Human Research Protections Program
Beginning August 3, 2009, the IRB will require that for studies involving Protected Health Information (PHI), investigators must submit a completed HIPAA Research Authorization Form with their IRB submission, if a waiver of HIPAA Authorization is not being requested.
Once the study is approved, the HIPAA Research Authorization Form will be uploaded by Human Research Protections (HRP) Staff into the e-IRB Docs Depot to allow for easier access and use by the research team.
Once the study is approved, the HIPAA Research Authorization Form will be uploaded by Human Research Protections (HRP) Staff into the e-IRB Docs Depot to allow for easier access and use by the research team.
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
