Humans: Institutional Review Board (IRB)
Iowa State as Reviewing IRB
How to request that Iowa State agree to serve as Reviewing IRB
Step 1: Review these guidelines to determine whether your project qualifies for oversight by the Iowa State IRB. IRB staff can help with any questions.
Step 2: Work with the external collaborator(s) to find out whether their IRB(s) is(are) willing rely on Iowa State’s IRB to provide oversight. Note the IRB contact person(s) as you will need to enter their name(s) and email address(es) in the Iowa State IRB application.
This early contact is strongly advised as it smooths communication between IRBs. Additionally, the external IRB can advise your collaborators on any necessary forms that must be completed on their end before the reliance agreement can be considered.
Step 3: Requests for Iowa State to serve as Reviewing IRB are integrated into the IRB Application for the project in IRBManager. For previously approved projects, you may submit a modification to the approved protocol in IRBManager and update the application throughout to reflect collaboration plans.
The Basic Study and PI Information page in the IRB Application contains a question asking whether the project involves collaboration with researchers at other institutions. A “Yes” response triggers subsequent questions about IRB review and approval plans, including a request for oversight by the Iowa State IRB.
External collaborators must be listed as key personnel in the Iowa State IRB application. Records of human subjects training for external personnel should be uploaded when you create a New Contact for them in IRBManager.
Step 4: IRB staff coordinate with the external IRB to request and finalize the reliance agreement. PIs at Iowa State and the external site are notified when the agreement is finalized.
1. In what cases will the Iowa State IRB consider serving as Reviewing IRB?
The Assistant Director of the Office of Research Ethics (or designee) determines whether serving as Reviewing IRB 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, the Iowa State IRB will consider serving as Reviewing IRB for most collaborative, minimal-risk research where the Iowa State IRB has the appropriate disciplinary expertise to review the project. Please see the next FAQ for important exceptions.
2. When will the Iowa State IRB typically Not agree to serve as Reviewing IRB?
The Iowa State IRB will not typically serve as Reviewing IRB in the following situations:
- The project is federally mandated to receive review by an sIRB.
- An Iowa State faculty or staff person eligible to independently serve as PI is not involved in the research.
- Iowa State is not engaged in human subjects research, as defined by the Office of Human Research Protections.
- The external site does not have a Federalwide Assurance for the Protection of Human Subjects.
- The study involves greater than minimal risk to participants.
- The Iowa State IRB does not have sufficient expertise regarding the study procedures or knowledge of the local context at the external site(s) (as required by federal guidelines).
- The Iowa State IRB feels it or the Iowa State PI cannot adequately oversee the external site or personnel in manner that will ensure the protection of human subjects.
- Studies for which administrative or campus policies otherwise prohibit or limit options for serving as Reviewing IRB.
Note: The Assistant Director, Office of Research Ethics (or designee) reserves the right to decline to serve as Reviewing IRB if previous experience with the external IRB indicates the reliance process will be protracted, or if significant concerns arise during the reliance process (e.g., terms and conditions for the reliance agreement are unacceptable to Iowa State, the proposed Relying IRB does not respond to queries, concerns arise about the ability of the external site to protect human subjects or ensure regulatory compliance, etc.)
3. Do external collaborators need to complete human subjects training?
Yes. External collaborators must either complete the CITI training modules required by Iowa State or provide documentation of completion of comparable training. External collaborators must also be approved as key personnel on the Iowa State IRB protocol.
4. Will external site IRBs always agree to rely on the Iowa State IRB?
No. Each IRB has its own policies for deciding when – or if – deferring IRB oversight is allowable. Principal investigators are advised to work with their external collaborators and contact external site IRBs to discuss possible reliance arrangements before formally requesting that Iowa State’s IRB serve as Reviewing IRB.
5. What type of agreement is needed in order for the Iowa State IRB to serve as Reviewing IRB for external collaborators?
A formal IRB Reliance Agreement is required unless the research is eligible for exempt review. The agreement must signed by institutional officials at both institutions before the work of the external collaborators is “covered” by the Iowa State IRB. External collaborators’ human subjects research activities can begin only after their work is approved by the Iowa State IRB and the reliance agreement is finalized.
6. What if my study is eligible for exempt review?
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.
In general, the Iowa State IRB will serve as Reviewing IRB for exempt research provided the external site agrees to rely. The request and review process is the same as for non-exempt research. However, Iowa State does not require formal reliance agreements; instead, we coordinate informally (through email) with the Relying IRB.
7. How long does it take to establish the agreements?
This process often goes quickly, but it can take months. Timeframes for finalizing reliance agreements depend on several factors, including the responsiveness of the relying IRB and its experience with reliance agreements, research team responsiveness to IRB staff requests for information, 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. Study teams are advised to keep this timeframe in mind when considering a request for Iowa State to serve as Reviewing IRB.
8. Does the agreement need to be finalized before the research can begin?
Yes. The reliance agreement must be finalized before the activities of external collaborators are “covered” by the Iowa State IRB. However, the reliance agreement is only one step. All human subjects research activities conducted by Iowa State researchers and external collaborators must also have approval or determination of exemption from the Iowa State IRB before they may begin.
9. What are the responsibilities of the Iowa State Principal Investigator under the agreements?
The Iowa State Principal Investigator is responsible for oversight of the project, including the work of the external collaborators. Principal Investigators must seek from the Iowa State IRB initial and continued approval of the project, as well as prior approval of any proposed modifications. Thus, the PI must be fully informed of all activities taking place at all relying sites to ensure all are incorporated into the protocol(s) submitted to the Iowa State IRB.
PIs must ensure that the entire research team adheres to the IRB-approved protocol, all amendments/modifications receive approval prior to implementation, unanticipated problems or noncompliance is reported, etc.
Iowa State Principal Investigators are also responsible for establishing processes to:
- Inform external collaborators of any IRB decisions that may affect their work (e.g., approved changes to the protocol, renewal of approval, any suspensions or termination of IRB approval, findings associated with adverse events or unanticipated problems, etc.).
- Promptly collect from external collaborators information about any problems, complaints, noncompliance, etc. to report to the Iowa State IRB.