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Human Subjects Division (HSD)


New Guidance and Form: Use of Non-Identifiable Specimens/Data (#I-308, #I-295)

Sep 3, 2010 at 10:16am
New Guidance and Form for the "Use of Non-Identifiable Specimens/Data" have been posted.  This guidance and form will replace the previous Biological Specimens Review Determination form and Biological Specimens Guidance. The purpose of this guidance and form is to determine whether human subjects are involved in research that consists of obtaining private information (data) and/or biological specimens, according to federal, state, and University of Washington definitions.  If not, the project requires neither Certification of Exemption nor IRB review. The guidance and form represent a revised understanding of relevant federal and state regulations and clarifies when the use of human specimens and/or data does, or does not, need IRB review.