Template Documents and Tools

Consent Documents

Health Sciences Consent version: 12/18/2024 

*NEW* Social and Behavioral Sciences Consent

Cog. Impaired Adults Assent Form

HIPAA Authorization

Surrogate Consent Rider/Language

Genetic Screening Rider/Language

Single Patient IND

Protocol Development

CTEP Protocol Development Guidelines

Sample Behavioral and Social Sciences Protocol

Sample Health Sciences Protocol

Supplemental Forms

Radiation

RDRC - FDA Form 2915

Biosafety

Test Article Hazard Profile SOP

Incident Report

Genomic Data Sharing

NIH Policy on Data Sharing

Provisional (Pre-award) Certification

Certification Form for Studies started after Jan 2015

Certifications for pre-2015 that have consent

Certifications for pre-2015 with no consent

For Children's Assent Template(s) and other resources for pediatric research go to the NEW Children in Research page.

As of October 1, 2024: The Health Sciences consent and VUMC part 2 consent for Single IRB studies have been updated to reflect that a participant's research information may be shared with their insurance provider. All new studies should begin using the new consent template. The previous consent template will no longer be accepted on new studies after December 1, 2024.

The SMOG Readability Tool is a recommended and tested tool for determining the readability level of written materials.