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Institutional Review Board

NCI CIRB Submissions

Wheaton Franciscan Healthcare is a participant in the National Cancer Institute Central Institutional Review Board (CIRB) initiative. Because WFH has established a formal agreement with the NCI CIRB, investigators who wish to participate in Cooperative Group trials reviewed by the NCI CIRB may take advantage of these reviews.

The CIRB’s primary function is initial and continuing review of eligible Phase III Cooperative Group trials. WFH’s primary function is consideration of local context (including the Ethical and Religious Directives for Catholic Health Care Services) and oversight of local performance for these studies. The WFH IRB will decide on a study-by-study basis whether to accept the review of the CIRB or conduct its own review of the study.

Brief Overview:

Principal Investigator requests CIRB oversight to open a new study or for a study currently approved by the WFH IRB
Designated WFH IRB member conducts a Facilitated Review
If CIRB review is accepted, IRB staff will notify the local PI and the CIRB.
CIRB becomes the IRB of record for the study and is responsible for continuing review as well as review of subsequent amendments and serious adverse events as notified by the Cooperative Group.
The WFH IRB is responsible for overseeing local conduct of the study. WFH study team provides the WFH IRB with copies of all revised consent forms and continuing review updates. WFH IRB remains responsible for ensuring the consent form addresses local context concerns and for reviewing all local occurrences (e.g., unanticipated problems, deviations, noncompliance, changes in study team members).