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How to Submit an IRB of Record Request
In some cases, the HS-IRBs may agree to serve as IRB of record for sites or personnel (including collaborators) engaged in human subjects research who are outside UW-Madison/UW Health/Madison VA. Study teams who wish to request the HS-IRBs serve as IRB of record must submit a formal request.
Version date: July 2017
What is the process for requesting the HS-IRBs to serve as IRB of record?For IRB of record requests involving existing IRB reliance partnerships (e.g., UnityPoint Health Meriter, GPC), please consult the Single IRB Review Partners for information on how to submit a request for each partnership.
For all other IRB of record requests not involving an existing IRB reliance partnership, please follow the steps below: 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 IRB of record, please contact the Health Sciences IRBs Reliance Team (email@example.com) for assistance before submitting an application. Step 2: If you determine UW-Madison may consider serving as IRB of record, 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. Please note that when completing the study team page, you will need to list the personnel for whom you are questing the UW serve as IRB of record. Step 3: When you reach the Study Location section of the application, please use the following guidelines for completing this section:
- In response to question 1.1, answer “Yes” to indicate the study involves an external site or external personnel or collaborators.
- In response to question 2.1, list all the non-UW-Madison sites involved in the study or project.
- In response to question 2.2, answer "Yes" to indicate that you are requesting that the HS-IRBs serve as IRB of record for an external site or external personnel or collaborators.
- In response to question 2.2.1, select all of the options that apply to your study. NOTE: If you are asking the HS-IRBs to serve as IRB of record for an entity or individual without an IRB, select the last option in the list.
- Anyone for whom the HS-IRBs are serving as IRB of record must be listed as a study team member in the IRB application in ARROW. For information on how to list external personnel in the IRB application, see the NetID and Training Requirements for External Personnel When the Health Sciences IRBs Are IRB of Record .
- In the IRB application and protocol, study teams must address several issues regarding the involvement of sites and collaborators outside the UW-Madison/UW Health/Madison. Please see IRB Application Guidance for Multisite and Collaborative Research Studies and protocol guidance for details.
- Preparing an IRB application involving an IRB of record request and multisite research issues can take additional time. Study teams are advised to plan accordingly and consult with the HS-IRBs' Reliance Team when preparing the IRB application.