Policies & Guidance

Document Number	Human Research Protection Program
100-01	Federal-Wide Assurance
100-02	Components of the Human Research Protection Program
100-03	State Laws Related to Human Subject Research
100-04	Fees
Document Number	IRB Membership
200-01	IRB Membership
200-02	IRB Meetings
200-03	Conflict of Interest - IRB Members
200-04	IRB Autonomy and Function
Document Number	IRB Review Process
300-01	Research Which Requires Review by the IRB
300-02	Exemptions
300-03	Review Procedure
300-04	Continuing Review
300-05	Expedited Review
300-06	Modifications and Protocol Amendments
300-07	Informed Consent
300-08	Short Form Consent
300-09	Research Involving Children
300-10	Research Involving Pregnant Women, Fetuses and Neonates
300-11	Research Involving Prisoners
300-12	Research Involving Cognitively Impaired
300-13	Reporting Problems
300-14	Data Safety Monitoring
300-15	Department of Defense
300-16	Department of Education
300-17	Environmental Protection Agency
300-18	International Research
300-19	Payment to Participants
300-20	Multi-site Research
300-21	Certificate of Confidentiality
300-22	Performance of Biopsies and Other Medical Acts
300-23	Departmentally Funded Protocols
300-24	Research Personnel Not Licensed to Practice Medicine in the State of Texas
Document Number	Investigational Drugs & Devices
400-01	Investigational Drugs, Agents and Biologics
400-02	Investigational Device
400-03	Humanitarian Device
400-04	Individual Patient Expanded Access Investigational Drug or Biologic
400-05	Individual Patient Expanded Access Investigational Device
Document Number	IRB Responsibilities
500-01	Appeals to IRB Decisions
500-02	Reporting
500-03	Suspension and Termination of IRB Approval
500-04	Human Subjects Research Non-compliance
500-05	Quality Assurance
500-06	Subject Calls
Document Number	Principal Investigator Responsibilities
600-01	Principal Investigator Requirements and Responsibilities
Document Number	Documentation
700-01	Developing Approving and Maintaining IRB Policies
700-02	Record Keeping

Additional Guidance

Quick Start Guide for IRB Submissions

HRPP Recruitment Guidelines

HRPP Social Media Guidance

Initiating Reliance with an External IRB