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?
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.
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