Genetic Renaissance: A Legal, Philosophical, and Ethical Examination of Consent Using Autonomy & Privacy in Genetic Testing

Abstract

Genetic testing has gained traction in the media with the recent Pentagon ban and continuing increases in public consumption of at-home tests. Public discourse surrounding this technology prompts further exploration of the multifaceted parameters that govern its use. This thesis takes on the task of analyzing and dissecting these comprehensive features, with a specific focus on the legal, philosophical, and ethical aspects of the matrix of genetic testing. It aims to understand the application of these layers to the different contexts of genetic testing: the clinical and research contexts, as well as the direct-to-consumer context. By examining the process of genetic testing, from obtaining informed consent and collecting samples to the interpretation and communication of results, this project aims to understand all the dimensions involved. The most prevalent dimensions are autonomy, privacy, and ownership, and it is this trifecta which is most impactful on informed consent. The examination will begin by providing an overview of the technical science behind genetic testing, to better understand the uses of this biotechnology in each of the contexts (i.e. clinical, research, and direct-to-consumer). Understanding this will allow for a smooth transition into an extensive outline of the legal, philosophical and ethical concepts that are tied to informed consent. This thesis focuses on laws and policies that are applicable in the United States of America and Canada, although there are many international regulations that vary in severity and depth. These legal frameworks essentially delineate how persons should be treated across contexts, including specific regulations surrounding how informed consent must be obtained, how samples must be stored or retained, and how personal data (e.g. genetic testing results) can be used and protected. Following from this legal backdrop, a literary and historical evaluation of informed consent is outlined to establish just how foundational it is to bioethics. And essential to this are the philosophical principles of autonomy, privacy, and ownership. Although most of the thesis will focus on established frameworks, it will raise questions about the fundamental issues that plague these concepts, including the lack of consideration of collectives in consent and ownership, and the inconsistent protocols involved in direct-to-consumer testing that allow for major trespasses on personal rights by corporations that are not required to operate as healthcare institutions. In exposing these weaknesses, this thesis does not necessarily seek to provide concrete solutions for such large problems, but rather to suggest possible criteria for solutions going forward. The main point this thesis seeks to show is that despite the huge strides in biotechnology, there is still substantial space for improvement in bioethics, with specific focus on the development of policies and legislations that can capture the nature of consent across social and testing contexts. This kind of work towards ameliorating the essential legal, philosophical, and ethical aspects is essential for ensuring the protection and empowerment of individual and collective rights, especially in emerging fields such as genetic testing, where the current frameworks are inadequately suited for comprehensive coverage.