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Human Subjects Division (HSD)


Document Details

Last Updated 05/31/2016
Version 3.50
Filesize 575 KB
Audiences Researcher
Doc Type Form



Researchers who plan to establish a human data or specimen repository must submit the Repository Application to request IRB approval.

The creation of a research database or repository, and the use or disclosure of Private Health Information (PHI) from a database or repository for research, is subject to oversight by the Institutional Review Board (IRB) to ensure compliance with relevant HIPAA privacy rules. Oversight may include review and approval of a protocol specifying the conditions under which data and specimens may be collected and shared. The IRB may also assess whether adequate provisions are being taken to protect the privacy of subjects and maintain the confidentiality of repository specimens and data.

To learn more about HIPAA Privacy rule related to research repositories, see Research Repositories, Databases, and the HIPAA Privacy Rule.

This document is for use with paper-based applications only. Do not use with Zipline. HSD accepts versions from 3/27/2015 on.

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Change Notes

  • Related to Ver. 3.40, noted 04/24/2015 @ 10:48am
    Removed references to HIPAA authorizations.
    - sherrye
  • Related to Ver. 3.30, noted 03/27/2015 @ 09:48am
    Updates to help identify federal support.
    - sherrye
  • Related to Ver. 3.20, noted 08/29/2014 @ 10:35am
    Clarification of Cooperative Agreements vs. IRB Authorization Agreements. Please use this version going forward.
    - sherrye
  • Related to Ver. 3.10, noted 05/12/2014 @ 10:14am
    Updates to engagement section. Please use this version going forward.
    - sherrye
  • Related to Ver. 3.00, noted 02/28/2014 @ 10:29am
    Added reference to Genetic Supplement, removed genetic questions from this form. Please use this version going forward.
    - sherrye
  • Related to Ver. 2.90, noted 01/31/2014 @ 10:19am
    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. 2.80, noted 10/19/2013 @ 04:41pm
    Updated name to new naming convention on website.
    - sherrye
  • Related to Ver. 2.80, noted 08/09/2013 @ 10:29am
    Updated HSD information box and information regarding translated consent materials. Please use latest version.
    - sherrye
  • Related to Ver. 2.70, noted 05/31/2013 @ 09:47am
    Updated mailing address information. Okay to use previous version.
    - sherrye
  • Related to Ver. 2.60, noted 01/25/2013 @ 09:22am
    Updated FCOI language. Okay to use previous version.
    - sherrye
  • Related to Ver. 2.50, 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. Okay to use previous version.
    - sherrye
  • Related to Ver. 2.40, noted 12/07/2012 @ 09:49am
    Corrected numbering error, replaced broken MTA links. Okay to use previous version until 1/31/13
    - sherrye
  • Related to Ver. 2.30, noted 06/22/2012 @ 08:31am
    Addition of check box if file should go to Minimal Risk team.
    - sherrye
  • Related to Ver. 2.20, noted 05/25/2012 @ 09:12am
    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 01/27/2012 @ 08:58am
    Updated signature policy, okay to use previous version.
    - sherrye
  • Related to Ver. 2.00, noted 05/27/2011 @ 09:37am
    Addition of double-sided copies instructions, updated training requirements, removal of ARRA funding section.
    - sherrye
  • Related to Ver. 1.43, noted 03/10/2011 @ 09:03am
    Added text to instructions regarding signature submission.
    - sherrye
  • Related to Ver. 1.42, noted 09/16/2010 @ 01:55pm
    Updated document links.
    - sherrye