IRB Policies and Procedures

Table of Contents: IRB Policies and Procedures

Human Subjects Protection Program 

  • 101 - Regulatory and Ethical Mandate
  • 102 - Mission and Authority
  • 103 - Activities Requiring Review
  • 104 - Conflicts of Interest: IRB Members and Staff
  • 105 - Conflicts of Interest: Investigators
  • 106 - Training and Education 
  • 107 - Policy and Procedures Maintenance
  • 108 - Common Rule 2018 Implementation 

IRB Organization and Administration

  • 201 - IRB Membership and Duties
  • 202 - Ancillary Committee Reviews

IRB Functions and Operations 

  • 301 - Meeting Preparation
  • 302 - Materials for Review
  • 303 - Meeting Procedures and IRB Actions 

Records and Documentation

  • 401 - IRB Meeting Agenda
  • 402 - IRB Meeting Minutes
  • 403 - IRB Record Keeping 

IRB Review

  • 501 - IRB Review
  • 502 - Exempt Research
  • 503 - Exempt Research - Limited IRB Review
  • 504 - Expedited Research
  • 505 - Study Completion, Suspension or Termination
  • 506 - Criteria for IRB Approval of Research
  • 507 - Risks to Subjects

Incident Reporting

  • 601 - Unanticipated Problems and Adverse Event Reporting
  • 602 - Protocol Deviations, Violations and Exceptions 

Informed Consent and HIPAA

  • 701 - Informed Consent
  • 702 - Consent Documentation
  • 703 - Informed Consent: Research Involving Children
  • 704 - HIPAA Authorization
  • 705 - Translation and Interpretation
  • 706 - Posting of Informed Consent for Clinical Trials

Special Topics

  • 801 - Research Involving Data and Biological Specimens 
  • 802 - Research Involving Secondary Data
  • 803 - Social and Behavioral Research 
  • 804 - Internet Research
  • 805 - Case Studies/Reports
  • 806 -  Involvement in Clinical Research for Non-Healthcare Providers 

Vulnerable Populations

  • 901 - Research Involving Children
  • 902 - Research Involving Pregnant Women, Fetuses, and Neonates
  • 903 - Research Involving Prisoners
  • 904 - Decisionally Impaired Participants
  • 905 - Students and Employees

FDA-Regulated Research

  • 1001 - Medical  Devices: Significant Risk/Non-Significant Risk Determinations
  • 1002 - Emergency Use: Investigational Drugs, Biologics and Device
  • 1003 - Compassionate/Treatment Use
  • 1004 - Humanitarian Use Device 

External IRB Review

  • 1101 - Western IRB
  • 1102 - National Cancer Institute: Central IRB
  • 1103 - External Institutional Review Boards

Participant Protection

  • 1201 - Advertising and Subject Recruitment Materials
  • 1202 - Recruitment of Research Participants
  • 1203 - Compensation/Incentives for Participation
  • 1204 - Data Safety Monitoring Plan
  • 1205 - Certificate of Confidentiality 

Quality Assurance and Improvement 

  • 1301 - Quality Assurance Review Program