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Free, informed and ongoing consent
- For research with humans to be considered ethical, it is essential that participants provide their free, informed and ongoing consent. Research can begin only after the participants have provided their initial consent, and individuals must have the possibility to withdraw their consent at any point during the research project.
This section provides researchers an overview of the key considerations regarding the process for obtaining consent or assent from research participants, as well as templates and sample forms for obtaining their consent or assent.
Researchers should obtain consent from their participants prior to their participation in research-related activities (i.e., before collecting any data from participants, or accessing data). In some cases, however, this requirement may be waived.
Despite the widespread agreement on the legal and ethical appropriateness of the general rule of informed consent for human research with an intervention, there are examples of very specific situations in which there are reasons to make an exception.
May 5, 2021 · All prospective participants must have the opportunity to give informed consent before entering a research project (see TCPS2 (2018) Chapter 3); however, a signed consent form is not always necessary (TCPS2 (2018) Articles 3.12 and 10.2).
The researcher must ensure that the participant is competent to give informed consent. Competency means the ability to understand the information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice whether or not to take part in the study.
Mar 25, 2024 · Informed consent is a process of communication between a researcher and a potential participant in which the researcher provides adequate information about the study, its risks and benefits, and the participant voluntarily agrees to participate.
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Who can obtain informed consent from research participants? A member of the study staff must obtain consent. This may be the principal investigator or designate. Consideration must be given to possible coercion by virtue of pre-existing relationships (i.e., physician-patient, professor-student).
