Instructions for Using the UnityPoint Health - Meriter & UW IRB Partnership

Version date: March 2015

  1. Carefully review Guidance on the the UnityPoint Health - Meriter & UW IRB Partnership to determine if your research qualifies to use the Partnership agreement and to identify which IRB can serve as IRB of record for your study.
  2. After you have determined that your project qualifies to use the Partnership, prepare and submit an application to the IRB which will serve as the IRB of Record. Both UnityPoint Health - Meriter and UW-Madison IRB applications include a place to request use of the Partnership agreement. Submit an application to only one IRB, following these procedures:
      • Step 1: Log in to Meriter’s IRB submission website at If you do not already have an account, click the Request New Account button. You will receive an e-mail in a day or two with your user name and password.
      • Step 2: After logging in to the website, click Add a Study under Study Assistant. The Meriter IRB application form will be presented to you in sections. A set of questions about requesting UW-Madison to rely on Meriter’s IRB will appear early in the application.
      • Step 3: After the application has been completed and all related study documents have been attached, submit the application.
    • Request for UW-Madison to assume oversight for Meriter Hospital:
  3. For studies enrolling subjects, please use the Partnership consent template when developing consent documents. This template includes institutionally-specific language for each institution and allows for a single consent template to be used for Partnership studies.
  4. After the request has been received, it will be reviewed by the IRB being asked to serve as IRB of record. If the IRB determines it is willing to serve as IRB of record, the request form and supporting study materials will be shared by the IRB of record with the IRB at the relying institution. This communication will be managed by the IRB offices. Research teams do not need to do anything additional at this point.
  5. The relying institution will review the request and determine if IRB oversight can be ceded or deferred. The relying institution will also review the protocol and consent materials for compliance with institutional requirements (e.g., conflict of interest disclosure, human subjects training certification). The relying IRB may require additional information from the study team to resolve any issues regarding local requirements or other questions regarding the study.
  6. After all requirements for the relying institution have been met, the IRB of record will notify the study team contact and principal investigator that the study can now be reviewed by the IRB of record.
  7. After the study is approved, ongoing IRB oversight is provided by the IRB of record. If a deferral has been granted, the IRB assuming oversight will ensure that the relying IRB is informed of any of the following:
    • Serious or continuing noncompliance;
    • Any unanticipated problems reported to the Office for Human Research Protections, study sponsor or the FDA; or
    • Closure of the research study.
  8. The study team is responsible for following the directives and policies of the IRB of record as well as those of the relying institution during the conduct of the study.

Helpful Tips for Research Teams

  • Do not submit an application requesting IRB reliance to both UW and UnityPoint Health - Meriter IRBs. Submit only one application to the IRB that will likely serve as IRB of record.
  • After you have submitted an application requesting IRB review be ceded deferred to the other IRB, please contact the proposed IRB of record with any questions about your request.
  • If you have questions about whether your study qualifies to use the Partnership or about the Partnership process, please use the contact information below to ask for assistance.

Contact Information

See Also:

Keywords:IRB of record, deferral request   Doc ID:17735
Owner:Monica E.Group:Health Sciences IRBs
Created:2011-03-29 19:00 CDTUpdated:2016-10-25 16:56 CDT
Sites:Health Sciences IRBs
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