Alternatives to Written Consent

TCPS 2, Article 3.12 Application: “Written consent in a signed statement from the participant is a common means of demonstrating consent, and in some instances, is mandatory (e.g., Health Canada regulations under the Food and Drugs Act, the Civil Code of Québec). However, there are other means of providing consent that are equally ethically acceptable. In some types of research, and for some groups or individuals, written signed consent may be perceived as an attempt to legalize or formalize the consent process and therefore may be interpreted by the participant as a lack of trust on the part of the researcher. In these cases, oral consent, a verbal agreement or a handshake may be required, rather than signing a consent form. In some cultures, the exchange of gifts symbolizes the establishment of a relationship comparable to consent.

Where consent is not documented in a signed consent form, 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 participant (e.g., through the return of a completed questionnaire). Where there are valid reasons for not recording consent in writing, the procedures used to seek consent must be documented (Article 10.2).

Verbal Consent

Depending on the project’s level of risk it may be appropriate to obtain verbal informed consent. This may be accomplished through in-person interview, videoconferencing or by telephone. It is recommended that written information about the project be provided to the potential participant or LAR to guide the verbal discussion and for their future reference.

In your Harmony Health Research Application, please justify the proposed method of obtaining consent and provide a written script which contains the basic elements of informed consent.

Implied Consent

When research involves the collection of anonymous data via a survey, the researcher is not required to obtain written evidence of consent but must provide potential participants with appropriate information on the project. The researcher may develop a document/statement that outlines the required elements of the informed consent (e.g., purpose of the project, amount of time to complete the survey, confidentiality provisions, etc.). The document/consent statement must also indicate that consent is inferred from the fact of completing and submitting the survey.