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IRB Policies, Procedures and Guidance

Part A: IRB Overview

²»Á¼Ñо¿Ëù Human Research Protection Program

• IRB Authority, Purpose, and Principles (pdf)
• What Needs Review – Determination of Human Subjects Research (pdf)
• Institutional Review Board Policies and Procedures Development (pdf)

IRB Membership, Organization and Responsibilities

• IRB Composition, Member Appointment, Terms of Service and Member Evaluation (pdf)
• IRB Member Conflicts of Interest (pdf)
• IRB Confidentiality (pdf)

Part B: IRB Operations

General Operations

• Conduct of Full Board Meetings (pdf)
• Reporting to Regulatory and Oversight Agencies (pdf)

Review Types

• Exempt Status Review (pdf)
• Expedited Review (pdf)
• Full Board Review (pdf)
• Continuing Review (pdf)
• Review of Amendments (pdf)
• Suspension or Termination of Previously Approved Research (pdf)
• Investigations of General, Serious, or Continuing Noncompliance (pdf)

Principal Investigator and Faculty Supervisor Requirements and Responsibilities

• Responsibilities of the Principal Investigator for Research in Progress (pdf)
• Standard of Performance for Faculty Supervisors of Trainees Conducting Human Subject Research (pdf)

Monitoring and Reporting Activities

Required Reporting of Unanticipated Problems and Protocol Deviations (pdf)

Part C. Guidance

Informed Consent

• Recruitment and Selection of Participants (pdf)
• Informed Consent (pdf)

Additional Guidance

• Additional Approvals (pdf)
• IRB Authorization Agreements (pdf)
• Individual Investigator Agreements (pdf)
• Children, Guardians and Authorized Representatives (pdf)
• Ethnographic Research (pdf)
• Autoethnographic Research (pdf)
• International Research (pdf)
• Quality Improvement/Quality Assurance Projects (pdf)
• Retrospective Chart Reviews (pdf)
• Case Reports (pdf)
• Crowdsourcing Tools (MTurk, Prolific, CrowdFlower) (pdf)
• Secondary Data Analysis (pdf)
• Student Class Projects (pdf)
• Use of Drawings as Compensation or Incentive (pdf)