Study of ethical, legal, and social implications (ELSI) of human microbiome research has been integral to the Human Microbiome Project (HMP). This study explores core ELSI issues that arose during the first phase of the HMP from the perspective of individuals involved in the research. We conducted semi-structured in-depth interviews with investigators and NIH employees ("investigators") involved in the HMP, and with individuals recruited to participate in the HMP Healthy Cohort Study at Baylor College of Medicine ("recruits"). We report findings related to three major ELSI issues: informed consent, data sharing, and return of results. Our findings demonstrate that investigators and recruits were similarly sensitive to these issues yet generally comfortable with study design in light of current knowledge about the microbiome.
"Once profiled, actions taken towards particular groups may be problematic. To take an example from biomedicine, the extent to which data subjects are informed about research results, such as disease proclivity, may require new policies of professional conduct concerning when and how results are released to data subjects sorted into particular disease groups (McGuire et al. 2008, p. 1862, 2012). "
[Show abstract][Hide abstract] ABSTRACT: The capacity to collect and analyse data is growing exponentially. Referred to as 'Big Data', this scientific, social and technological trend has helped create destabilising amounts of information, which can challenge accepted social and ethical norms. Big Data remains a fuzzy idea, emerging across social, scientific, and business contexts sometimes seemingly related only by the gigantic size of the datasets being considered. As is often the case with the cutting edge of scientific and technological progress, understanding of the ethical implications of Big Data lags behind. In order to bridge such a gap, this article systematically and comprehensively analyses academic literature concerning the ethical implications of Big Data, providing a watershed for future ethical investigations and regulations. Particular attention is paid to biomedical Big Data due to the inherent sensitivity of medical information. By means of a meta-analysis of the literature, a thematic narrative is provided to guide ethicists, data scientists, regulators and other stakeholders through what is already known or hypothesised about the ethical risks of this emerging and innovative phenomenon. Five key areas of concern are identified: (1) informed consent, (2) privacy (including anonymisation and data protection), (3) ownership, (4) epistemology and objectivity, and (5) 'Big Data Divides' created between those who have or lack the necessary resources to analyse increasingly large datasets. Critical gaps in the treatment of these themes are identified with suggestions for future research. Six additional areas of concern are then suggested which, although related have not yet attracted extensive debate in the existing literature. It is argued that they will require much closer scrutiny in the immediate future: (6) the dangers of ignoring group-level ethical harms; (7) the importance of epistemology in assessing the ethics of Big Data; (8) the changing nature of fiduciary relationships that become increasingly data saturated; (9) the need to distinguish between 'academic' and 'commercial' Big Data practices in terms of potential harm to data subjects; (10) future problems with ownership of intellectual property generated from analysis of aggregated datasets; and (11) the difficulty of providing meaningful access rights to individual data subjects that lack necessary resources. Considered together, these eleven themes provide a thorough critical framework to guide ethical assessment and governance of emerging Big Data practices.
Science and Engineering Ethics 05/2015; DOI:10.1007/s11948-015-9652-2 · 0.96 Impact Factor
"Investigators provided verbal consent, and all procedures were reviewed and approved by the Baylor College of Medicine Institutional Review Board and the University of Texas Health Science Center Committee for the Protection of Human Subjects. A comprehensive explanation of our methods has been previously documented
[Show abstract][Hide abstract] ABSTRACT: Background
Continued advances in human microbiome research and technologies raise a number of ethical, legal, and social challenges. These challenges are associated not only with the conduct of the research, but also with broader implications, such as the production and distribution of commercial products promising maintenance or restoration of good physical health and disease prevention. In this article, we document several ethical, legal, and social challenges associated with the commercialization of human microbiome research, focusing particularly on how this research is mobilized within economic markets for new public health uses.
We conducted in-depth, semi-structured interviews (2009–2010) with 63 scientists, researchers, and National Institutes of Health project leaders (“investigators”) involved with human microbiome research. Interviews explored a range of ethical, legal, and social dimensions of human microbiome research, including investigators’ perspectives on commercialization. Using thematic content analysis, we identified and analyzed emergent themes and patterns.
Investigators discussed the commercialization of human microbiome research in terms of (1) commercialization, probiotics, and issues of safety, (2) public awareness of the benefits and risks of dietary supplements, and (3) regulation.
The prevailing theme of ethical, legal, social concern focused on the need to find a balance between the marketplace, scientific research, and the public’s health. The themes we identified are intended to serve as points for discussions about the relationship between scientific research and the manufacture and distribution of over-the-counter dietary supplements in the United States.
BMC Medical Ethics 10/2012; 13(1):28. DOI:10.1186/1472-6939-13-28 · 1.50 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background:
Human microbiome research has the potential to transform the practice of medicine, fundamentally shifting the ways in which we think not only about human health, illness and disease, but also about clinical practice and public health interventions. Drawing from a larger qualitative study on ethical, legal and social dimensions of human microbiome research, in this article, we document perspectives related to the translation of human microbiome research into clinical practice, focusing particularly on implications for health, illness and disease.
We conducted 60 in-depth, semi-structured interviews (2009-2010) with 63 researchers and National Institutes of Health project leaders ('investigators') involved with human microbiome research. The interviews explored a range of ethical, legal and social implications of human microbiome research, including investigators' perspectives on potential strategies for translating findings to clinical practice. Using thematic content analysis, we identified and analyzed emergent themes and patterns.
We identified 3 themes: (1) investigators' general perspectives on the clinical utility of human microbiome research, (2) investigators' perspectives on antibiotic use, overuse and misuse, and (3) investigators' perspectives concerning future challenges of translating data to clinical practice.
The issues discussed by investigators concerning the clinical significance of human microbiome research, including embracing a new paradigm of health and disease, the importance of microbial communities, and clinical utility, will be of critical importance as this research moves forward.
Public Health Genomics 04/2013; 16(3). DOI:10.1159/000350308 · 2.21 Impact Factor
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