University of Oregon researchers often engage in collaborative research with individuals and organizations external to the UO. In many circumstances, agreements between collaborators are necessary and must be in place before research with human subjects may begin. The page provides guidance on the most common agreements used in collaborative research and links to additional resources.
Principal Investigators are reminded of their responsibilities as outlined in the Investigator Agreement, which extend to collaborative research activities.
We anticipate changes to our procedures and mechanisms relating to reliance arrangements in early 2021. Please contact our office if you have any questions about what applications, agreements, and next steps are appropriate for your research.
UO researchers may be involved in research that engages multiple organizations. This research may occur at multiple sites or the research may involve personnel from multiple institutions. IRB reliance agreements allow one IRB to review and serve as the single IRB of record (sIRB) for human research and document respective authorities, roles, responsibilities, and communication between organizations.
If the research activities engage UO in human subject research, the UO researcher’s involvement in the collaboration may not begin until the investigator secures either an exempt determination, IRB approval, and/or until an agreement to rely on another IRB is executed and that IRB has granted final approval.
When the UO agrees to either assume IRB oversight or rely on another IRB, the arrangement will be documented using a reliance agreement to outline the roles and responsibilities of each institution engaged in the research.
In some circumstances, use of a single IRB review is elective. In others, sIRB requirements are mandated by federal regulations and program requirements due to federal support for the research. Unless mandated, entering into a reliance agreement is at the discretion of the institution.
Initiating a Reliance Request
The UO investigator would begin this process by completing and submitting one of two forms along with supporting materials to Research Compliance Services:
- Reliance Request Form - UO Relying IRB - complete this form when requesting that the UO rely on another institution's IRB to provide oversight for UO research.
- Reliance Request Form - UO Reviewing IRB - complete this form when requesting that UO serve as the reviewing IRB for one or more other institutions. Each institution will need to complete the Relying Site Survey.
If the study is established in the Research Administration Portal (RAP), the investigator will submit the above materials through the system and will need to associated each participating site with the study. See the RAP Guidance - Create a Multi-Site Study Submission (UO Relying) and RAP Guidance - Create a Multi-Site Study Submission (UO Reviewing).
The reliance arrangement will then need to be executed either using SMART IRB or an IRB Authorization Agreement (IAA). See below for details.
After initiating the reliance request by submitted the forms above, if the collaborating researchers belong to participating institutions, the SMART IRB Reliance Agreement can be used to establish reliance on a single IRB. The use of SMART IRB to establish reliance on a single IRB for a study can be documented either through a Letter of Acknowledgement or the SMART IRB Online Reliance System. More information about SMART IRB and the SMART IRB Online Reliance System, including templates, guidance, and video tutorials, can be found in the SMART IRB Learning Center.
IRB Authorization Agreements (IAA)
If the non-UO institution(s) engaged in research do not participate in SMART IRB or prefer to use an alternate or study-specific agreement in its place, an IRB Authorization Agreement (IAA) can be executed to establish reliance. RCS staff will work with you to create this documentation.
Individual Investigator Agreement (IIA)
When a non-UO individual is engaged in the human subject research and their work is not performed as an agent of an institution with an established Federal Wide Assurance (FWA), it may be necessary to establish an Individual Investigator Agreement (IIA). This form needs to be included with the initial protocol submission or an amendment request if an individual is being added to an existing protocol.
Other agreements entered into as part of collaborative research such as Memos of Understanding (MOUs) and Data Use Agreements (DUAs) are common. These agreements can include parameters for the conduct of research relevant to human subjects research and permission for use of data and/or specimens and may need to be considered as part of the IRB review. These may require consultation with UO Innovation Partnership Services.
- Engagement of Institutions in Human Subjects Research (2008)
- Assurance Process Frequently Asked Questions
- Extending an FWA to Cover Collaborating Investigators
- NIH Policies: