Harms and risks to groups and third-parties can be significant in the context of research, particularly in data-centric studies involving genomic, artificial intelligence, and/or machine learning technologies. This article explores whether and how United States federal regulations should be adapted to better align with current ethical thinking and protect group interests. Three aspects of the Common Rule deserve attention and reconsideration with respect to group interests: institutional review board (IRB) assessment of the risks/benefits of research; disclosure requirements in the informed (...) consent process; and criteria for waivers of informed consent. In accordance with respect for persons and communities, investigators and IRBs should systematically consider potential group harm when designing and reviewing protocols, respectively. Research participants should be informed about any potential group harm in the consent process. We call for additional public discussion, empirical research, and normative analysis on these issues to determine the right regulatory and policy path forward. (shrink)

Since the late 1980s, the human genetics and genomics research community has been promising to usher in a “new paradigm for health care”—one that uses molecular profiling to identify human genetic variants implicated in multifactorial health risks. After the completion of the Human Genome Project in 2003, a wide range of stakeholders became committed to this “paradigm shift,” creating a confluence of investment, advocacy, and enthusiasm that bears all the marks of a “scientific/intellectual social movement” within biomedicine. Proponents of this (...) movement usually offer four ways in which their approach to medical diagnosis and health care improves upon current practices, arguing that it is more “personalized,” “predictive,” “preventive,” and “participatory” than the medical status quo. Initially, it was personalization that seemed to best sum up the movement's appeal. By 2012, however, powerful opinion leaders were abandoning “personalized medicine” in favor of a new label: “precision medicine.” The new label received a decisive seal of approval when, in January 2015, President Obama unveiled plans for a national “precision medicine initiative” to promote the development and use of genomic tools in health care. (shrink)

This paper discusses the announcement by a team of researchers that they identified a genetic influence for a range of “antisocial” behaviours in the New Zealand Māori population (dubbed the “warrior gene”). The behaviours included criminality, violence, gambling and alcoholism. The reported link between genetics and behaviour met with much controversy. The scientists were described as hiding behind a veneer of supposedly “objective” western science, using it to perpetuate “racist and oppressive discourses”. In this paper we examine what went wrong (...) in the dissemination of the research. We chose as our framework the debate around the “internal/external” responsibilities of scientists. Using this discourse we argue that when the researchers ventured to explain their research in terms of social phenomena, they assumed a duty to ensure that their findings were placed “in context”. By “in context”, we argue that evidence of any genetic influence on behavioural characteristics should not be reported in isolation, but instead presented alongside other environmental, cultural and socio-economic influences that may also contribute to the studied behaviour. Rather than imposing a new obligation on scientists, we find this duty to contextualise results is in keeping with the spirit of codes of ethics already in place. Lessons from the “warrior gene” controversy may assist researchers elsewhere to identify potential areas of conflict before they jeopardise research relationships, or disseminate findings in a manner that fuels misleading and/or potentially discriminatory attitudes in society. (shrink)

ABSTRACT Dealing primarily with implications rather than foundations, and focusing downstream at the expense of upstream prevention, mainstream bioethics is at a toxic watershed. Through an extended analysis of the Environmental Genome Project (EGP), we offer new tools from the philosophy of science and from critical epidemiology to help bioethics to move ahead. Our aim in this paper is not to resolve the moral and conceptual problems we reveal, but rather to outline ways to prevent such problems from arising in (...) future research. (shrink)

Over the last decade, more U.S. taxpayers money has been spent trying to anticipate and address the bioethical issues raised by advances in human genetics than any other set of issues in the field. Does this make sense? Not everyone in bioethics thinks so. Some think there are more important topics, like issues of health care justice, that will be neglected if the field continues to follow the money to dwell on the moral challenges of a relatively small community of (...) research scientists. Others decry genetic exceptionalism as inappropriately singling out this scientific enterprise for criticism and regulation, when the same issues are faced even more acutely in other parts of the biomedical world. Human genetics is not accelerating as fast as pharmacology, for example, or as easy to abuse as virology, or as philosophically challenging as neurology. (shrink)

Research on human genetic variation can present collective risks to all members of a socially identifiable group. Research that associates race or ethnicity with a genetic disposition to disease, for example, presents risks of group discrimination and stigmatization. To better protect against these risks, some have proposed supplemental community-based reviews of research on genetic differences between populations. The assumption behind these appeals is that involving members of study populations in the review process can help to identify and minimize collective risks (...) that otherwise could go unnoticed. In contrast to this position, critics have argued that supplemental community-based reviews are unnecessary, impractical, and morally problematic. This paper is our attempt to advance this debate by distinguishing the various goals of community review and the forms that it can take. (shrink)

A great part of human genetics research is carried out collecting data and building large databases of biological samples that are in a non-anonymous format. These constitute a valuable resource for future research. The construction of such databases and tissue banks facilitates important scientific progress. However, biobanks have been recognized as ethically problematic because they contain thousands of data that could expose individuals and populations to discrimination, stigmatization and psychological stress if misused. Informed consent is regarded as a cornerstone in (...) the protection of personal autonomy in research involving human subjects. Yet in recent years this fundamental concept has been overwhelmed by the genomic revolution. From a general overview of international literature, it seems evident that informed consent issues have come into sharp focus, in particular in relation to the twin issues of time extension (blanket versus specific/repeated consent) and personal extension (group consent). After an introduction on obtaining informed consent in the context of genetic research, this paper addresses the apparent lack of a single, universal model of obtaining informed consent among populations involved in genetic research and it argues for the need to develop an ethical framework tailored to the specific features of each project. In order to support this theory of contextualizing, the case of a private biotechnology company, SharDNA is presented. The present paper explores the management of its biobank, developed from a genetic research project carried out on isolated populations living on the Italian island of Sardinia. In particular, the paper highlights how the company is tackling the problem of informed consent and other ethical requirements for genetic research, such as the respect of individual privacy, the population approach and the existing Italian legal regulatory framework. (shrink)

During the past 20 years, the importance of human genetic information has exploded. Whether sought for medical treatment, disease prediction studies, cultural studies, or the general study of human origins, human genetic information is now viewed as crucial for scientific research and general attempts at human understanding.With the importance of genetic information have come bitter battles over its control. The demonstrated power of human genetic information has moved the issue of its “ownership” from the realm of musty academic musings to (...) protracted political and legal battles among “source” individuals, researchers, commercial concerns, government agencies, and others. Whether collected through targeted scientific studies, “discarded” biological tissue, initial charitable bequest, or other means, genetic information and the biological materials in which it is contained have become the subject of protracted legal battles for control and intense social and ethical controversy. (shrink)