Free and informed consent lies at the heart of ethical research involving human subjects. It encompasses a process that begins with the initial contact and carries through to the end of the involvement of research participants in the project. The process of free and informed consent refers to the dialogue, information sharing, and general process through which prospective participants elect to participate in research.
Research approved by the REB may begin only if (1) the prospective participant, or authorized third parties, have been given the opportunity to freely voluntarily consent to participate in the research, and (2) that consent has been obtained (and re-affirmed as necessary) and is maintained throughout their participation in the research.
The informed consent process must comply with the requirements of the TCPS (2), Section 3 – The Consent Process, and where appropriate, with the ICH Good Clinical Practice: Consolidated Guidelines, Section 4.8, Informed Consent of Trial Subjects.