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Human Subjects Division (HSD)


Document Details

Last Updated 08/26/2016
Version 3.80
Filesize 106.5 KB
Audiences Researcher
Doc Type Template



This consent template is to be used with UW studies that are being reviewed by Western IRB (WIRB).

Change Notes

  • Related to Ver. 3.80, noted 08/26/2016 @ 04:35pm
    Added collect call information
    - sherrye
  • Related to Ver. 3.70, noted 05/29/2015 @ 09:59am
    Updated to reflect revised processes.
    - sherrye
  • Related to Ver. 3.60, noted 09/26/2014 @ 10:20am
    Two items removed from the list of information about this research study that will be put in your medical record. 1. Expected start and end dates for your time in the study and 2. Whether there are healthy volunteers in the study
    - sherrye
  • Related to Ver. 3.50, noted 04/25/2014 @ 09:47am
    Change to number 3 under Information that will be put in your medical record. Use this version going forward.
    - sherrye
  • Related to Ver. 3.40, noted 12/27/2013 @ 09:47am
    Updated WIRB address
    - sherrye
  • Related to Ver. 3.30, noted 10/19/2013 @ 04:55pm
    Updated name to new naming convention on website.
    - sherrye
  • Related to Ver. 3.30, noted 01/16/2013 @ 01:18pm
    Updated FCOI language. This change does not require modification of any existing approved consent forms.
    - sherrye
  • Related to Ver. 3.20, noted 06/29/2011 @ 08:27am
    • COST section includes new proposed language for subjects with Medicare Advantage Plan. This section has been reviewed and approved by the UW Attorney General’s Office. • CONFIDENTIALITY AND PRIVACY section includes new language required by the Food and Drug Administration (FDA) about registering clinical trials with ClinicalTrials.gov. This language is mandated by law and may not be changed. • COMPENSATION FOR INJURY section has updated language about the sponsor’s obligation to report to Medicare if the sponsor pays for research related injuries. This language is preferred by major sponsors. • SOURCE OF FUNDING section includes new language for device studies. MedicareNoridian will not pay for the device without this language.
    - sherrye
  • Related to Ver. 3.10, noted 02/07/2011 @ 01:18pm
    Updates to section on Significant Financial Interest.
    - sherrye