Competence

: : What is Competence?
: : Legal Incompetence
: : Third Party Authorization
: : Assent/Dissent

The TCPS defines competence as "the ability of prospective subjects to give informed consent in accord with their own fundamental values. It involves the ability to understand the information presented, to appreciate the potential consequences of a decision, and to provide free and informed consent" (p. 2.9).

Although an individual's abilities may vary depending on the context, people over the age of majority are generally presumed to have these abilities. People under the age of majority are generally presumed not to have these abilities. In practice, though, not all adults have the capacity to make free and informed decisions and not all children lack this capacity.

>> Competence

Determination of legal incompetence involves special procedures spelled out in provincial law. Individuals who are not legally competent to provide free and informed consent may be asked to become research subjects in limited circumstances. Free and informed consent is sought from their authorized representative, but the extent to which the authorized representative may consent to research on behalf of a legally incompetent individual can be limited by provincial statute, advance directives, or wills.

In research involving those under the age of majority, the child's parent or legal guardian is usually required to provide consent (although in some situations, adolescents can be regarded as competent and provide their own consent). An authorized representative is usually required to give consent in research involving legally incompetent adults. Where the adult is legally competent but not competent to provide consent to participate in the research, a family member or friend may be required to provide consent.

>> Article 2.5

The researcher must show how free and informed consent will be obtained and maintained from the authorized representative of incompetent individuals. In cases where the individual's ability to provide free and informed consent may change during the course of the research, researchers must show how they will re-evaluate this ability.

>> Article 2.6

Many individuals who are not legally competent are able to indicate whether they wish to participate in research, even though they may not be able to provide free and informed consent. In these instances, the assent or dissent of the research subject should be ascertained. Assent alone may not be sufficient to permit participation in research. Dissent, however, precludes the potential research subject's participation.

>> Article 2.7