IRB Policies & Procedures

The following manual outlines for investigators and study personnel the policies and procedures that ensure the ethical conduct of research with human participants at Lurie Children’s. Click on each section below to download a PDF that is searchable and contains within the Table of Contents internal links to help navigate through the manual.

Contact the IRB at irb@luriechildrens.org for all questions related to this manual.

IRB Policies and Procedures Manual​

  • Section 1 FWA, Ethical Principles and Regulations (Updated 3/27/18) 
  • Section 2 Lines of Authority, Responsibilities, and Other IRB Meeting Attendees (Updated 3/29/18)
  • Section 3 IRB Recordkeeping (Updated 5/15/15)
  • Section 4 Conflict of Interest (Updated 3/29/18)
  • Section 5 Investigator Responsibilities (Updated 3/29/18)
  • Section 6 Required Education and Training for Human Subjects Research (Updated 3/29/18)

    • Section 6.1 Required Education for Research Community

    • Section 6.2 Required Education for IRB Members and Staff
  • Section 7 Guidance on Quality Improvement and Assurance Projects and IRB Review (Updated 6/3/15)
  • Section 8 Investigational and Emergency Use of a Test Article (Updated 10/18/17)
  • Section 9 Types of Review and Submissions
 (Updated 3/29/18)
  • Section 10 Subject Recruitment and Internet and Social Media (Updated 3/29/18)

  • Section 11 Informed Consent (Updated 3/29/18)

  • Section 12 Vulnerable Populations (Updated 9/26/17)

  • Section 13 Data Safety Monitoring and Regular Reporting Requirements (Updated 11/10/16)

  • Section 14 Non-Compliance and Research Subjects Complaints (Updated 3/29/18)
  • Section 15 Sponsored Programs' Role in Human Research Protection (Updated 1/13/13)
  • Section 16 Databases and Registries in Human Subjects Research (Updated 3/29/18)
  • Section 17 Special Considerations for Department of Defense Sponsored Research (Updated 11/2/15)
  • Appendix A​ Maximum Allowable Blood Draws (Updated 12/14/17)