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Human Subjects Division (HSD)

Documents

Document Details

Last Updated 02/27/2015
Version 8.30
Filesize 91 KB
Audiences Researcher
Doc Type Template

Change Notes

  • Related to Ver. 8.30, noted 02/27/2015 @ 09:08am
    Significant wording changes to injury compensation section. Please use this version going forward.
    - sherrye
  • Related to Ver. 8.20, noted 01/30/2015 @ 12:27pm
    Updated language regarding the financial conflict of interest plan. Removed bulk of language regarding medical records. Please use this version going forward. No need to change already approved consent forms.
    - sherrye
  • Related to Ver. 8.10, noted 10/01/2014 @ 11:05am
    The injury compensation section has been revised slightly, to provide somewhat more detailed explanation of who might have to pay for treatment of research-related injuries in UW studies that are not eligible for the UW Human Subjects Assistance Program.
    - sherrye
  • 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