Committee For the Protection of Human Subjects

CPHS / IRB Policies

Human Research Protection Program

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

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
• Research Involving Children
• Research Involving Pregnant Women, Fetuses and Neonates
• Research Involving Prisoners
• Research Involving Cognitively Impaired
• Reporting Problems
• Data Safety Monitoring
• Genome Wide Association Studies
• Department of Defense
• Department of Education
• Environmental Protection Agency
• International Research

Investigational Drugs and Devices

• Investigational Drugs, Agents and Biologics
• Investigational Device
• Humanitarian Device
• Emergency Use Investigational Drug or Device
• Exception from Informed Consent Requirements for Planned Emergency Research

CPHS 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

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

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Committee for the Protection of Human Subjects 6410 Fannin, Suite 1100 Houston, Texas 77030 Phone 713-500-7943 Fax     713-500-7951 Email cphs@uth.tmc.edu  IRIS Support 713-500-7960
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