Kieran C. O’Doherty

Navigating social and ethical challenges of biobanking for human microbiome research

BackgroundBiobanks are considered to be key infrastructures for research development and have generated a lot of debate about their ethical, legal and social implications (ELSI). While the focus has been on human genomic research, rapid advances in human microbiome research further complicate the debate.DiscussionWe draw on two cystic fibrosis biobanks in Toronto, Canada, to illustrate our points. The biobanks have been established to facilitate sample and data sharing for research into the link between disease progression and microbial dynamics in the lungs of pediatric and adult patients. We begin by providing an overview of some of the ELSI associated with human microbiome research, particularly on the implications for the broader society. We then discuss ethical considerations regarding the identifiability of samples biobanked for human microbiome research, and examine the issue of return of results and incidental findings. We argue that, for the purposes of research ethics oversight, human microbiome research samples should be treated with the same privacy considerations as human tissues samples. We also suggest that returning individual microbiome-related findings could provide a powerful clinical tool for care management, but highlight the need for a more grounded understanding of contextual factors that may be unique to human microbiome research.ConclusionsWe revisit the ELSI of biobanking and consider the impact that human microbiome research might have. Our discussion focuses on identifiability of human microbiome research samples, and return of research results and incidental findings for clinical management.

Opinion: Conservation and stewardship of the human microbiome

Many studies have shown how the human gut microbiome can be altered by diet, antibiotics, and other factors. All of these factors can contribute to dysbiosis, where the services typically provided by symbiotic microflora are disrupted because of shifts in function or diversity. Just as humans have impacted many large animal species in the environment, drastic changes in human lifestyle over the past century may have altered the global pool of human-associated microbes; if so, these shifts may pose substantial threats to individual and public health. Hardin (1) defined “The Tragedy of the Commons” as a situation where each individual benefits from overexploitation of a public resource, and we argue that there is benefit to regarding the global human microbiome as a collective good (i.e., a Microbial Commons).

Public deliberation to develop ethical norms and inform policy for biobanks: Lessons learnt and challenges remaining

Public participation is increasingly an aspect of policy development in many areas, and the governance of biomedical research is no exception. There are good reasons for this: biomedical research relies on public funding; it relies on biological samples and information from large numbers of patients and healthy individuals; and the outcomes of biomedical research are dramatically and irrevocably changing our society. There is thus arguably a democratic imperative for including public values in strategic decisions about the governance of biomedical research. However, it is not immediately clear how this might best be achieved. While different approaches have been proposed and trialled, we focus here on the use of public deliberation as a mechanism to develop input for policy on biomedical research. We begin by explaining the rationale for conducting public deliberation in biomedical research. We focus, in particular, on the ELS (ethical, legal, social) aspects of human tissue biobanking. The last few years have seen the development of methods for conducting public deliberation on these issues in several jurisdictions, for the purpose of incorporating lay public voices in biobanking policy. We explain the theoretical foundation underlying the notion of deliberation, and outline the main lessons and capacities that have been developed in the area of conducting public deliberation on biobanks. We next provide an analysis of the theoretical and practical challenges that we feel still need to be addressed for the use of public deliberation to guide ethical norms and governance of biomedical research. We examine the issues of: (i) linking the outcomes of deliberation to tangible action; (ii) the mandate under which a deliberation is conducted; (iii) the relative weight that should be accorded to a public deliberative forum vs other relevant voices; (iv) evaluating the quality of deliberation; and (5) the problem of scalability of minipublics.

Notes on the development of health psychology and behavioral medicine in the United States

A “standard” historiographical overview of the development of health psychology in the United States, alongside behavioral medicine, first summarizes previous disciplinary and professional histories. A “historicist” approach follows, focussing on a collective biographical summary of accumulated contributions of one cohort (1967–1971) at State University of New York at Stony Brook. Foundational developments of the two areas are highlighted, contextualized within their socio-political context, as are innovative cross-boundary collaboration on “precursor” studies from the 1960s and 1970s, before the official disciplines emerged. Research pathways are traced from social psychology to health psychology and from clinical psychology to behavioral medicine.

Company disclosure and consumer perceptions of the privacy implications of direct-to-consumer genetic testing

This study examines the way direct-to-consumer genetic testing (DTCGT) companies communicate privacy information and how consumers understand privacy implications of DTCGT. We first conducted an analysis of DTCGT websites to determine what information they provide regarding the treatment of consumer information and samples. 86 companies offered DTCGT services that could be purchased online from Canada. We then surveyed 415 consumers (180 had purchased, 235 considered but did not purchase DTCGT). While most websites had some privacy information, few provided sufficient information for consumers to make informed purchase decisions. Nearly half of participants reported reading the company’s privacy policy and many felt they received enough information about privacy implications, but their expectations were generally not consistent with company practices. The most common expectation was that the company would share results only with them and destroy their sample after testing. We discuss these issues regarding privacy expectations in the context of DTCGT.

Public concerns regarding the storage and secondary uses of residual newborn bloodspots: an analysis of print media, legal cases, and public engagement activities

Recently, public concerns have been expressed regarding the non-consented storage and secondary research uses of residual newborn bloodspot (RBS) samples. The purpose of this paper is to examine public responses to the storage and secondary uses of RBS that can be identified through analysis of media, legal cases, and documented public engagement activities. Coverage in the examined print media confirmed the importance of RBS to journalists and those people who expressed their concerns to these journalists. Several lawsuits, brought by parents concerned about the storage of newborn bloodspots, placed the practice of storing NBS into the spotlight. This resulted in controversial debates and the mandatory destruction of millions of samples. Analysis of public engagement activities across several jurisdictions indicated that across (inter)national boundaries there are common elements to what is perceived as inappropriate governance of RBS. Public concerns were grouped into five main themes: trust, transparency, confidentiality, ownership, and stigmatization/discrimination. The results of our analysis help to make a compelling case for placing citizens at the center of the debate and developing policy about the storage and secondary uses of newborn bloodspots.

Media Discourse on the Social Acceptability of Fecal Transplants

Advances in human microbiome research have generated considerable interest in elucidating the role of bacteria in health and the application of microbial ecosystem therapies and probiotics. Fecal transplants involve the introduction of gut microbes from a healthy donor’s stool to the patient and have been documented as effective for treating Clostridium difficile infections (CDIs) and some other gastrointestinal disorders. However, the treatment has encountered regulatory hurdles preventing widespread uptake. We examined dominant representations of fecal transplants in Canadian media and found that fecal transplants are often represented as being inherently disgusting or distasteful (the “ick factor”). This “ick factor” is used to construct different messages about the treatment’s social acceptability and legitimacy. We conclude that an over-emphasis on the “ick factor” constrains public discourse from a more nuanced discussion of the social challenges, scientific concerns, and regulatory issues surrounding the treatment.

Explosives, genomics, and the environment: conducting public deliberation on topics of complex science and social controversy

RDX is an explosive that is also a neurotoxin and implicated in adverse health outcomes. Because of its widespread use in military and civilian operations, there is growing concern about potential environmental and health implications. One promising method of bioremediation involves genomic studies of soil microbes. These health concerns and technological issues intersect with social and political dimensions raising questions about public responses to genomic technologies and the degree of environmental accounting expected from the military. In cases of novel technologies entering into contested social spaces, public engagement can be useful to inform broader policy debates. Building on previous work, in this article, we outline the rationale, methods, and results of a public deliberation on these issues. To our knowledge, this is the first study of its kind on the issues of RDX pollution and microbial genomics, and thus provides an important baseline on public sentiment on these issues.

How Do Young People with Cystic Fibrosis Conceptualize the Distinction Between Research and Treatment? A Qualitative Interview Study

Background: Recently, it has been argued that the distinction between medical research and medical care is not as clear-cut as is often implied in research ethics protocols. Young people with cystic fibrosis, a progressive genetic disorder requiring daily management, often grow up participating in biomedical research. Given debates about the importance of the treatment/research distinction, as well as recent challenges to maintaining this distinction, the purpose of this article is to provide empirical evidence about young peoples understanding of their research experiences. Methods: Semistructured interviews were conducted with 19 young people (ages 8 to 18 years) with cystic fibrosis. Interviews focused on their experiences participating in research related to cystic fibrosis, their reasons for participating, and their understanding of the distinction between research and treatment. Qualitative methods were used to analyze patients’ perceived distinction between research and treatment. Results: Some participants clearly distinguished between research and clinical care, using signifiers including the type and nature of procedure, purpose, and voluntariness of the activity. Other participants described research and treatment as connected activities. In some cases they labeled research-related activities as treatment activities, and in other cases their descriptions highlighted the overlapping nature of research and treatment in sophisticated ways. Conclusions: The results of this study support suggestions that the distinction between research and care as upheld by research ethics is not meaningfully sustainable in all contexts. Sometimes participants see research and treatment as separate activities, but in other instances they understand that research and treatment may be closely connected. The results of this study may aid researchers and research ethics boards in helping potential participants to understand the possible impacts of research participation.

Women’s genital body work: Health, hygiene and beauty practices in the production of idealized female genitalia

Women’s genitalia are constructed as a bodily site requiring ongoing surveillance, maintenance and modification to conform to social norms. Women engage in a range of genital health, hygiene and beauty practices, including the use of commercial and homemade vaginal douches, washes, wipes, sprays and pubic hair removal, to modify their bodies. Using a social constructionist framework, we draw on interviews with 49 Canadian women to examine the construction of idealized (Western) genitalia as hairless, odourless and free of discharge, and “natural” female genitalia as problematic through the mobilization of normative femininity and (hetero)sexuality discourses. Theorizing women’s genital health, hygiene and beauty practices as a form of body work, we examine how women’s genital body work is constructed as a necessary and thus normative practice of femininity undertaken in the pursuit of idealized genitalia. A minority perspective that drew on alternative discourses to construct female genitalia as acceptable irrespective of genital body work is examined. Throughout our analysis, we examine the ways in which women negotiate issues of agency and choice in relation to their genital body work. Implications for women’s health in the context of the vaginal microbiome are explored.