Announcements Archive
CIRB Stakeholders,
The NCI CIRB has updated its guidance regarding the requirements for a witness. Witnesses will no longer be required by NCI. The inclusion of a witness in the remote consent process is now dictated by local institutional policy and must follow FDA and OHRP requirements.
Thank you
CIRB Operation Office
1. What if a participant cannot make their scheduled study visit?
If a participant at a site is unable to complete a required study related activity per the CIRB approved protocol due to COVID-19 or COVID-19 control measures, the investigator must assess whether this constitutes a minor protocol deviation or a major protocol deviation.
The CIRB appreciates the rapidly changing environment and the unique challenges that you are experiencing during the COVID-19 public health emergency. The NCI and CIRB are collaborating to ensure patient safety while optimizing the flexibility necessary to conduct ongoing clinical trials. The CIRB COVID-19 page continues to list relevant guidance issued by the NCI.
CIRB Stakeholders,
To standardize the posting process for study documents, the CIRB will no longer post Expedited Review Worksheets to the CTSU website. After a thorough review, it has been determined that the CIRB Approval Letter contains all the relevant information required by stakeholders. This change mirrors the documents posted for Full Board Reviews and reduces extra work for all stakeholders.
Effective January 1, 2022, CIRB-approved boilerplate language must be updated in all local institution consent documents within 30 days of the next CIRB amendment for all studies open to enrollment.
Dear CIRB Stakeholders,
The NCI CIRB Helpdesk phone line issue has been resolved.
Dear CIRB Stakeholders,
It has come to our attention that the NCI CIRB Helpdesk phone line is down and we are unable to receive incoming calls. We are working to resolve the situation.