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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.
This chapter sets out the ethical requirements for consent in research involving humans. Throughout this Policy, the term “consent” means “free, informed and ongoing consent.” For the purpose of this Policy, “free” and “voluntary” are used interchangeably.
Mar 25, 2024 · Informed consent is a process through which researchers obtain voluntary agreement from participants to partake in a study after providing comprehensive information about the study’s objectives, procedures, risks, benefits, and their rights.
1.0 TCPS2 (2018) describes the consent process as one in which the researcher demonstrates respect for study participants by ensuring that individuals’ rights are protected and they are able to make a free and informed decision to participate in research.
Consent to participate in a research study should be understood as a process rather than an event. 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.
Mar 28, 2024 · Process provides: a list of required characteristics and elements of consent; the criteria for waiving consent, altering elements, and waiving documentation; and example language for common procedures and risks.
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Information that needs to be included in the consent form as required by federal regulations includes the following: MUST include: That the activity is being conducted for research purposes; The purpose and duration of the research; Study procedures and identification of any procedures that are experimental; Any anticipated risks or benefits