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Human Subjects Division (HSD)

Documents

Document Details

Last Updated 08/29/2014
Version 8.00
Filesize 100.5 KB
Audiences Researcher
Doc Type Template

Change Notes

  • Related to Ver. 8.00, noted 08/29/2014 @ 10:10am
    Update to the language regarding research related injury. No need to revise consent forms currently in use. Use for new studies going forward.
    - sherrye
  • Related to Ver. 7.00, noted 06/27/2014 @ 09:39am
    Minor update to Medical Record Information section. Removal of last two bullet points per CRBB.
    - sherrye
  • Related to Ver. 6.90, noted 04/25/2014 @ 10:35am
    Change to number 3 under Information that will be put in your medical record. Use this version going forward.
    - sherrye
  • Related to Ver. 6.80, noted 03/28/2014 @ 10:24am
    Clarified wording in subject statement regarding who to contact regarding harm due to study.
    - sherrye
  • Related to Ver. 6.70, noted 01/31/2014 @ 09:25am
    Changes to who needs to be listed at top of form. Please use this version going forward. No need to change currently approved consent forms.
    - sherrye
  • Related to Ver. 6.60, noted 11/01/2013 @ 01:34pm
    Updated language regarding subject payment. Use this version going forward.
    - sherrye
  • Related to Ver. 6.50, noted 10/19/2013 @ 04:54pm
    Updated name to new naming convention on website.
    - sherrye
  • Related to Ver. 6.50, noted 08/09/2013 @ 10:43am
    Updated language regarding subject injury. Please use this version going forward.
    - sherrye
  • Related to Ver. 6.40, noted 01/25/2013 @ 09:32am
    Updated FCOI language. This change does not require modification to any exisitng approved consent forms.
    - sherrye
  • Related to Ver. 6.30, noted 05/25/2012 @ 08:52am
    New text added for subject numbers in drug studies. Do not use older versions of this template. HSD will not accept older versions after July 1, 2012.
    - sherrye
  • Related to Ver. 6.20, noted 02/24/2012 @ 08:45am
    Updated wording under Other Information to match current subject payment policy. Removed line from Certificate of Confidentiality wording regarding someone who is accused of a crime. Okay to use already approved versions. New version should be used for new studies.
    - sherrye
  • Related to Ver. 6.10, noted 09/01/2011 @ 08:39am
    Fixed typos in new confidentiality section.
    - sherrye
  • Related to Ver. 6.00, noted 08/26/2011 @ 08:20am
    New section about confidentiality.
    - sherrye
  • Related to Ver. 5.50, noted 05/27/2011 @ 09:41am
    Three minor additions have been made to the standard consent form template. (1) Federally-required statement about registration of clinical trials at www.clinicaltrials.gov; (2) Source of funding section, for research supported by external funding or other type of support; and (3) Information about Social Security number for research where industry sponsors will pay to treat research-related injuries.
    - sherrye
  • Related to Ver. 5.10, noted 12/13/2010 @ 04:43pm
    A sentence in the SFI sample paragraphs has been changed to read: "This financial interest and the design of the study have been reviewed and approved by the University of Washington." The sentence previously read: "This financial interest and the design of the study have been reviewed by the University of Washington for possible conflicts of interest."
    - sherrye
  • Related to Ver. 5.00, noted 11/15/2010 @ 09:33am
    Addition of Significant Financial Interest language.
    - sherrye
  • Related to Ver. 4.10, noted 08/02/2010 @ 11:48am
    Content changes to sections related to billing and CRC.
    - sherrye