IRB Procedures and Policies

UCSC IRB Procedures

• Submitting a Human Subjects Research Application (Initial Submission)
  • IRB Review and Approval Process
• Administrative Check-Ins & Continuing Review (Renewal Submission)
• Modifications to Existing Studies (Modification Submission)
• Unanticipated Problems (UPRs), Non-Compliance, and Other Reportable Incidents (Incident Submission)
• Study Closures and Withdrawals (Closure/Withdrawal Submissions)
• Obtaining Informed Consent
• Protecting Subject Data
• Educational Records and Research (FERPA)

UCSC IRB Policies for studies after January 21, 2019

• Policy on Children
• Policy on Consultants
• Policy on Continuing Review
• Policy on Exempt Review
• Policy on HIPAA
• Policy on HRPP Oversight
• Policy on Human Subjects Research
• Policy on Human Subjects Research Training and Education
• Policy on Informed Consent
• Policy on Initial Review
• Policy on Investigator Responsibilities
• Policy on IRB Meeting and Minutes
• Policy on IRB Member Conflict of Interest
• Policy on IRB Membership
• Policy on IRB Reliance
• Policy on Modifications
• Policy on Noncompliance
• Policy on Pregnant Women
• Policy on Prisoners
• Policy on Records Retention
• Policy on Regulatory Flexibility
• Policy on Researcher Financial COI
• Policy on State and Local Laws
• Policy on Studies Involving the DOD
• Policy on Study Closure or Withdrawal
• Policy on Subject Rights and Concerns
• Policy on Subjects with Impaired Decisional Capacity
• Policy on Suspension and Termination
• Policy on Unanticipated Problems Involving Risks to Subjects or Others

UCSC IRB Policies for studies on or before January 21, 2019

• Policy on Amendments
• Policy on Continuing Review
• Policy on Exempt Review
• Policy on Extended Approval Minimal Risk Research
• Policy on Human Subjects Research
• Policy on Informed Consent
• Policy on Initial Review
• Policy on IRB Member Conflict of Interest
• Policy on IRB Membership
• Policy on IRB Reliance
• Policy on Noncompliance
• Policy on Unanticipated Problems Involving Risks to Subjects or Others
• Policy on Regulatory Flexibility
• Policy on Suspension and Termination

UC Human Subjects Policies

University of California Policies and Guidelines for Human Subjects Research