Determine what is needed for collaborations
Is WSU the right IRB?
This depends on whether or not WSU is considered “engaged” in human subjects research. “Engagement” is a regulatory term used to describe certain types of involvement in human subjects research. When an institution’s employee or agent is “engaged” in non-exempt human subjects research, the institution is obligated by federal regulations to conduct an IRB review of the research, or to arrange for another IRB to conduct the review. WSU is often the primary IRB if the institution is receiving funding or if the WSU investigator is involved with all or a majority of the research activities.
Below are resources regarding “engagement” in research:
WSU IRB Manual: 100.3.3 – Cooperative Research
Office for Human Research Protections (OHRP): Engagement of Institutions in Human Subjects Research
WSU research projects with other institutions
WSU is unable to execute reliance agreements for research deemed Exempt. Each institution involved in the Exempt project will be responsible for the reviews of their investigators.
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 (See NIH Single IRB requirements and Cooperative Research requirement). 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.”
The primary IRB must provide information about the study and investigators’ roles to other institutions involved.
If WSU is the primary IRB, collaborating institutions may choose to do either of the following:
- Rely on WSU for full project review
- Review their own investigator’s portion(s) of the project themselves
If the lead PI is located at another institution, WSU has the same choices. It may either:
- Cede responsibility for research oversight to the other institution
- Review only WSU investigators’ portion(s) of the project
International Research Reliance
*Guidance regarding this topic is still being clarified. Please contact us if you have questions about international collaborations: firstname.lastname@example.org
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.
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.
Individuals with no institutional affiliation
If you are collaborating with an individual who does not have an institution or IRB that oversees their research activities, WSU has a few routes to address these scenarios. The level of “engagement” in regards to these collaborators will also need to be clarified to determine what is needed. Typically, if an individual is not considered engaged in human subjects research, no additional agreements are required.
Individuals engaged in Non-Exempt or Funded research
When WSU researchers are collaborating with an individual for Non-Exempt or Funded research, the WSU IRB will need to document oversight for that person. Depending on their level of engagement, an Individual Investigator Agreement (IIA) can be executed to document WSU’s oversight as well as that individual’s responsibilities.
Volunteers in research
If your project involves volunteers, please see WSU’s policy: BPPM 60.81 “Volunteers”. These individuals must be registered as volunteers at WSU and have the necessary human subjects research training in place before they can engage in the project.
Institutional Authorization Agreement Process
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 prevents simultaneous review of a study by multiple institutions, each of which may have different review requirements. Overlapping reviews could 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.
Exceptions to IAAs: Research requiring Tribal IRB review, international research requiring local IRB/Ethics review, and research supported/funded by a Non-Common Rule agency.
Procedure for assigning review responsibility
Imagine a hypothetical research project that involves WSU and two other universities. WSU is the institution of the lead PI and is the location for most data collection, recruiting, and research administration activities.
- The WSU researchers provides the WSU IRB with the following:
- The WSU Human Research Protection Program (HRPP) drafts the IAA and sends it to PIs at each institution for their respective IRBs to sign.
- WSU can review and approve the research project while the agreement is being finalized. The other universities will agree to rely on that review.
- Once the agreement is fully executed, WSU sends a copy to all participating institutions for their records.
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 Heath 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.
As a WSU researcher, you need to submit only one IRB application if you are conducting research with the following entities:
How to proceed:
- Complete and submit the application and associated documents to the appropriate entity.
- Separately, e-mail the WSU HRPP to inform its staff of the submission. WSU must keep a record of these projects to fulfill the cooperative agreement.
- Provide copies of the protocol and approval letters to WSU HRPP for documentation.
If you are involved in a project with multiple institutions, contact the HRPP. It will seek to understand roles and relationships of the institutions involved in order to determine review responsibility.
Each case is unique. Please allow time for the HRPP to assess the roles of each research partner and determine where review responsibility lies.