Ethical priority of the most actionable system of biomolecules: the metabolome

The metabolome is a system of small biomolecules (metabolites) and a direct result of human bioculture. Consequently, metabolomics is well poised to impact anthropological and biomedical research for the foreseeable future. Overall, we provide a perspective on the ethical, legal, and social implications (ELSI) of metabolomics, which we argue are often more alarming than those of genomics. Given the current mechanisms to fund research, ELSI beyond human DNA is stifled and in need of considerable attention.     

Perspectives on human microbiome research ethics

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.     

Ethical issues and GenomEUtwin.

The post-genomic era is witnessing a proliferation of large-scale and population based genetic and genomic research projects. Many countries have or are establishing research biobanks and, as with GenomEUtwin, there is great interest in building multinational projects that link genotypic and phenotypic information from different centers. Clearly, the conduct of these projects raises multiple ethical issues, and the knowledge generated will continually recast the ethical, legal and social implications (ELSI) of such research. Maximising the scientific profit from this work while minimizing the risks to the participants requires full integration of ethics components into the structure and functioning of these projects. GenomEUtwin is organized around five intellectual cores, including an Ethics Core which operates across the entire project. This paper describes the role of the Ethics Core and presents an overview of the guidelines on which the principles followed in GenomEUtwin are based. We outline the major ethical concerns of our project and highlight complexities arising from diverse national legislations. Finally, the role of empirically based ethics research is discussed for understanding the ethical, legal, social and economic implications of human genetics and genomics research.     

What are 60 warblers worth? Killing in the name of conservation

Ecological research sometimes entails animal suffering and even animal killing. The ethical appropriateness of animal suffering and killing in conservation research may entail considerations that differ from many other kinds of research. This is true, insomuch as conservation research is specifically motivated by an ethical premise: an appreciation for non-human life. In striking contrast with other academic fields (e.g. medicine), however, the ethical dimension of conservation research is only rarely discussed. When it is discussed, it tends to be characterized by logical errors. These errors are important because they are general (i.e. both common and with far-reaching implications), and they are easily made by intelligent people; especially those with no formal training in ethics or logic. Failure to recognize these errors could stymie efforts to increase the ethical quality of ecological research conducted in the name of conservation.
We take advantage of a recently published dialogue concerning the ethical appropriateness of a specific field experiment that entailed killing black-throated blue warblers, Dendroica caerulescens . Both sides of this debate exemplify the kinds of errors to which we refer. In this paper we briefly review the arguments presented on each side of this debate, highlight their mistakes, and indicate necessary corrections. We argue that: (1) compliance with animal research regulations, while important, inadequately accommodates the ethical aspects of animal research, and (2) individual ecologists ought to understand themselves what does and does not represent sound and valid arguments for ethical decisions. Finally, we discuss how any ecological researcher might begin to apply our analysis to his or her own research.     

Contacting the brain – aspects of a technology assessment of neural implants

The public interest in neural implants has grown considerably in recent years. Progress within related research areas in combination with increasing – albeit overly optimistic and indiscriminate – mass media coverage have led to the impression that the possibilities of neural prosthetics have grown enormously. But a closer look reveals that the reasons for the intensified interest are varied and cannot be attributed to technical progress alone. Some neural prostheses that have been under development for many years have not left the clinical development phase despite intensive research activities. Other implants, like cardiac pacemakers and cochlea implants, are mature products that have already been implanted in a large number of patients. From the public perspective and in media reports, progress in the development of neural implants is associated with new achievements in other fields of neuroscience. Communications on new applications of functional magnetic resonance imaging (fMRI) may suggest that a number of cognitive functions are now easily accessible with technological means. The fact that the interpretation of the results of fMRI studies depends on many conditions and is partly disputed also within the scientific community has been discussed in many publications but only very limited, in the general media. Besides this, research results and implementations in the area of electroencephalography and magnetoencephalography have sparked further debate on the question of free will, on determinism and indeterminism, and have attracted a large media response. The purpose of this paper is to discuss some societal and ethical aspects of neural implants from a technology assessment perspective. Technology assessment (TA) aims at providing knowledge about impacts and consequences of (new) technologies as well as about political and societal ways of dealing with them. It reflects about implementation conditions of technology and potential technology conflicts. Over the last years, neural implants became a subject for TA since they have gained a higher attention in both the political arena and the general public. Especially the ethical and social implications of technologies that electrically stimulate the brain and the possibilities of changing personality traits, changing moods, and perhaps enhancing human cognitive capabilities are central issues in related discussions. In this paper, we want to briefly summarize some of the key arguments as well as topics for future discussion and research.     

Conflicts of interest in e-cigarette research: A public good and public interest perspective

The tobacco industry’s involvement in the electronic cigarette research that informs public health policy is controversial. On the one hand, some are concerned that their involvement presents conflicts of interest that bias research outputs and invalidate the policies that use them. On the other hand, some have argued that the tobacco industry may support valid research and contribute to the goals of public health, for instance, if the interests of the e-cigarette industry could be part of a tobacco smoking cessation policy. We approach this debate from the ethical perspective of the public interest and the public good, considering how legitimate researchers can square their expert opinion with validating tobacco industry-funded research, given the perfidy of the tobacco industry and paucity of robust, conclusive evidence on the public health impacts of liberalizing e-cigarette use.     

The role of fMRI in cognitive neuroscience: where do we stand?

Functional magnetic resonance imaging (fMRI) has quickly become the most prominent tool in cognitive neuroscience. In this article, I outline some of the limits on the kinds of inferences that can be supported by fMRI, focusing particularly on reverse inference, in which the engagement of specific mental processes is inferred from patterns of brain activation. Although this form of inference is weak, newly developed methods from the field of machine learning offer the potential to formalize and strengthen reverse inferences. I conclude by discussing the increasing presence of fMRI results in the popular media and the ethical implications of the increasing predictive power of fMRI.     

Fetal neural transplantation: placing the ethical debate within the context of society's use of human material

In this paper I wish to place the debate about the use of fetal tissue, as in fetal neural transplantation, within the context of society's use of, and dependence upon, human material for many teaching, research, and therapeutic purposes. I shall argue that such an emphasis is required if we are to be consistent in our approach to the ethical dimensions of the fetal neural transplantation debate. What will emerge is the ambivalence of society's ethical attitudes and also the diversity of perspectives in most debates involving the use of human material.     

胚胎干细胞技术的研究进展

干细胞可以分为成体干细胞和胚胎干细胞两类,是当前生物医学领域的一个热点。由于干细胞在医学领域有巨大应用前景,世界各国都对此给予了相当的重视;投入大量资金支持本国的科学家从事干细胞的科学研究。目前,干细胞的研究还处于试验室阶段,很多技术难题还没有解决,尤其是胚胎干细胞的不定向分化问题,以及一些伦理方面的争议。宗教界人士和社会论理学方面的人士对于干细胞的研究还有异议。集中论述了胚胎干细胞的研究进展和医学功用。     

Are Phase 1 Trials Therapeutic? Risk,Ethics, and Division of Labor

Despite their crucial role in the translation of pre‐clinical research into new clinical applications, phase 1 trials involving patients continue to prompt ethical debate. At the heart of the controversy is the question of whether risks of administering experimental drugs are therapeutically justified. We suggest that prior attempts to address this question have been muddled, in part because it cannot be answered adequately without first attending to the way labor is divided in managing risk in clinical trials. In what follows, we approach the question of therapeutic justification for phase 1 trials from the viewpoint of five different stakeholders: the drug regulatory authority, the IRB, the clinical investigator, the referring physician, and the patient. Our analysis shows that the question of therapeutic justification actually raises multiple questions corresponding to the roles and responsibilities of the different stakeholders involved. By attending to these contextual differences, we provide more coherent guidance for the ethical negotiation of risk in phase 1 trials involving patients. We close by discussing the implications of our argument for various perennial controversies in phase 1 trial practice.     

The Ethics of Research Biobanking: A Critical Review of the Literature

Abstract

Human tissue has been stored and used for research on a regular basis for more than 80 years. During the 1990s, collections of human tissue suddenly became framed as ethical problems in a process reflecting developments in genetic research intertwined with developments in patient rights and steps towards increased commercialization of research. This review describes the process of framing tissue storage as an ethical problem and the solutions proposed in the process. It gives an overview of the academic debate and relates this debate to empirical studies of donor attitudes and interests. It points to the clear discrepancy between the concerns of donors, legislators and ethicists. The academic debate and legislatory action tend to focus on informed consent, and most of the concerns that donors have remain unattended to.     

OUTLINING ETHICAL ISSUES IN NANOTECHNOLOGIES

Nanotechnologies are an expression of the human ability to control and manipulate matter on a very small scale. Their use will enable an even and constant monitoring of human organisms, in a new and perhaps less invasive way. Debates at all levels – national, European and international – have pointed out the common difficulty of giving a complete, clear definition of nanotechnologies. This is primarily due to the variety of their components, to the fact that there is not just one technology but several.
The most significant medical applications of nanotechnologies are in the diagnostic and the therapeutic fields, eg biosensors and molecular imaging, providing diagnosis and drug delivery with no invasive methods involved.
Like any other emerging field, such technologies imply new possibilities for improving health but, on the other hand, they are still at an experimental stage and therefore should be implemented under rigorous safety testing before going on general release. For this purpose, the ethical, legal and social implications (ELSI) of nanotechnologies have been elaborated by study groups, in order to develop solutions before the results of the tests are diffused into medical practice.
The aim of this paper is to define some of the ethical issues concerning biomedical applications and to evaluate whether there is a need for new or additional guidelines and regulations.     

Admixture mapping: from paradigms of race and ethnicity to population history

Admixture mapping is a whole genome association strategy that takes advantage of population history-or genetic ancestry-to map genes for complex diseases. However, because it uses racial/ethnic groupings to examine differential disease risk, admixture mapping raises ethical and social concerns. While there has been much theoretical commentary regarding the ethical and social implications of population-based genetic research, empirical data from stakeholders most closely involved with these studies is limited. One of the first admixture mapping studies carried out was a scan for Multiple Sclerosis (MS) risk factors in an African-American population. Applying qualitative research methods, we used this example to explore developing views, experiences and perceptions of the ethical and social implications of admixture mapping and other population-based research-their value, risks and benefits, and the future prospects of the field. Additionally, we sought to understand how social and ethical risks might be mitigated, and the benefits of this research optimized. We draw on in-depth, one-on-one interviews with leading population geneticists, genome scientists, bioethicists, and African-Americans with MS. Here we present our findings from this unique group of key informants and stakeholders.     

Ethical hurdles for translational research

The notion of translational research has gained considerable currency over the past few years. While such an approach promises great scientific and clinical advances, the penumbra of translational research tends to incorporate prioritizing scientific projects based upon their potential for translation; tight financial connections between sponsors, scientists and clinical investigators; and sometimes research involving biological approaches for which there is little experience determining safety. It is these aspects of translational research that raise some serious ethical challenges. In this report, we examine three specific areas that raise ethical questions: (1) the potential implications of prioritizing research objectives based on the potential for translation; (2) cautions related to moving from bench to bedside (and back again); and (3) unique questions for translational research initiatives in academic medical centers. Based on this examination, it is clear that the financial and ethical costs as well as benefits of taking a translational approach need to be considered. In the meantime, exquisite attention needs to be paid whenever translational research is likely to affect the traditional fiduciary responsibilities of scientists, clinicians and institutions to research subjects, patients and students. Successful mechanisms that might be developed to address any untoward effects should be shared and evaluated.     

The role and responsibilities of witnesses in the informed consent process

Various mechanisms to ensure the protection of subjects in human research have been suggested, including the presence of witnesses during the informed consent process. For our commentary on the use of witnesses and their potential role and responsibility during the consent process, we start by addressing current guidelines for human subjects research in four Latin American countries. By using examples from public health research, we highlight some of the practical difficulties of using witnessed consent, from becoming a meaningless ritual at one end of the spectrum to the research subject feeling intimidated or coerced to participate at the other. Apart from these practical difficulties, it is unclear what responsibility the witness could and should have. We argue that there are important ethical questions about the role of witnesses that have not been adequately addressed in national and international regulations. This work addresses these gaps and argues that more debate is required to define the role and responsibilities of witnesses in the consent process, their training requirements and whether a universal legal requirement for witnessed consent, regardless of the type of research, is desirable.     

The ethics of biobanking: Assessing the right to control problem for broad consent

The biobank consent debate is one with deeply held convictions on both the ‘broad’ and ‘specific’ side with little sign of resolution. Recently, Thomas Ploug and Soren Holm have developed an alternative to both specific and broad consent: a meta‐consent framework. The aim here is to consider whether meta‐consent provides a ‘solution’ to the biobank consent debate. We clarify what ‘meta‐consent’ actually is (arguing that the label is a misnomer and ‘consent à la carte’ is more accurate). We identify problems with Ploug and Holm's arguments, and some challenges for meta‐consent. We focus on whether there is any ethical obligation to provide consent à la carte. There may seem to be so, especially if we draw upon an unclear appeal to the ethical significance of ‘respect for autonomy’. Similarly, there might seem to be an intuitive inference from the fact that ethically legitimate research requires informed consent to the conclusion that it thereby requires consent à la carte. It is shown that this line of inference is mistaken.     

Gender in bioethics: theory and practice -- an introduction

Does the care perspective make a difference? Can it reach as far as we would like? It is the goal of this special issue on Gender in Bioethics: Theory and Practice to begin to address some of these important questions. In the first article, Virginia Sharpe provides a comprehensive and thoughtful analysis of how the orientations of justice and care are played out in medical ethical theory. In the second article, James Nelson argues that the more traditional approach in Bioethics to maternal-fetal conflicts is not useful, and that a care perspective is more appropriate. Thoughtful commentary on Nelson's article is provided by Rosemarie Tong. For readers new to the justice-care debate in moral theory, the following articles will provide an informative introduction. For those who are more familiar, it is hoped that you will be challenged by the extension of the debate to the practical issue of maternal-fetal conflicts.     

Reviews of Functional MRI: The Ethical Dimensions of Methodological Critique

Neuroimaging studies involving human subjects raise a range of ethics issues. Many of these issues are heightened in the context of neuroimaging research involving persons with mental health disorders. There has been growing interest in these issues among legal scholars, philosophers, social scientists, and as well as neuroimagers over the last decade. Less clear, however, is the extent to which members of the neuroimaging community are engaged with these issues when they undertake their research and report results. In this study, we analyze the peer-reviewed review literature involving fMRI as applied to the study of mental health disorders. Our hypothesis is that, due to the critical orientation of reviews, and the vulnerability of mental health population, the penetrance of neuroethics will be higher in the review literature in this area than it is in the primary fMRI research literature more generally. We find that while authors of reviews do focus a great deal of attention on the methodological limitations of the studies they discussed, contrary to our hypothesis, they do not frame concerns in ethical terms despite their ethical significance. We argue that an ethics lens on such discussion would increase the knowledge-value of this scholarly work.