UW-Madison Procedures for Using the National Cancer Institute Central Institutional Review Board (NCI CIRB) Independent Review Model
Using the NCI CIRB Independent Review Model
This document describes UW-Madison requirements and procedures for conducting research that is sponsored by the National Cancer Institute (NCI) and under the purview of an NCI Central Institutional Review Board (NCI CIRB). For general information about the NCI CIRB, see National Cancer Institute Central IRB (NCI CIRB) Basics and www.ncicirb.org
REQUIRED USE OF NCI CIRB
UW-Madison investigators intending to conduct any clinical trial that has been reviewed and approved by an NCI CIRB are now required to use the CIRB as the IRB of record for the study. When planning to conduct any NCI-sponsored cooperative group trial, UW-Madison study teams should consult the NCI CIRB website to see if the trial is listed on the menu of CIRB-approved trials. The menu is available using the "Studies" link on the NCI CIRB homepage (title/group and current status only) or by logging in to the Participant's Area (registered users only; all study-related documents available).
UW-MADISON REVIEW REQUIRED PRIOR TO SUBMISSION TO NCI CIRB
At UW-Madison, investigators planning to conduct a study for which the NCI CIRB can serve as the IRB of record must first undergo local review to ensure compliance with institutional requirements that are not assessed by the CIRB's Local Context Subcommittee. This local review will be conducted by the Health Sciences IRBs Office on behalf of the institution. Follow the steps below to prepare a submission for UW review. NOTE: Do not submit a Study-Specific Worksheet to the CIRB prior to confirmation from the Health Sciences IRBs (HS-IRBs) Office that a study can be deferred to the NCI CIRB.
1. Obtain access to secured NCI CIRB sites
The UW principal investigator for the study must have an NCI CIRB "Annual Principal Investigator Worksheet About Local Context" on file with the CIRB prior to submitting a new study. See Completing the Initial NCI CIRB Annual Principal Investigator Worksheet About Local Context at UW-Madison.
Research personnel responsible for preparing submissions for the NCI CIRB must have access to the CIRB website Participant's Area and to the CIRB's IRBManager (https://irbmanager.becirb.com/). Only registered users of the NCI CIRB may access study documentation, receive communications from the CIRB, and maintain current study records. To obtain access for new research staff, contact the NCI CIRB Helpdesk.
2. Follow UW scientific/ancillary committee review procedures
Studies that may be deferred to the NCI CIRB must undergo UW scientific review (Protocol Review and Monitoring Committee [PRMC]) and applicable ancillary committee reviews (e.g. Clinical Research Unit [CRU]) as normally required prior to submission to the HS-IRBs Office.
3. Prepare a "Request for Deferral" application in ARROW
After the study has received PRMC approval, the study team should prepare an initial review application in ARROW. Please follow the instructions below for specific sections:
General Study Information: Complete all sections as usual, except: on the Basic Study Information page, add "NCI CIRB" in both study title fields, before the cooperative group study number, to enable easier tracking of these studies in ARROW.
Application Type: Select "Request for Deferral of IRB Oversight to a Non-UW-Madison IRB." [Note: Until advised otherwise, do not select the NCI CIRB Facilitated Review application type.]
Deferral request page: Provide the requested information; select "no" for Q8.4.
- Q10.1: Enter "NCI CIRB" as the IRB of record.
- Q10.2: Select "yes"
- Q10.3: Enter "NA" in the field for Federalwide Assurance number (the NCI CIRB is not required to have an FWA).
- Q10.4: Enter "NCI CIRB Contact" as the IRB contact.
- Section 10.4.1: Enter NCICIRBcontact@emmes.com
- Section 10.4.2: Enter 888-657-3711
- Section 10.4.3: Enter NCI CIRB c/o EMMES Corporation, 401 N. Washington Street, Suite 700, Rockville, MD 20850
Supplemental Information page:
- Consent, assent (if applicable), and HIPAA documents should be uploaded on this page. See the section below for detailed instructions for preparing consent and authorization documents for NCI CIRB studies.
- If the PRMC has approved the study for conduct at Gundersen Health System (pediatric studies only), 1 South Park, UW Cancer Center - Johnson Creek, or UW Cancer Center - Riverview, upload an Affiliate Site Personnel for NCI CIRB Studies document that identifies the affiliate site(s), cites the existing IRB Authorization Agreement (IAA) between the UW and the affiliate(s), identifies the personnel at the affiliate site(s), and confirms that all these personnel are listed in the application as study team members.
4. Prepare consent documents for local use
- Use the NCI CIRB's approved consent form(s) for the study as a template. Current consent forms are posted with other study documentation in the Participant's Area of the CIRB website.
- The NCI CIRB's Local Context Subcommittee has approved specific consent form "boilerplate language" for UW studies. There are two versions of boilerplate language: one for use with CIRB consent forms that follow the Cancer Therapy Evaluation Program (CTEP) Informed Consent Template, version date 5/12/2013; and one for CIRB consent forms based on older templates. Consent documents that use the CTEP template require fewer edits to make them acceptable for local use.
- Due to the length of oncology consent forms, an information sheet should be created to accompany each consent form, using the Consent Form Summary Information Sheet to provide a brief, simple overview of the study.
- For Children's Oncology Group (COG) studies only: If the CIRB has determined that assent is required for a COG study, upload COG Youth Information Sheets or assent documents.
- Institutional requirements for deferral are met, such as training and absence of conflict of interest issues.
- Consent documents use the current CIRB-approved template and include all required UW language.
- HIPAA authorization forms meet UW requirements.
- If all institutional requirements are met, the letter will state that the study is eligible for deferral to the NCI CIRB.
- Rarely, UW-Madison/UWHC may determine that a study cannot be conducted at the UW-Madison or UWHC, and a disapproval notice will be issued.
- Study teams must monitor the NCI CIRB website and web-posting summary emails for NCI CIRB approval of amendments and other IRB actions for the study.
- Any locally-occurring reportable events must be reported to the NCI CIRB via IRBManager, following the NCI CIRB Instruction Manual for Worksheet Completion in IRBManager (on the CIRB website).
- Study teams must comply with all other NCI CIRB requirements, as described in the NCI CIRB's Standard Operating Procedures manual (on the CIRB website) and any other CIRB directives.
- Personnel changes: Submit all changes to UW study team members in ARROW. Select "full change" if the principal investigator is changing. See Personnel Change Guidance and How to Complete Changes of Protocol.
- Changes to HIPAA authorizations: Submit via a change of protocol in ARROW. Select "full change" so that the submission is routed to the appropriate HS IRB staff member.
- HIPAA noncompliance: Report any local noncompliance with HIPAA rules as a reportable event in ARROW. In addition, report the noncompliance directly to the UW HIPAA Privacy Officer.
- Changes to performance sites under HS-IRB purview: If 1 South Park, Johnson Creek, Riverview, or Gundersen is added or removed as a site participating under the HS-IRB's oversight, report this via ARROW. Select "full change" so that the submission is routed to the appropriate HS IRB staff member. Follow steps 2 - 6 in the "UW-Madison review required prior to submission to NCI CIRB" section above when preparing the change of protocol.
- Study closure: When all study activities are completed at UW and Protocol Closure Guidance are met, submit a Study Completion Report in ARROW.
5. Prepare HIPAA authorization form(s)
Create HIPAA authorization form(s) for the study that follow standard UW conventions, using appropriate templates from the HIPAA Authorization Guidance. Use stand-alone authorization forms (not combined consent/HIPAA forms).
6. Confirm completion of UW-required human subjects training
Use the "Record Human Subjects Training Snapshot" activity in ARROW to confirm that all study team members have completed required training per UW-Madison policy. If personnel at a participating affiliate site (e.g. Gundersen, Johnson Creek) have completed human subjects training through a mechanism other than CITI, upload their training certification on the Supplemental Information page of the ARROW application.
7. Submit deferral request to the HS-IRBs Office via ARROW
WHAT HAPPENS AFTER SUBMISSION IN ARROW?
1. After the deferral request is submitted in ARROW, it is routed to the UW Carbone Cancer Center PRMC for documentation of their approval, and then to the HS-IRBs Office.
2. The deferral request is reviewed by HS-IRB staff on behalf of UW-Madison and UW Hospital and Clinics (UWHC) to ensure that:
3. After any needed revisions have been resolved, the study team will receive correspondence in ARROW:
1. Once the study team has received correspondence in ARROW confirming that the study can be deferred to the NCI CIRB, the UW principal investigator must submit a Study-Specific Worksheet to the NCI CIRB to obtain approval to conduct the study at the UW-Madison/UWHC. NOTE: Do not submit a Study-Specific Worksheet prior to receiving confirmation in ARROW that a study can be deferred to the NCI CIRB.
2. The Study-Specific Worksheet is completed and submitted online in the NCI CIRB's IRBManager system following the NCI CIRB Instruction Manual for Worksheet Completion in IRBManager (on the CIRB website). Questions about this process should be directed to the NCI CIRB Helpdesk.
3. Per NCI CIRB SOPs, subject information sheets are "locally-developed materials" that must be submitted for CIRB approval. Questions about this process should be directed to the NCI CIRB Helpdesk.
4. The Study-Specific Worksheet and subject information sheets will be reviewed by the NCI CIRB per their standard operating procedures.
5. Once the CIRB has approved the study for conduct at UW, the NCI CIRB is the IRB of record for the study and is responsible for local site issues as well as study-wide oversight. This means:
ONGOING LOCAL COMPLIANCE REVIEW
1. UW-Madison remains responsible for monitoring institutional compliance as described in the CIRB's Division of Responsibilities document and the Annual Signatory Institution Worksheet. Compliance monitoring will be the shared responsibility of study teams, the UW Carbone Cancer Center (UWCCC) Compliance Office, and the HS-IRBs Office.
2. Only the following should be submitted in ARROW, for compliance monitoring purposes: