Privacy and ethical challenges in next-generation sequencing.

INTRODUCTION: Next-generation sequencing (NGS) is expected to revolutionize health care. NGS allows for sequencing of the whole genome more cheaply and quickly than previous techniques. NGS offers opportunities to advance medical diagnostics and treatments, but also raises complicated ethical questions that need to be addressed. AREAS CONSIDERED: This article draws from the literature on research and clinical ethics, as well as next-generation sequencing, in order to provide an overview of the ethical challenges involved in next-generation sequencing. This article includes a discussion of the ethics of NGS in research and clinical contexts. EXPERT OPINION: The use of NGS in clinical and research contexts has features that pose challenges for traditional ethical frameworks for protecting research participants and patients. NGS generates massive amounts of data and results that vary in terms of known clinical relevance. It is important to determine appropriate processes for protecting, managing and communicating the data. The use of machine learning for sequencing and interpretation of genomic data also raises concerns in terms of the potential for bias and potential implications for fiduciary obligations. NGS poses particular challenges in three main ethical areas: privacy, informed consent, and return of results.