Section Overview Before continuing, you should: : : Read the Section Summary : : Review the Section Objectives

This section describes the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) requirements for free and informed consent, and outlines when these requirements may be waived or modified. It discusses the TCPS standards and procedures relating to competence, and introduces the relationship between the TCPS and the law. Case studies help you apply this information. You can check your progress at the end of the section.

By the end of this section, you should be able to:

• define free and informed consent
• describe the TCPS requirement for free and informed consent
• identify when the free and informed consent procedure may be modified or waived
• explain procedures to ensure consent is voluntary
• explain procedures to ensure consent is fully informed
• define competence to give free and informed consent
• describe the type of situations in which individuals who are not legally competent may be asked to be research subjects
• describe the free and informed consent requirements in a situation where an authorized third party provides consent
• identify when an individual who is not legally competent should be given the opportunity to assent to or dissent from research participation
• apply the TCPS standards and procedures for obtaining free and informed consent in the context of a research project.