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 2021.

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

• Review detailed information on using a single IRB.
• 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 instructions on how to submit these studies.

IRB Support Staff Contact Information

General IRB inquires: irb@luriechildrens.org​. 

Office of Research Integrity & Compliance

IRB & IBC Staff:

• Tricia Eifler, Associate Director of IRB Operations. teifler@luriechildrens.org
• Allison Harris, Senior Research Compliance Coordinator (Single IRB & Reliance Agreement(s)). agharris@luriechildrens.org
• Kaleigh Sands Michalko, Senior Research Compliance Coordinator, (IRB/IBC). ksandsmichalko@luriechildrens.org
• Jennie Thai, Senior Research Compliance Coordinator, (IRB/IBC). jthai@luriechildrens.org
• Kristen Brown, Research Compliance Coordinator. krbrown@luriechildrens.org 
• Khrystyna Helner, Research Compliance Coordinator. khelner@luriechildrens.org
• Alexa Karczmar, Research Compliance Coordinator. akarczmar@luriechildrens.org 

Clinical Research Education and Quality Assurance & Improvement:

• Michelle Corbett, Assistant Director, Clinical Research Education. mlcorbett@luriechildrens.org
• Erin Lynch, Clinical Research Educator. eglynch@luriechildrens.org
• Carol Macpherson, Clinical Research Quality Assurance & Improvement Specialist. cmacpherson@luriechildrens.org