Ethical issues in microbiome research and medicine

According to popular accounts of research ethics history [12, 13], the development of research standards and regulations begins with the Nuremberg Code, followed by the World Medical Association’s Helsinki Agreement [14, 15]. The second half of the twentieth century was also the period of the assertion of civil rights, women’s rights, and rights of people with disabilities, all of which are movements argued in terms of autonomy. It is no surprise, therefore, that The Belmont Report and the Common Rule, the US research regulations that it produced, as well as the International Ethical Guidelines for Biomedical Research Involving Human Subjects are informed by that concept and expressed in terms of respect for persons [16, 17]. That commitment to autonomy gives primacy to informed consent and privacy in contemporary research ethics.

In this tradition of research ethics, the authority to employ human subjects in studies derives from the participant’s informed consent. The decision to participate in a study is taken as endorsement of the research goals and as free acceptance of the burdens and risks involved as being reasonable under the circumstances. In keeping with the twentieth century’s focus on autonomy, a good deal of the NIH Human Genome Project work on the ethical, legal, and social implications of research on the human genome has focused on individual liberty- and autonomy-related human rights concerns.

At the same time, the literature on the ethical, legal, and social implications of the human genome study has largely overlooked what John Gray has described as the other face of social contract theory, the obligations of the participant [18]. Yet, at this stage in the development of the science, researchers have expanded their focus from the diagnosis of individual genetic anomalies to the broader issues of understanding the human genome and its interactions with the microbiome, for example, in diabetes and inflammatory bowel diseases. As many have noted, studies to advance personalized medicine will require broad participation to provide the material for biobanks and sample banks [19, 20]. These efforts will raise issues of whether we should all contribute to the enterprise. In that some genetic and microbiome research is supported by public funds, we all contribute our financing to the efforts. Should we also contribute bits of ourselves, our genomes, and our microbiomes? If we expect to benefit from what is learned, but are unwilling to participate, will we be free-riders on the altruism of others? Will we be treating others unjustly? Answering these questions will require clarification of the individual responsibilities of members of society.