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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. In this regard, consent is not a single event but rather an ongoing process, starting with the researcher's first contact with the individual and continuing until the study is complete or the ...
Purpose. The purpose of this guideline is to provide researchers with information on consent and assent as it pertains to research involving human participants. Consent templates and appendices are also provided below to help researchers prepare their consent and assent documents. 2. Background.
separate options for consenting to participate in a specific research project and for consenting to the storage of data and human biological materials for future unspecified research. Application. The general requirements for consent to be free, informed, and ongoing apply to all types of consent and are explained in Chapter 3 of the TCPS.
I.1 Competency and proxy consent. 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.
The key idea is to go over the information verbally and document the process of gaining consent in field notes so as to leave a written trail. It is still reasonable to leave written material with the participant (e.g., an information letter). Regardless of the way in which consent is sought or documented, the primary focus of ethical concern ...
1.2 Informed consent requires “full disclosure of information necessary for making an informed decision to participate in a research project” (Article 3.2). 1.3 Although it is sometimes thought that consent is limited to the beginning of the research, the TCPS2 refers to the consent process as ongoing throughout the research. This means that
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Normally investigators should prepare a Letter of Information describing the research project and the demands it will place on participants (items 1-8 below), accompanied by a brief Consent Form which the participants can sign. If this process is not to be followed, the investigator should provide justification. See submission form.
