URochester as IRB for Others - Office for Human Subject Protection

When does URochester act as an IRB for others?

Often, it happens when URochester 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 URochester is acting as the IRB of record for an external site, it is most commonly referred to as the sIRB process.

Steps in the sIRB Process

Step 1: Reliance Consultation Request

To initiate a request for URochester to be the IRB for external researchers, URochester research team submits a Reliance Consultation Request to the OHSP Reliance team. OHSP will schedule a meeting to discuss the project with the URochester researchers. At this meeting, the reliance team will ask questions to learn more about the project in order to determine if the sIRB process is appropriate and will provide the URochester researchers with more information about the process and their responsibilities.

Step 2: Reliance Process

During or after the reliance consultation meeting, OHSP will determine if the sIRB review process is appropriate for the project and if they are able to act as the reviewing IRB. Anytime URochester 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. OHSP handles all of the arrangements for the reliance agreement.

Step 3: New Study Application

Once URochester agrees to act as the reviewing IRB for the project, the URochester 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 URochester only.

Step 4: Site Applications

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. OHSP will communicate with the URochester PI to obtain needed information from relying sites. Once the URochester research team has all necessary documents from the external sites or researchers, the URochester PI will submit a Site Application for each external site.

Step 5: Site IRB Approval

URochester IRB will review and approve the individual site applications as they are completed and submitted. URochester IRB will provide the IRB approval letters to the URochester PI. The URochester PI and research team provide the site(s) with IRB approval letters, copies of the approved protocol, and consent documents.

Steps in the sIRB Process

Step 1: Reliance Consultation Request

Step 2: Reliance Process

Step 3: New Study Application

Step 4: Site Applications

Step 5: Site IRB Approval

Additional URochester PI Responsibilities

When URochester IRB is acting as the reviewing IRB for other researchers, it is the URochester PI’s and research team’s responsibility to manage all communication among the URochester 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 a 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.

When External Sites are Academic Institutions

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 URochester IRB process.

The relying site’s HRPP remains responsible for some aspects of the project review, even when URochester 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 URochester 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 Have Different Training Requirements

External researchers from institutions with Human Research Protection Programs do not follow the URochester IRB training requirements (specific modules via CITI). They take only the courses required by their own institution.

When external sites are not academic institutions

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, OHSP will explain the necessary requirements to the URochester researchers. They can develop a plan for how these requirements will be met.

Researchers should discuss training requirements with OHSP 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 URochester trainings.