Glossary Term
Consent Document
Glossary Term:
Consent Document
Definition
Commonly referred to as the "ICF" or "Informed Consent Form". These are the documents presented to a subject or parent/guardian prior to beginning a study. Most studies will have this document submitted with the proposal, unless requesting a Waiver. The IRB has provided a template on the web site for investigators to prepare their documents.
- Adult Informed Consent: This is required when subjects are 18 years and older. This should be written to the subject using appropriate language ("you").
- Parental Permission Document:This is required when subjects are 17 years and younger. This should be written to the parent/guardian using appropriate language ("your child").
- Assent Document: Assent is an agreement by an individual not competent to give legally valid informed consent (e.g., a child aged 7+ or cognitively-impaired person) to participate in research. This is required for children enrolled in studies that are 7-17 years of age. If the board deems appropriate, this can be requested for younger children.