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 – updated January 2019 to reflect new Common Rule requirements 

Other Consent Document Templates

Other 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.
Research Protocol Template Use for all other studies.
Registry/Repository Template – Non-Exempt When your registry or repository will involve data or specimens collected from research interventions, or your repository will contain private information that is not protected health information regulated under HIPAA.
Registry/Repository Template – Exempt When your registry or repository will involve secondary research uses of identifiable private information or identifiable biospecimens that were collected as part of routine clinical care.

Recruitment Material Templates

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