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 IRBManagerThe 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 email@example.com.
Step 2: Access the Annual Principal Investigator Worksheet about Local ContextFollow 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 languageAnswers 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.
- Question 5 (Conflicts of interest): If the answer to this question is “yes,” UW HS IRBs review will be required. If the PI or any of the PI’s research staff has a conflict of interest related to studies on the CIRB menu that result in a management plan, the UW will not defer IRB oversight to another IRB. Contact the Reliance Team (firstname.lastname@example.org) in the UW HS IRBs Office.
- Question 8 (Recruitment): A description similar to what would be included in an HS-IRB application should be adequate here. Be sure to specify whether medical records will be reviewed prior to consent to check potential eligibility.
- Question 16 (Consent process for non-English speaking subjects): Explain in the response that, due to the demographics of the UW’s patient population, it is unusual for non-English speaking patients to present as subjects, and UWCCC investigators do not typically prepare translations of consent documents in advance. It would be advisable to describe a consent process that will be followed if a non-English speaker is a potential subject. Refer to Non-English or Limited English Speaking Research Participants Consent Process for acceptable procedures.
- Question 17 (Who provides consent): Note that, just as for studies under the HS-IRB’s purview, subjects who lack consent capacity should not be enrolled unless there is justification for including these vulnerable subjects, and an appropriate plan for surrogate consent is provided. Do NOT select “LAR” for Q17 unless your research includes patient populations expected to have impaired decision-making capacity.
- Question 19 (institution’s policy re: assent of children and impaired adults): Base your description on the Assent and Consent Requirements for Children and Research with Adult Participants Lacking Capacity to Consent. Copies of these documents may also be attached to the Worksheet.
- Question 20 (institution’s process for receiving and addressing concerns from study participants and others about the conduct of the research): Include the following information:
- UW consent language directs subjects to discuss questions and concerns about the research with their study doctor; contact information is provided for investigators at the UW and any participating affiliate sites.
- For questions about the rights of research subjects, or for concerns that cannot be resolved with the study team, subjects are advised to contact the University of Wisconsin Hospital and Clinics or University of Wisconsin Medical Foundation Patient Relations Representative, who are trained in handling these questions and referring complaints related to human subjects protection to the IRB Office. Subjects participating at affiliate sites may also use CancerConnect.
- UW Office for Research Compliance (ORC) directs study teams to report as Unanticipated Problems any subject complaints that indicate unexpected risks or that cannot be resolved by the research team. In addition, ORC maintains a Human Research Protection Helpline that subjects and others may use to report concerns about research conduct.
- Question 26 (intention to use a legally authorized representative [LAR] to enroll subjects): In most, if not all, cases, the response to this question should be “no.” Just as for studies under the HS-IRB’s purview, subjects who lack consent capacity should not be enrolled unless there is justification for including such subjects, and an appropriate plan for surrogate consent is provided. Do not select “yes” for Q26 unless your research includes patient populations expected to have impaired decision-making capacity.
- Question 27(who may serve as an LAR): Attach a copy of the UW policy regarding Research with Adult Participants Lacking Capacity to Consent.
Step 4: Prior to submitting the Worksheet to the NCI CIRB, submit for UW reviewIf 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:
- When you reach the end of the Worksheet, select “Print” and save the Worksheet as a PDF. Then select “Save for Later.” Do NOT submit to the NCI CIRB at this point.
- Send the PDF as an email attachment to the Reliance Team (email@example.com) in the UW HS IRBs Office.
- The form will be reviewed within two business days of receipt. Any questions or recommended revisions will be sent to the study team via email.
- If there are no questions, or when any issues have been resolved, the HS IRBs Office will send an email to the study team confirming that the Worksheet may now be submitted to the NCI CIRB.
- Follow the NCI CIRB Instruction Manual for Worksheet Completion in IRB Manager to submit the Worksheet to the NCI CIRB.