Annoucements Archive

The CIRB determines the age ranges when a child’s assent is required. If a child in the age range determined by the CIRB cannot provide assent, an Assent Waiver must be obtained prior to the child’s enrollment in the study. An electronic process has been developed for staff at enrolled institutions to request an assent waiver from the CIRB for an individual child in IRBManager.

Please consult the Completing the Assent Waiver Worksheet for the specific instructions to complete the Worksheet.

If you have any questions about this change, please contact the CIRB Helpdesk by telephone at 1-888-657-3711.

NCI CIRB Operations Office
The EMMES Corporation
401 N. Washington Street, Suite 700
Rockville, MD 20850
888.657.3711

 

Dear CIRB Stakeholders,

As part of ongoing quality improvement efforts, the CIRB Operations Office has made changes to the document posting process in order to improve timeliness as well as centralize the location of CIRB-approved study documents.  These changes eliminate the 24-48 hour lag time between study activation and document posting, as well as limiting duplicative and inconsistent posts.

CIRB Unified Document Posting

As of Friday, December 15, 2017, all CIRB-approved study documents, including the protocol, consent form(s), amendment and continuing review memorandums, and CIRB approval letters, will be posted only to the CIRB Documents tab of the CTSU website.  Other pages and websites on which these documents were previously posted will now link to the CTSU CIRB Documents tab.

Other changes that may impact you include:

•    Initial and Amendment Activation Acknowledgements
CIRB acknowledgements for the initial and amendment activations will be posted to the CTSU website under the CIRB Updates tab associated with that event. The posting will include the date of the activation.

•    Study Status Change Notices
Notices regarding study status changes, including re-activation, closure to accrual, and temporary closure to accrual, will be posted under the Supporting Documents tab of the CTSU website. The CIRB will only acknowledge these status changes if they are associated with significant new findings or if they may impact a participant’s willingness to continue in the study.  Routine activities that are conducted per protocol will not be acknowledged by the CIRB.

•    Continuing Review
Supporting documents, such as Data Safety Monitoring Board (DSMB) reports and study summaries associated with the CIRB’s continuing review, will be posted under the Supporting Documents tab of the CTSU website.  

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. As we receive feedback on this process, we will be posting frequently asked questions (FAQs) on the CIRB website (www.ncicirb.org). Revised standard operating procedures (SOPs) will be released shortly and in the interim this notice is documentation of the changes.

 
NCI CIRB Helpdesk
NCI CIRB Operations Office
The EMMES Corporation
401 N. Washington Street, Suite 700
Rockville, MD 20850
888.657.3711
NCICIRBcontact@emmes.com
http://www.ncicirb.org

Dear CIRB Participants,

The NCI CIRB Operations Office will be closed Monday, December 25, 2017 and Tuesday, December 26, 2017 for the Christmas Holiday. We will also be closed Friday, December 29, 2017 and Monday, January 1, 2018 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

An updated version of the CIRB SOPs has been posted.     

If you have any questions regarding the changes to the SOPs, contact the CIRB Helpdesk:  1-888-657-3711.

An overview of the changes to the SOPs is detailed in the SOP Change Memo below.

We’re so pleased to unveil our new CIRB website!  It’s the foundation of an improved communications effort to our CIRB community, and the result of listening to your feedback and taking your suggestions to heart.  

Why did we rework the website?
When we surveyed our CIRB participants and conducted focus groups to get your thoughts on the effectiveness of our communication tools, you told us that our brand didn’t project a clear theme.  You said our website needed a lot of help.  We now have a new mission statement, a brand that reflects it, and a new website that’s streamlined and focused on getting you the information you need to do your job.

How has the website changed?  
The first thing you’ll probably notice is that it looks different.  We hope it’s much more visually appealing and modern .  We’ve designed it to make it as easy as possible for you to find what you need, with clearer navigation and search functionality.  We’ve shortened and simplified the content, and we’ve added more Quickguides to help address your requests – for example, instructions on completing forms, opening a study, and other topics.

What next?
We hope you’ll like what you see, not only on the website but in our complete branding “package,” from PowerPoint templates to stationary.  But our work is far from over.  We’re going to continue to add content and experiment with other communication channels.

What can you do?
Please check out the new site and email us your thoughts.  What do you like?  How can it be better?
Thank you for your candid feedback and observations.  
The CIRB Operations Team

Additional information on how to become a board member can be found at Become a Board Member.

The CIRB’s Annual Signatory Institution Worksheet, Annual Principal Investigator Worksheet, and the Study-Specific Worksheet have been revised to make it easier for you to provide the required local context information to the CIRB. 

To support these revisions, instructions for completing these Worksheets can be found on the CIRB website within the for Institutions section, under Quickguides (http://www.ncicirb.org/institutions/institution-quickguides).  

If you have any questions regarding the changes to the Worksheets, contact the CIRB Helpdesk (ncicirbcontact@emmes.com or  1-888-657-3711).

An overview of the changes by Worksheet is provided below.

Annual Signatory Institution Worksheet:

1. Question 1 changed from identifying Network membership to identifying the boards used by the institution.
2. Question 12 has additional directions for the submission of boilerplate language.
3. Question 15 has been added to request the institution’s plan for updating changes to boilerplate language in studies currently open at the institution.
4. Questions 19 and 20 have been added to provide a specific area for translations and templates used by the institution.

Annual Principal Investigator Worksheet:

1. Question 6 now auto-populates all studies the PI has opened with the CIRB.
2. Question 9 has added clarification regarding the assent requirements of the CIRB and the information requested from the PI.
3. Question 29 includes the addition of employees as a potential vulnerable population.

Study-Specific Worksheet:

1. Questions 16, 17, and 18 have been added to provide a specific area for recruitment, assent, and translations and templates used by the institution.