Annoucements Archive

Dear CIRB Stakeholders,

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: ncicirbcontact@emmes.com or 1-888-657-3711.

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

Section 2.3 Scope of Review Activities

• 2.3.1.4 defines electronic
• 2.3.1.5 defines written or in writing
• 2.3.1.6 defines eSignature
• 2.3.1.7 defines eConsent
• 2.3.8 now states that the CIRB reviews eSignature and eConsent formats

Amanda P. Sly, MS, CIP
Director of Central Operations
NCI CIRB Operations Office

CIRB Participants,

The CIRB Standard Operating Procedures (SOPs) have been updated.  The changes were made to reflect updates to the CIRB’s review process for of recruitment videos, changes to the length of CIRB meeting agendas and other administrative changes.  A detailed summary of the changes may be found in the Summary of Changes to the SOPs.  
The CIRB Operations Office has updated the review and approval process for recruitment videos.   As making changes to videos post-production can be costly and time consuming, the CIRB requires submission of draft materials, such as scripts and storyboards, prior to production. If the CIRB approves the draft materials for production the final video must be submitted to the CIRB for review.  

To facilitate submission of the final video we have created a new form entitled CIRB Participant Recruitment Materials Video Submission Form.  Once completed this form should be submitted to the CIRB Operations Office for CIRB review of the final video. This review is generally conducted via an expedited review and a final determination letter will be issued This form will be posted to CTSU for sites to utilize and easily locate the approved video online.   If you do not utilize CTSU for posting of documents, a version of the form will be provided via your standard document sharing processes.

To assist you in understanding the process we have created a Quickguide entitled Submitting Recruitment Material For Review which may be found on the CIRB website. 

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 changes were made to state the CIRB reviews for eSignature and eConsent.  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.
 

Dear CIRB Stakeholders,

Here is a memo providing interim guidance for patients on clinical trials supported by CTEP and the NCORP due to concerns regarding the spread of the novel coronavirus.  CTEP and the NCORP are providing clarification on measures to address some of the current challenges in providing care to patients enrolled on trials supported by CTEP and the NCORP in order to mitigate immediate hazards to the patients.

Please distribute this information to the appropriate staff and participating sites in your organization.

We will continue to monitor closely the studies being conducted across all the CTEP/NCORP clinical trials network programs to see if additional accommodations can be made to help maintain continuity of care of patients on trials as much as possible in this challenging situation.  Please do not hesitate to contact the Program Director for your specific trials program with any questions/concerns that may arise during this outbreak of the novel coronavirus.

Sincerely,
Meg Mooney, MD, Associate Director, CTEP
Worta McCaskill-Stevens, MD, Director, NCORP, DCP, NCI

Dear CIRB Stakeholders,

NCI’s goal is to limit changes to the model consent document, and to ensure that any information added to the consent document is related to research. Please review  Dr. Jeff Abrams’s letter regarding this new policy.

The NCI CIRB website contains an updated version of the Boilerplate Q &A Quickguide and new Boilerplate Guidelines Quickguide to assist your institution in complying with this directive.

If you have any questions, please contact the CIRB at ncicirbcontact@emmes.com.

Thank you,

Laura Covington, MS, CIP
Director, Local Operations
NCI CIRB Operations Office

DEAR CIRB PARTICIPANTS,

The NCI CIRB Operations Office will be closed Tuesday, December 25, 2018 for the Christmas Holiday. We will also be closed Tuesday, January 1, 2019 for the New Year’s Holiday.

If you need to reach us, please do so before the holiday by sending an email to ncicirbcontact@emmes.com, or by calling us toll-free at 1-888-657-3711.

Thank you and have a great day!

NCI CIRB Helpdesk

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

As of February 1, 2019, the NCI CIRB will no longer acknowledge or post the COG Activation Memos.  The CIRB action of posting the CIRB-approved documents to the Documents tab on the CTSU website is the CIRB’s acknowledgement of the activation.  The COG Activations Memos are available on the COG website.   

The CIRB only posts the documents that they have approved.  If a document is posted on the CTSU website under the  Documents tab and on the COG website, the CIRB-approved version posted on the CTSU website should be used. 

Please contact the CIRB Helpdesk at NCICIRBContact@emmes.com with questions or for further information.