Transitioning to the NCI CIRB Independent Review Model

Using the NCI CIRB Independent Review Model

Transition Steps

In 2013, the National Cancer Institute’s Central Institutional Review Board (NCI CIRB) adopted an independent review model. Unlike the previous facilitated review process, in which IRB oversight was shared by the NCI CIRB and the UW IRB, the NCI CIRB will now serve as the single IRB of record for eligible, approved studies. UW-Madison will be among the first institutions to make the transition from facilitated review to the independent model. The transition will take place in stages in the first half of 2013.

Step I: Authorizing Access to NCI CIRB Online Tools

Study teams that have used the facilitated review process are familiar with the Participants’ Area of the NCI CIRB website, which provides access to NCI CIRB-approved studies. Under the independent model, study teams will also need to use the NCI CIRB’s online submission system, IRBManager. The NCI CIRB will distribute usernames and passwords to all UW personnel identified as requiring access to these tools. This will include Principal Investigators (PIs) who conduct cooperative group studies.

Step II: Annual Principal Investigator Worksheet About Local Context

To provide adequate oversight of study conduct at local sites, the NCI CIRB needs to collect information about the institution and study team, such as resources, staff, recruitment methods, consent procedures. The NCI CIRB will now require each PI conducting research under NCI CIRB oversight to provide this “local context” information on an annual basis using the NCI CIRB’s IRBManager system. PIs must have an Annual Principal Investigator Worksheet About Local Context approved by the NCI CIRB before they can continue ongoing NCI CIRB studies or open any new studies under the NCI CIRB’s oversight.

To ensure that the information provided in the Annual PI Worksheet is consistent with UW policies and guidance, the Health Sciences (HS) IRBs Office will review the initial Worksheet for each PI before it is submitted to the NCI CIRB. See Completing the Initial NCI CIRB Annual Principal Investigator Worksheet About Local Context at UW-Madison for specifics.

Step III: One-time Rollover of Current NCI CIRB Studies to the Independent Model

To enable better tracking of NCI CIRB studies open at the UW, the HS IRBs Office will require studies still in the “paper” system to be submitted in ARROW. The HS IRBs Office will advise study teams how and when to enter these studies into ARROW. Study teams should not need to do anything for studies initially submitted in ARROW under the facilitated review model. The HS IRBs Office will be responsible for transitioning ongoing NCI CIRB studies to the NCI CIRB's new review system.

Step IV: Open Eligible New Studies using CIRB Oversight

Once the transition to the new NCI CIRB independent review model is complete, the HS IRBs Office will require study teams to submit any new NCI cooperative group study on the NCI CIRB’s menu for possible deferral to the NCI CIRB. The HS IRBs Office will conduct an administrative review of each submission and decide if the study may be deferred to the NCI CIRB.  Study teams must receive confirmation in ARROW that a study can be deferred to the NCI CIRB before submitting a Study-Specific Worksheet to the CIRB.  Approval from the CIRB is required before study activities may begin.  For specific instructions for submitting new CIRB studies, see UW-Madison Procedures for Using the National Cancer Institute Central Institutional Review Board (NCI CIRB) Independent Review Model.  

Keywords:National Cancer Institute, NCI CIRB, NCI, Central IRB, independent review, independent model, IRBManager, IRB Manager, worksheet, local context, transition, UWCCC, oncology, cooperative group, rollover, transition, CIRB study, CIRB studies   Doc ID:28681
Owner:Monica E.Group:Health Sciences IRBs
Created:2013-02-18 16:21 CDTUpdated:2015-10-13 15:16 CDT
Sites:Health Sciences IRBs
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