WSU researchers collaborating with personnel not affiliated with the university should review the following guidance to determine the correct IRB for review, or whether a reliance agreement may be implemented.
If you are involved in a project with multiple institutions, please contact the HRPP to set up a meeting regarding the collaboration. It will seek to understand roles and relationships of the institutions involved in order to determine review responsibility.
A Reliance Agreement is an agreement between WSU and another institution or individual to either review for that institution/individual or to cede review and rely on another institution for the single IRB review of the protocol.
Types of Reliance Agreements
- Individual Investigator Agreement (IIA): This agreement can be implemented when the collaborator is not affiliated with an institution that has an IRB. This may also be implemented if the collaborator’s IRB does not have an active Federalwide Assurance (FWA).
- Institutional Authorization Agreement (IAA): This agreement can be implemented when the external collaborator(s) on the project are affiliated with a university or other institution/organization that has an IRB with an active FWA
Collaborations for Exempt Research
WSU is unable to execute reliance agreements for research deemed Exempt, except when required by the sponsor. Each institution involved in the Exempt project will be responsible for the reviews of their investigators. Subject to institutional approval, in some rare instances, WSU may elect to enter into agreements for multi-institutional exempt projects (e.g. when there is a pre-existing relationship related to the project or when the project could not be practicably accomplished without an agreement. More commonly, either WSU or the other institution may elect to “accept” the exempt determination of another institution in lieu of entering into an agreement with appropriate documentation.
Collaborations for Non-Exempt (Expedited and Full Board) Research
If a Non-Exempt WSU project involves researchers from multiple institutions, all parties involved must determine in advance how human subjects review will be handled—and by whom. Responsibility for project review and approval typically falls to the IRB at the institution of the lead principal investigator (PI). The responsible board is known as the “primary IRB.”
Federally funded research must comply with the Federalwide Assurance (FWA) for the Protection of Human Subjects. When federally funded investigations span multiple institutions, an Institutional Authorization Agreement (IAA) is needed to assign responsibility for review of research. WSU has the ability to execute agreements via SMART IRB if the collaborating institution is also registered under SMART IRB.
An IAA negates the need for simultaneous review of a study by multiple institutions, each of which may have different review requirements. Overlapping reviews often create logistical problems for investigators.
Officials at each institution involved sign the IAA. If WSU is the primary IRB, it sends each collaborating institution a copy of the final, signed IAA for their records.
When Reliance Agreements are Not Needed
- When the collaborator is not engaged in human subject research: For example, if they are not interacting with subjects but will receive de-identified data from the WSU researchers.
- Volunteers on projects: Sometimes, the WSU researchers may wish to hire a volunteer to work on their research. According to WSU’s BPPM 60.81, volunteers can be designated by a specific department to help with research activities. In order to do this, the volunteer must be registered as a volunteer for the department of the PI they will be working under. Once designated a volunteer, these researchers can be treated as a WSU affiliate like all other research personnel and will be held to the same IRB requirements as far as CITI training and IRB review goes. In these instances, the volunteer would not need a reliance agreement to be added onto the project. Please see BPPM 60.81 for more information.
- Exempt projects: A reliance agreement for a single IRB review is not required for projects that have been determined to be Exempt.
- Tribal IRB Review: Research conducted on tribal land or targeting a specific tribe requires separate tribal IRB review.
Research Involving American Indian/Alaska Native Populations
Projects that are conducting research targeting a specific tribe or tribes, or are conducting research on tribal land, must seek approval from those tribes. These tribes are considered sovereign and can conduct their own review. Agreements to rely on the tribes or have the tribes rely on WSU cannot be executed. The Single IRB Provision in the regulations do not apply to tribal IRBs or committees, per 45 CFR 46.114 – Cooperative Research.
WSU’s Center for Native American Research and Collaboration is an excellent resource for investigators interested in this area of research.
Reliance agreements may be implemented for research involving international collaborators. Please contact us if you have questions about international collaborations: email@example.com
You can also refer to WSU Export Controls for more information. Export Controls govern the transfer of controlled items or information to foreign nationals or foreign entities.
Existing Cooperative Agreements with External IRBs
- Providence IRB Spokane
The University has forged a cooperative agreement with Providence IRB Spokane (effective September 7, 2004). If any portion of your research is conducted at any Providence Health Care Ministry (including Providence Medical Groups) and/or St. Luke’s Rehabilitation Institute, your project must receive review and approval by the Providence IRB Spokane. This includes Clinical Trials.
- Washington State IRB (WSIRB)
The University has forged a cooperative agreement with Washington State Institutional Review Board (WSIRB) (effective August 28, 2006). Under this agreement, The Washington State Institutional Review Board (WSIRB) is responsible for reviewing all research conducted in the jurisdiction of the Washington State Department of Social and Health Services (DSHS). WSU maintains a cooperative agreement with WSIRB for their review of Non-Exempt projects.
Commercial IRBs (Advarra/WCGIRB)/Industry Sponsored Research For externally sponsored research, WSU will occasionally agree to external review by a commercial IRB (e.g. Advarra or WCGIRB). When this occurs, the sponsor will often directly engage the external IRB, but the WSU IRB must still be informed by the WSU PI of any human subject research being conducting by WSU personnel. The WSU HRPP may elect to directly engage an external IRB for review on behalf of the PI, particularly for complex multi-site projects. A PI may request review by an external IRB with which WSU has an established agreement, when this occurs, the PI is responsible for payment of any fees charged by the external IRB. For some industry sponsored trials, if the sponsor requests that WSU to be the IRB of record, WSU may elect to review and will charge reasonable fees to the sponsor or may elect to defer this review to an external IRB.