Documentation of Informed Consent

Evidence of consent shall be contained either in a signed consent form, or in appropriate documentation by the researchers of another appropriate means of consent, e.g. a script for an oral consent process.

Written consent in the form of a signed statement from the participant is a common means of demonstrating consent. However, there are other means of providing consent that are equally ethically acceptable.

Researchers may use a range of consent procedures, including oral consent, field notes and other strategies for documenting the consent process. Consent may also be demonstrated solely by the actions of the participants (i.e. through the return of completed questionnaire or participation in orther research activity). Where there are valid reasons for not recording consent in writing, for instance safety of the participants, the procedures used to seek consent must be documented in the ethics application.