Evidence-based management of nutrigenomics expectations and ELSIs.

Nutrigenomics is a new application context for genomics technologies that focuses on the bidirectional study of genetic factors influencing host (individuals' or populations') response to diet and the effects of bioactive constituents in food on host genome and gene expression. Nutrigenomics is considered the next wave after pharmacogenomics for individualization of health interventions. However, relatively little attention has been given to the specific ethical-legal-social issues (ELSIs) and sociotechnical expectations raised by nutrigenomics research. Some of the ELSIs, such as ensuring privacy of genetic information and implications of genetic testing for health insurance and employment, may be shared across the continuum of genomic technology applications in human disease genetics, pharmacogenomics and nutrigenomics. However, there are certain aspects of nutrigenomics research that may result in unique or unprecedented ELSIs. For example, nutrigenomics has a strong focus on public health and the prevention/modification of 'predisease phenotypes' in apparently healthy individuals. Thus, in contrast to previous applications of genomics technologies, where the goal is to distinguish existing disease from absence of disease, the aim of nutrigenomics is the discernment of nuanced differences in predisease states. Moreover, there is evidence to suggest that ELSIs may be different in biomarker discovery, translational research and clinical testing stages of nutrigenomics. Ideally, ELSI research and nutrigenomics bioscience should progress in parallel and in a commensurate manner. We suggest that qualitative research methods, using a hypothesis-free approach, can be employed to gain deeper insights on complex bioethics issues that do not ordinarily lend themselves to formal hypothesis testing with the quantitative methods used in biomedical sciences.