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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.
Broad consent must align with these principles. Similar to consent for a specific research project, the broad consent process must focus on what is relevant to an individual participant's decision-making process.
Researchers should plan for and articulate the steps by which consent is initially obtained and the steps by which it is reviewed throughout the study.
Informed consent is the process of explaining the research, discussing it with the potential participant, and answering questions about the research, with a decision by the potential participant about whether or not to participate.
Normally, written evidence of informed consent should be obtained. If a written consent is not possible, the researcher may use an alternative method to document consent, and the reasons for using a modified method of obtaining must be explained in the application to the UHREB.
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In specific research, the researcher has a responsibility to ensure that the terms of participant consent are respected (Respect for Persons) and that participant welfare is protected (Concern for Welfare) throughout the life of the research project.
