Several foundational documents of bioethics mention the special obligation researchers have to vulnerable research participants. However, the treatment of vulnerability offered by these documents often relies on enumeration of vulnerable groups rather than an analysis of the features that make such groups vulnerable. Recent attempts in the scholarly literature to lend philosophical weight to the concept of vulnerability are offered by Luna and Hurst. Luna suggests that vulnerability is irreducibly contextual and that Institutional Review Boards (Research Ethics Committees) can only (...) identify vulnerable participants by carefully examining the details of the proposed research. Hurst, in contrast, defines the vulnerable as those especially at risk of incurring the wrongs to which all research ethics participants are exposed. We offer a more substantive conception of vulnerability than Luna but one that gives rise to a different rubric of responsibilities from Hurst's. While we understand vulnerability to be an ontological condition of human existence, in the context of research ethics, we take the vulnerable to be research subjects who are especially prone to harm or exploitation. Our analysis rests on developing a typology of sources of vulnerability and showing how distinct sources generate distinct obligations on the part of the researcher. Our account emphasizes that the researcher's first obligation is not to make the research participant even more vulnerable than they already are. To illustrate our framework, we consider two cases: that of a vulnerable population involved in international research and that of a domestic population of people with diminished capacity. (shrink)
Recent developments of three-dimensional printing of biomaterials in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more particular ethical (...) issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article considers whether there is a limit as to what should be bioprinted in medicine; examines key risks of significant harm associated with testing 3D bioprinting for humans; investigates the clinical trial paradigm used to test 3D bioprinting; analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments. (shrink)
In their article published in Nanoethics, “Ethical, Legal and Social Aspects of Brain-Implants Using Nano-Scale Materials and Techniques”, Berger et al. suggest that there may be a prima facie moral obligation to improve neuro implants with nanotechnology given their possible therapeutic advantages for patients [Nanoethics, 2:241–249]. Although we agree with Berger et al. that developments in nanomedicine hold the potential to render brain implant technologies less invasive and to better target neural stimulation to respond to brain impairments in the near (...) future, we argue against presenting the development of nanobionic clinical devices in terms of a moral obligation to conduct this research. In the first part of the paper, we consider what a duty to pursue new technologies might mean, and in the second we explore some of the negative consequences of defending such development as a moral obligation based on potential benefit. We argue that promoting the advances available to brain implants through developments in nanotechnology and bionics could contribute to medical rhetoric that indirectly increases the risk of exposing patients to harm when participating in clinical trials. We argue that rather than there being a moral obligation to improve nanobionics implants because of their potential benefit, the pursuit of improved neuro implants must be balanced against the prima facie obligations to protect patients against harm and to promote and protect patient autonomy. (shrink)
Despite the amount of public investment in nanotechnology ventures in the developed world, research shows that there is little public awareness about nanotechnology, and public knowledge is very limited. This is concerning given that nanotechnology has been heralded as ‘revolutionising’ the way we live. In this paper, we articulate why public engagement in debates about nanotechnology is important, drawing on literature on public engagement and science policy debate and deliberation about public policy development. We also explore the significance of timing (...) in engaging the public, and we make some suggestions concerning how to effectively engage publics. Our conclusions indicate the significance of scientific researchers, policy makers and representative consumer groupings in public reasoning towards a better public policy framework for debate about technological development. (shrink)
This paper considers the legislative debates in Australia that led to the passage of the Research Involving Human Embryos Act (Cth 2002) and the Prohibition of Human Cloning Act (Cth 2002). In the first part of the paper, we discuss the debate surrounding the legislation with particular emphasis on the ways in which demands for public consultation, public debate and the education of Australians about the potential ethical and scientific impact of human embryonic stem cells (hESC) research were deployed, and (...) the explicit and implicit framing of the scope of public consultation. We then ask whether, given the calls for public consultations, debate and understanding, current work in democratic theory could be helpful in analysing the process of policy-making in these areas. In particular, we canvass the literature relating to aggregative and deliberative models of democracy for processes that support the legitimacy of policy. We identify features of the debate that reflect the appeal of deliberative approaches as well as some of the possible hurdles or limitations to developing deliberative democratic approaches to policy in ethically contentious areas. (shrink)
This volume breaks new ground by investigating the ethics of vulnerability. Drawing on various ethical traditions, the contributors explore the nature of vulnerability, the responsibilities owed to the vulnerable, and by whom.
Political theorists have begun to re-examine claims by indigenous peoples to lands which were expropriated in the course of sixteenth-eighteenth century European expansionism. In Australia, these issues have captured public attention as they emerged in two central High Court cases: Mabo (1992) and Wik (1996), which recognize pre-existing common law rights of native title held by indigenous people prior to European contact and, in some cases, continue to be held to the present day. The theoretical significance of the two Australian (...) cases is examined and the links drawn out between the current debate about Aboriginal land rights in Australia and the wider philosophical debate about indigenous land rights, property rights, and indigenous justice as characterized by Jeremy Waldron and James Tully. Justice towards indigenous groups requires substantial acknowledgement and recognition of the values and institutions of the relevant indigenous group; yet, these values and institutions may not readily fall under the framework of existing state structures. Attempts to redress injustice towards indigenous groups which do not question the justice of existing state institutions will therefore prove to be inadequate responses to indigenous peoples' demands for substantive justice. (shrink)
The authors argue, against Frank Jackson, that weakness (and strength) of will involves higher-order mental states. The authors hold that this is compatible with a decision-theoretic belief-desire psychology of human action.
There has been a surge in mass media reports extolling the potential for using three-dimensional printing of biomaterials to treat a wide range of clinical conditions. Given that mass media is recognized as one of the most important sources of health and medical information for the general public, especially prospective patients, we report and discuss the ethical consequences of coverage of 3D bioprinting in the media. First, we illustrate how positive mass media narratives of a similar biofabricated technology, namely the (...) Macchiarini scaffold tracheas, which was involved in lethal experimental human trials, influenced potential patient perceptions. Second, we report and analyze the positively biased and enthusiastic portrayal of 3D bioprinting in mass media. Third, we examine the lack of regulation and absence of discussion about risks associated with bioprinting technology. Fourth, we explore how media misunderstanding is dangerously misleading the narrative about the technology. (shrink)
Women's access to health and medicine in developed countries has been characterized by a range of inconsistent inclusions and exclusions. Health policy has been asymmetrically interested in womens reproductive capacities and has sought to regulate, control, and manage aspects of womens reproductive decision making in a manner unwitnessed in relation to men's reproductive health and reproductive decision making. In other areas, research that addresses health concerns that affect both men and women sometimes is designed so as not to yield data (...) relating to the ways in which women's physiology and gendered location may affect their experience of the condition and its response to treatment, despite a literature on the significance of sex and gender differences in health research. This paper draws on the situation in Australia to explore the ethical significance of these inconsistencies as failing the ideals of high-quality medical research and evidenced-based health care. (shrink)
This collection brings together fourteen contributions by authors from around the globe. Each of the contributions engages with questions about how local and global bioethical issues are made to be comparable, in the hope of redressing basic needs and demands for justice. These works demonstrate the significant conceptual contributions that can be made through feminists' attention to debates in a range of interrelated fields, especially as they formulate appropriate responses to developments in medical technology, global economics, population shifts, and poverty.
The case of Dr. Nancy Olivieri, the Hospital for Sick Children, the University of Toronto, and Apotex Inc. vividly illustrates many of the issues central to contemporary health research and the safety of research participants. First, it exemplifies the financial and health stakes in such research. Second, it shows deficits in the ways in which research is governed. Finally, it was and remains relevant not only in Toronto but in communities across Canada and well beyond its borders because, absent appropriate (...) policies, what happened in Toronto could have happened (and could well still happen) elsewhere. In Part One of this paper, we review the facts of the Olivieri case relevant to the issues we wish to highlight: first, the right of participants in a clinical trial to be informed of a risk that an investigator had identified during the course of the trial and the obligation of the investigator to inform participants (both her own and those of other investigators); and second, the obligation of institutions to protect and promote the well-being of research participants as well as academic freedom and research integrity, the obligations of research sponsors to inform participants, research regulators, and others about unforeseen risks, and the obligations of research regulators to ensure that participants are informed of unforeseen risks and to otherwise protect and promote research integrity. In Part Two, we relate these facts and issues to New Zealand and Australia. We also make detailed recommendations for changes to the various instruments used for the governance of research involving humans in Australasia. (shrink)
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