OHSU as the Relying IRB or the Reviewing IRB
In most cases, the OHSU IRB will waive oversight to an External IRB; however, we will generally NOT agree to be Reviewing IRB (i.e., the Single or Central IRB) for multi-site studies. The OHSU IRB can help researchers determine whether an External IRB can be used, and which type(s) of agreement will be needed between OHSU and the other institution.
Note: The OHSU PI and study team still have responsibilities to the OHSU IRB even when OHSU relies on an External IRB. These include submitting and maintaining the study in the OHSU eIRB, ensuring OHSU consent and ancillary review requirements are met, and completing OHSU training. Before the study may start both the External IRB and the OHSU IRB Office must sign off on the study.
When OHSU is the Relying IRBIn most cases, the OHSU IRB will waive oversight to an External IRB. The final decision to waive oversight occurs during the review of the OHSU eIRB submission. When OHSU is acting as the Relying IRB, there must are two kinds of reliance agreements that can be used:
- IRB Authorization Agreement (IAA)
- Memorandum of Understanding (MOU, e.g., the SMART IRB Agreement)
OHSU PI and Study Team Responsibilities: When OHSU is the Relying IRB, the responsibilities of the OHSU PI and study team include:
- Submitting the study in the OHSU eIRB in addition to submitting to the External IRB
- Promptly providing the Lead PI, Lead study team, or External IRB with any required information, such as the names and roles of local study personnel, local context information affecting conduct of the study at OHSU, and information needed for continuing review
- Providing Conflict of Interest Management plans for any OHSU study team members to the External IRB
- Following all determinations of the External IRB
- Following the External IRB's policies including those for reporting unanticipated problems, noncompliance, and subject complaints
- Notifying the Lead PI of any local reportable events (per the External IRB's policies)
- Notifying the Lead PI of any changes, such as changes in personnel, funding, or Conflict of Interest Management plans
When OHSU is the Reviewing IRB
- Research involving a single collaborator with limited study activities at another institution, for example:
- Collaborators are receiving identifiable data or specimens
- A former OHSU faculty member that would like to continue data analysis while working at their new institution
- Local/Regional Collaborations, including research under the respective MOUs with Kaiser, Portland State University, or Oregon State University
- Whether OHSU will be the Reviewing IRB (vs. one of the collaborators) will be decided during the review process
- The Reviewing IRB will be chosen based on multiple factors, such as where the Lead PI is and where the bulk of research is occurring
- Research where OHSU personnel will be conducting the study procedures at another institution
If you are not sure that your research clearly falls into the above categories, contact us at IRBReliance@ohsu.edu to ask whether the OHSU IRB can be the Reviewing IRB for your study. These requests will be reviewed by the IRB Chair.
When OHSU is acting as the Reviewing IRB, the following reliance agreements can be used:
- Individual Investigator Agreement (IIA)
For more information on these reliance agreements, see Collaborations –Non-OHSU Researcher Decision Tree (Quick Guide) or IAAs, IIAs, and MOUs.
OHSU PI and Study Team Responsibilities: When OHSU is acting as the Reviewing IRB, the responsibilities of the OHSU PI and study team include:
- Promptly responding to questions or requests for information about external collaborators
- Collecting any information from external collaborators the OHSU IRB requires for review
- Providing the external collaborators with the OHSU IRB policies (including policies for reporting unanticipated problems and noncompliance)
- Providing the external collaborators with the OHSU IRB approved versions of pertinent study documents
- Notifying external collaborators of pertinent OHSU IRB determinations for initial review, continuing review, modifications, and reportable events
- Promptly reporting to the external collaborators any unanticipated problems involving risks to subjects or other issues that may affect subject participation