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
- Greater than Minimal Risk Study
- Minimal Risk Studies
- Blood Draw Studies
- Prospective Chart Review Studies
- Emergency Use of an Experimental Drug or Device
Other Consent Document Templates
- Assent of a Minor (for children 7-17 years old)
- Assent of an Adult Subject with LAR
- Information Sheet Template – For use in Anonymous Survey Studies
- Re-consent Form – For use with Subjects in Follow-up Only OR Minor subjects turning 18
- Comprehension Assessment Form
- Short Informed Consent and HIPAA Translations – For the occasional circumstance in which a potential subject does not read or understand English
- Consent Addendum – 1099
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.