What are my obligations as the overall study PI where Northwestern is the IRB of Record for a multi-site or collaborative study?
- Coordinate with HRPP staff to determine whether this institution’s IRB can act as the IRB of Record for all or some institutions participating in the study or if an external IRB will assume oversight.
- Identify whether any IRB fees will be charged for this study and address any budget considerations.
- Identify all sites that will be engaged in human research and require oversight by the IRB.
- Submit a Single IRB Consultation Request Form if the proposed research involves federal funding, human participants, and multiple research sites.
- Follows procedures to submit a new study application to this institution, including the relevant study information for this institution’s IRB to make an initial assessment.
- Prepare and submit the initial IRB application, modifications, personnel updates, reportable new information, and continuing review information for all sites.
- Establish a process for obtaining and collating information from all sites and submitting this information to the reviewing IRB, including site-specific variations in study conduct, such as the local consent process and language, research participant identification and recruitment processes, and local variations in study conduct.
- Ensure that consent forms used by relying sites follow the consent template approved by the reviewing IRB and include required language as specified by the relying sites.
- Ensure that this institution’s study staff are appropriately qualified, have completed Human Subjects Protections training, and have been adequately trained to conduct the study in alignment with the reviewing IRB approved protocol.
- Collaborate with the reviewing IRB to document roles and responsibilities for communicating and coordinating key information from study teams and the IRB or HRPP at relying sites.
- Respond to questions or information requests from study teams or the IRB or HRPP staff at relying sites.
- Provide site investigators with all determinations and communications from the reviewing IRB and maintain documentation following the reviewing IRB and relying sites’ policies (See WORKSHEET: Communication and Responsibilities (HRP-830).
- Provide relying site investigators with the IRB-approved versions of all study documents, including an approved consent template.
- Obtain all appropriate institution/organization permissions (i.e., IRB, OSR, COI, etc.) before implementing procedures at this institution and relying sites.
- Submit reportable new information from relying sites to the reviewing IRB following the terms outlined in the authorization agreement or communication plan.
- Report the absence of continuing review information from relying sites if they do not provide the required information before submitting the continuing review materials to the reviewing IRB.
- Notify relying sites of their lapses in approval and applicable corrective actions.
- Provide study records to the relying institution, reviewing IRB, or regulatory agencies upon request.