Data Collection from Legally Incompetent Subjects: A Paradigm Legal and Ethical Challenge for Population Databanks

Abstract

In the last couple of years, several new biobanks have been established with the goal to enable the study of health developments of people and their families over their entire lifetime. These biobanks involve a collection of biological samples as well as other health information, such as clinical, genealogy, overall-health, and life-style data. The establishment of biobanks creates significant legal and ethical challenges, particularly with respect to informed consent. Several authors have discussed these dilemmas, describing how truly meaningful consent is difficult to obtain in the context of biobanks, since they are infrastructures for future research rather than specific projects. Most articles focus on the difficulty of obtaining consent for biobank collections and on some of the practical challenges created by strict application of consent procedures. Less attention has been paid to the fact that many biobanks will inevitably be faced with the fact that several of those who provide samples and consent to the use of these samples and of health information that pertains to them will lose decision-making capacity at one point in time. Indeed, the studies that aim at understanding the complex interaction between genes, environment, and disease in an older population will involve people who have lost or will lose capacity during the study. This paper reviews the legal and ethical implications of a loss of decision-making capacity by research subjects in long-term research associated with large biobanks. It focuses on the questions whether and to what extent researchers can continue to perform research procedures on such subjects and can continue to gather health information on them according to Canadian law and Canadian research ethics guidelines.

Keywords: Consent, Competency, Research, Research Ethics, Biobanks, Databanks, Genetics, Advanced Directives