Human Research Protections
New IRB Fee Rates:
Effective April 1, 2012, IRB fees for Industry-Sponsored Clinical Trials will be increased. Please include the new IRB fees in industry sponsored clinical trial budgets. For more information, please refer to the updated web page and FAQs @ http://research.uci.edu/ora/ct/index.htm
Getting Started
- Student Researchers
- Activities that Require IRB Review
- Lead Researcher Eligibility
- Ethical Guidelines, Regulations and Statutes
- Frequently Asked Questions
- How to Submit Protocols to the IRB
- Electronic Research Tutorials
- Other Required UCI Reviews
(e.g., School of Medicine review committees) - Additional Requirements for Research Involving the Department of Defense
Special Issues
- Vulnerable Subject Populations
- Use of Surrogate Consent in Research
- Consenting Subjects Who Do Not Read, Speak or Understand English
- Placebo Controlled Studies
- Protected Health Information (HIPAA)
- Drugs, Biologics and Devices
- Research Performed With Other Institutions
- Human Gene Transfer Research
- Use of Controlled Substances
Protocol Review Process
- Assessing Risks and Benefits
- Data and Safety Monitoring for Clinical Research
- Levels of Review
- Protocol Preparation Checklist
- Required Elements of Informed Consent
- Informed Consent Preparation
- Privacy and Confidentiality
- Data Security
- Most Common Reasons why electronic Applications
(E-IRBAPP, e-MOD, e-CPA…) are Deferred by the IRB - Results of Full Committee Meetings
- UC MOU for Exempt & Expedited Research
- CHOC-UCI IRB Agreement for Research Conducted at CHOC
- NCI CIRB Facilitated Review Process at UCI
Conducting Research
