One-time Rollover of Current NCI CIRB Studies
Transitioning to the NCI CIRB Independent Review Model
As part of the UW-Madison’s transition to the NCI CIRB independent review model, all ongoing studies previously accepted as NCI CIRB studies using facilitated review will be “rolled over” into the new system. In order for the UW Health Sciences IRBs (HS IRBs) Office to complete the rollover, study teams with ongoing NCI CIRB studies need to follow the steps outlined below.
1) Ensure that the principal investigator (PI) has an approved NCI CIRB Annual Principal Investigator Worksheet about Local Context
This NCI CIRB-required form must be submitted by the PI and approved by the NCI CIRB before the PI can conduct research through those IRBs. See 28683 for details.
2) Move studies deferred to the NCI CIRB before ARROW was implemented into ARROW
To make tracking studies easier for study teams and the HS IRBs Office, all NCI CIRB studies will need to be entered into ARROW. Thus, studies that were deferred to the NCI CIRB before ARROW was implemented in 2010 will need to be resubmitted through ARROW before they can be rolled over to the NCI CIRB’s independent review model.
Follow these steps to submit these studies in ARROW:
- Use the "Create New IRB Application" activity to open a new application.
- Create a "Request for Deferral" application and include the information outlined below.
- 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 (i.e. "NCI CIRB [Cancer Center #][cooperative group #] Study Title")
- Application Type: Select "Request for Deferral of IRB Oversight to a Non-UW-Madison IRB." [Note: Do not select the NCI IRB Facilitated Review application type.]
- Deferral request page: Provide the requested information; select "no" for Q8.4.
- Non-WIC page:
- 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:
- Q1.1: Select “yes.”
- Q1.1.1: As the reason for the replacement, state that the study was accepted as an NCI CIRB study prior to implementation of ARROW and the replacement is being submitted so that the study can be continued under the CIRB’s independent review model.
- Q1.1.2: Enter the HS-UW IRB protocol number previously assigned to the study.
- Q2.1: Upload the following documents:
- Study consent form(s). Be sure that consent documents are based on the current CIRB-approved template, revised to add UW-specific information and edit to follow UW conventions for terminology. To be sure the UW language is current, review ___ and the Informed Consent .
- Due to the length of oncology consent forms, an information sheet should be created to accompany each consent form, using the appropriate UW Consent Form Summary Information Sheet to provide a brief, simple overview of the study.
- Upload the previously approved HIPAA authorization form(s) after verifying that the forms are up-to-date and follow current UW conventions. See HIPAA Authorization Guidance .
- Upload any other study materials approved by the NCI CIRB that will be used at the UW (e.g. educational or recruitment materials).
- If any affiliate sites are participating, upload a 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.
- Record Human Subjects Training Snapshot: Before submitting the application, use this activity to verify that all study team members have completed required training.
Until the study team receives confirmation from the HS IRBs Office and/or the NCI CIRB that the study has been rolled over into the new NCI CIRB system and will be reviewed under the independent review model, continue following the procedures the study team has used in the past to report amendments, continuing reviews, and reportable events for the study. Forms for paper submissions will continue to be available on the HS-IRB website until all studies have been rolled over.
When the study team receives confirmation that the study is now under the independent review model, submit a paper Protocol Closure Form to close out the old version of the study. The closure form will be available on the HSIRBs website until all studies have been rolled over.
3) For ongoing NCI CIRB studies already in ARROW
NCI CIRB studies initially submitted in ARROW do not need to be modified for the purposes of the rollover. Until the study team receives confirmation from the HS IRBs Office and/or the NCI CIRB that the study has been rolled over into the new NCI CIRB system and will be reviewed under the independent review model, continue following the procedures the study team has used in the past to report amendments and reportable events for the study in ARROW.
4) After the rollover is complete
Once a study is under the NCI CIRB’s independent review model, no UW IRB review is required for continuing reviews or amendments. Study teams should no longer submit continuing reviews or protocol amendments in ARROW.
UW HS IRB review may be required to determine if a reportable event or noncompliance occurring at the UW requires reporting to the NCI CIRB and personnel changes may require submission to the HS IRB (see the National Cancer Institute Central Institutional Review Board (NCI CIRB) webpage for updates).