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ATTENTION RESEARCHERS:

Effective May 1, 2013, the Institute for Clinical and Translational Science (ICTS) Scientific Review Committee will no longer be responsible for the scientific review of research. UCI’s Institutional Review Board (IRB) will assume responsibility for the scientific review of research, in conjunction with the Biostatistics, Epidemiology, & Research Design (BERD) unit in the ICTS.  Lead Researchers requiring scientific review must complete and submit the most recent version (April 2013) of the Protocol Narrative for Expedited and Full Committee Review (available for download on the Applications and Forms web page under the IRB Forms heading) as part of the IRB submission process. Studies meeting the following criteria will require scientific review as part of the review for IRB approval:

• UCI investigator-authored
• Biomedical or clinical research 
• Does not involve the indication of cancer*
• Involves greater than minimal risk  to subjects (i.e., full board review)
• Research described  in the IRB protocol has not been previously peer reviewed or
• The IRB requires scientific review as part of its review (study-by-study basis)

All applications currently under scientific review by the ICTS Scientific Review Committee will remain under review with the ICTS Scientific Review Committee.  * For research involving cancer, scientific review will continue to be performed by the Chao Family Comprehensive Clinical Trials Protocol Review and Monitoring Committee (CTPRMC).   For more information, please review the complete announcement and the frequently asked questions document or contact HRP Staff.

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
• ClinicalTrials.gov Registry

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
• Common IRB Submission Errors
• Results of Full Committee Meetings
• UC Campuses Memorandum of Understanding (MOU)
• CHOC-UCI IRB Agreement for Research Conducted at CHOC
• NCI CIRB Facilitated Review Process at UCI

Conducting Research

• Tracking Protocol Status
• Subject Selection, Recruitment and Compensation
• Informed Consent Process
• Modifications to Approved Research
• Adverse Events, Unanticipated Problems & Violations
• Continuing Review Process
• Closing a Protocol
• Recordkeeping Responsibilities
• Research File Documentation