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
Investigator Responsibilities
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 |
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CLINICAL TRIALS RESOURCE CENTER OFFICE OF RESEARCH ENVIRONMENTAL HEALTH & SAFETY |
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