Free and informed consent is an on-going process that starts with the researcher's first contact with the individual and continues until the
study's completion. (Guidance: http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter3-chapitre3/#toc03-1a)
Although written consent is most common, the REB understands that many disciplines and cultures do not accept written consent as
appropriate. It is the quality of the consent process, not the format, that is most important. Any verbal exchange about the study, the
consent form and all documentation given to participants should provide adequate and full information for the participant to make a free
and informed decision about his/her participation.
Researchers shall provide to prospective participants, or authorized third parties, full disclosure of all information necessary for making an
informed decision to participate in a research project.
At the commencement of any process of consent, researchers (or their qualified representatives) shall provide prospective participants with
the information set out in the following list, as appropriate to the particular research project. Not all the listed elements are required for all
research. However, additional information may be required in particular types of research or under particular circumstances.
If you do not include some of the listed disclosure requirements, please explain to the REB why these requirements do not apply to the
project. It is also up to the REB to consider whether all elements listed, or additional elements, are necessary to the consent process of the
research project.
While it may need to be more or less elaborated, the requirements of a consent form/script are listed below. Ensure to check below all that
apply from (a) to (f) in the consent process used in this research.
FREE AND INFORMED CONSENT PROCESS
1. Check what process will you use to inform the potential participants about the study's details and to seek
consent for participation? (Append copies of the draft consent form or script document.)
Information letter with signed written Informed Consent Form
Electronic Informed Consent Form
2. CONSENT FORM/SCRIPT CHECKLIST:
Sample SMU Informed Consent Form
Related guidance: TCPS 2, Article 3.2- Consent Shall Be Informed
SMU REB File Number (Provided at the time of registration.)
(a) an invitation to participate in the research project;
(b) a statement of the research purpose in plain language, the identity and contact information of the researcher(s), the
supervisor (for student research), the identity of the funder or sponsor, the expected duration and nature of
participation, a description of research procedures and an explanation of the responsibilities of the participant;
(c) a plain language description of all reasonably foreseeable risks and potential benefits;
(d) an assurance that participants:
~ are under no obligation to participate; are free to withdraw at any time without prejudice to pre-existing entitlement;
~ 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;
~will be given information on the participant's right to request the withdrawal of data, including any limitations on the
feasibility of that withdrawal;
(e) 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;
(f) the measures to be undertaken for dissemination of research results and whether participants will be identified
directly or indirectly;
(g) direction about how the participant can find out about the results of the study;
(h) Insert standard SMU REB wording:
"This research has been reviewed and cleared by the Saint Mary's University Research Ethics Board. If you have any
questions or concerns about ethical matters, you may contact the Chair of the Saint Mary's University Research Ethics
Board at ethics@smu.ca or 420-5728.";
(i) 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 the participants, a description of how confidentiality will be
protected, a description of the anticipated uses of data; and information indicating who may have a duty to disclose
information collected and to whom such discolures could be made.