IRB Standard Operating Procedures

In This Section

• Standard Operating Procedures for Researchers 
• Standard Operating Procedures for IRB Administration
  • General
  • Management of Incoming Information 
  • Non-Committee Review 
  • Committee Review 
  • Review Process
  • Periodic Tasks
  • Records
  • Committee Management 
  • Reliance Agreements

Standard Operating Procedures for Researchers

• HRP-013
  Legally Authorized Representatives, Children, and Guardians
• HRP-055
  Financial Conflicts of Interests
• HRP-090
  Informed Consent Process for Research
• HRP-091
  Written Documentation of Consent
• HRP-092
  Clinical Trials Recruitment Websites
• HRP-093
  Requirements for Investigators Conducting Clinical Trials and Clinical Investigations
• HRP-094
  Subject Recruitment

Standard Operating Procedures for IRB Administration

General

• HRP-001
  Definitions
• HRP-012
  Observation of the Consent Process
• HRP-013
  Legally Authorized Representatives, Children, and Guardians

Management of Incoming Information

• HRP-020
  Incoming Items Directed to the IRB
• HRP-021
  Pre-Review
• HRP-023
  Emergency Use Review
• HRP-024
  New Information
• HRP-025
  Investigations
• HRP-026
  Suspension or Termination of IRB Approval
• HRP-027
  Emergency Use Post-Review

Non-Committee Review

• HRP-030
  Designated Reviewers
• HRP-031
  Non-Committee Review Preparation
• HRP-032
  Non-Committee Review Conduct
• HRP-033
  Designated Faculty Reviewers
• HRP-034
  Designated Faculty Review Conduct

Committee Review

• HRP-040
  IRB Meeting Preparation
• HRP-041
  IRB Meeting Conduct
• HRP-042
  IRB Meeting Attendance Monitoring
• HRP-043
  IRB Meeting Minutes

Review Process

• HRP-050
  Conflicting Interests of IRB Members
• HRP-051
  Consultation to the IRB
• HRP-052
  Post-Review
• HRP-054
  Institutional Conflicts of Interest
• HRP-055
  Financial Conflicts of Interests
• HRP-056
  PPM 230-05 Public Health Service Regulations on Objectivity in Research
• HRP-057
  University of California Policy on Financial Conflicts of Interest
• HRP-058
  IRB Reliance When UC Davis Relies on an External IRB
• HRP-059
  IRB Reliance When UC Davis is the IRB of Record

Periodic Tasks

• HRP-060
  Annual Evaluations of the HRPP
• HRP-061
  Monthly Evaluations of the HRPP
• HRP-062
  Daily Tasks
• HRP-063
  Expiration of IRB Approval

Records

• HRP-070
  IRB Records
• HRP-071
  Standard Operating Procedures
• HRP-072
  IRB Records Retention

Committee Management

• HRP-080
  IRB Formation
• HRP-081
  IRB Removal
• HRP-082
  IRB Membership Addition
• HRP-083
  IRB Membership Removal
• HRP-084
  IRB Meeting Scheduling and Notification

Reliance Agreements

• HRP-085
  Reliance Agreements