Annoucements Archive

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 support@ncicirbcontact.zendesk.com with questions or for further information.
 

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 Stakeholders,

In response to requests from CIRB stakeholders, we are happy to announce a significant enhancement when requesting a change of PI.  A new separate Worksheet, the 3_5 - Change of PI Worksheet, allows multiple studies to be changed to a new PI 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 as well as the CIRB’s review process.

The removal of study specificity will require staff to submit a separate revised Annual Principal Investigator Worksheet or revised Study-Specific worksheet for any affected study that has a change in the local context considerations. 

A revised Changing the PI on a Study Quickguide has also been posted to the NCI CIRB website to assist users in completing the new Change of PI worksheet

If you have any questions regarding the use of new Change of PI worksheet, please contact the CIRB Helpdesk:  ncicirbcontact@emmes.com or 1-888-657-3711.

Kind regards,
 

CIRB Operations Office

Dear CIRB Stakeholders,

As of August 27, 2018, CTEP-issued Action Letters will be posted to the Supplemental Documents tab of the CTSU website by the coordinating groups.  The CIRB will no longer post the Action Letter with its review.  This change allows for immediate distribution of the Action Letter by the coordinating Group.  

The CIRB will continue to process and review all Action Letters according to its SOPs.  An Acknowledgement of Receipt and a determination of whether the event constitutes an Unanticipated Problem will be issued and posted by the CIRB to the CIRB Documents tab. 

Please refer to the CIRB Document Posting Quickguide for more information regarding which documents are posted to the CIRB Documents tab. 

Please contact the CIRB Helpdesk at NCICIRBContact@emmes.com or at 1-888-657-3711 if you have any additional questions or comments.  
 

Dear CIRB Stakeholders,

We are happy to announce that CIRB-approved short form consents are now available in 11 languages on CTSU’s website under Resources.  

Sites can use these approved short forms for any study approved by the CIRB if:

1. There is no eligibility restriction in the protocol based on language that would prohibit enrollment of the participant;
2. The Signatory Institution’s policies permit the use of short form consents;
3. These policies have been reported to the CIRB on either the Annual Signatory Institution Worksheet or the Annual PI Worksheet; and
4. A CIRB-approved short form exists in a language understandable to the potential participant.

The CIRB SOPs have been updated to reflect the use of short forms; the SOP change memo provides an overview of the changes.

A Short Forms Q & A is also available.   

If you have any questions regarding the use of short forms or changes to the SOPs, contact the CIRB Helpdesk:  ncicirbcontact@emmes.com or 1-888-657-3711.

Kind regards,

Dear CIRB Stakeholders,

The CIRB Operations Office has developed a Quickguide to clarify the role of the CIRB in the Uniform Document Posting (UDP) Initiative.

The new Quickguide, (‘CIRB Document Posting’) can be found on the CIRB Website under both the For Institutions and the For Networks pages.

The UDP Initiative was developed by CTEP and became effective on December 15, 2017.  Previous announcements describing the CIRB’s role in this process can be located on the Announcements Archive page of the CIRB Website, which is accessible from the Homepage.  This includes the original announcement issued December 15, 2017 and a clarification made on January 30, 2018.

The UDP Initiative is part of ongoing quality improvement efforts with the goal of reducing timelines and eliminating redundancy in postings.  This policy was mandated by CTEP and applies to the CIRB and all participating Network Groups. It requires that all study documents be posted to a single location to prevent duplication errors.

Please contact the CIRB Helpdesk at support@ncicirbcontact.zendesk.com or at 1-888-657-3711 with questions or for further information.  As always, we welcome your comments and suggestions.

Dear CIRB Participant,

Last year, the CIRB rolled out a new website and materials aimed at improving communication.  These actions were in response to input from both a survey and a set of focus groups of CIRB participants.  

Because our last survey occurred several years ago, we’d like to get a current view of CIRB communication methods and materials.  We will make additional improvements based on your feedback.

We value your opinions.  Please help us improve CIRB communication by completing the survey using the link below. The survey will be completely anonymous; we will not track any individual responses.  It should take less than 10 minutes to complete.

https://www.surveymonkey.com/r/6RKWRTM

Thank you for your participation.

Dear CIRB Stakeholders,

A notification regarding the CIRB Unified Document Posting (UDP) initiative was issued on December 15, 2017.  In response to the UDP initiative and as part of ongoing quality improvement efforts to reduced timelines and eliminate redundancy in postings, the CIRB Operations Office made changes to the document posting process.  Based on the nature of the questions received in response to the notification, further information/clarification is provided below.

CIRB Unified Document Posting

As of Friday, December 15, 2017, CIRB-approved study documents will be posted only to the CIRB Documents tab of the CTSU website.  Documents posted to other tabs such as the Supplemental Documents and Adverse Event tabs will not be duplicated under the CIRB Documents tab.  Other pages and websites on which these documents were previously posted now link to the CIRB Documents tab.

The documents commonly posted to the CIRB Documents tab include the protocol, consent form(s), amendment and continuing review change memorandums, CIRB Applications, CIRB approval letters, and participant facing documents such as Quality of Life Questionnaires.  

Other changes that may impact you include:

•    Acknowledgements

Routine activities that are conducted per protocol, such as initial and amendment activations and routine status changes, will no longer be acknowledged by the CIRB.  If the status change or event is associated with significant new findings or information that may impact a participant’s willingness to continue in the study, such as study closures associated with participant safety issues, the CIRB will post an Acknowledgement or another review outcome, as appropriate.  

Participant letters issued directly to sites by coordinating groups to communicate emergent issues to participants and posted to the Supplemental Documents tab will be acknowledged by the CIRB but not duplicated under the CIRB Documents tab.

•    Supplemental Documents

Supporting documents provided to the CIRB for reference, such as Data Safety Monitoring Board (DSMB) reports and study summaries, will be posted by the coordinating group under the Supplemental Documents tab or other relevant tab and not duplicated under the CIRB Documents tab.  

The coordinating groups are responsible for the posting of Supplemental Documents and questions about these documents should be directed to the appropriate coordinating group.  Please note that COG does not yet comply with this policy but will in the coming months.

Please contact the CIRB Helpdesk at NCICIRBContact@emmes.com or at 1-888-657-3711 with questions or for further information.  As always, we welcome your comments and suggestions. Revised standard operating procedures (SOPs) will be released shortly and in the interim this notice is documentation of the changes.