Policies and 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.
- Section 1 FWA, Ethical Principles and Regulations (Updated 6/4/20)
- Section 1.1 FWA
- Section 1.2 Ethical Principles and Regulations
- Section 1.3 Human Research Protection Program (HRPP)
- Section 2 Lines of Authority, Responsibilities, and Other IRB Meeting Attendees (Updated 8/24/20)
- Section 2.1 Lines of Authority and Responsibilities
- Section 2.2 Other IRB Meeting Attendees
- Section 3 IRB Recordkeeping (Updated 6/12/20)
- Section 4 Conflict of Interest (Updated 6/11/20)
- Section 4.1 Conflict of Interest for Sponsored Programs
- Section 4.2 Conflict of Interest for IRB Members
- Section 5 Investigator Responsibilities (Updated 6/21/20)
- Section 6 Required Education and Training for Human Subjects Research (Updated 6/15/20)
- 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 6/15/20)
- Section 8 Investigational and Emergency Use of a Test Article (Updated 1/21/19)
- Section 8.1 Responsibilities for Biomedical Research
- Section 8.2 Investigational Use of Drugs or Biologics
- Section 8.3 Emergency Use of an Investigational Drug or Biologic
- Section 8.4 Expanded Access Use of Investigational Drugs/Biologics
- Section 8.5 Group C Treatment IND
- Section 8.6 Investigational use of Medical Devices
- Section 8.7 Humanitarian Use Devices
- Section 8.8 Emergency Use and Expanded Access for Medical Devices
- Section 8.9 Off-Label use of Marketed Drugs, Biologics and Devices
- Section 9 Types of Review and Submissions (Updated 3/23/22)
- Section 9.1 Types of IRB Submissions
- Section 9.2 Types of IRB Review
- Section 10 Subject Recruitment and Internet and Social Media (Updated 9/9/20)
- Section 10.1 Subject Selection and Recruitment
- Section 10.2 Internet and Social Media
- Section 11 Informed Consent (Updated 5/23/22)
- Section 11.1 Informed Consent Process
- Section 11.2 Parent Consent and Child Assent
- Section 11.3 Consenting Non-English Speaking Subjects
- Section 11.4 Consenting Subjects who Lack Decisional Capacity
- Section 11.5 Waivers of Informed Consent, Parental Permission, And Assent
- Section 11.6 Consent for Surveys
- Section 11.7 Alternate Methods of Consent
- Section 12 Vulnerable Populations (Updated 1/21/19)
- Section 12.1 Protection of Vulnerable Populations
- Section 12.2 Protections for Pregnant Women, Human Fetuses, and Neonates
- Section 12.3 Protections for Prisoners
- Section 12.4 Protections for Children
- Section 12.5 Non-English Speaking Subjects
- Section 12.6 Cognitively Impaired Subjects
- Section 12.7 HIV-Positive Subjects and Subjects with AIDS
- Section 13 Data Safety Monitoring and Regular Reporting Requirements (Updated 6/21/2020)
- Section 13.1 Data Safety Monitoring
- Section 13.2 Regular Reporting Requirements
- Section 14 Non-Compliance and Research Subjects Complaints (Updated 8/7/20)
- Section 14.1 Allegations of Non-Compliance
- Section 14.2 Inspections by Regulatory Agencies
- Section 14.3 Research Subjects/Family Concerns and Complaints
- Section 14.4 Reports of Unauthorized Disclosure of PHI
- Section 15 Sponsored Programs' Role in Human Research Protection (Updated 8/6/20)
- 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)
