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:
- information that the individual is being invited to participate in a research project;
- 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,
- a description of research procedures
- explanation of the responsibilities of the participant;
- a plain language description of all reasonably foreseeable risks both to the participants and in general, that may arise from research participation
- a plain language description of all potential benefits, both to the participants and in general, that may arise from research participation
- are under no obligation to participate
- 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 data or human biological materials, including any limitations on the feasibility of that withdrawal;
- information concerning the possibility of commercialization of research findings
- 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
- 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 whom participants may contact regarding possible ethical issues in the research;
- an indication of what information 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.