Managing Clinical Research in the Post-HIPAA World

Originally Published MX November/December 2003

GOVERNMENTAL & LEGAL AFFAIRS

The privacy rule will permanently alter the dynamics of relationships among sponsors, investigators, IRBs, and human subjects.

Benjamin S. Hayes and Jodi Finder

Perhaps no previous statutory and regulatory scheme has garnered as much attention from—or incited as much anxiety within—the U.S. healthcare system as the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its implementing regulations (including the privacy rule) issued by the U.S. Department of Health and Human Services (HHS).^1,2 The scope and complexity of HIPAA present compliance challenges that directly or indirectly affect virtually every aspect of the U.S. healthcare industry.

This article explores the specific impact that the privacy rule is likely to have in the area of clinical research. It focuses on the relationships among study sponsors, institutional review boards (IRBs), clinical investigators, and human subjects in that setting, and discusses how they are likely to be changed.

Traditional Roles of Clinical Research Participants