Consent Templates are available on this page - Consent Templates
PROTOCOL TEMPLATE AND STUDY TOOLS
Protocol Template for Observational Studies (including chart reviews): Protocol Template - Observational Study
Protocol Template for Clinical Trials: Clinical trial is research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.) Decision Tool: Does Your Human Subjects Study Meet the NIH Definition of a Clinical Trial? You do not have to use these templates - just make sure that the protocol contains all the necessary information (see page 39 - Section 6. Clinical Trial Protocols - ICH E6(R2) Good Clinical Practice Guidelines)
Data Safety Monitoring
Data Safety Monitoring
ANCILLARY REVIEWS
Please download fillable PDF forms and open in Adobe to enable digital signature option
Departmental Research Review Form (fillable PDF)
List of MMS Department Reviewers
Guidance on Setting up a Departmental Research Review Process
Conflict of Interest Certification
Diagnostic Imaging Review and Approval Form
REGULATORY DOCUMENTS
IRB Roster September 2025 - August 2026
UTHealth Statement on Epic Part 11 Compliance
UTHealth Statement on DocuSign Part 11 Compliance
REVIEWER CHECKLISTS
CPHS HELPLINE: 713-500-7943
iRIS HELPLINE: 713-500-7960
UTHealth Houston Compliance Hotline: 800-846-0632 (English & Spanish)
IRB OFFICE HOURS: Thursdays, 1–4pm via Teams Room
Committee for the Protection of Human Subjects
7000 Fannin St, Suite 1840Houston, Texas 77030
Phone: 713-500-7943
Fax: 713-500-7951
Email: [email protected]
Committee for the Protection of Human Subjects
IRIS Support: 713-500-7960
