Customers or research participants?: Guidance for research practices in commercialization of personal genomics

摘要

Applications of genetic and genomic technologies underlie several emerging businesses offering assessments of individual variations in DNA directly to consumers. Yet customers of these companies often become transformed into research participants, sometimes as a condition of purchase. The subtle nature of this transition has implications both for consumers and for the research enterprise in general. To assess how companies are negotiating this transition, we examined posted research policies from four companies regarding the ethical principle of autonomy (i.e., informed and voluntary consent) that is key to research involving human subjects. In such novel situations, professional expertise may be helpful to guide applications of ethical principles for protection of human subjects.