Protocol and Consent Form Templates

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

IMPORTANT: These protocol templates are required for any new study submission using Northwell IRB. Study information should be entered directly into the appropriate template (do not cut and paste template sections into a new document). Submissions that do not use the required template will be returned without review.

Protocol Template When to Use
Clinical Trial Template This is the NIH/FDA published protocol template that Northwell Health is adopting for all studies involving an FDA regulated product.
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.