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Human Subjects Division (HSD)

Documents

Document Details

Last Updated 05/12/2014
Version 3.00
Filesize 2.54 MB
Audiences HSD Staff, IRB Member, Researcher
Doc Type Form
Use of HSD PDF Forms

HSD Forms are compatible with Adobe Reader, Version 10 and higher, though we recommend use of the most recent version. You may receive messages from Adobe to upgrade.

For Mac users: be sure to open the form in Adobe Reader or Acrobat.

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APPLICATION: Specimen or Data Use, Identifiable (PDF) 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 PDF version of this form

Change Notes

  • 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 04/04/2014 @ 10:34am
    Bug fix to question 7.3. Version number not updated.
    - sherrye
  • Related to Ver. 2.90, noted 02/28/2014 @ 10:27am
    Added reference to new Genetic Supplement.
    - sherrye
  • Related to Ver. 2.80, noted 01/31/2014 @ 10:23am
    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 @ 10:58am
    Added references to FERPA, PPRA, and ability for researcher to add more than one data/specimens from a repository or other study. Please use this version going forward.
    - sherrye
  • Related to Ver. 2.60, noted 10/19/2013 @ 04:42pm
    Updated name to new naming convention on website.
    - sherrye
  • Related to Ver. 2.60, noted 08/09/2013 @ 10:30am
    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 @ 09:50am
    Updated mailing address information. Okay to use previous version.
    - sherrye
  • Related to Ver. 2.30, noted 04/26/2013 @ 11:32am
    Separated title and position fields in contact information section. Okay to use previous version.
    - sherrye
  • Related to Ver. 2.20, noted 01/25/2013 @ 09:17am
    Updated FCOI language. Okay to use previous version.
    - sherrye
  • Related to Ver. 2.10, noted 12/28/2012 @ 09:46am
    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 @ 09:42am
    Final version post beta-test. Previous versions will be accepted until 12/31/2012.
    - sherrye
  • Related to Ver. 1.10, noted 09/14/2012 @ 09:20am
    Corrected technical issues, made more clear that Waiver Request is needed with this form.
    - sherrye
  • Related to Ver. 1.00, noted 08/10/2012 @ 09:47am
    Document newly added.
    - sherrye