Template Documents and Tools

Consent Documents

Health Sciences Consent

Social and Behavioral Sciences Consent

Short Form-English

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

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

Non-English Short Forms/Translator Declaration

Translator's Declaration Form

Each of the short forms below are attached to the Translator's Declaration for the translation. The short forms are .pdf editable in the areas where contact information is required.

Arabic

Burmese

Chinese (Simplified)

Lao

Nepali

Somali

Spanish

Vietnamese

Additional Consent Document Resources

Tip Sheet for Key Information Section

Template Consent for Emergency Use

Repository Consent Rider

Assent and Consent Instructions

Short Form Instructions

Examples of Consents

Adult Consent Using Deception

Focus Group Consent

Parent Consent

Teacher Consent

University Student Consent

Examples of Assents

Assent Script for ages 6 and under

Assent and/or Script for ages 7-12

Assent for ages 13-17 who are cognitively impaired

Assent for ages 18+ who are cognitively impaired