IRB Reliance
Access To Investigational Drugs, Devices And Biologics For Clinical Use
The Ascension Wisconsin (AW) Institutional Review Board (IRB) is responsible for the oversight of all research that involves human subjects (as defined by HHS and FDA regulations) conducted at an AW hospital or facility and/or by AW associate(s) or medical staff.
For research projects that are being conducted at multiple sites, Investigators may request for a single IRB to conduct the IRB review for both institutions. For a single IRB review to occur, the IRBs must establish an IRB Reliance Agreement (IRA) so that one IRB can defer oversight to the other IRB. Requests for the AW IRB to rely on the review of another IRB are evaluated on a case-by-case basis. This evaluation focuses on all aspects of a study including, but not limited to: study procedures, level of risk, researcher history and experience, conflicts of interest not otherwise precluding ceding and funding.
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Defer IRB Oversight to NCI CIRB
The Central Institutional Review Board (CIRB) Initiative is sponsored by the National Cancer Institute (NCI). The Adult NCI CIRB reviews Cooperative Group trials, as well as any other studies opened in the Cancer Trials Support Unit (CTSU).
In this Single IRB review model, the NCI CIRB serves as the IRB of record for eligible NCI cooperative group trials. The Ascension Wisconsin IRB remains responsible for monitoring the conduct of the research at the Ascension Wisconsin site(s). Because Ascension Wisconsin has established a formal agreement with the Adult NCI CIRB, investigators who wish to participate in these Cooperative Group trials can take advantage of this single IRB review model.
Criteria for Use of NCI CIRB
- Ascension Wisconsin study teams are required to use the NCI CIRB for all eligible studies
- Eligible studies are determined by the NCI CIRB and are listed on the NCI CIRB website
- Subject population may not include prisoners. (NCI CIRB does not review prisoner research)
Review by the Ascension Wisconsin IRB
The Ascension Wisconsin IRB must still conduct limited review of studies which will include a determination that the research is consistent with local policies and guidance, and to confirm that the necessary NCI and institutional requirements (e.g., approved NCI Annual Principal Investigator Worksheet about Local Context form, CITI training, COI disclosure, HIPAA review) have been completed.
The Guidance and Instructions for Studies Delegated to NCI CIRB will provide Investigators and study teams with guidance about initial submissions and submission after NCI CIRB approval.
Information and Resources
- Mentor User Guide
- IRB SOPs & Guidance
- FAQs below
IRB Forms, Templates and Guidance
- IRB Guidance & Submission Guide – NCI CIRB
- NCI CIRB Update form
- HIPAA Authorization Form
- NCI CIRB Boilerplate Language
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Process for IRB Reliance where the Ascension WI will Rely on an
External IRBSTEP 1: Reliance Request
Submit the IRB Reliance Request Form to the AW IRB. You can use the form below, or a similar form from another institution.
- IRB FORM: IRB Reliance Request Form
- IRB GUIDANCE: Requesting Single IRB Review (non-NCI-CIRB)
STEP 2: IRBs Establish Reliance
The AW IRB will review the request and determine if AW will consider deferring to the External IRB. The AW IRB and the External IRB will work together to enter into an IRB Reliance Agreement. As a reminder, IRBs are only required to have single IRB agreements for certain federally funded research and both IRB may not agree to a single IRB review.
If the IRBs do not already have the information on file from the the institution, the following forms may be used.
- IRB FORM: Request to Use an External IRB- IRB Survey
- IRB FORM: AW IRB and Local Context Information
STEP 3: Submit to AW IRB for Deferral Approval
If both IRBs agree to the reliance agreement, the AW IRB will notify the local AW PI. The PI can then submit the request for AW IRB registration and approval deferral to the AW IRB. The main study PI may also submit to the IRB of record.
STEP 4: Submit to External IRB for Approval
The overall study PI can submit to the IRB of record on behalf of the AW site, whether as the new study or an amendment. The overall PI should be sure to include local context consideration in teh IRB submission. The following tools are available to aid the overall PI and Relying PI in understanding and manage the responsibilities of the sites, IRBs and Institutions.
STEP 5: Submit the External IRB Approval to the AW IRB
The local AW PI must notify AW of the final External IRB approval by uploading the IRB approval letter in Mentor.
What about after the review?
The Reviewing IRB will conduct all IRB reviews. However, you will still need to notify the deferring IRB of certain updates, events and study closure. See the guidance from that IRB for details. You will also need to be sure that you follow the Policies and Procedures of both IRBs and of the Institution where the research is being conducted.
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Process for IRB Reliance where the Ascension IRB will Oversee for an External Site
STEP 1: Reliance Request
In general, the overall PI should follow the guidance, forms and processes of the relying site when requesting that the AW IRB serve as the IRB of record for an external site. The overall PI should work with the local site PIs. The AW IRB IRB Reliance Request Form can be used if instructed by the relying site.
- IRB FORM: IRB Reliance Request Form
STEP 2: IRBs Establish Reliance
The external IRB will work with the AW IRB to review the request and determine if both IRBs agree to for the AW IRB to be the reviewing IRB. The AW IRB and the External IRB will work together to enter into an IRB Reliance Agreement. As a reminder, IRBs are only required to have IRB agreements for certain federally funded research and both IRB may not agree to a single IRB review.
If the institution and/or Investigator has these documents completed in SmartIRB, they do not need to be duplicated. If SmartIRB is not used, complete the following forms and forward to the AW IRB.
- IRB FORM: Institutional Profile
- IRB FORM: Protocol Specific Survey
STEP 3: Submit to External IRB/Institution for Deferral Approval
If both IRBs agree to the reliance agreement, the AW IRB will notify the PI. The overall and local site PIs must ensure that all requirements for the external site are met prior to completing the submission to the AW IRB; forllow the guidance and procedures of the external IRB.
STEP 4: Submit to AW IRB for Approval
Once the overall PI has received notification of IRB reliance and that the external site requirements have been met, the overall PI can submit to the AW IRB for review. See the IRB submission page for details. The following tools are available to aid the overall PI and Relying PI in understanding and manage the responsibilities of the sites, IRBs and Institutions.
- Institution v. IRB Responsibilities Guidance (SmartIRB)
- Overall PI Checklist (SMART IRB)
- Relying PI Checklist (SMART IRB)
- Communications Plan (SMART IRB)
What about after the review?
The AW IRB will conduct all IRB reviews. However, you will still need to notify the relying IRB of certain updates, events and study closure. See the guidance from that IRB for details. You will also need to be sure that you follow the Policies and Procedures of both IRBs and of the Institution where the research is being conducted.