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Human Subjects Division (HSD)


Document Details

Last Updated 01/31/2014
Version 5.70
Filesize 272.5 KB
Audiences Researcher
Doc Type Form

APPLICATION: Specimen or Data Use, Non-Identifiable (and self-determination)


The purpose of this 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 determination of exempt status nor IRB review. 

Use this form only if your research does not involve direct contact with human subjects for research purposes.

Change Notes

  • Related to Ver. 5.70, noted 01/31/2014 @ 09:22am
    Removed reference to SOP on Public Data sets, and section to add co-investigators. Please use this version going forward.
    - sherrye
  • Related to Ver. 5.60, noted 11/01/2013 @ 01:14pm
    Reordered and updated question 4.A.1. Okay to use previous version.
    - sherrye
  • Related to Ver. 5.50, noted 10/19/2013 @ 04:44pm
    Updated name to new naming convention on website.
    - sherrye
  • Related to Ver. 5.50, noted 06/28/2013 @ 11:45am
    Updated form to align with new SOPs. Please use latest version.
    - sherrye
  • Related to Ver. 5.40, noted 05/31/2013 @ 09:54am
    Updated mailing address information. Okay to use previous version.
    - sherrye
  • Related to Ver. 5.30, noted 02/22/2013 @ 09:57am
    Updated directional in section A to clarify when to complete the questions regarding coded data. Okay to use previous version.
    - sherrye
  • Related to Ver. 5.20, noted 01/27/2012 @ 08:56am
    Updated signature policy, okay to use previous version.
    - sherrye
  • Related to Ver. 5.10, noted 08/29/2011 @ 10:17am
    Minor edits.
    - sherrye
  • Related to Ver. 4.30, noted 05/27/2011 @ 09:07am
    Addition of double-sided copies instruction.
    - sherrye
  • Related to Ver. 4.20, noted 04/07/2011 @ 04:59pm
    Updated \"Certificate of Exemption\" to \"determination of exempt status\" where appropriate.
    - sherrye
  • Related to Ver. 4.10, noted 03/10/2011 @ 09:21am
    Added text to instructions regarding signature submission.
    - sherrye
  • Related to Ver. 4.00, noted 09/03/2010 @ 12:06pm
    The revisions to this 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.
    - sherrye