Content of Informed Consent

In accordance with TCPS 2, the informed consent process generally includes:

  • information that the individual is being asked to participate in a research project;
  • a plain language statement of the research purpose, as well as, the identity of the researcher, the identity of the funder or sponsor, the expected duration and nature of participation, a description of the research procedures, and an explanation of the responsibilities of the participant;
    • NOTE: Trainees MUST describe themselves as undergraduate or graduate students, medical residents or post-doctoral fellows. Do not use abbreviations which may be interpreted to suggest you have attained the degree you are working towards (ie. PhD (ABD) or PhD (c) etc.)
  • a plain language description of all reasonably foreseeable risks and potential benefits, both to the participants and in general, that may arise from research participation;
  • an assurance that prospective participants:
    • are under no obligation to participate and are free to withdraw at any time without prejudice to pre-existing entitlements;
    • will be given, in a timely manner throughout the course of the research project, information that is relevant to their decision to continue or withdraw from participation; and
    • will be given information on the participant's right to request the withdrawal of their data or human biological materials, including any limitations on the feasibility of that withdrawal;
  • information concerning the possibility of commercialization of research findings and the presence of any real, potential or perceived conflicts of interest on the part of the researchers, their institutions or the research sponsors;
  • the measures to be undertaken for dissemination of research results and whether participants will be identified directly or indirectly;
  • the identity and contact information of a qualified designated representative who can explain scientific or scholarly aspects of the research to participants;
  • the identity and contact information of the appropriate individual(s) outside the research team who participants may contact regarding possible ethical issues in the research;
  • an indication of the information that will be collected about participants and for what purposes;
  • an indication of who will have access to information collected about the identity of participants, a description of how confidentiality will be protected (see Article 5.2), a description of the anticipated uses of data, and information indicating who may have a duty to disclose information collected, and to whom such disclosures could be made;
  • information about any payments, including incentives for participants, reimbursement for participation-related expenses and compensation for injury;
  • a statement to the effect that, by consenting, participants have not waived any rights to legal recourse in the event of research-related harm; and
  • in clinical trials, information on stopping rules and when researchers may remove participants from trial.

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