不良研究所

IRB Policies, Procedures and Guidance

Part A: IRB Overview

不良研究所 Human Research Protection Program

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

IRB Membership, Organization and Responsibilities

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

Part B: IRB Operations

General Operations

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

Review Types

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

Principal Investigator and Faculty Supervisor Requirements and Responsibilities

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

Monitoring and Reporting Activities

Required Reporting of Unanticipated Problems and Protocol Deviations

Part C. Guidance

Informed Consent

• Recruitment and Selection of Participants
• Informed Consent

Additional Guidance

• Additional Approvals
• IRB Authorization Agreements
• Individual Investigator Agreements
• Ethnographic Research
• International Research
• Quality Improvement/Quality Assurance Projects
• Retrospective Chart Reviews
• Case Reports
• Crowdsourcing Tools (MTurk, Prolific, CrowdFlower)
• Secondary Data Analysis
• Student Class Projects