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Tools and Guides

RESEARCH PROTOCOL TEMPLATES

Exempt/Not Human Subjects Research (NHSR) Protocol

Expedited Protocol

Full Board Protocol

IRB Reliance Agreement Protocol

Studies that Require Continuing Review Template

Pre-Audit Submission Form

NON-RESEARCH PROTOCOL TEMPLATES

Compassionate Use Request

Emergency Use of an Investigational Device

Emergency Use of a Drug or Biologic

Humanitarian Use Device Request

Treatment Use of a Medical Device

Treatment Use of a Drug or Biologic

Requesting Single Patient Access Checklist

RESEARCH/PROJECT RECORD TEMPLATES

Acknowledgement of Investigator/s’ Responsibilities (Signature/s)

Adverse Event Tracking

Consent Form Templates

Consent Discussion Documentation

Delegation of Responsibilities

Eligibility Checklist

Gift Card Documentation Spreadsheet

Master Subject List – No consent

Screening/Enrollment Log

Visit Checklist

SUBMISSION CHECKLISTS

Exempt/Not Human Subjects Research Submission Checklist

Expedited Protocol Submission Checklist

Full Board Protocol Submission Checklist

IRB Reliance Agreement Submission Checklist

RESEARCHER TOOLS

Study Procedures and Level of IRB Review

IRB Review Process Map

IRB Review of Quality Assurance/Quality Improvement Projects

When a PI Leaves UTHSC or Partner Institution

RESEARCH/PROJECT CHECKLISTS

Consent/Assent Checklist

Exempt Study Checklist

Expedited and Full Board Study Checklist

Things to Remember When Conducting Human Subject Research

DASH RESEARCH IRB TRAINING & EDUCATIONAL MATERIALS

Sharepoint Site with Huron instructional videos

AGREEMENTS FOR COLLABORATIONS

Consult the IRB Reliance Agreements webpage to download forms and corresponding instructions.

OTHER TIPS

Word: Tracked Changes

IRB Tips Archives (common questions & problem areas)

Feb 26, 2026