SOP Update Memo

MEMORANDUM TO FILE

To:       CIRB Regulatory File

From:  Laura Covington, MS, CIP 
           Director; NCI CIRB Operations Office

Date:   August 1, 2024

Subject:    Modification to the CIRB SOP’s 

An updated version of the CIRB SOPs is now available on the CIRB website.

If you have any questions regarding the changes to the SOPs, contact the CIRB Helpdesk.

An overview of the changes to the SOPs is detailed below.    

• Section 1.5 – Added section NIH Single IRB Policy.
• Section 2.3.1.8 and 2.3.1.10 – Added definitions for remote consent and clinical trial.
• Section 2.3.7 – Added definitions for ancillary studies and companion studies.
• Section 5.9.9.7 – Clarified the review of outside source translated instruments.
• Section 7.2.3 – Listed the additional pediatric determinations required for exempt research.
• Section 7.2.4 – Further defined the CIRB’s policy regarding the review of exempt research.
• Section 7.3.7 – Defined payment and the determinations to be made by the CIRB related to payments.
• Section 8.7.2.5.1 – Added a definition of compensation.
• Section 10.7 – Included a section Reporting to AAHRPP.

Changes to this policy as noted above are effective immediately.