External IRB of Record
Listed out below are the steps to follow in order to request that Lurie Children's rely on an external IRB of record:
1. Agree that reliance is appropriate following email communication and exchange of study documents with Lurie Children’s IRB
To initiate the reliance process please submit an email to IRBreliance@luriechildrens.org. In the email, please provide:
- A copy of the approved protocol
- Source of funding for the protocol
- Draft/approved consent documents (as applicable)
- Draft/Approved recruitment materials (as applicable)
- Any other documents as applicable that will help Lurie Children’s assess the appropriateness of the reliance request
A decision will be made as to whether Lurie Children's will cede review to an external IRB. Several factors are considered when determining whether Lurie Children's should rely on an external IRB or whether Lurie Children's should conduct its own IRB review. The decision to accept or decline the use of a reliance agreement is done on a protocol-by-protocol basis with the following factors in mind:
- Whether IRB reliance is required, e.g. the study is federally funded
- The qualifications of the reviewing IRB
- The involvement of each institution and it’s investigators
- The complexity of the protocol
- Risk level as determined by the reviewing IRB
2. Execute the reliance agreement between Lurie Children’s IRB and the reviewing IRB
Once established that Lurie Children’s will rely on an external IRB for a protocol, the Lurie Children’s IRB must enter into an IRB Authorization Agreement (IAA) with the qualified external IRB. 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 to document reliance. Visit our FAQs for more information on using SMART IRB.
The Institutional Official (IO, Chief Operating Officer) is the final authority on whether Lurie Children’s will rely on an external IRB 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.
3. Provide applicable local context to the reviewing IRB
Local context refers to applicable Lurie Children’s 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 and study team will work with the reviewing IRB point of contact to:
- exchange local context information with the reviewing IRB
- modify the Lurie Children’s consent forms and recruitment documents as needed to meet Lurie Children’s informed consent template requirements
- confirm that all study personnel have completed the required Human Subjects Protection and/or Good Clinical Practice training); and to
- confirm that no conflict of interest exists on study or that a Management Plan is in place to manage any conflicts of interest
4. Obtain overall IRB approval letter and approved study documents from the reviewing IRB
The reviewing IRB will review and approve (and stamp) the Lurie Children's - specific parental permission, assent and adult consent forms as well as other supporting study documents. The reviewing IRB will send these approved and stamped documents to the study team at Lurie Children’s.
5. Submit the study in the electronic Cayuse system
The Lurie Children’s study team will create a New Study in Cayuse which includes:
- the executed reliance agreement between the institutions
- a copy of the initial approval letter from the reviewing IRB (IRB of record)
- a copy of the protocol
- a copy of the informed consent document(s) and any recruitment materials that will be used at Lurie Children’s; and
- other study materials as applicable (e.g., Investigator’s Brochure).
Please note that the Cayuse application is NOT a duplicate IRB review. Submission of this abbreviated application into the electronic submission system serves to ensure:
- The proposed protocol adheres to the Institutional requirements for ensuring the protection of human subjects
- The Institution has adequate facilities and staffing to carry out the proposed research
- The proposed consent form includes language that addresses Institutional policy and requirements
- An appropriate assent process will be followed (where applicable, the facilitated/expedited reviewer will approve an assent document to be used during the conduct of the research); and
- An appropriate Authorization for the use of PHI in a research setting is issued
6. Review of study in Cayuse IRB (Lurie Children’s IRB Chair or Vice Chair)
The abbreviated application will be reviewed using expedited review. The Single IRB Coordinator may return the submission to the study team to resolve any outstanding issues or missing documents, as needed.
7. Lurie Children’s Issues External IRB of Record Acknowledgment letter in Cayuse IRB
Once the study has been approved in Cayuse, study activities may begin at Lurie Children’s.