HS-IRBs Guidelines for Ceding IRB Review
January 2012 Revised July 2012 Revised March 2015
In limited cases, the UW-Madison may cede IRB oversight to another IRB, particularly when the involvement of UW-Madison personnel is limited(e.g., data analysis). Please review the information below before submitting a request for the HS-IRBs to cede oversight to another IRB. Study teams also are encouraged to contact the HS IRBs' Reliance Team for additional guidance. For specific instructions on how to request to rely on a non-UW IRB oversight, see How to Submit a Request to Cede or Defer IRB Review to Another IRB.
When will the HS-IRBs consider ceding IRB oversight to another IRB?
The HS-IRBs Office determines whether ceding IRB review is appropriate on a case-by-case basis. In general, however, the HS-IRBs will consider ceding IRB review in situations including, but not limited to, the following:
- The role of the UW-Madison personnel is limited to activities such as data analysis, consultation, or other administrative roles;
- The study is minimal risk and the role of UW-Madison personnel is either limited or very straightforward (e.g., administration of a single survey, assisting with recruitment of subjects);
- The study is eligible for review using an existing IRB Reliance Partners.
UW-Madison serves as an enrolling site or coordinating center for a non-industry sponsored clinical trial (regardless of phase) with some exceptions (e.g., select cooperative group protocols); The study is more than minimal risk and the role of UW-Madison personnel is substantial (e.g., interaction with subjects, conduct of study procedures); The study qualifies as a Veteran's Administration (VA) study (e.g., veterans will be enrolled, the PI conducts the research under a VA appointment, VA facilities will be used); The proposed IRB of record does not have sufficient knowledge of local context(as required by federal guidelines) to assume IRB oversight for sites that fall under UW-Madison purview; A UW-Madison study team member has a conflict of interest that requires a management plan and the management plan prohibits or limits activities that the individual can engage in related to human subjects research; Any study involving SBIR or STTR funding; The study likely qualifies for exemption; and/or Studies for which administrative or campus policies otherwise prohibit or limit options for IRB reliance.
No. Federal regulations require that an IRB authorization agreement (IAA) be developed and signed by both institutions. This process can sometimes go quickly, but it is not uncommon for it to take months. How long it may take to finalize a reliance agreement depends on several factors, including the responsiveness of the proposed IRB of record and its experience with deferral agreements as well as whether language in the IAA requires negotiation. Study teams are advised to keep this in mind when considering requesting deferral to another IRB.
To prevent significant delays in studies obtaining IRB oversight, the HS-IRBs have established a 2 month timeline for reliance agreements.
If an IRB authorization agreement (IAA) is not in the process of being signed 2 months after the reliance request was received by the HS-IRBs, the study will no longer be eligible for reliance and the study team must submit an application for review by the HS or MR IRB.
Do the HS-IRBs have criteria that other IRBs need to meet in order to cede IRB oversight?
Yes. When determining whether IRB oversight for a study can be ceded to another IRB, the HS-IRBs considers the following factors about the proposed IRB of record:
- The human research protections program (HRPP) of UW-Madison must adhere to the standard set by AAHRPP (Association for Accreditation of Human Research Protection Programs) for accreditation. The HS-IRBs take into account whether the proposed IRB is AAHRPP-accredited or has an HRPP that is comparable to AAHRPP standards. If the proposed IRB of record does not meet these standards, it is unlikely the HS-IRBs will consider ceding IRB oversight to that institution.
- The HS-IRBs will review the IRB application, consent document, and study protocol approved by the proposed IRB of record. If these documents do not include a complete description of UW-Madison's role in the study or do not meet regulatory standards, the HS-IRBs will likely not cede IRB oversight to that IRB.
- The proposed IRB of record must agree to accept oversight of all study activities. The HS-IRBs will not cede IRB oversight to an IRB that will agree to only oversee some study activities.
- The HS IRBs office reserves the right to elect not to cede IRB review of an otherwise eligible study to another IRB if previous experience with that IRB indicates the reliance process will be protracted or if concerns arise during the reliance process (e.g., extensive negotiation regarding the IAA are required, the proposed IRB of record is not response to queries from the HS-IRBs office).
Will all IRBs agree to serve as IRB of record?
No. Policies regarding accepting IRB oversight for other institutions vary widely and some IRBs will NOT serve as IRB of record for another institution. Study teams are expected to contact the proposed IRB of record regarding whether it is willing to serve as IRB of record before submitting a request to cede IRB review. Confirmation should be obtained from the proposed IRB of record's staff and not from other researchers at that institution.
Is ceding IRB review/an IAA the same thing as having IRB approval?
No. When the HS-IRBs formally cede IRB review to another IRB, the study team must still obtain IRB approval from the IRB of record before beginning any research activities and before Research and Sponsored Programs (RSP) will release funds to the UW-Madison study team. the study team also is responsible for ensuring all UW institutional requirements are met before beginning study activities.