The duty of care in the genomics area: Rights, responsibilities and legal duties

The genomics era has arrived. However, many of the practical and ethical challenges associated with genetic information in healthcare and biomedical research are yet to be fully resolved. Genome sequencing significantly increases the scale of the challenge, as well as introducing further, on-going complexities such as a blurring between clinical and research activities. This thesis aims to inform the academic, legal and policy debate on the appropriate responsibilities of professionals in the genomic era. The central question is what are, or should be, the main responsibilities of professionals in light of their broader duty of care, when using genome sequencing technologies for healthcare or research? Through doctrinal and normative analysis of laws, ethical statements and self-regulatory codes, as well as qualitative research on the views of expert clinicians, scientists and senior healthcare executives, the thesis addresses some of the most pressing questions faced by professionals. It identifies three overarching elements which form the core of an emerging duty of care in the genomic era and draws more specific conclusions about the current extent of professional responsibilities in relation to informed consent, reporting of VUS, searching for or feedback of secondary findings, recontacting patients/participants and warning genetic relatives of actionable risks without patient consent. Finally, recommendations are made for the courts, regulators and professionals, as they develop policy and decide the scope of professional responsibilities in the genomics era.