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Human Subjects Division (HSD)

Documents

Document Details

Last Updated 11/22/2013
Version 1.20
Filesize 2.6 MB
Audiences HSD Staff, IRB Member, Researcher
Doc Type Form
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WORKSHEET: Human Subjects Research

Purpose

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.)

Related Documents

Change Notes

  • 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