Template Documents

Consent Form Templates

How to Write a Consent Form

Informed consent documents must be written at a reading level that is understandable to someone with an 8th grade level of education.

The Glossary of Lay Terminology is designed to help investigators achieve that goal. It was compiled from a number of sources including the Simplification Guide to Medical Terms from the University of Michigan Medical School Institutional Review Board (IRBMED).

For additional guidance on obtaining consent, please refer to Tools and Guidance.

Consent Templates

Other Consent Document Templates

Protocol Templates

These protocol templates are required to be used with initial submissions through InfoEd.

Protocol Template When to Use
Clinical Trial Template Use if your study involves an FDA regulated product, and this is an investigator initiated study
Protocol Plus Template Use if your study has a protocol from a sponsor, cooperative group, coordinating center, lead PI
Registry Studies Template Use if your study will be a registry or repository for data and/or samples
Research Protocol Template Use for all other studies

Recruitment Material Templates

For guidance on which template to use, please click here.