Informed Consent and Assent Process and Forms

“Informed consent” is the voluntary agreement of an individual, or his or her authorized representative, who has the legal capacity to give consent, and who exercises free power of choice without any form of constraint or coercion to participate in research. Consenting is a process where the researcher clearly communicates the risks and benefits of the study, the voluntary nature of participation in the study, and the expectations from the subject if they agree to participate in the study. Informed consent is a conversation between the researcher and potential research participants, and the consent form is a record of this conversation.

“Assent” is a term used to express willingness to participate in research by persons who are by definition too young to give informed consent but are old enough to understand the proposed research in general, its expected risks and possible benefits, and the activities expected of them as subjects. Assent by itself is not sufficient, however. If assent is given, informed consent must still be obtained from the subject’s parents or guardian. A person 18 years and older are considred adult and therefore one who can provide consent without parental permission.

Informed consent is not a single event or just a form to be signed – rather, it is an educational process that takes place between the investigator and the prospective subject. The informed consent and assent process is usually documented with a consent form and an assent form signed by the research participant and/or read to the research participant. In certain cases, documentation of consent may be waived and an information sheet used instead.

Once the researcher’s IRB submission is approved, the consent forms submitted by the researcher will be stamped by the IRB Office. All researchers must use IRB stamped consent forms with their research participants.

Consent and Assent Form Templates:

We recommend using the following templates for consent and assent forms. These forms are designed for research studies with minimal or less than minimal risks, and thus to be used with expedited reviews. If your application requires full review (more than minimal risk), adjust the language in these templates accordingly.