Lurie Children’s IRB staff can assist in determining if reliance agreements with the identified sites already exist
Draft consent documents (as applicable)
Draft recruitment materials (as applicable)
Any other documents as applicable that will help Lurie Children’s assess the appropriateness of Lurie Children’s serving as the IRB of Record
If the study is a network or consortium funded study, the network will often name the IRB of Record. For NIH funded studies, the lead PI may request his/her institution to be the IRB of Record; however, the institutional official (IO) makes the determination of whether the institution will serve as IRB or Record or not. All requests should be submitted to IRB office for consideration via email at IRBreliance@luriechildrens.org.
2. Submit the study in Cayuse IRB for Lurie Children’s IRB approval (if not already approved)
3. Execute the IAA between Lurie Children’s IRB and any relying sites (can be done in parallel with review of study)
Once established that Lurie Children’s will serve as the IRB of Record for a protocol, the Lurie Children’s IRB must enter into an IRB Authorization Agreement (IAA) with the relying site(s). The IAA (also called a reliance or cooperative agreement) defines the terms, scope and limits, and roles and responsibilities of the joint review arrangement and must be signed by the Institutional Official of each institution involved.
Lurie Children’s is a signatory to the SMART IRB master reliance agreement. Where possible, the SMART IRB agreement will be used as the basis for reliance. Visit our FAQs for more information on using SMART IRB.
If a proposed relying site(s) is/are not listed above and the institution is NOT part of SMART IRB, an individual and study-specific authorization agreement will need to be established with that institution. The Single IRB Coordinator will work with the study team and study contacts at both sites to execute this agreement.
The Institutional Official (IO, Chief Operating Officer) is the final authority on whether Lurie Children’s will serve as the IRB of Record for a multi-site study. The IO has delegated authority to the Director, Office of Research Integrity and Compliance, as well as the Associate Director, Office of Research Integrity and Compliance to make ongoing determinations about IRB reliance arrangements under the SMART IRB or other master agreements.
All new reliance agreements are signed by the IO. The IO will consult with the Director, Office of Research Integrity and Compliance, the IRB Chair and General Counsel as necessary to make these decisions.
4. Collect applicable local context from relying site(s)
Local context refers to applicable relying site institutional policies or state laws, study team member HSR/GCP training and qualifications, and information regarding any conflicts of interest for study personnel that apply to the proposed research. The Lurie Children’s single IRB coordinator will work with the relying IRB point of contact to collect local context information for each relying site. The Single IRB Coordinator will work with relying sites to modify the IRB approved Lurie Children’s consent forms and recruitment documents as needed to relying site informed consent requirements.
5. Provide Lurie Children’s IRB approval letter and approved study documents to relying site(s)
Lurie Children's IRB will need to review and approve (and stamp) the relying site- specific parental permission, assent and adult consent forms as well as other supporting study documents.
6. Submit modification in Cayuse IRB to add relying sites and their local documents
7. Review of modification in Cayuse IRB (Lurie Children’s IRB Chair or Vice Chair)
8. Lurie Children’s IRB issues Approval for relying sites including stamped consent forms