Tuesday, January 15, 2013

Something's Not Right Here: Part 2 (or, "Did anyone in your CAFE study sign a HIPAA authorization form?")

In his 2010 complaint to the University of Minnesota’s Board of Regents, Mike Howard argued that Dan Markingson’s health privacy rights had been violated in the CAFÉ study. He pointed out that Stephen Olson had testified in a deposition that he was unaware of how HIPAA (health privacy) requirements applied to clinical trials.  Mark Rotenberg replied: “A complete review of Dr. Olson's deposition transcript, consisting of hundreds of pages, simply does not support this allegation.

Really?  Have a look at what the deposition actually says.  (In what follows, I have corrected spelling errors and edited out the attorney’s objections.)

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

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 HIPAA authorization form? 

A.   I don't know.

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

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

Read the entire deposition transcript here.

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