Annoucements Archive

CIRB Participants,

The CIRB is pleased to announce an enhancement to the process for copying existing worksheets in IRBManager.   There are now two methods for copying a completed worksheet.  The Copy feature and the Copy to Amend feature.

The Copy feature should be used when you want to use an existing worksheet as a starting point for a new worksheet (for example, using a completed PI Worksheet for a new PI).  The Copy to Amend feature should be used when you want to revise an existing worksheet (for example, making a change to your Signatory Institution Worksheet).

To use the Copy feature for a completed Worksheet, click on the(Copy icon) under the ‘Action’ column to open a new copy of the Worksheet.  The copy will open in a new window in your browsers and will retain all answers associated with the previous Worksheet.  From this screen, you are able to update the specific questions or fields to make the Worksheet current.

To use the Copy to Amend feature for a completed Worksheet, click on the (Copy to Amend icon) under the ‘Action’ column to open a new copy of the Worksheet as well as highlight any revised answers. The copy will open in a new window in your browsers and will retain all answers associated with the previous Worksheet. From this screen, you are able to update the specific questions or fields to make the Worksheet current.

The Copy to Amend feature will help to expedite our review process as well as provide valuable tracking information for the submitting user.

Please contact the CIRB Helpdesk if you have any questions or comments.

Dear CIRB Stakeholders,

The CIRB Standard Operating Procedures (SOPs) have been updated.  The primary changes were made to reflect the updates to the CIRB’s membership processes.  Other minor administrative updates were also made and are summarized in the Summary of Changes to the SOPs.  

Please contact the CIRB Helpdesk with any questions.

Kind regards,

Dear CIRB Stakeholders,

The CIRB Operations Office is now providing a set of instructions for use by Study Chairs when preparing and submitting revised documents in response to a board determination of Approval Pending Modification (APM) or Tabled. The purpose of the new instructions is to ensure consistency in both the content and formatting of Study Chair Responses (SCR).   These new instructions will be made available via a weblink which will be included in each APM or Tabling email along with the CIRB’s outcome letter. The Study Chair Response instructions are also available on the CIRB website.  

Specifically, please note the following:     

1. Change Memos and tracked changes must be cumulative to inform the Protocol Information Office (PIO) of all the changes upon final approval from the CIRB. Maintain the Change Memos and tracked changes that were included in the initial submission to the CIRB from PIO to ensure they are cumulative.
2. Include ONLY changes related to the CIRB stipulations.  Studies managed by CTEP PIO with additional changes will require a new review and approval from CTEP PIO prior to CIRB review and will result in a review delay which is highly discouraged.  For DCP PIO managed studies, DCP PIO does not allow any changes other than those requested by the CIRB.

Please contact the appropriate CIRB Central Inbox with any questions: 

• Adult CIRB – Late Phase Emphasis
• Adult CIRB – Early Phase Emphasis
• Pediatric CIRB
• Cancer Prevention and Control CIRB

We are now accepting applications through July 31st for new NCI CIRB members. There are openings on the boards for medical oncologists, medical oncologists with immunotherapy experience, pharmacists, ethicists, statisticians and those with Cancer Care Delivery Research (CCDR) experience.  Refer to the Become a Board Member page for the application and more details about membership.

Thank you,

NCI CIRB Operations Office

Dear CIRB Stakeholders,

The CIRB Standard Operating Procedures (SOPs) have been updated to reflect the CIRB’s ability to review for study participants who become incarcerated while enrolled on a CIRB approved study.  

The CIRB is currently developing a local reporting worksheet.  Until the release of this worksheet, please contact the CIRB helpdesk if a participant becomes incarcerated and they will be able to properly route your request for review.

Refer to the Summary of Changes to the SOPs for more information.  

Please contact the CIRB Helpdesk with any questions.

Kind regards,

Dear CIRB Stakeholders,

In response to requests from CIRB stakeholders, we are happy to announce a significant enhancement to the Study Closure and Transfer of Review Responsibilities worksheet. The Study Closure and Transfer of Review Responsibilities worksheet has been modified to allow multiple studies as part of a single submission. This modification will reduce the need for individual worksheet submissions for each affected study, thus reducing the administrative burden on local site staff.

A new How to Submit a Study Closure and Transfer of Review Responsibilities Worksheet quickguide has also been posted to the NCI CIRB website to assist users in completing the revised worksheet.

If you have any questions, please contact the CIRB Helpdesk:  support@ncicirbcontact.zendesk.com or 1-888-657-3711.

Kind regards,

Dear CIRB Stakeholders,

To provide increased clarity and consistency in the CIRB’s official outcome letters the NCI CIRB Operations Office will begin referencing all amended protocols by only the associated Protocol Version Date (PVD).  There will no longer be references to a specific number for an amendment, revision, addendum, etc.   This change will take effect as of April 15, 2019.

Please contact the CIRB Central Inboxes or the CIRB Helpdesk with any questions: 

• Adult CIRB – Late Phase Emphasis:  AdultCIRB@emmes.com
• Adult CIRB – Early Phase Emphasis: EarlyPhaseCIRB@emmes.com
• Pediatric CIRB: PediatricCIRB@emmes.com or
• Cancer Prevention and Control CIRB: CPCCIRB@emmes.com

Sincerely, 
NCI CIRB Operations Office

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: 

• Adult CIRB – Late Phase Emphasis
• Adult CIRB – Early Phase Emphasis
• Pediatric CIRB
• Cancer Prevention and Control CIRB

Dear CIRB Stakeholders,

The CIRB policies have been updated to reflect the Common Rule 2018 Requirements per the revised regulations.  The revised SOPs capture the Common Rule pre-2018 Requirements, 2018 Requirements, and FDA regulations.  The CIRB is not transitioning any studies that were approved under the pre-2018 Requirements to the 2018 Requirements.  These will remain under the pre-2018 Requirements for the life of the study.  Since FDA did not adopt the revised Common Rule, FDA regulations are unchanged and will be followed for all applicable studies.

What you can expect?

• Continuing Review: The CIRB will continue to conduct continuing review for all studies under our purview.  
• Adult Informed Consent Documents: The December 2018 NCI Informed Consent Template complies with the 2018 Requirements.  
• Pediatric Informed Consent Documents:  Pediatric studies approved after January 21, 2019 will use the COG template addressing regulatory changes.
• Broad Consent: The CIRB is not adopting the use of broad consent for future use of biological samples.  

Click here for a summary of the changes to the SOPs.  

Please contact the CIRB Helpdesk with any questions.

Kind regards,

Laura Covington