Completing the Initial NCI CIRB Annual Principal Investigator Worksheet About Local Context at UW-Madison

All investigators conducting research with the National Cancer Institute’s Central IRB (NCI CIRB) as the IRB of record are required to complete an “Annual Principal Investigator Worksheet about Local Context” and submit it to the NCI CIRB for approval. The NCI CIRB will use the information in this worksheet to document how local investigators will comply with site-specific elements of study conduct.

To ensure that the information provided to the NCI CIRB is consistent with UW-Madison policies and guidance, the first time an investigator completes an Annual Principal Investigator Worksheet about Local Context, the investigator must submit a draft of the Worksheet for review by the UW’s Health Sciences (HS) IRBs Office prior to submitting the Worksheet to the NCI CIRB. The Worksheet may be submitted to the NCI CIRB only after the HS IRBs Office has confirmed that it is acceptable.

Step 1: Obtain a username and password to access the NCI CIRB's IRBManager

The UW Carbone Cancer Center (CCC) has provided the NCI CIRB with a list of principal investigators (PIs) and research staff who may be involved on NCI CIRB studies and need access to secure CIRB resources. UWCCC personnel on that list should receive a username and password from the NCI CIRB Operations Office. The username and password allow UW personnel to log in to the NCI CIRB’s IRBManager system (an online submission tool akin to the UW’s ARROW system). PIs or research staff who have not received a username and password from the NCI CIRB should contact the Reliance Team in the UW HS IRBs Office at irbreliance@medicine.wisc.edu

Step 2: Access the Annual Principal Investigator Worksheet about Local Context

Follow the directions in the NCI CIRB Instruction Manual for Worksheet Completion in IRB Manager (available here) to log in to IRBManager and open a new Annual Principal Investigator Worksheet about Local Context. Note that a study team member may enter information in the Worksheet on the PI’s behalf, but only the PI can submit the completed form.

Step 3: Incorporate recommended language

Answers for many of the questions in the Annual PI Worksheet will be specific to each PI. However, because recruitment practices, informed consent process, use of legally authorized representatives, and inclusion of vulnerable subject populations must be consistent with UW-Madison policies and guidance, study teams should incorporate the information provided below into these sections of the Worksheet.

Step 4: Prior to submitting the Worksheet to the NCI CIRB, submit for UW review

If you are completing your first Annual Principal Investigator Worksheet about Local Context, review by the HS IRBs Office is required before the Worksheet is submitted to the NCI CIRB. This is a courtesy to study teams, intended to ensure that information related to recruitment and consent process are consistent with UW guidelines. To submit for UW review:

Step 5: Receive NCI CIRB confirmation of approval for the Annual Principal Investigator Worksheet

When the UW PI submits the Annual Principal Investigator Worksheet About Local Context to the CIRB, it is reviewed in detail by the NCI CIRB’s Local Context Subcommittee. This subcommittee determines if the Worksheet is acceptable and the PI is eligible to conduct studies under the NCI CIRB’s oversight.

Both an Annual Principal Investigator Worksheet and a Study-Specific Principal Investigator Worksheet must be approved by the NCI CIRB before a study may be conducted.

See UW-Madison Procedures for Using the National Cancer Institute Central Institutional Review Board (NCI CIRB) as well as the NCI CIRB Instruction Manual for Worksheet Completion in IRB Manager (www.ncicirb.org).