IRB Guidance: UW-Madison Acting as IRB of Record
This page addresses when the UW-Madison ED/SBS IRB typically will or will not act as the IRB of Record.
In some cases, UW-Madison may agree to serve as IRB of record for an external site or individual engaged in human subjects research as part of a study reviewed by a UW-Madison IRB. Before submitting a request for the ED/SBS IRB to serve as IRB record, please review the guidelines below. PLEASE NOTE: Per the Revised Common Rule, single IRB review will be required for all non-exempt federally supported multi-site studies as of January 19, 2020. In order to ensure compliance with this mandate, UW-Madison will begin requiring single IRB review as of July 1, 2019. If you have any questions about these guidelines, please contact the ED/SBS IRB Office.
The ED/SBS IRB Office determines whether serving as IRB of record is appropriate on a case-by-case basis in accordance with institutional policy. With recent federal regulatory and NIH policy changes, the ED/SBS IRB often will agree to serve as the reviewing IRB, with certain exceptions including when:
- UW-Madison faculty, staff, or students are not involved in the research;
- The ED/SBS IRB do not have sufficient knowledge of the local context (as required by federal guidelines) to assume IRB oversight for external sites or personnel that are requesting UW-Madison serve as IRB of record. This may include sites or personnel located in states other than Wisconsin or international locations.
- The study likely qualifies for exemption;
- Studies for which institutional policies otherwise prohibit or limit options for serving as IRB of record.
If the ED/SBS IRB agrees to serve as IRB of record for external personnel or collaborators, do the external personnel or collaborators need to complete human subjects training?Yes. External personnel must complete human subjects training through their own institution OR they may take the training available through the UW-Madison HRPP: https://irb.wisc.edu/education-training/training/human-subjects-training/external-personnel-training/
Will IRBs outside UW-Madison always agree to allow the ED/SBS IRB to serve as IRB of record?
No. Each IRB has its own standards for when - or if - it will cede IRB oversight to another institution. Before submitting an IRB of record request, study teams are advised to contact the IRB for external personnel or collaborators to learn whether that IRB is willing to cede IRB oversight to UW-Madison.
**Please note: if an external IRB is ceding review, there needs to be a PI listed from that institution, the UW PI should not be listed as the collaborating institution's PI.
How do I submit a request for UW-Madison to serve as IRB of record?
If UW-Madison has agreed to serve as the IRB of record for a multi-site project, and the collaborating site(s)' role appears to meet the criteria outlined above, the PI should request in the ARROW application that UW-Madison serve as the IRB of record. Further information will also need to be entered in the following pages, including confirmation that all external collaborators have completed human subjects training and an explanation of the role each collaborator will play in the project. Personnel affiliated with an institution or entity with an IRB will need to list personnel in a delegation log
, using one log for each site. The delegation log(s) will need to be uploaded on the "Reviewing IRB: Sites" page in the study location section of the application. See ARROW FAQ: Non-UW Collaborators
for more detail on how to include these personnel on the ARROW application.
What type of agreement is needed in order for the ED/SBS IRB to serve as IRB of record for external personnel or collaborators?
When the ED/SBS IRB agrees to serve as IRB of record, a formal IRB reliance agreement is often required per federal regulations. The type of agreement required depends on whether collaborators are affiliated with an institution with its own IRB and whether the study is federally funded. The main types of agreements include:
- IRB Authorization Agreement (IAA)*: An IAA is needed when the external personnel or collaborators are affiliated with an institution with its own IRB. The ED/SBS IRB office will facilitate development and processing of IAAs when needed.
- Independent Investigator Agreement (IIA): An IIA is used when the external personnel or collaborators are not affiliated with an institution with its own IRB and the study is federally funded. The ED/SBS IRB office will work with study teams to facilitate processing of IIAs when needed.
- Investigator Responsibilities When UW-Madison Serves as the Reviewing IRB: This document lists the responsibilities all study team members (UW-affiliated and non-UW collaborators) should abide by when UW-Madison is serving as the Reviewing IRB for external sites and/or personnel.
- Collaborating Investigator Summary: A collaborating investigator summary is used when the ED/SBS IRB agrees to serve as IRB of record for external personnel or collaborators who are not affiliated with an institution with its own IRB and the study is NOT federally funded. The ED/SBS IRB office will work with study teams to facilitate distribution of collaborating investigator summaries when needed.
*UW-Madison is a participating member signed on to the SMART IRB Master Reliance Agreement, which can serve in place of an IAA if both institutions are signed on and agree to use SMART IRB for reliance. If considering using SMART IRB for reliance on a collaborative project, please contact the Reliance Team for further instructions prior to submitting an application in ARROW when possible.