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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.
  1. If participants will be provided the choice to opt in or out of certain research elements, consent for those should be sought separately from overall study participation. Clearly indicate that participants can still participate in the study if they do not consent to the optional elements.

  2. Researchers may request an alteration to consent requirements if they can meet the criteria of Article 3.7A. These include a requirement to satisfy the research ethics board (REB) that it is impossible, impracticable (see Glossary) or inappropriate to address the research question without the requested alteration.

  3. Voluntary (free) consent means that individuals are free to choose to take part in a research study. They should make this choice without coercion or undue inducement. They are also free to refuse to participate.

  4. In specific situations it may be necessary to make an exception to the general rule of informed consent for scientific research with an intervention. Earlier reviews only described subsets of arguments for exceptions to waive consent. Here, we ...

  5. 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).

  6. 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.

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  8. 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).

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