CPHS / IRB Policies
Human Research Protection Program
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
Investigator Responsibilities
Participant Payment
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
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 IRIS Support 713.500.7960 |
