Human Research Protection Program

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Projects Deferred to NCI-CIRB

Per 45 CFR 46.114, an institution participating in a cooperative project may enter into a joint review arrangement in an effort to avoid duplication of effort. To this end, MCW has entered into an Agreement with NCI CIRB that allows NCI CIRB to provide IRB review and oversight for cooperative group projects.

IRB SOP: Projects Deferred to National Cancer Institute Central IRB outlines the process for MCW faculty who wish to conduct NCI CIRB approved protocols with NCI CIRB as the IRB of record. Appropriate information must be submitted to the MCW/FH IRB Office for deferral notification.

These projects will still be required to use the appropriate MCW ICF Template: A-NCI to ensure local requirements and HIPAA authorizations are incorporated.

Information and work guides are available to assist teams in entering these projects into eBridge. These documents have been developed by eBridge Support in collaboration with the MCW/FH IRB Office. 

Finally Investigators will be required to inform the Institution or MCW/FH IRB Office (via eBridge) in addition to NCI-CIRB of the following changes or events which may occur during the conduct of the project:

  • Change of PI 
  • Study staff changes
  • Protocol changes which require additional Safety Committee review
  • Internal UPIRSOs that are not also AEs or SAEs, for example stolen laptop, security breach
  • Internal events that CIRB determines are UPIRSOs
  • Internal potential serious or continuing noncompliance
  • Internal subject complaints
  • All audit reports from the MCW/FH site, including those from CIRB, cooperative groups, or the FDA
  • Study Closure


 

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