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Human Subjects Division (HSD)


Document Details

Last Updated 06/01/2016
Version 1.70
Filesize 2.58 MB
Audiences HSD Staff, IRB Member, Researcher
Doc Type Form
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WORKSHEET: Human Subjects Research


This worksheet provides support for individuals in determining whether an activity is human subjects research. It is completed and retained only when the activity is determined to be Not Human Subjects Research. The sections should be considered in the order presented. The term "data" refers to information of all types (information, records, specimens, records, photos, X-rays, etc.)

Change Notes

  • Related to Ver. 1.70, noted 05/20/2016 @ 10:24pm
    Update to the definition of research.
    - sherrye
  • Related to Ver. 1.60, noted 07/31/2015 @ 05:49pm
    Added information about newborn bloodspots.
    - sherrye
  • Related to Ver. 1.50, noted 04/15/2015 @ 09:15am
    Updated to reflect new criteria for what is FDA regulated research.
    - sherrye
  • Related to Ver. 1.40, noted 08/11/2014 @ 01:24pm
    Added clarification to definition of obtain in Part 5.
    - sherrye
  • Related to Ver. 1.30, noted 04/25/2014 @ 09:37am
    Removed note regarding FDA definition of Human Subjects Research.
    - sherrye
  • Related to Ver. 1.20, noted 11/22/2013 @ 11:45am
    Added new direction in part 6 regarding when the UW is involved in conducting only some components of an FDA regulated study, criteria for when the resarch activities do not meet the FDA\'s definition of human research subject.
    - sherrye
  • Related to Ver. 1.10, noted 11/01/2013 @ 01:12pm
    Updated FDA definition.
    - sherrye
  • Related to Ver. 1.00, noted 10/19/2013 @ 05:01pm
    Updated name to new naming convention on website.
    - sherrye
  • Related to Ver. 1.00, noted 06/28/2013 @ 11:13am
    Document newly added.
    - sherrye