Policies
Policies
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UIC Human Subjects Protection Program
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Amendments to Previously Approved Research
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Continuing Review and Administrative Closure of Research
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Informed Consent
- Informed Consent Process and Documentation
- Guidance for Investigators: Informed Consent
- Sponsor Payment for Costs Related to Subject Injury in Industry-Sponsored Clinical Trials Guidance
- Guidance: Involvement of Non-English Speaking Subjects in Research at the University of Illinois at Chicago
- Guidance for Investigators: Certificates of Confidentiality
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When Problems Occur
- Unanticipated Problems and Other Events Requiring Prompt Reporting
- Administrative Hold, Suspension or Termination of IRB Approval
- Complaints or Concerns Received from Subjects or Others
- Handling Complaints and Potential Non-Compliance with Human Subject Protection Regulations
- Reporting of Unanticipated Problems, Suspensions, Terminations and Non-Compliance
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Investigator Guidance and Responsibilities
- Investigator Essential Documents
- Guidance for Investigators: Certificates of Confidentiality
- Guidance for Investigators: Informed Consent
- Guidance: Involvement of Non-English Speaking Subjects in Research at the University of Illinois at Chicago
- Investigator Conflict of Interest Disclosure Policy for Human Subjects Research
- Investigator and Research Personnel Education Program and Training Requirements
- Investigator Guidance: Recruitment Materials
- Protocol Exceptions
- Protocol Processing Fee for Industry Sponsored IRB Submissions
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Research Training Program and Requirements
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Compliance for the HSPP
- Administrative Hold, Suspension or Termination of IRB Approval
- Complaints or Concerns Received from Subjects or Others
- Ethical Standards and Legal Principles
- Handling Complaints and Potential Non-Compliance with Human Subject Protection Regulations
- OPRS Quality Assurance Program
- Reporting of Unanticipated Problems, Suspensions, Terminations and Non-Compliance
- Research Data Security
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IRB Approval Criteria
- Guidance: Data and Safety Monitoring Plans (DSMPs), Data and Safety Monitoring Boards (DSMBs), and Data Monitoring Committees (DMCs)
- IRB Evaluation Criteria: Equitable Selection of Subjects
- Evaluating Potential Risks and Benefits
- Investigator Guidance: Recruitment Materials
- Approval Criteria: Confidentiality
- Approval Criteria: Privacy
- Approval Criteria: Recruitment, Advertising, and Subject Payment
- Engagement of UIC in Human Subjects Research
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Other Review Units and Committees
- Cancer Center/Institutional Review Board Coordination
- Clinical Research Center/Institutional Review Board Coordination
- Collaborative Communication Procedures for Research Involving Radiation Exposure Between Radiation Safety Entities and UIC IRBs
- ESCRO/IRB Coordination
- Institutional Biosafety Committee (IBC)/Institutional Review Board (IRB) Coordination
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Vulnerable Populations
- Approval Criteria: Additional Protections for Vulnerable Populations
- Decisionally Impaired and Cognitively Impaired Subjects
- Guidance and IRB Review: Research Involving Students or Performed in Educational Settings
- Guidance: Involvement of Non-English Speaking Subjects in Research at the University of Illinois at Chicago
- Research Involving Children (Including Wards of the State)
- Research Involving Pregnant Women, Human Fetuses and Neonates, and Fetal Tissue
- Research Involving Prisoners
- Research involving Department of Defense Components
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Additional Guidance and Policies
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External IRBs and Reliance Agreements