Informed consent – freely given – is required of all human subjects participating in a research project according to all accepted ethics guidelines. This means that participants should be fully informed of expectations, risks and other factors before they agree to take part in the project.
At Fanshawe College, full disclosure to subjects of the nature of the research is required, unless the research design requires that certain elements of the research not be provided to subjects, and provided the REB is satisfied that no harm would accrue to the subjects.
Informed consent takes into consideration many aspects of the investigation including:
- How will prospective subjects be contacted?
- What procedures will be in place to inform prospective subjects that they do not have to participate?
- When and how will the purpose and nature of the research, the anticipated benefits, inconveniences, risks to the subject, and the tasks to be performed by the subject be explained to the subjects?
- How will consent be obtained, and how may it be withdrawn?
- Will the subjects be under any kind of pressure to consent?
- If the subject is not competent or eligible to give consent, how will consent be obtained and from whom?
- How will confidentiality be maintained?
All of these factors must be considered whenever researchers use human subjects.
The REB requires researchers to obtain Informed Consent Forms, signed by all subjects, prior to the researcher receiving permission to begin the project. There is no, one single template for these forms; they vary according to the project, and are developed by the researcher/research team. However, they usually contain the following types of information:
- Information that the individual is being invited to participate in a research project;
- A statement of the research purpose, identity of the researcher, the expected duration and nature of participation and a description of the research procedures;
- A description of the reasonably foreseeable harms and benefits that may arise from research participation, as well as the likely consequences of non-action, particularly in research related treatment;
- An assurance that prospective subjects are free not to participate and have the right to withdraw at any time without prejudice to pre-existing entitlements;
- The possibility of commercialization of the research findings; and
- The presence of any apparent, actual or potential conflict of interest on the part of researchers, their institutions or sponsors.
If you require advice or assistance in developing an Informed Consent Form, please contact Steve Crema, Chair of REB, at firstname.lastname@example.org.