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Human Subjects Division (HSD)


Document Details

Last Updated 07/31/2015
Version 1.90
Filesize 849 KB
Audiences HSD Staff, IRB Member, Researcher
Doc Type Guidance

Use of Non-Identifiable Biological Specimens/Data Guidance


The purpose of this guidance is to assist UW researchers in determining 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 determination of exempt status nor IRB review.

The guidance represents 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.

Change Notes

  • Related to Ver. 1.90, noted 07/31/2015 @ 05:51pm
    Added information about newborn bloodspots.
    - sherrye
  • Related to Ver. 1.80, noted 06/26/2015 @ 10:27pm
    Removed erroneous statement from section 2.5.
    - sherrye
  • Related to Ver. 1.70, noted 08/13/2013 @ 01:31pm
    Updated Material Transfer Agreement link
    - sherrye
  • Related to Ver. 1.60, noted 08/29/2011 @ 10:13am
    Minor edits.
    - sherrye
  • Related to Ver. 1.40, noted 04/07/2011 @ 04:52pm
    Updated \"Certificate of Exemption\" to \"determination of exempt status\" where appropriate.
    - sherrye
  • Related to Ver. 1.30, noted 01/11/2011 @ 11:46am
    Updated purpose statement on website only.
    - sherrye
  • Related to Ver. 1.30, noted 09/12/2010 @ 06:57pm
    Minor edits.
    - sherrye