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HS-IRBs Guidelines for Serving as IRB of Record
Version date: August 2018
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 HS-IRBs to serve as IRB record, please review the guidelines below. If you have any questions about these guidelines, please contact the Reliance Team (firstname.lastname@example.org) for assistance.
When will the HS-IRBs consider serving as IRB of record for an external site or individual?
The HS-IRBs 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 HS IRBs often will agree to serve as the reviewing IRB, with certain exceptions including when:
- UW-Madison, UWHC, or Madison VA faculty, staff, or students are not involved in the research;
- The HS-IRBs 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.
What research is eligible for review by an independent IRB?
- Studies receiving funding (e.g., NIH or from a private sponsor) that requires the use of a Single IRB, and the HS-IRBs Reliance Term makes a determination permitting the use of an independent IRB
- Any multi-site study initiated by a for-profit industry sponsor, including studies that are observational and/or minimal risk
What research is NOT eligible for review by an independent IRB?
- Research involving the VA
- Research involving fetal tissue
- Research involving embryonic stem cells
If the HS-IRBs agree 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 either complete the CITI training modules required by UW-Madison or provide documentation of completion of comparable training. See Training Options for External Personnel for more details.
Will IRBs outside UW-Madison always agree to allow the HS-IRBs to serve as IRB of record?
Each IRB has its own standards and processes for ceding IRB review to another institution. Before submitting an IRB of record request, study teams should encourage their collaborators to contact their own IRBs to discuss the process for ceding IRB review to an external IRB.
How do I submit a request for UW-Madison to serve as IRB of record?
For instruction on how to submit a request for UW-Madison to serve as IRB of records, please see How to Submit an IRB of Record Request.
What type of agreement do the HS-IRBs need to serve as IRB of record for external sites or personnel?
When the HS-IRBs agree to serve as IRB of record, a formal IRB reliance agreement is required per federal regulations. What type of agreement is required depends whether collaborators are affiliated with an institution with its own IRB and, if not, whether the study is federally funded. The HS IRBs Reliance Team will assist study teams in securing the appropriate agreements needed for their study. The main types of agreements include:
- IRB authorization agreement (IAA): An IAA is needed when the HS-IRBs agree to serve as IRB of record for external personnel affiliated with an institution with its own IRB. For institutions signed on to the SMART IRB agreement, a separate IAA is not required.
- Independent investigator agreement (IIA): An IIA is used when the HS-IRBs agree to serve as IRB of record for external personnel who are not affiliated with an institution with its own IRB AND the study is federally funded.
- Collaborating investigator summary: A collaborating investigator summary is used when the HS-IRBs agree to serve as IRB of record for external personnel or collaborators who are not affiliated with an institutions with its own IRB AND the study is NOT federally funded.