What does the TCPS2 say about the Consent Process?

The following outlines what the TCPS2 says about the information which should be communicated during the consent process. This inforamtion is paraphrased from the discussion of Article 3.2

The information generally required for informed consent includes:

  1. information that the individual is being invited to participate in a research project;
  2. a statement of 
    • the research purpose in plain language, 
    • the identity of the researcher,
    • the identity of the funder or sponsor
    • the expected duration
    • the nature of participation
  3. a description of research procedures
  4. explanation of the responsibilities of the participant;
  5. a plain language description of all reasonably foreseeable risks both to the participants and in general, that may arise from research participation
  6. a plain language description of all potential benefits, both to the participants and in general, that may arise from research participation
  7. are under no obligation to participate
  8. are free to withdraw at any time without prejudice to pre-existing entitlements;
  9. 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
  10. will be given information on the participant’s right to request the withdrawal of data or human biological materials, including any limitations on the feasibility of that withdrawal;
  11. information concerning the possibility of commercialization of research findings
  12. the presence of any real, potential or perceived conflicts of interest on the part of the researchers, their institutions or the research sponsors;
  13. the measures to be undertaken for dissemination of research results 
  14. whether participants will be identified directly or indirectly;
  15. the identity and contact information of a qualified designated representative who can explain scientific or scholarly aspects of the research to participants;
  16. the identity and contact information of the appropriate individual(s) outside the research team whom participants may contact regarding possible ethical issues in the research;
  17. an indication of what information will be collected about participants and for what purposes;
  18. 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;
  19. information about any payments, including incentives for participants, reimbursement for participation-related expenses and compensation for injury;
  20. 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
  21. in clinical trials, information on stopping rules and when researchers may remove participants from trial.