The Application and Amendment have been updated to accommodate projects associated with ARRA (Stimulus Plan) research. A staff note will be added to submissions associated with ARRA research and two custom searches have been created to identify these submissions.
Application question 1-1.2: The following text has been added to the Exempt description: Research limited to the use of de-identified data sets, including publicly available data sets, is not research with human subjects and is NOT exempt. Please see "Activities Not Regulated as Human Subjects Research" below.
The following text has been added to the Not Regulated outcome letter for Case Studies - Clinical: If this case study is about a UMHS patient's healthcare, journals are now requiring authorization from the patients in order to publish. If the patient is deceased submit your application to the IRB (changing any questions regarding decedents that you may have mis-answered). If the patient is living the Patient Authorization form can be found on the IRBMED forms page at http://www.med.umich.edu/irbmed/forms.htm.