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HS-IRBs Guidelines for Serving as IRB of Record
Version date: March 2015
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 HS-IRBs to serve as IRB record, please review the guidelines below. Please also see How to Submit an IRB of Record Request for instructions on how to submit an IRB of record request in ARROW.
In what cases will the HS-IRBs consider serving as IRB of record for another site or individual who does not have an appointment at UW-Madison, UWHC, or Madison VA?
The HS-IRBs Office determines whether serving as IRB of record is appropriate on a case-by-case basis. In general, however, the HS-IRBs will consider serving as IRB of record in the following situations:
- The role of the external site or personnel is limited to activities such as data analysis, consultation, or other administrative roles;
- The study is minimal risk and the role of the external site or personnel is either limited or very straightforward (e.g., administration of a single survey, assisting with recruitment of subjects); and/or
- The study is eligible for review under an existing Single IRB Review Partners.
When will the HS-IRBs typically not consider serving as the IRB of record?
The HS-IRBs will not typically consider serving as IRB of record in certain situations, including the following:
- UW-Madison, UWHC, or Madison VA faculty, staff, or students are not involved in the research;
- The external site is the coordinating center for a clinical trial (regardless of phase);
- The study is more than minimal risk, the role of the external site or personnel is substantial (e.g., interaction with subjects, conduct of study procedures) and the study is not being conducted under an existing IRB reliance partnership;
- The HS-IRBs do not have sufficient knowledge of the local context (as required by federal guidelines) to assume IRB oversight for 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 and is not being reviewed under an IRB reliance partnership that allows for reviews of exempt projects;
- The HS-IRBs feel they cannot adequately oversee the external site or personnel in manner that will ensure the protection of human subjects; and/or
- Studies for which administrative or campus policies otherwise prohibit or limit options for serving as IRB of record.
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 the Human Participants Research Training policy for more details.
Will IRBs outside the UW-Madison always agree to allow the HS-IRBs to serve as IRB of record?
No. Each IRB has its own standards for when - or even 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 would cede IRB oversight to UW-Madison.
What type of agreement is needed in order for the HS-IRBs to serve as IRB of record for external personnel or collaborators?
When the HS-IRBs agree to serve as IRB of record, a formal IRB reliance agreement is often 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 main types of agreements include:
- IRB authorization agreement (IAA): An IAA is always needed when the HS-IRBs agree to serve as IRB of record for external personnel or collaborators affiliated with an institution with its own IRB. The HS-IRBs office will facilitate development and processing of IAAs when needed. NOTE: The HS IRBs participate in a number of IRB reliance partnerships and no separate IAAs are needed for studies reviewed under these agreements.
- Independent investigator agreement (IIA): An IIA 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 federally funded. The HS-IRBs office will work with study teams to facilitate processing of IIAs when needed.
- 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. The HS-IRBs office will work with study teams to facilitate distribution of collaborating investigator summaries when needed.
For additional information on what type of agreement is needed when, please see IRB Requirements Flowchart for Multisite Research.