Informed Consent Process

Informed consent

All subjects must be adequately consented to participate in research. It is important to remember that informed consent is a process and not just a document.

Different terms are used to describe the multiple consent types. Consent forms are used to consent subjects 18 years or older. Permission forms are used to obtain permission from parents or guardians of subjects 17 years or younger. Assent forms are used to obtain agreement from the minor subject to be in the study.

A model informed consent form is provided to assist the researcher in creating an appropriate informed consent form. This form provides general guidelines for the language and format that should be used. The consent form should be modified to be appropriate for each study. The model informed consent form is updated regularly; therefore, researchers should be sure to use the most up to date version for each consent form.

Consent forms should be uploaded in their final form with no tracked changes or incomplete information. The document should be uploaded in the .doc format (not .pdf, .docx, or any other format). For directions, see Saving a Document in .doc Format.

To check the reading level of your informed consent document, see How to Check Reading Levels.

Assent

If minors under the age of 18 will be participants in the research, appropriate assent procedures must be in place.