IRB Policies and Procedures

Human Research Protection Program

• Federal-wide Assurance
• Components of the Human Research Protection Program 
• State Laws Related to Human Subjects Research 

IRB Membership

• Executive Committee
• IRB Membership
• IRB Meetings
• Conflict of Interest - CPHS Members and Consultants
• IRB Autonomy and Functions

IRB Review Process

• Research Requiring Review by the IRB
• Exemptions
• Review Procedure
• Continuing Review
• Expedited Review
• Change Requests and Protocol Amendments
• Informed Consent
• Short Form Consent
• Research Involving Children
• Research Involving Pregnant Women
• Research Involving Prisoners
• Research Involving Cognitively Impaired
• Reporting Unanticipated Problems Including Adverse Events
• Data Safety Monitoring
• Genome Wide Association Studies
• Department of Defense
• Department of Education
• Environmental Protection Agency
• International Research
• Payment to Participants 
• Multisite Research
• Certificate of Confidentiality

Investigational Drugs and Devices

• Investigational Drugs, Agents and Biologics
• Investigational Device
• Humanitarian Device
• Individual Patient Expanded Access Investigational Drug or Biologic
• Individual Patient Expanded Access Investigational Device
• Exception from Informed Consent Requirements for Planned Emergency Research

IRB Responsibilities

• Reporting
• Suspension and Termination of IRB Approval
• Appeals to IRB Decision
• Human Subjects Research Non-compliance
• Quality Assurance
• Subject Calls

Documentation

• Developing, Approving and Maintaining CPHS Policy and Procedures
• Record Keeping

Investigator Responsibilities

• Investigators Responsibilities

CPHS HELPLINE   713-500-7943
iRIS HELPLINE    713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)

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