Requirement for Free and Informed Consent

: : TCPS Requirement
: : Exceptions
: : Consent Process
: : Naturalistic Observation

The TCPS defines free and informed consent as "the dialogue, information sharing and general process through which prospective subjects choose to participate in research" (TCPS p. 2.1). In most instances, researchers seek the free and informed consent of prospective research subjects or their authorized third party before participation in research begins. Consent should be maintained throughout the research subjects' participation in the research. Consent is usually obtained in writing.

Modification of the free and informed consent procedure may be ethically justified in instances where all of the following criteria are met:

• The research involves no more than minimal risk
• The waiver or alteration is unlikely to adversely affect the rights and welfare of the subject
• The research could not practicably be carried out without the waiver or alteration
• Whenever possible and appropriate, the subject will be provided with additional pertinent information after participation
• The waiver or altered consent does not involve a therapeutic intervention.

In health emergency research, the REB may allow the free and informed consent to be temporarily waived if all of the following apply:

• The prospective subject requires immediate intervention
• There is no standard therapy available, or the research offers possible benefit over standard therapy
• The risk of harm is not greater than standard care or is clearly justified by the benefits
• The subjects is unconscious or lacks capacity to understand
• Third-parties cannot be secured in time, despite efforts to do so
• No prior directive by the subject is known to exist
• When the subject regains capacity, or when an authorized third party is found, free and informed consent will be promptly sought.

When in doubt about an issue involving free and informed consent, researchers should consult their REB.

Free and informed consent lies at the heart of ethical research involving human subjects. It encompasses a process that begins with initial contact and carries through to the end of the involvement of research subjects in the process. Researchers must provide prospective research subjects with sufficient information about the nature of the research and the associated risks and benefits to allow for informed decision-making. They must also allow prospective research subjects adequate opportunities to discuss and think about their participation in the research. Consent must be given voluntarily and subjects must be advised that they can withdraw at any time. Individuals in a position of authority over prospective subjects should not use coercion, manipulation, or undue influence during the consent process.

In most instances, the study's principal researcher (or his or her delegate) discusses the contents of the information sheet and consent form with the prospective research subject. This information is given in a culturally appropriate way, and in language that the potential research subject can understand.

Naturalistic observation is used to study behaviour in a natural environment. Researchers and REBs should consider closely the ethical implications of factors such as: the nature of the activities to be observed; the environment in which the activities are to be observed; and the means of recording the observations.

	>> Article 2.1 Requirement for Free and Informed Consent >> Article 2.2 Voluntariness >> Article 2.3 Naturalistic Observation >> Article 2.4 Informing Potential Subjects and Table 1 >> Article 2.8 Research in Emergency Health Situations