The Utah Population Database was recently determined to be outside of the University of Utah Covered Entity. This means that for studies using the UPDB, new HIPAA requirements and privacy and confidentiality protections may be applicable, depending on (a) the location of the study (i.e. Inside or outside the covered entity), as well as (b) the nature of the data being shared by the study to the UPDB. These new requirements will affect the HIPAA Authorization section of consent document, as well as various sections of the IRB application (no new questions have been added to the IRB application at this time).

The IRB and the Resource for Genetic and Epidemiologic Research (RGE) have published guidance (attached) that is available online at: http://www.research.utah.edu/irb/forms/hipaa/pdf/UPDB-ConsentAndAuth-Feb11.pdf.

This guidance discusses

• The applicability of the new requirements to studies using the UPDB
• The new requirements that must be addressed in the IRB application and the consent document
• Template language regarding UPDB that may be used in the consent document

Beginning 2/2/2011, this policy will be enforced for all applicable new studies and at continuing review. For additional guidance regarding these new requirements, you may contact the following offices:

Resource for Genetic and Epidemiologic Research
Phone: 801.581.6351

Institutional Review Board