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:

  1. 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).
  2. Studies with funding through Northwestern University, but research activity will be conducted at Lurie Children’s
  3. 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)
    • Send an e-mail request for a login and password to irb@luriechildrens.org along with a completed HSR Education Form​ to verify the user meets the requirements for training in the protection of human subjects. More information can be found on the Lurie Children’s Education page​. Once this is done, access is usually available the next business day.
  • To obtain access to eIRB+ (at Northwestern University)

STEP ONE:

Submit the study to the Lurie Children’s IRB. [Download Cayuse Instructions]

  • 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.

STEP TWO:

Submit the study to the Northwestern University IRB. [Download eIRB+ Instructions]

  • 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.

STEP THREE:

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.

Additional Information/Resources


Lurie IRB Policy and Website
Northwestern University IRB Website
Draft Consent Forms
HSR and/or Cayuse IRB
Instructions to register in eIRB+

If you have any questions, please contact: Tricia Eifler (Lurie Children’s IRB) or Marcella Oliver (Northwestern University IRB)