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Informed Consent Guidelines

If you are conducting any research involving human participants, you must normally give them, and have them sign, an informed consent statement. Detailed information about the research may be provided as part of the informed consent statement or in an additional information letter.

An informed consent statement/information letter has two purposes:

  • To enable potential research participants to make an informed choice as to their whether they wish to participate in a study; and
  • To document their decision to participate.
In order to make an informed choice, potential participants must understand the study, how they are involved in the study, and what sort of risks it poses to them. The words and language used to describe these factors must be understandable to potential participants.

Evidence of informed consent by the participant or authorized third party should often be obtained in writing and in some instances is mandatory (e.g., Health Canada regulations under the Food and Drugs Act). However, there are instances in which written consent is culturally unacceptable, or where there are good reasons for not needing to or not being able to record informed consent in writing. When 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. For example:
  • oral consent documented in some form of recording (e.g., field notes, consent log, audio recording)
  • building a consent form into your online survey and utilizing checkboxes to document consent (e.g., Qualtrics)

Guidelines for Completing the Informed Consent Statement

The Research Ethics Board provides a downloadable informed consent statement template. We strongly suggest you use the wording provided in the template and add additional information as it applies to your study. Guidelines for the additional information are provided here.

The informed consent statement should be written in second person ("You are invited..."). Use of first person ("I") can be interpreted as suggestive and coercive. If the informed consent statement or information letter is to be in a foreign language, submit the foreign language version and an English translation when seeking Research Ethics Board (REB) review.

Depending on the research method used in the project, each participant must be given a copy of the informed consent statement (and information letter if applicable) to read prior to participation in the study, in paper or electronic format.