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Ceding/Deferring IRB Oversight to Another IRB
How to request that ISU rely on the IRB of another institution (External Reliance)
Step 1: Consult with the researchers at the other institution to determine whether they are willing to assume responsibility for obtaining IRB approval for the ISU research team’s involvement in the project.
Step 2: Review these guidelines to determine whether the project may qualify for oversight by another IRB. IRB Staff can help if there are any questions.
Step 3: Work with the collaborating investigator to contact the proposed IRB of record to ascertain their willingness to serve as IRB of record for the study. Note the contact person from the proposed IRB of record.
Step 4: Complete an IRB Application xForm in IRBManager. This is the same form used to obtain IRB approval for a new study, however the xForm is conditioned to ask questions only pertinent to the reliance arrangements when you indicate that researchers at other institutions will be involved and you wish for the ISU IRB to rely on another institution’s IRB for oversight.
Special circumstances for federally-funded research
Federally funded multi-site research may be subject to special IRB review requirements. For more information see:
NOTE: Principal Investigators planning to seek federal funding should consult with the ISU IRB very early in the proposal stage for guidance on single IRB arrangements.
When will the ISU IRB consider ceding IRB oversight to another IRB?
2. When will the ISU IRB not consider relying on a non-ISU IRB to provide oversight?
3. If a study qualifies for review by a non-ISU IRB, is ceding IRB review always faster than going through the ISU IRB?
4. Will all IRBs agree to serve as IRB of record?
5. Is ceding IRB review/an IAA the same thing as having IRB approval
6. What responsibilities does the ISU research team have when IRB oversight is ceded?
In some cases, the ISU IRB may agree to rely on another institution’s IRB for oversight of a project. The Director, Office of Research Ethics (DORE) or designee determines whether ceding/deferring IRB review is appropriate on a case-by-case basis. The DORE/designee may seek consultation from the IRB Chair(s), University Administration, University Counsel, or others, when 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 put forth by the Office of the Vice President for Research.
The expertise of the proposed IRB of record is equally or more appropriate to assess the research plans compared to ISU’s IRB;
There are no extenuating circumstances such that ceding review places ISU or the reviewing institution at compliance risk, or requires releasing confidential information about ISU personnel (e.g., history of noncompliance by study personnel).
The project requires review by an sIRB.
These decisions are also made on a case-by-case basis. In general, relying on a non-ISU to provide oversight is generally not allowable in the following situations:
- The proposed IRB of record does not have an established or current Federalwide Assurance.
- 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 ISU purview;
- The project does not include an ISU-eligible principal investigator.
- An ISU 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;
- The study likely qualifies for exemption (ceding review is not required for exempt research); and/or
- Studies for which federal regulations, or administrative or campus policies otherwise prohibit or limit options for IRB reliance.
Note: The DORE (or designee) 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 does not respond to queries, concerns about the human subjects protection or regulatory compliance of the proposed IRB are noted, etc.).
No. Federal regulations require that a formal IRB Authorization Agreement (IAA) be developed and signed by institutional officials both institutions. This process can sometimes go quickly, but it can take months. Timeframes for finalizing these agreements depends on several factors, including the responsiveness of the proposed IRB of record and its experience with deferral agreements, the complexity of the research project, as well as whether language in the IAA requires negotiation. In some cases, advice from legal counsel at both institutions is required. Researchers are advised to keep this in mind when considering requesting deferral of oversight to another IRB.
No. Policies regarding accepting IRB oversight for other institutions vary widely and some IRBs will NOT serve as IRB of record for another institution. An IRB may also decline to accept oversight responsibility for particular studies. Principal Investigators are advised to work with their collaborating investigators at external sites to contact their IRB office to ascertain whether it is willing to serve as IRB of record. Doing so typically promotes a smoother process for establishing agreements between institutions.
No. When the ISU IRB formally cedes IRB review to another IRB, the research team must still obtain IRB approval from the IRB of record before beginning any research activities.
ISU researchers are responsible for strictly adhering to the approved protocol and following the directives of the IRB of Record. The ISU research team must consult with the principal investigator at the site of the IRB of Record regarding how to seek approval for research activities or proposed changes in research activities, continuing review, reporting unanticipated problems, record keeping requirements, etc.
The ISU research team also is responsible for ensuring any other ISU 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.).