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Human Subjects Division (HSD)


Document Details

Last Updated 11/22/2013
Version 1.22
Filesize 59.29 KB
Audiences HSD Staff, IRB Member, Research Participant, Researcher
Doc Type Policy

SOP Human Subjects Research


This document describes the process for determining whether an activity is human subjects research.

Change Notes

  • Related to Ver. 1.22, noted 11/22/2013 @ 11:47am
    Added 2.1.1, direction to see the SOP FDA-Regulated Research for more detailed information on their definition of human subjects research.
    - sherrye
  • Related to Ver. 1.10, noted 11/01/2013 @ 11:25am
    Added reference to FDA Guidance
    - sherrye
  • Related to Ver. 1.00, noted 06/28/2013 @ 09:38am
    Updated title, format and information with new SOPs
    - sherrye
  • Related to Ver. 1.00, noted 08/12/2011 @ 10:37am
    Document newly added.
    - sherrye