Version date: March 2019
The HS-IRBs may agree to serve as IRB of record for external sites or personnel (including collaborators) engaged in human subjects research. Study teams who wish to request the HS-IRBs serve as IRB of record must submit a formal request. Please note that this guidance applies ONLY to the regular IRB application in ARROW and not the single IRB (sIRB) application that was launched in January 2019. If you are planning a new study that will involve four or more sites, please contact the HS IRBs' Reliance Team for guidance on using the sIRB application.
What is the process for requesting the HS-IRBs to serve as IRB of record?
Step 1: Review HS-IRBs Guidelines for Serving as IRB of Record to determine whether the HS-IRBs are likely to consider serving as IRB of record. If you have any questions about whether the UW can serve as the reviewing IRB, please contact the HS IRBs Reliance Team (firstname.lastname@example.org) for assistance before submitting an application.
Step 2: If a UW-Madison IRB is likely willing to serve as the reviewing IRB, please ensure that any external personnel affiliated with an entity or site with an IRB have consulted with their own IRB to a) confirm that the site is willing to cede IRB review to the UW and b) understand what steps are required to cede IRB review to UW-Madison. Every site has its own policy and process for relying on another IRB, so UW study teams can save time and effort if they first confirm that an external site is willing to rely on a UW Madison IRB and the process for ceding IRB review has begun at that site.
Step 3: If you determine UW-Madison may serve as IRB of record and the external site is willing to cede IRB review, create a new IRB application or change of protocol in ARROW. Complete the first section of the IRB application in ARROW as you would for any other study.
Step 4: When you reach the Study Location section of the application, please do the following:
- In response to question 1.2, answer “Yes” to indicate you are requesting UW-Madison serve as the reviewing IRB for external sites or personnel.
- In response to question 1.2.1, check the appropriate box(es) to indicate if you are requesting UW-Madison serve as reviewing IRB for external sites (e.g., university, community hospital) and/or individuals (e.g., people working with community organizations). You may select both options if appropriate for your study.
- You will then be branched to the appropriate page of the application to provide details about the external sites or personnel. If you are adding sites or personnel to an already approved study, you may add those to whatever page of the application is appropriate.
- As of October 1, 2018, study teams are no longer required to obtain netIDs to list external personnel in the IRB application. Instructions on how to provide information about external personnel are included in the ARROW application.
- For more information, see How to List and Obtain IRB Approval for Relying Sites.