Wednesday, January 16, 2013

Something’s not right here: part 3 (or, Don't you usually ask permission to see a subject's medical records before you enroll them in a study?)

Were Dan Markingson’s privacy rights violated in the CAFÉ study?   As I pointed out in my request for an investigation by the university’s Research Ethics Consultation Service, the Health Insurance Portability and Accountability Act (HIPAA) prohibits health care providers from releasing a patient’s private health information for use in research without the express written authorization of the patient. Violation of that law is a felony.  This means that before AstraZeneca (the study sponsor) or Quintiles (the CRO managing the study) could see any of Dan Markingson’s health information, they would have needed his signed authorization.  At the time of the lawsuit by Mary Weiss against the University of Minnesota, there was no record of any such authorization in Markingson’s medical records.

Yet when Mike Howard filed his complaint about Stephen Olson to the University of Minnesota, Mark Rotenberg produced a written HIPAA authorization dated November 24, 2003.  The emergence of a HIPAA authorization at such a late date is odd.  If the University of Minnesota had a HIPAA authorization, why didn’t it produce that document when Stephen Olson was being grilled on HIPAA in his deposition?  But equally odd is the date on the authorization, which comes three days after Markingson was enrolled in the CAFÉ study.   That is three days too late.  Subjects need to provide authorization before they are enrolled, not after.  Of course, if Quintiles and AstraZeneca had not been given access to Markingson’s health information before he gave his authorization, they would not have even known if he was eligible for the study.

None of this is justified or explained in Rotenberg’s letter.  Yet University of Minnesota officials appear to have accepted it without question.  Why is Rotenberg’s response seen as an adequate explanation? 

1 comment:

  1. I've been recently asked a number of times what motivates the drive and energy that it takes to keep seeking justice in the Dan Markingson's case when the odds appeared to be against it at times. The answer is actually pretty simple...not a day would go by for the rest of my life that I wouldn't have regretted quitting and giving up. The same goes for Mary Weiss who's continuing her recovery from a severe stroke and yet wouldn't want to be anywhere but on the front lines seeking justice. They talk all about anti-bullying in schools and how that needs to dealt with...what also needs to be addressed is how the University of Minnesota has been allowed to bully so many families and use their intimidation tactics to try and punish people whom have objected to the University's lack of integrity and and tried to fight back.