Thursday, March 7, 2013

Stephen Olson's deposition and the mysterious HIPAA forms

One of the puzzles that I have repeatedly tried to get the University of Minnesota to investigate, without any success, concerns possible privacy violations for psychiatric research subjects -- specifically, the absence of a signed HIPAA form in Dan Markingson's medical file, the mysterious emergence of a signed HIPAA form a number of years later, and a duplicate unsigned form in the chart of a another CAFE study subject.  (For background, see here and here.)  Where did this mysterious document for Markingson come from?  Why was it not produced during the lawsuit?  Were the privacy rights of other psychiatric subjects violated?  These are important, pressing issues -- not least because HIPAA violations are federal crimes. Yet no one at the university will look into the issue.

To see how suspicious this refusal to investigate is, it is worth looking at the following excerpt from the deposition of Stephen Olson in the lawsuit brought against the university by Mary Weiss.  I won't comment on the factual errors in the deposition, except to note that federal HIPAA regulations were in place at the time that Markingson was enrolled in the CAFE study.

Q.  And someone conducting research with human subjects and trained by the University of Minnesota and supervised by the IRB and Dr. Schulz, how many signatures and what kinds of signatures do you need to get a study subject enrolled?

MR. GROSS:  Objection, form.

MR. ALSOP:  It's vague and ambiguous also.  Go ahead.

A.   I think the patient needs to sign the consent form, the informed consent document, and  currently patients also sign a separate document that contains language about protected  health information and how it will be used, but  I don't believe at the time that Dan entered the CAFE study that a separate document was required.  I believe that that protected health information was incorporated into the informed consent document.

Q  Isn't it in fact the case that Dan was supposed  to sign a HIPA authorization and he never was asked to do so and never did so in your study?

MR. ALSOP:  It's a multiple question, vague and ambiguous.  Go ahead, Doctor.

A.   I'm not aware that there were any documentation failures like that, no.

Q.   (BY DR. BARDEN)  Did anyone in your CAFE study sign a HIPA authorization form?

A.   I don't know.

Q.   So you don't know if Dan was the only one who did not sign a HIPA authorization?

A.   I don't know.

Q.   Do you know what the University rules are with regard to conducting research when a subject has not signed a HIPA authorization form.

A.   No, I don't know what the consequences are or the rules.

Q.   Do you think that would be a good thing to know before you do research with human subjects?

MR. ALSOP:  Object as argumentative.

Q   It's also irrelevant.  Go ahead, Doctor.

A.   Yes.  I always try to follow the appropriate documentation rules.  And if at the time that Dan entered the study we were required to have his signature on a separate HIPA document and we failed to do so, I  could have expected that when the IRB and the FDA inspected the program, I would have been informed of that.

Q.   And it's your understanding that Dan never during the entire time he was in your study, he never did sign a HIPA document?

A.   That's not my understanding.  I don't know.  I don't recall offhand what he signed or not.

Q.  Well, there is not in any of the documents we've been disclosed, in fact, there is a blank form.  So if there was a blank form in the file for a HIPA authorization that was never signed by anybody, would that help you to understand when you needed to do that?

MR. ALSOP:  Object as speculative, lacking foundation.

A.   Could you repeat the question?

Q.   If there was a blank HIPA form in the CAFE  documents that were disclosed to us with a place for people to sign that was never signed, would that help you understand when you needed to get a HIPA signature?

A.   Well, that would suggest that we in fact should have had a -- he should have signed that, yes.

Q.   Isn't that required by federal law and the University of Minnesota policy to have a study specific HIPA form approved by the IRB and signed by each subject?

MR. ALSOP:  Object to foundation.  Go ahead, Doctor, if you know.  Also multiple.

A.   Yeah, I believe that's correct.

Q.   (BY DR. BARDEN) Did you violate that rule in the CAFE study?

A.   I don't -- I don't have any -- I don't have any personal knowledge that we violated that.   Again, if I had -- if that were the case, I would be surprised that it hadn't been brought to my attention before, and maybe it has and I forgot about it.

1 comment:

  1. We have the IRB at the UMN that claims it's not their job to protect human subjects in clinical trials, we have the principal investigator that can't for the-the-life of him...remember whether Dan Markingson or any other human subject ever signed a HIPAA document...before..during...or after their participation in the CAFE' study...he also didn't know if the HIPAA regulations were even relevant yet at the time, didn't know how HIPAA would affect the subjects in the study if it was required...but he took all the required classes that the UMN says he should take!!!!course..did anyone actually see him there...or did he just sneak in and sign his name...and sneak out again. I think we all know the answer.