This section of the Reliance Manual provides an overview of the cede agreement process and how and when to submit a cede request.
Overview of Agreement Process
For UW-Madison to rely on an external IRB, a reliance agreement needs to be put in the place as required by federal regulations. The purpose of such agreements is to document the roles and responsibilities of each institution and their study teams in the conduct and oversight of the study.
Reliance arrangements need to be documented on a per study basis, even in cases where institutions have signed on to SMART IRB. UW-Madison prefers to use the SMART IRB agreement and document reliance via memo, but will enter into an IRB authorization agreement (IAA) if required by the external IRB. RELIANT facilitates the reliance agreement process and the UW study team does not need to be involved in this process. If the lead study team or reviewing IRB asks you questions about the reliance agreement process here, please forward them to us and we will respond to them directly. (Note that the information in this section does not apply to commercial IRBs with which the institution is already contracted or the NCI CIRB.)
The process involves several steps that RELIANT facilitates. For information on how you can help make the reliance process go as smoothly as possible, see the Ceding Review – How You Can Help with the Reliance Process section of this manual. Note that the steps below describe the most common reliance process. Since processes may vary across institutions, different steps may be required.
Step 1: Study team submits a cede request in ARROW.
- You will need to submit the study protocol or approved IRB application. If this document does not describe the study activities that will occur at UW-Madison, you will need to complete and upload the HRP – 508 – TEMPLATE SITE SUPPLEMENT. This will provide RELIANT with the information needed for its review process. Some sections of the site supplement may not apply to your study and you may edit the document as needed.
- You will need to upload the UW-Madison specific consent document and, if applicable, separate
authorization form. For information on how to create these documents, see other sections in this manual.
- If the lead study team and/or reviewing IRB provides forms to you (e.g., local context form) that need to be completed as part of the reliance process, please do not complete these on your own and instead upload them on the supplemental information page of the application. RELIANT will typically complete these forms on your behalf and provide them to the reviewing IRB.
Step 2: RELIANT reviews the request to determine all required documents have been submitted with the request. RELIANT will send any questions to you during this pre-review process.
Step 3: RELIANT reaches out to the reviewing IRB to confirm it is willing to provide IRB oversight for the study and, if so, what type of agreement is needed. Note that RELIANT is responsible for working with the reviewing IRB to determine what type of agreement will be used to document reliance. If you receive queries from the reviewing IRB or lead study team about what type of agreement UW-Madison uses, please refer them to us and we will follow up as needed.
- If the reviewing institution has received a request from its study team to serve as the reviewing IRB for UW-Madison, the reliance agreement process continues.
- If this request has not been received, by the reviewing IRB, the reliance process is on hold until that application is submitted.
Step 5: If either institution requires revisions to study documents (often the consent or authorization document), it will work with its own study team to make those changes. The next step of the reliance process will be on hold until these modifications have been made.
As a relying site study team, you will need to work with the lead study team and/or coordinating center to address any request for modifications as needed.
Step 6: Once all modifications have been addressed, RELIANT will finalize the agreement with the reviewing IRB:
- If the SMART IRB agreement is used, RELIANT and the reviewing IRB will document reliance via memo that does not require signatures.
- If an IAA is required, UW-Madison’s institutional official will need to sign the agreement first. When signed, RELIANT will send it to the reviewing IRB, who will then forward it to their institutional official for signature. The agreement is complete when all necessary signatures have been obtained.
Step 7: After the agreement is completed, RELIANT will approve the request to cede IRB review and you will receive an approval letter via ARROW. Note that you cannot begin study activities until the reviewing IRB has approved your participation in the study and all relevant UW-Madison/UWHC requirements have been met. For more information, see HRP-309-WORKSHEET-Ancillary Review Matrix.
How and When to Submit a Request to Cede IRB Review
Study teams must submit a request to cede IRB review when they want to use an external IRB. The cede request is its own application type in ARROW and includes places to upload the study protocol as well as consent and authorization documents that will be used to enroll subjects at UW-Madison/UWHC, as applicable. RELIANT cannot review your request until all required study documents are provided. We recommend you follow the steps below when considering ceding review to an external IRB as well as when to submit a request. (Note these steps do not apply to NCI or commercial IRBs.) Since processes vary across institutions that serve as reviewing IRB, these steps may differ.
Step 1: Ensure that your study falls within the parameters for when UW-Madison will cede IRB review to an external IRB. See the When UW-Madison Will Rely on an External IRB section for more information.
Step 2: Ensure that external IRB is willing to serve as the IRB of record for you. We recommend that your collaborators at the site which may serve as IRB of record confirm this with their IRB rather than you directly contacting that IRB. Not all IRBs will agree to serve as the reviewing IRB, so it is important to check that they are amenable to serving.
Step 3: If the proposed reviewing IRB agrees to serve, you typically should not submit a cede application until the reviewing IRB has approved the study, including a template consent document, if applicable. Waiting until the reviewing IRB has approved the study ensures you are working with the most current study documents rather than drafts still undergoing revision. The lead study team is responsible for sending you the approved study documents for use in your cede request application. In the event a funder or reviewing IRB requires that a cede request be submitted at UW-Madison before a study is approved, please reach out to RELIANT so we can help identify next steps in these unique situations.
Upon receipt of your cede request, RELIANT will begin the reliance agreement process with the reviewing IRB.