We have had our first instance in which a clinical trial sponsor is willing
to pay patient costs resulting from an adverse event caused by the study
treatment, BUT is unwilling to reimburse the patient directly.  They seem
to feel that this is contrary to HIPAA regulations which require that the
research must use deidentified data, and that paying the patient directly
would identify him/her.

So we are struggling with  the question of WHO would be responsible for
accepting and transmitting the company's reimbursement for the adverse
event.  And how to make that "agent's" activities HIPAA compliant.

Anyone seen this position by any clinical trial sponsor?  Any solutions to
the problem?

Any ideas of a way to thrust this back onto the company in a way that is
HIPAA compliant?

BTW, we haven't discussed with our attorneys.  We're looking for advice
from the list first!

Chuck   --- and Michael Katz
Herbert B. Chermside, CRA
Director, Sponsored Programs Administration
Virginia Commonwealth University
PO BOX 980568
Richmond, VA  23298-0568
Express Delivery Only:
 Biotech One, Suite 113
 Virginia Biotechnology Research Park
 800 East Leigh Street
 Richmond, VA 23219
Voice:  804-828-6772
Fax     804-828-2521
OFFICE e-mail   xxxxxx@VCU.EDU
Personal e-mail xxxxxx@vcu.edu
http://www.research.vcu.edu/ospa.htm

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