Ceding/Deferring IRB Oversight to Another IRB (External Reliance)

The Assistant Director, Office of Research Ethics (or designee) determines whether ceding/deferring IRB review is appropriate on a case-by-case basis. Consultation from the IRB Chair(s), University Administration, University Counsel, or others, may be needed to make this determination.  In general, however, ceding IRB review is allowable in situations including, but not limited to, the following:

• The Principal Investigator for the project is eligible to serve as principal investigator, without supervisory oversight, in accordance with the PI Eligibility Guidelines.
• The expertise of the proposed Reviewing IRB is equally or more appropriate to assess the research plans compared to Iowa State’s IRB.
• The project is subject to a federal mandate requiring review by an sIRB.

These decisions are also made on a case-by-case basis. External reliance is generally not allowable in the following situations:

• The proposed Reviewing IRB does not have a current Federalwide Assurance.
• The proposed Reviewing IRB does not have sufficient knowledge of local context (as required by federal guidelines) to assume IRB oversight for sites that fall under Iowa State purview.
• The project does not include an individual eligible to independently serve as PI under Iowa State guidelines..
• There are extenuating circumstances such that ceding review places Iowa State or the reviewing institution at compliance risk or requires releasing confidential information about Iowa State personnel (e.g., history of noncompliance by study personnel).
• Studies for which federal regulations, or administrative or campus policies otherwise prohibit or limit options for IRB reliance.

Note:  The Assistant Director, Office of Research Ethics (or designee) may decline to cede IRB review of an otherwise eligible study to an external IRB if previous experience with that IRB indicates the reliance process will be protracted or if concerns arise during the reliance process (e.g., terms and conditions in the reliance agreement are problematic, the proposed Reviewing IRB does not respond to queries, concerns arise about the ability of the external site to protect human subjects or ensure regulatory compliance, etc.).

Institutions vary greatly in how they handle reliance arrangements for research classified as “exempt”.  Some require formal reliance agreements; others informally agree (such as through email correspondence between IRB offices) to provide exempt-level oversight.  Some institutions do not permit any kind of reliance arrangements for exempt research—in those cases, researchers must obtain exempt determinations at their home institutions.

The Iowa State IRB will cede review for exempt research provided the external site agrees to provide exempt-level oversight.  The request and review process is the same as for non-exempt research. However, formal reliance agreements are not required by Iowa State; instead, we coordinate informally (through email) with the Reviewing IRB.

No. The reliance process often goes quickly, but it can take months. Timeframes for finalizing reliance agreements depend on several factors, including the responsiveness of the proposed Reviewing IRB and its experience with reliance agreements, research team responsiveness to questions from IRB staff, the complexity of the research project, and whether language in the reliance agreement requires negotiation.  In some cases, advice from legal counsel at both institutions is required.  Researchers are advised to keep this timeframe in mind when considering a request that Iowa State cede to an external IRB.

No. Policies regarding accepting IRB oversight for other institutions vary widely, and some IRBs will NOT serve as Reviewing IRB for another institution.  An IRB may also decline to accept oversight responsibility for particular studies.  Principal Investigators are advised to ask their external collaborators to contact the external site IRB office(s) to ascertain their willingness to serve as Reviewing IRB.  Doing so typically promotes a smoother process.

No. The research team must still obtain IRB approval or determination of exemption from the Reviewing IRB before beginning any human subjects research activities.

Iowa State researchers are responsible for strictly adhering to the approved protocol and following the directives of the Reviewing IRB.  The Iowa State research team must consult with the principal investigator at the site of the Reviewing IRB regarding how to seek approval for research activities or proposed changes in research activities, continuing review, reporting unanticipated problems, record keeping requirements, etc.

The Iowa State research team is also responsible for ensuring any other Iowa State-specific institutional requirements are met before beginning study activities (e.g., conflict of interest disclosures, funding/contract requirements, approval from other compliance committees, HIPAA/FERPA-related approvals, etc.).