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 7.8.3.4– Updated to specify that the protocol should identify which instruments are validated. 

Changes to the policies noted above are effective immediately.