Modification to the CIRB SOP’s - HIPAA and Translation of Participant Directed Instruments Sections
MEMORANDUM TO FILE
To: CIRB Regulatory File
From: Laura Covington
Director; NCI CIRB Operations Office
Date: October 14, 2021
Subject: Modification to the CIRB SOP’s- HIPAA and Translation of Participant Directed Instruments sections
An updated version of the CIRB SOPs is now available.
If you have any questions regarding the changes to the SOPs, contact the CIRB Helpdesk or 1-888-657-3711.
An overview of the changes to the SOPs is detailed below.
- Section 3.3.2– Updated to specify that the HIPAA document must be a standalone document and should not have the same header or continue pagination from the CIRB-approved model consent form.
- Section 22.214.171.124– Updated to specify that the protocol should identify which instruments are validated.
Changes to the policies noted above are effective immediately.