IRB Resources

All research studies at Lurie Children’s involving human participants require prior approval from the Institutional Review Board (IRB). Lurie Children’s two IRBs, Panel #1 and Panel #2, are composed of a diverse selection of experts in the field of pediatric research. 

Both IRBs are organized and operate in compliance with the Department of Health and Human Services (DHHS) regulations, as described in 45 CFR 46, for federally funded research and FDA regulations, as described in 21 CFR Parts 50 and 56, for FDA regulated research. In addition, the IRBs operate in compliance with portions of the HIPAA Privacy Rule that apply to research, as described in 45 CFR Parts 160 and 164. 

FWA/IORG/I​RB R​oster

For a copy of the Federalwide Assurance (FWA)/IRB Registration (IORG)/IRB Roster, please click here. 

IRB Meeting Dates and Submission
Dea​dlines 

IRB Panel #1 and Panel #2 Deadlines & Meeting Dates for 2020.

Policies & Guidelines​

Please navigate to the following pages for all policies, procedures, and guidance for conducting research with human participants and obtaining and maintaining IRB approval at Lurie Children’s.​

• IRB Policies and Procedures Manual.
• Requirements for Human Subjects (HSR) and Good Clinical Practice (GCP) Education
• IRB Post-Approval Monitoring Program
• Federal Regulations and Guidance​
• Lurie Children’s Clinical Studies Resources & Contacts 
• Emergency Use of an Investigational Drug Tip Sheet

Forms & Templates​

• Cayuse IRB Electronic Submission System 
• Consent Form & Short Form Templates
• Incident Assessment Tool ​for Investigators and Staff
• New PI Sign-Off Letter

Single IRBs and IRB Authorization Agreements

IRB Authorization Agreements

• When two or more institutions are participating in the same research protocol, they may enter into an agreement referred to as either a Cooperative Agreement, an IRB Authorization Agreement or an IRB Reliance Agreement. These agreements, which are executed between a Reviewing IRB and one or more Relying Institutions, delineate the roles and responsibilities of the institutions involved.
• For more information or questions about IRB Authorization Agreements (IAA) contact Kaleigh Michalko at 312.503.7058

Studies involving Lurie Children’s and Northwestern University

• For studies that involve Lurie Children’s and Northwestern University, a Master IRB Authorization Agreement is in place for Lurie Children’s to serve as the IRB of record. Please refer to the Studies involving Lurie Children’s and Northwestern page for instructions on how to submit these studies for review.

IRB Support Staff Contact Information

General IRB inquires: irb@luriechildrens.org​. 

Office of Research Integrity & Compliance

Catherine Powers, Director, Ph: 312.503.7120

Kimberly Villota, Senior Administrative Assistant, Ph: 312.503.7110

IRB & IBC Staff:

Tricia Eifler, Associate Director of IRB Operations, Ph: 312.503.7077

Jillian Anderson, Research Compliance Coordinator, PI Last Names A-F, Ph: 312.503.7663

Kristen Brown, Research Compliance Coordinator, PI Last Names G-L, Ph: 312.503.7641

Kaleigh Michalko, Senior Research Compliance Coordinator, Single IRB & Reliance Agreements, Ph: 312.503.7058

Kimberly Rowan, Senior Research Compliance Coordinator (IRB/IBC), PI Last Names M-Q/IBC, Ph: 312.503.7048

Jennie Thai, Research Compliance Coordinator, PI Last Names R-Z, Ph: 312.503.7027

Clinical Research Education and Quality Assurance & Improvement:

Jessica Macha, Associate Director of Research Compliance and Education, Ph: 312.503.7076

Charlotte Joshi, Assistant Director, Clinical Research Education, Ph: 312.503.7054

Erin Lynch, Clinical Research Educator, Ph: 312.503.7025

Carol Macpherson, Clinical Research Quality Assurance & Improvement Specialist, Ph: 312.503.7028

Sneha Solanki, Clinical Research Quality Assurance & Improvement Specialist, Ph: 312.503.7049

The ORIC main hospital satellite office (19-376) is open for walk-ins and appointments. It will be staffed by ORIC team members during the following times for walk-ins. If any appointments are needed, please contact the individual to set up a meeting. The weekly schedule will also be available in the Cayuse IRB announcement banner. 

Every other Monday and Tuesday, 8am-12pm: Research Compliance Coordinators

Every other Thursday, 8am-12pm: Clinical Research Quality Assurance & Improvement

Every other Friday, 8am-12pm: Clinical Research Educators