Informed consent is designed to provide potential subjects or those who must give permission for potential subjects, all the information they need to decide whether or not to participate in a research project.
Consent, permission, and assent materials must be written in language appropriate to the intended subjects. If an investigator plans to recruit subjects from non-English speakers or those who do not speak it well, certified translations should be provided once the English versions of the consent, permission, and assent materials have been approved by the IRB.
Any subjects over the age of 18 (or respective age of majority in other countries) must provide informed consent to participate in research. This is typically done by reading and signing a consent form. The IRB presumes that children ages four and older should be given an opportunity to provide assent. Generally, oral assent through the use of a script should be obtained from children four-seven years of age.
Please see Forms and Guidance for further information on the required elements of informed consent.