UW-Madison Central IRB Gateway 12/29/2018 9:09 AM UW-Madison Central IRB Gateway How and When To Use An Independent IRB May 2018 © 2007 Microsoft Corporation. All rights reserved. Microsoft, Windows, Windows Vista and other product names are or may be registered trademarks and/or trademarks in the U.S. and/or other countries. The information herein is for informational purposes only and represents the current view of Microsoft Corporation as of the date of this presentation. Because Microsoft must respond to changing market conditions, it should not be interpreted to be a commitment on the part of Microsoft, and Microsoft cannot guarantee the accuracy of any information provided after the date of this presentation. MICROSOFT MAKES NO WARRANTIES, EXPRESS, IMPLIED OR STATUTORY, AS TO THE INFORMATION IN THIS PRESENTATION.

Definitions Independent IRB An IRB that is not operated by the research organization for which it provides review services. An independent IRB is subject to the same federal and state regulatory requirements applicable to all IRBs.  HS IRBs' Reliance Team The Reliance Team serves as the institutional liaison between the HS IRBs Office and the independent IRBs. The Reliance Team can provide guidance regarding submission to an independent IRB. For general inquiries, contact centralirb@medicine.wisc.edu.  S

Independent IRBs UW-Madison has contracts with the following: independent IRBs:  Advarra Quorum WIRB (Western IRB)  Some research studies being conducted by UW-Madison personnel should be reviewed by an independent IRB and not by the HS IRBs.    UW-Madison currently has no plans to contract with additional independent IRBs S

Research Eligible for Review by an Independent IRB Any multi-site study initiated by a sponsor, typically industry Includes observational and/or minimal risk studies   Studies for which the sponsor or funding source (e.g., NIH or private sponsor) requires the use of a single IRB as a condition of study participation  Confirmation of eligibility is made by the Reliance Team on a study-by-study basis

Research Not Eligible for Review by an Independent IRB Studies involving the following are not eligible for review by an independent IRB:  VA research  Fetal tissue research Embryonic stem cell research The Reliance Team is acting on behalf of the institution and thus has the authority to decline ceding IRB review to an independent IRB for any new research protocol and may consult with institutional officials as necessary.

Review and Administrative Fees Each independent IRB maintains their own fee schedule. Sponsors will be billed directly by the independent IRB. UW-Madison charges a one-time institutional compliance fee of $1,500 for each study submitted to an independent IRB. Study teams should include the institutional compliance fee in the sponsor study budget. 

Review Process Outline Step 1: If a study qualifies for review by an independent IRB, consult with the sponsor regarding which IRB may be used to review the study.  Step 2: Prepare a Request to Cede IRB Review to an External IRB in ARROW.  Step 3: The Reliance Team reviews the application and issues an approval letter to rely. Step 4: After receiving the Reliance Team approval letter, submit an application to the independent IRB for its review.

Step 1: Identifying the Independent IRB Confirm the study qualifies for review by an independent IRB per current eligibility criteria (KB22374). Consult with the study sponsor regarding which independent IRB may review the study.  Some sponsors prefer working with specific independent IRBs. If the sponsor will not use one of the independent IRBs with which UW-Madison has a contract, contact the Reliance Team for help.

Step 2: Prepare a Request To Cede IRB Review Instructions: https://kb.wisc.edu/hsirbs/page.php?id=17759 Upload the following study documents to the cede review application: Study protocol Consent/assent document(s) to be used to enroll subjects at UW-Madison HIPAA authorization documents (if separate) 

Step 2: Prepare a Request To Cede IRB Review Use the Local Context Checklist to review what items apply to the protocol and what UW required language may be needed. Use the consent language template for independent IRBs to enter specific UW-required language into the sponsor’s consent template. Combined consent/authorization templates from sponsors are acceptable because independent IRBs can serve as the privacy board for UW.

Step 3: UW and Reliance Team Review After submitting the application, it will first be routed to the following if needed:  UW Carbone Cancer Center Protocol Review and Monitoring Committee (PRMC) Clinical Research Unit (CRU) The Reliance Team will then review the application and supporting materials to confirm the following:  Eligibility for review by the independent IRB Consent/assent documents meet institutional requirements Other select institutional requirements are met

Step 3: UW and Reliance Team Review After reviewing the application materials and working with the study team to resolve any outstanding issues, the Reliance Team will issue a “Reliance Approved” letter.  This means all requirements for ceding IRB review have been met. The UW study team can move forward with obtaining IRB approval from the independent IRB.  The UW study team remains responsible for meeting all institutional requirements, some of which lie outside the IRB ceded review process.  

Step 4: Submit Application to Independent IRB Once reliance has been approved, you can submit directly to the independent IRB using the documents that have been reviewed by the Reliance Team. Please see the Independent IRB Contact Information page for links to the submission systems for each independent IRB.