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
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Purpose
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 Public 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.