Studies Involving Lurie Children's and Northwestern
The Lurie Children's and Northwestern University Institutional Review Board Authorization Agreement
Lurie Children's and Northwestern University have an Institutional Authorization Agreement (IAA) which allows the Northwestern University Institutional Review Board (IRB) to rely on the Lurie Children's IRB for the review of human subjects research under the following circumstances:
Studies that involve research activity at Lurie Children’s and Northwestern University or an affiliate (Prentice Hospital, Northwestern Medicine, Shirley Ryan Ability Lab, etc.) (i.e. investigators/staff at both institutions are engaged in the research).
Studies with funding through Northwestern University, but research activity will be conducted at Lurie Children’s
Studies conducted only at Northwestern University which enroll minors (i.e., participants < 18 years of age).
Note: These studies must be submitted to both IRBs, as each institution has applicable responsibility of oversight of the research (e.g., Conflicts of Interest, education, ancillary reviews, etc.) as outlined in their Federal Wide Assurance. The Lurie Children’s IRB will conduct a full review of the study, and the Northwestern University IRB will conduct an abbreviated review. The instructions below outline the steps for submitting to both institutions.
When to Request this Reliance?
When investigators/study staff at both Lurie Children’s and Northwestern University are engaged in research, IRB approval is required at both institutions. As above, investigators may request that Northwestern University rely on the review of the Lurie Children’s IRB via Cayuse IRB and then submit an abbreviated application and approval documents submitted to Northwestern University via eIRB+.
Examples of study activity at Northwestern University or its affiliates when this would be applicable include:
Participants will have study visits/activity at a Northwestern University site
Identified data and/or samples will be sent to investigators at a Northwestern University site
Northwestern University faculty or staff (without a Lurie Children’s appointment) will be engaged in the research conducting study procedures or interacting with participants at Lurie Children’s
Northwestern University faculty or staff (without a Lurie Children’s appointment) will be engaged in the research conducting study procedures or interacting with participants at Northwestern University and/or its Affiliates (Ensure that these individuals are included on the abbreviated submission to Northwestern IRB)
Some or all of the funding will be coming through the Northwestern University Office of Sponsored Research
Examples of activity at Northwestern University or its affiliates that will not require study submission to both IRBs:
Data will be collected or stored using REDCap
Sharing de-identified data/specimens
Providing standard of care services (e.g. radiation therapy that is being done for standard of care)
Performing commercial service (e.g. statistical analysis, lab analysis, etc.)
Instructions for Submitting to Both Institutions
BEFORE YOU START:
In order to submit a new study at each institution, investigators will need access to both electronic systems:
To obtain access to Cayuse IRB (at Lurie Children’s)
Please refer to the IRB Education page for instructions on Human Subject Research Protection and Good Clinical Practice education requirements.
To obtain access to eIRB+ (at Northwestern University)
Each user must obtain a NetID. Faculty are automatically assigned a NetID (this may be confirmed with department administrators or emailing firstname.lastname@example.org). Staff may request a NetID by e-mailing Marianne Reed (email@example.com). Obtaining a NetID can take up to four days.
Log in to Cayuse IRB (Lurie Children’s) from any web browser.
Create a new study (click on “+ New Study”).
Create a new submission (click on “+ New Submission”, then click “Edit”).
Complete the application and include the following regarding study activity at Lurie Children’s and Northwestern University:
Section 2: Study Settings Part A Multi-Institutional Research A1: Select Northwestern University or a Northwestern University Affiliate Site and any other locations as applicable. A2: Select the option “Yes, Lurie Children’s will serve as the IRB for another Site.” Then select “Northwestern University or affiliate site” in the Subcategory.
Supporting Documents: Unless consent is waived, attach the consent form which includes relevant Northwestern University language (see template).
Once the study is reviewed and approved, approval documents will be available in the system.
Once registered, log in to eIRB+ (Northwestern University)
Create a new study. The title and short title, should start with (xIRB) before the actual name. (i.e. (xIRB) Drug 123 Study).
To make this an abbreviated application, make sure to answer “yes” when asked if relying on an external IRB of record.
Question 6: Will an external IRB act as the IRB of record for the study? Select “YES”.
Upload the IRB Approval Letter from Lurie Children’s IRB, the protocol, and the stamped consents.
Create a local site submission to submit the study to the IRB
Once the study is reviewed, an acknowledgement letter will be available in the system.
The same process will apply to subsequent submissions (Modifications, Renewals, etc.). Remember, the PI and study team are responsible for following the respective institutional policies and timelines for reporting. Note: The study expiration date will be the same at both institutions.