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Human Subjects Division (HSD)


Case Reports

Dec 6, 2010 at 1:56pm

We are happy to announce the release of two new long-awaited tools that will assist researchers who do case reports.  These tools are based on a recently completed analysis and revision of HSD's unwritten policy and procedures about case reports, performed in coordination with UW Medicine's HIPAA Privacy Office. Together these tools provide a written description of the policies and procedures on this topic.

A case report is information collected and presented on one or more individuals to highlight an interesting experience, observation, treatment, presentation, relationship, or outcome.  It typically (but not always) results from a retrospective review of the individual's record. This is different from a case study, which typically involves a prospective intervention or prospective collection of specimens or data that is not part of standard service or care.

Tool #1:   Case Report - IRB and HIPAA Requirements

Researchers can use this one-page decision tree to self-identify any HIPAA and IRB requirements that apply to a specific case report.  It also provides brief information on how to fulfill those requirements, and a definition of "case report".

Tool #2:   Case Report Research Self-Determination

The primary IRB issue is whether the case report meets the definition of research provided in federal human subjects regulations.   If it does not, then IRB review is not required.   Researchers can answer the three short questions on this form to self-determine whether IRB review of a specific case report is required.  The form should be completed and kept with the researcher's other records about the case report.   It does not need to be submitted to the Human Subjects Division in most cases.

We welcome any questions or comments you may have; please send them to hsdinfo@uw.edu.