Human Research Protections Program
Beginning February 1, 2010, investigators are required to use the updated Protocol Narrative forms (Version January 2010) when submitting new IRB applications. A summary of changes to the forms is available online.
The Protocol Narrative templates have been revised to provide additional guidance or clarification on issues that are commonly identified by the IRB Committee during the review of protocols.
The Protocol Narrative templates have been revised to provide additional guidance or clarification on issues that are commonly identified by the IRB Committee during the review of protocols.
Getting Started
- Student Researchers
- Activities that Require IRB Review
- Lead Researcher Eligibility
- Ethical Guidelines, Regulations and Statutes
- HRPP Policies and Procedures
- Frequently Asked Questions
- Especially for IRB Committee Members
- Especially for Research Volunteers
- How to Submit Protocols to the IRB
- Electronic Research Tutorials
- Other Required UCI Reviews
(e.g., School of Medicine review committees)
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
- NCI CIRB Facilitated Review Process at UCI
Conducting Research
