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Human Subjects Division (HSD)

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Document Details

Last Updated 11/26/2014
Version 3.30
Filesize 537.5 KB
Audiences HSD Staff, IRB Member, Researcher
Doc Type Form

APPLICATION: Specimen or Data Use, Identifiable (Word) Use for Medical Records Review

Purpose

To gather the necessary information for the review of identifiable data and/or specimens of human subjects.  The form is limited to researchers who are not directly interacting with people, but who are reviewing identifiable private information about individuals and/or analyzing identifiable specimens.

Examples:

  • medical records
  • protected health information (PHI)
  • employment data
  • study records
  • pathology specimens
  • data and/or specimens from a repository

NOTE: This is the Word version of this form.

Change Notes

  • Related to Ver. 3.30, noted 11/26/2014 @ 11:36am
    Updated Period of Approval to allow for flexibility policy longer approval periods
    - sherrye
  • Related to Ver. 3.20, noted 08/29/2014 @ 10:34am
    Clarification of Cooperative Agreements vs. IRB Authorization Agreements. Please use this version going forward.
    - sherrye
  • Related to Ver. 3.00, noted 05/12/2014 @ 10:13am
    Updates to engagement section. Please use this version going forward.
    - sherrye
  • Related to Ver. 2.90, noted 02/28/2014 @ 10:28am
    Added reference to new Genetic Supplement
    - sherrye
  • Related to Ver. 2.80, noted 01/31/2014 @ 10:24am
    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. 2.70, noted 12/10/2013 @ 10:12am
    Title change to web page.
    - sherrye
  • Related to Ver. 2.70, noted 11/22/2013 @ 11:43am
    Added reference to FERPA and PPRA. Please use this version going forward.
    - sherrye
  • Related to Ver. 2.60, noted 10/19/2013 @ 04:43pm
    Updated name to new naming convention on website.
    - sherrye
  • Related to Ver. 2.60, noted 08/09/2013 @ 10:31am
    Updated HSD information box. Please use latest version.
    - sherrye
  • Related to Ver. 2.50, noted 06/28/2013 @ 11:52am
    Updated instructions. Please use latest version of this form.
    - sherrye
  • Related to Ver. 2.40, noted 05/31/2013 @ 09:53am
    Updated mailing address information. Okay to use previous version.
    - sherrye
  • Related to Ver. 2.30, noted 04/26/2013 @ 11:35am
    Separated title and position fields in contact information section. Okay to use previous version.
    - sherrye
  • Related to Ver. 2.20, noted 01/25/2013 @ 09:15am
    Updated FCOI language. Okay to use previous version.
    - sherrye
  • Related to Ver. 2.10, noted 12/28/2012 @ 09:47am
    Updated to reflect change that we require only a notation of how frequently a sponsor may require training refreshers, rather than full documentation. Question 10.1. reformatted to reduce confusion. Okay to use previous version.
    - sherrye
  • Related to Ver. 2.00, noted 11/30/2012 @ 09:47am
    Document newly added.
    - sherrye