The Conduct of Canadian Researchers and Institutional Review Boards regarding Substituted Consent for Research

Abstract

As the population ages worldwide, a growing number of individuals suffer from diseases that impair their decisionmaking capacity.1 Over the years, researchers around the world have intensified their efforts to identify the causes of these diseases, develop effective treatments to slow their progression, and further our understanding of their impact on affected individuals and their families.2 At the same time, there has been increasing recognition of the ethical dilemma that arises in conducting research on diseases that alter decisionmaking capacity.3 All research involving human subjects should be conducted in accordance with three cardinal ethical principles: justice, beneficence, and respect for persons.4 Respect for persons entails securing free and informed consent from potential research participants before their enrollment in a study. This requirement poses special challenges to investigators conducting dementia research on diseases that impair decisional capacity, such as advanced dementia. Subjects in the early stages of the disease may retain sufficient decisionmaking capacity to give informed consent for some studies. However, the irreversible and progressive nature of the illness ultimately robs its victims of the ability to fully appreciate the consequences of their involvement in research.5 Due to this distinguishing characteristic, decisionally-compromised subjects are viewed as a group particularly vulnerable to exploitation whose rights and welfare call for special legal protection.6 Recognizing the need to produce knowledge that may lead to improved care for future incapacitated patients, many jurisdictions authorize the enrollment of subjects unable to consent themselves provided certain precautions are fulfilled. These often include the obligation to obtain the approval of an Institutional Review Board (IRB), the consent of the subjects’ legal representatives, and the subjects’ assent. Although a matter of some debate, these legal provisions are viewed by many commentators as a socially acceptable compromise between proceeding without any consent and foregoing all research on diseases that impair decisionmaking capacity. In order to protect vulnerable individuals, these special provisions must be known and respected by JA N UA RY-FE B RUA RY 2004 • VO L U M E 26, NU M B E R 1