HSD posts updated documents to the web site on the last Friday of each month. In rare cases, due to an urgent need, an updated document will be posted during the month.
HSD and the IRB ask that researchers make every effort to use the most recent document version.
Questions about a specific document version? Contact hsdforms@uw.edu.
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.
| 
Purpose
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.