Updates to CIRB Initial, Continuing and Amendment Review Applications

Policies
03.01.2019

Updates to CIRB Initial, Continuing and Amendment Review Applications

DEAR COORDINATING GROUPS,

The NCI CIRB Initial Review Application, NCI CIRB Continuing Review Application and NCI CIRB Amendment Review Application have been updated to streamline administrative processes and to gather additional information required for CIRB review determinations.  They are also located on the CIRB Website under the Quickguides for Submitting Studies.

The following change was made to the CIRB Initial Review and Continuing Review Applications: 

  1. The CIRB Operations Office will continue to send all outcome letters to the primary contacts provided on the CIRB Application including the Study Chair, Study Chair’s Administrative Assistant and the Study Contact Person. In addition, all applicable NCI program staff members will continue to be provided copies of the relevant outcome letters. To streamline the CIRB’s administrative processes and provide efficient communication with the study teams, the section for Additional Contacts to be included on official CIRB correspondences has been modified to allow for up to 4 additional contacts and their associated emails.  These contacts may be individuals or centralized email inboxes. 

The following change was made to the CIRB Initial Review and Amendment Review Applications:

  1. Initial Review Application Section 2.4 has been added to obtain information about the Informed Consent Process.  The location of the protocol section that addresses the consent process and eligibility criteria may be cited in response to this question.  In addition, there are questions which address if full written informed consent will be obtained or if a waiver or alteration of informed consent is being requested.
  2. Amendment Review Application Section 2.7 has been added to obtain information about the Informed Consent Process if a change in the study occurs that impacts the consent process.  A question has been added if a waiver or alteration of informed consent is being requested.

Additionally, a CIRB Waiver of Consent Request Supplemental Form has been developed for use when requesting a waiver or alteration of the consent process.  This form will be required in order to provide the CIRB with additional information required to determine if a waiver or alteration of the consent process may be granted.   This form is also available on the CIRB website under the Initial Review Submission Quickguide at the following link: CIRB’s Waiver of Consent Supplemental Form.

The revised applications are effective Friday, March 1, 2019 and should be used for all submissions submitted for review on or after that date.  

Please contact the CIRB Central Inboxes with any questions: