About IAAs, IIAs, and MOUs
There are a few common types of agreements used to arrange reliance for studies involving collaboration. Agreements are not only used when an IRB is waiving oversight, but also when external collaborators are involved with a study. The Collaborations –Non-OHSU Researcher Decision Tree (Quick Guide) can help determine which agreement may be needed depending on the type of collaboration.
See the Working with Other IRBs section of the IRB FAQs page for further information.
About IRB Authorization Agreements (IAAs)
The most common agreement is an IRB Authorization Agreement (IAA). An IAA is usually specific to a single study, but are sometimes used by trial networks to cover their studies. Commonly, IAAs are also used for collaborators that are engaging in research on behalf of an institution that has its own IRB.
Typically, an IRB has its own short template IAA, and simply requires the signatures of each institution's signatory authority. The OHSU IRB has two versions of the IAA template available on the IRB Policies and Forms page, one for OHSU waiving oversight and the other for OHSU acting as the reviewing IRB. Review by the OHSU Legal Department may be required if the IAA has contractual or legal terms.
Process for use: Some reviewing IRBs require the use of their IAA template instead of OHSU's template. Check with the reviewing IRB to see which IAA template is required.
- Fill out the study information in the template and upload the IAA in the eIRB.
- Submit the study for pre-review, during which the OHSU IRB will review and sign the IAA.
- The OHSU IRB can sign the IAA before or after the other institution.
- Upload the final version of the IAA with both signatures in the eIRB.
NOTE: For any IAAs for multiple studies, trial networks, or complex agreements, send the agreement by email to IRBReliance@ohsu.edu as soon as possible, as a more extensive review will be needed.
About Individual Investigator Agreements (IIAs)
Individual Investigator Agreements (IIAs) are used for collaborators that are engaging in research on their own behalf, rather than on the behalf of an institution. These agreements typically apply to individuals without an affiliation to any institution, or those affiliated to organizations that do not have their own IRB (such as employees of small clinics). These agreements are commonly seen with studies in which OHSU is collaborating with local clinics or practices. The OHSU IRB template IIA is available on the IRB Policies and Forms page.
Process for use:
- The individual must fill out and sign the form.
- Upload the IIA in the eIRB.
- Submit the study to obtain the appropriate OHSU signature.
NOTE: If the organization receives federal funding for the study, they must hold a Federal-wide Assurance (FWA) and IAA must be used rather than an IIA.
About Memorandums of Understanding (MOUs)
Memorandums of Understanding (MOUs), also known as Master Agreements, specify a reliance arrangement between entities that can cover any research involving the stated entities, rather than being applicable to only one or a handful of specific studies. These agreements are used by large reliance networks, trial networks, and as individual agreements between OHSU and other institutions with whom we commonly collaborate.
MOUs can require several months to develop and execute, as they require extensive legal and regulatory input from all involved institutions. For this reason, the establishment of an MOU is driven by the institutions instead of by individual investigators.
The SMART IRB Agreement is an MOU that covers hundreds of institutions, and is a frequently used agreement for collaborations. This agreement typically involves the use of an internet-based reliance system, either the SMART IRB Online Reliance System or the IRB Reliance Exchange. For more information about the SMART IRB Agreement, the IREx or SMART IRB Online Reliance Systems, or the processes for arranging reliance based on these mechanisms, see SMART IRB.
Process for Use: These steps apply to all MOUs except the SMART IRB Agreement, which is explained on SMART IRB.
- On the Basic Information page of your study submission, include in brackets at the beginning of the Long Study Title "[External Site –MOU]." For example, if the Kaiser MOU will be used for this study, the Long Study title should begin with [Kaiser –MOU].
- The OHSU IRB will confirm the use of the MOU for the study with the stated institution, and will upload a copy of the MOU.