informed consent Terry Vandenbosch 30 Apr 2002 17:31 EST
We have a large ongoing outcomes data collection for patients undergoing total hip arthroplasty at our center.  Followup will occur up to 10 years after the hip replacement and data from the chart will be integrated with patient self-report information.  Because the outcomes data has been collected for quality monitoring, we have not gotten informed consent for patients.  No research has yet been done with this data, however, some outcomes research is in the works.  Under current regulations we do not need patient consent to do this research as patient identifiers are removed.  However, we would like to prepare a consent that allows us to collect data for quality monitoring that will be used later in outcomes research.  How might we do this and be HIPAA compliant?  Thanks.

Terry M. VandenBosch, Ph.D.
Interim System Integration Leader, Clinical Research Department
P.O. Box 995, RHB R-2018,
St. Joseph Mercy Hospital
Ann Arbor, Michigan 48106-0995