Research Consent
Fundamental to the responsible conduct of research with human subjects is the concept of informed choice. This requires a person to receive sufficient information about participating in research; while in a situation where the decision is voluntary and free from undue influence or inducement. Informed choice may lead to the individual's agreement to become a research subject, or may equally result in refusal. When acting upon informed choice, the person agreeing to become a subject is required to provide "informed consent" prior to being enrolled in the study. No matter what personal decision is arrived at concerning research participation, a person’s right to receive appropriate health care services at the MUHC will be maintained.
Informed consent is not a single event. Rather, it refers to the ongoing process to respect the ethical principle that underlies all human subjects research. Informed consent is morally valid when the process includes three key elements: competence, disclosure/understanding, and voluntariness. The process involves the investigator and the prospective subject exchanging information and questions to establish a dialogue about the research. The conversation must satisfy the information needs of a prospective subject or their substitute decision-maker. Prospective subjects must be assured they understand the nature of the research well enough to decide about participating knowledgeably and freely. The investigator must determine whether the person recognizes the research related risks and potential benefits, and realizes what commitments are required of a study subject.
From the “Code of Ethical Conduct for Research Involving Humans”:
“A morally valid choice [i.e. an informed choice] concerning research participation is made: (1) by a competent person; (2) on the basis of adequate information concerning the nature and foreseeable consequences of the research (as these are known at the time the request is made) and all available alternatives; and (3) without controlling influences such as ‘force, fraud, deceit, duress, over-reaching, or other ulterior forms of constraint or coercion’ (Nuremberg Code)”