The UIUC IRB oversees all human subject research conducted by UIUC faculty, staff, and students. In some cases, UIUC can provide IRB oversight to others working with UIUC researchers.
Often, it happens when UIUC researchers are working with researchers from other academic institutions. They may also be working with industry partners, community partners, or individuals not affiliated with an academic institution. In any situation where UIUC is acting as the IRB of record for an external site, it is most commonly referred to as the sIRB process.
To initiate a request for UIUC to be the IRB for external researchers, UIUC research team submits a Reliance Consultation Request to OPRS. OPRS will schedule a meeting to discuss the project with the UIUC researchers. At this meeting, OPRS will ask questions to learn more about the project in order to determine if the sIRB process is appropriate and will provide the UIUC researchers more information about the process and their responsibilities.
During or after the reliance consultation meeting, OPRS will determine if the sIRB review process is appropriate for the project and if they are able to act as the reviewing IRB. Anytime UIUC provides IRB oversight to someone not directly affiliated with the university, a reliance agreement is required to establish the responsibilities of each party to ensure the ethical conduct of research. OPRS handles all of the arrangements for the reliance agreement.
Once UIUC agrees to act as the reviewing IRB for the project, the UIUC PI submits the New Study Application form following the standard IRB submission and review process. The IRB will review the new study application and approve the study to be conducted at UIUC only.
When approving research, an IRB must take into account aspects of the local community where research will be conducted, as well as local and institutional policies. This is more difficult to do when acting as the reviewing IRB for another site. To assist with this requirement, the reviewing IRB asks the relying site HRPP to conduct a local context review and provide any feedback that the reviewing IRB may need to review and approve the research. OPRS will communicate with the UIUC PI to obtain needed information from relying sites. Once the UIUC research team has all necessary documents from the external sites or researchers, the UIUC PI will submit a Site Application for each external site.
UIUC IRB will review and approve the individual site applications as they are completed and submitted. UIUC IRB will provide the IRB approval letters to the UIUC PI. The UIUC PI and research team provide the site(s) with IRB approval letters, copies of the approved protocol, and consent documents.
When UIUC IRB is acting as the reviewing IRB for other researchers, it is the UIUC PI’s and research team’s responsibility to manage all communication among the UIUC IRB and the external researchers. This communication includes IRB submissions, handling revisions, providing IRB approval letters, and assisting with the reliance process. It’s often larger task than the research team is used to with single-site studies and should be factored into the time and effort requirements for the project.
Most academic institutions have a defined Human Research Protection Program. The relying site’s researchers must follow the process from their IRB/HRPP to initiate the reliance process. HRPP processes differ from institution to institution and each researcher is responsible for ensuring they are following the process at their home institution in addition to the UIUC IRB process.
The relying site’s HRPP remains responsible for some aspects of the project review, even when UIUC is the reviewing IRB. For example, the relying site is responsible for ensuring that each research team member has the appropriate training and qualifications to conduct the research activities. This means that the external researchers continue to follow their own institution’s training requirements. Once UIUC IRB issues IRB approval for the relying site, it is the relying site PI’s responsibility to ensure that all local HRPP requirements are met before any research can begin at the site.
External researchers from institutions with Human Research Protection Programs do not follow the UIUC IRB training requirements (Core IRB Training via CITI). They take only the courses required by their own institution.
When a relying site is not an academic institution, the site often does not have a defined Human Research Protection Program. This can create additional challenges in the IRB review process for the relying site or individual. During the reliance consultation, OPRS will explain the necessary requirement to the UIUC researchers. They can develop a plan for how these requirements will be met.
Researchers should discuss training requirements with OPRS before the external research team members begin a training program to ensure that the appropriate human subject research training requirements are being met, as well as instructions on access to UIUC trainings.