Templates & Forms
Note: These templates were recently revised with the UTHealth Houston logo. If any of these links are broken, please email clinicaltrials@uth.tmc.edu
CONSENT AND ASSENT TEMPLATES:
Informed Consent Template - English
Parental Permission Template - English
Informed Consent Template - Research Involving Interviews and Focus Groups
Informed Consent Template - Research Involving Records Review AND Questionnaires/Surveys
Informed Consent Template - Research Involving Blood Draws
Letter of Information Template
CONSENT AND ASSENT TEMPLATE - SPANISH NEW
Parental Permission Template - Spanish
Informed Consent Template - Research Involving Interviews and Focus Group - Spanish
Informed Consent Template - Research Involving Records Review AND Questionnaires/Surveys - Spanish
Informed Consent Template - Research Involving Blood Draws - Spanish
Verbal Script Template - Spanish
Letter of Information Template - Spanish
SAMPLE CONSENT FORMS FOR MINIMAL RISK RESEARCH (adapted from SACHRP Minimal
Sample consent - Research Involving Behavioral Testing
Sample consent - Research Involving In-vitro Diagnostic Device
Sample consent - Research Involving Blood Draw
Sample consent - Research Involving Interviews and Focus Groups - Verbal Script
Sample consent - Research Involving Interviews and Focus Groups - Written Consent
Sample consent - Research Involving Records Review and Questionnaires
PROTOCOL TEMPLATE AND STUDY TOOLS
Protocol Template (simple)
Protocol Template (complex)
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)
Guidance on Setting up a Departmental Research Review Process
Conflict of Interest Certification
Diagnostic Imaging Review and Approval Form
REGULATORY DOCUMENTS
IRB Roster September 2022 - August 2023
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’s Compliance Hotline (1-888-472-9868)
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 |