Human Research Protections Program


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 Other Required UCI Reviews (e.g., School of Medicine review committees)		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 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


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		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