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Committee For the Protection of Human Subjects

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

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 (simple)

Protocol Template (complex)

Protocol Deviation Log

Data Safety Monitoring PLAN (DSMP) Checklist

Data Safety Monitoring BOARD (DSMB) Charter Template

Adverse Event Log

Subject ID 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 2022 - August 2023

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’s Compliance Hotline (1-888-472-9868)

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Committee for the Protection of Human Subjects
6410 Fannin, Suite 1100
Houston, Texas 77030

Phone 713-500-7943
Fax     713-500-7951
Email cphs@uth.tmc.edu 

IRIS Support 713-500-7960

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