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Human Subjects Division (HSD)

Documents

Document Details

Last Updated 08/29/2014
Version 4.20
Filesize 403.5 KB
Audiences Researcher
Doc Type Form

APPLICATION: Human Subjects Review (13-11), Full Board or Subcommittee

Purpose

Most research reviewed by the UW IRB is submitted using the Standard IRB Application. Other options include:

  • Exempt Status Determination
  • Use of Identifiable Data/Specimens
  • Repositories
  • Delayed Onset Human Research Determination
  • Center, Program, or Training Grant

Please find these forms and their related instructions linked at right, and below. If your research will be reviewed by another IRB - check their web sites and instructions.

Change Notes

  • Related to Ver. 4.20, noted 08/29/2014 @ 10:36am
    Clarification of Cooperative Agreements vs. IRB Authorization agreements, removal of question regarding compensation for injury. Please use this version going forward.
    - sherrye
  • Related to Ver. 4.10, noted 05/12/2014 @ 10:09am
    Updates to engagement section. Please use this version going forward.
    - sherrye
  • Related to Ver. 4.00, noted 02/28/2014 @ 10:24am
    Added reference to Genetic Supplement.
    - sherrye
  • Related to Ver. 3.90, noted 01/31/2014 @ 10:18am
    Updates to the research staff information section; new section on non-UW institutions, removed training section, added directional to DOD and DOJ supplements when funding from these federal entities are included. Please use this version going forward.
    - sherrye
  • Related to Ver. 3.80, noted 11/22/2013 @ 10:55am
    Added references to FERPA, PPRA. Please use this version going forward.
    - sherrye
  • Related to Ver. 3.70, noted 11/01/2013 @ 01:25pm
    Removed section on drugs and devices, and added text referring to new drug and device supplements. Use this version going forward.
    - sherrye
  • Related to Ver. 3.60, noted 10/19/2013 @ 04:40pm
    Updated name to new naming convention on website.
    - sherrye
  • Related to Ver. 3.60, noted 08/09/2013 @ 10:34am
    Updated HSD information box and information regarding translated consent materials. Please use latest version.
    - sherrye
  • Related to Ver. 3.50, noted 06/28/2013 @ 11:49am
    Updated instructions. Please use latest version of this form.
    - sherrye
  • Related to Ver. 3.40, noted 05/31/2013 @ 09:26am
    Added routing questions and specific mailing address instructions. Okay to use previous version.
    - sherrye
  • Related to Ver. 3.30, noted 03/29/2013 @ 08:39am
    Added question related to IBC. Okay to use previous version.
    - sherrye
  • Related to Ver. 3.20, noted 01/25/2013 @ 09:19am
    Updated FCOI language. Okay to use previous version.
    - sherrye
  • Related to Ver. 3.10, noted 12/28/2012 @ 09:42am
    Updated to reflect change that we require only a notation of how frequently a sponsor may require training refreshers, rather than full documentation. Question #3 of Section VII.F. regarding who pays for adverse events has been expanded to create clarity. Okay to use previous version.
    - sherrye
  • Related to Ver. 3.00, noted 05/25/2012 @ 08:46am
    New questions added for subject numbers. New questions added for anesthesiology. New questions added for Lead Researcher. Do not use older versions of this form. HSD will not accept older versions after July 1, 2012.
    - sherrye
  • Related to Ver. 2.10, noted 03/30/2012 @ 09:09am
    Added language in the funding sections that states \"This should include grants that support faculty time for data analysis and manuscript preparation.\" Removed redundant PHI question. Okay to use previous version.
    - sherrye
  • Related to Ver. 2.00, noted 02/24/2012 @ 08:35am
    Corrected directional in section D. Okay to use previous versions as long as section D is filled out completely.
    - sherrye
  • Related to Ver. 1.90, noted 01/27/2012 @ 09:12am
    Updated signature policy, okay to use previous version.
    - sherrye
  • Related to Ver. 1.80, noted 11/30/2011 @ 03:41pm
    Enhanced questions regarding subject numbers and PHI. Newest version should be used.
    - sherrye
  • Related to Ver. 1.70, noted 08/12/2011 @ 03:40pm
    Minor adjustments to cover page.
    - sherrye
  • Related to Ver. 1.70, noted 05/27/2011 @ 10:09am
    Addition of cover page, double-sided copies instructions, updated training requirements, removal of ARRA funding section.
    - sherrye
  • Related to Ver. 1.63, noted 03/09/2011 @ 02:58pm
    Added text to instructions regarding signature submission.
    - sherrye
  • Related to Ver. 1.62, noted 02/25/2011 @ 09:19am
    Section H - edits to clarify when either a Waiver of HIPAA Authorization or a HIPAA Authorization Template is needed.
    - sherrye
  • Related to Ver. 1.61, noted 12/09/2010 @ 02:29pm
    Added request and link to Section E question 2 asking the researcher who is including protected groups of subjects to also fill out the Supplement: Protected and Vulnerable Populations.
    - sherrye