. In addition, your concerns about the consent evaluation process and possible HIPAA violations do not appear to fall under the definition of research misconduct (i.e., alleged fabrication, falsification or plagiarism), regardless of when the events occurred.”

I don’t think I’m alone in finding this reply disturbing, and not just because Lawrenz shared my request with the Office of the General Counsel.  Her citation of the university research misconduct policy is misleading at best, and almost certainly wrong.  Here is what the policy says about the seven year statute of limitations:  “Allegations of misconduct that occurred seven or more years prior to the submission of the allegation will not be investigated unless the circumstances indicate that the alleged conduct was not reasonably discoverable earlier.” In this case, of course, the evidence of duplicate documents only just emerged, so it would have been impossible to request an investigation of this issue earlier.  Yet Lawrenz claims that the seven year limit has expired.

As for the university definition of research misconduct: the policy says that misconduct involves, among other things, “fabrication or falsification of data, research procedures, or data analysis.”  It is hard to see how the “research procedures” for a clinical trial would not include these “evaluation to consent” and HIPAA forms. And of course, the possibility that they were fabricated or falsified was precisely what I was asking her to investigate.  (In fact, as the Board of Social Work documented in its “corrective action” against Jean Kenney, the study coordinator for the CAFÉ study, Kenney routinely falsified the initials of physicians on study records.)

It is responses like this one that have led me to doubt the integrity of human subject protection at the University of Minnesota.  If the university administration were actually concerned about the welfare of research subjects, would it not want to look into these issues?

I will have more to say about this. The shameful University of Minnesota's response in this matter is unworthy of a great university.