Consent Templates are available on this page - Consent Templates
PROTOCOL TEMPLATES
Protocol Template for Observational Studies (including chart reviews):
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(R3) Good Clinical Practice Guidelines)
STUDY TOOLS
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
Please contact the IRB office for answers to questions, express concerns, and convey suggestions regarding human subjects protections.
IRB Office House: Thursdays, 1–4pm via Teams Room
Email: [email protected]
IRB Helpline: 713-500-7943 (please leave a message and we will get back to you as soon as possible)
iRIS Helpline: 713-500-7960
IRB Review Feedback: IRB Survey
Houston, Texas 77030
Phone: 713-500-7943
Email: [email protected]
Committee for the Protection of Human Subjects
IRIS Support: 713-500-7960
