- Compliance Committees
- IRB (Humans)
- Is IRB Approval Required?
- IRB Study Actions
- IRB Process Training
- IRB Training
- Good Clinical Practice (GCP) Training
- Informed Consent Templates
- Participant Information
- Review Process/Timelines
- Post-Approval Monitoring and Education
- Policies and Guidance
- Committee & Meeting Info
- Multi-Site Research & sIRB
- 2018 Revised Common Rule
- IACUC (Animals)
- IBC (Biohazards)
- RSC (Radiation)
- IRB (Humans)
- Additional ORE Support Areas
- About Us
- Reporting Concerns
- Why Comply?
- How to Comply
- Responsible Conduct of Research
- ClinicalTrials.gov Registration
ISU Serving as IRB of Record
How to request that ISU agree to serve as IRB of record for a collaborative project:
Step 1: Review these guidelines to determine whether your project qualifies for oversight by the ISU IRB. IRB Staff can help if there are any questions.
Step 2: Work with the collaborating investigator(s) to contact their institutional IRB(s) to ascertain their willingness to rely on ISU to provide IRB oversight for the study. Note the IRB contact person(s).
Step 3: Requests for ISU to serve as IRB of Record are integrated into the IRB Application xForm in IRBManager. The Application asks whether your project involves collaboration with researchers at other institutions. A “Yes” response triggers subsequent questions about IRB approval plans, including a request for oversight by the ISU IRB.
For previously-approved projects, you may submit an Amendment to the approved protocol in IRBManager to describe collaboration plans.
Step 4: Be sure that all collaborating personnel are included as key personnel on the ISU IRB application. Records of human subjects training for collaborating or external personnel may be uploaded when you create their contact in IRBManager.
- In what cases will the ISU IRB consider serving as IRB of record?
- When will the ISU IRB typically NOT agree to serve as the IRB of record?
- If the ISU IRB agrees to serve as IRB of record for external collaborators, do the external personnel or collaborators need to complete human subjects training?
- Will external site IRBs always agree to allow the ISU IRBs to serve as IRB of record?
- What type of agreement is needed in order for the ISU IRB to serve as IRB of record for collaborating researchers from another institution?
- How long does it take to establish the agreements?
- Does the agreement need to be finalized before the research can begin?
- What are the responsibilities of the ISU Principal Investigators under the agreements?
The Director of the Office of Research Ethics (DORE) or their designee determines whether serving as IRB of record 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, the ISU IRB will consider serving as IRB of record for most collaborative, minimal-risk research where the ISU IRB has the appropriate disciplinary expertise to review the project.
The ISU IRB will not typically consider serving as IRB of record in certain situations, including the following:
An ISU faculty or staff person eligible to serve as PI is not involved in the research;
ISU is not engaged in human subjects research, as defined by the Office of Human Research Protections;
The study involves greater than minimal-risk;
The ISU 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 study qualifies for exemption; in this case, a formal reliance agreement is not required;
The ISU IRB feels it or the ISU 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 IRB of record; and/or
The external site does not have a Federalwide Assurance for the Protection of Human Subjects.
The project requires review by an sIRB.
Note: The DORE (or designee) reserves the right to elect not to agree to serve as IRB of record 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 relying IRB does not respond to queries, concerns about the human subjects protection or regulatory compliance of the proposed relying IRB are noted, etc.).
Yes. External personnel must either complete the CITI training modules required by ISU or provide documentation of completion of comparable training. External personnel must also be included as key personnel on the ISU IRB protocol.
No. Each IRB has its own standards and policies for deciding when – or if - deferring IRB oversight to another institution is allowable. Before submitting a request to ISU to serve as IRB of Record, principal investigators are advised to contact the IRB for external personnel or collaborators to learn whether that IRB would cede IRB oversight to ISU.
When the ISU IRBs agree to serve as IRB of Record, a formal IRB reliance agreement is required per federal regulations. This is called an IRB Authorization Agreement (IAA), and it must be agreed to and signed by institutional officials at both institutions.
This process often goes quickly, but it can take months. Timeframes for finalizing these agreements depends on several factors, including the responsiveness of the relying IRB and its experience with reliance 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. Study teams are advised to keep this in mind when considering requesting that ISU serve as IRB of Record.
When ISU agrees to serve as IRB of Record, all human subjects research activities conducted by ISU researchers and researchers at the collaborating institution(s) must have approval from the ISU IRB before they can begin. The IAA agreement is only one step—IRB review and approval is still necessary. However, the IAA agreement must be finalized before the activities of external researchers are considered to be “covered” by the ISU IRB.
Principal Investigators are responsible for oversight of the project, including the work of the external collaborators, to ensure that the research team adheres to the IRB-approved protocol, all amendments/modifications receive approval prior to implementation, unanticipated problems or noncompliance is reported, etc. Principal Investigators will seek from the ISU IRB initial and continued approval of the project, as well as approval of any proposed modifications. Thus, the PI must be fully informed of all activities taking place at all external sites to ensure all are incorporated into the protocol(s) submitted to the ISU IRB.
ISU Principal Investigators are also responsible for establishing processes to:
Inform collaborating researchers at external sites 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 researchers information about any problems, complaints, noncompliance, etc. so these can be promptly reported to the ISU IRB.