Committee For the Protection of Human Subjects

CPHS / IRB Polices

Human Research Protection Program

• Federal-wide Assurance
• Coordination with Other UTHSC-H Committees
• State Laws

IRB Membership

• Executive Committee
• IRB Membership
• IRB Meetings
• Conflict of Interest - CPHS Members and Consultants
• IRB Members Duties and Responsibilities

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 Fetal Tissue
• 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
• Compliance Oversight
• Subject Calls

Documentation

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

Investigator Responsibilities

• Investigators Responsibilities

iRIS Security

• Application, Owners, Steward, Users and Vendors for iRIS
• Data Classification and Retention Schedule for iRIS
• Physical and Internet Security for iRIS
• Backup Procedures for iRIS Data Records
• Disaster Recovery and Business Continuity Plan for iRIS
• Change Control Procedures for iRIS
• iRIS System Access
• iMedRIS Data Corporation’s response to address the requirements of FDA 21 CFR Part 11 in Closed System
• iRIS Compliance 21CFR11
• iRISZones