Templates & Forms

Note: These templates were recently revised with the UTHealth Houston logo. If any of these links are broken, please email [email protected]  

CONSENT AND ASSENT TEMPLATES:

Informed Consent Template - English

Assent 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

Verbal Script Template

Letter of Information Template

CONSENT AND ASSENT TEMPLATE - SPANISH NEW

Consent Template - Spanish 

Assent Template - Spanish

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 Risk Informed Consent Models) 

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  - Observational Study

Protocol Template - Clinical Trial 

Protocol Deviation Log

Data Safety Monitoring PLAN (DSMP) Checklist

Data Safety Monitoring BOARD (DSMB) Charter Template

Adverse Event Log

Linking Log

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

Quality Improvement Guidance

Conflict of Interest Certification

Pathology Review 

Diagnostic Imaging Review and Approval Form

Guest Account Information

REGULATORY DOCUMENTS

IRB Registration Statement

IRB Roster September 2024 - August 2025

UTHealth Statement on Epic Part 11 Compliance 

UTHealth Statement on DocuSign Part 11 Compliance

REVIEWER CHECKLISTS

Advertisement Checklist

 IRB Reviewer Checklist

CPHS HELPLINE 713-500-7943

iRIS HELPLINE 713-500-7960

UTHealth Houston Compliance Hotline: 800-846-0632 (for English and Spanish speaking)

IRB OFFICE HOURS Thursdays from 1 to 4pm, via this Teams Room

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