Annoucements Archive

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,

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:  ncicirbcontact@emmes.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 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,

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

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

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

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

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 at ncicirbcontact@emmes.com or 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
NCICIRBcontact@emmes.com
 

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.

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.