There is a growing consensus that results generated through multiplex genetic tests, even those produced as a part of research, should be reported to providers and patients when they are considered “actionable,” that is, when they could be used to inform some potentially beneficial clinical action. However, there remains controversy over the precise criterion that should be used in identifying when a result meets this standard. In this paper, we seek to refine the concept of “actionability” by exploring one proposed (...) use for genetic test results. We argue that genetic test results indicating that a patient is at risk for developing a chronic health condition should not be considered actionable if the only potential value of that result is to motivate patients to make changes in their health behaviors. Since the empirical research currently available on this question is equivocal, we explore relevant psychological theories of human motivation to demonstrate that current theory does not support the assumption that information about genetic risk will be motivating to most patients in their attempts to make changes in health behaviors. (shrink)

As the usual regulatory framework did not fit well during the last Ebola outbreak, innovative thinking still needed. In the absence of an outbreak, randomised controlled trials of clinical efficacy in humans cannot be done, while during an outbreak such trials will continue to face significant practical, philosophical, and ethical challenges. This article argues that researchers should also test the safety and effectiveness of novel vaccines in wild apes by employing a pluralistic approach to evidence. There are three reasons to (...) test vaccines in wild populations of apes: i) protect apes; ii) reduce Ebola transmission from wild animals to humans; and iii) accelerate vaccine development and licensing for humans. Data obtained from studies of vaccines among wild apes and chimpanzees may even be considered sufficient for licensing new vaccines for humans. This strategy will serve to benefit both wild apes and humans. (shrink)

Current orthodoxy in research ethics assumes that subjects of clinical trials reserve rights to withdraw at any time and without giving any reason. This view sees the right to withdraw as a simple extension of the right to refuse to participate all together. In this paper, however, I suggest that subjects should assume some responsibilities for the internal validity of the trial at consent and that these responsibilities should be captured by contract. This would allow the researcher to impose a (...) penalty on the subject if he were to withdraw without good reason and on a whim. This proposal still leaves open the possibility of withdrawing without penalty when it is in the subject's best interests to do so. Giving researchers recourse to legal remedy may now be necessary to protect the science, as existing methods used to increase retention are inadequate for one reason or another. (shrink)

In this article I set out to trace some of the implications of recharging the political potency of nature in more-than-human terms. This shifts attention from a biopolitical focus on the inventiveness of the life sciences and what this means in terms of the emergence of ‘cyborg’ political subjects to an onto-political focus on the inventiveness of knowledge controversies and what these mean for techno-political practices. Specifically, the article examines the onto-politics of ‘natural’ hazard events and their capacity to force (...) thought in those affected by them, and so to place new demands on research practices in terms of rendering such events affective and amenable to political interrogation. I work these arguments through the demanding experimental ethos of the philosopher Isabelle Stengers, for whom scientific practices produce reliable knowledge claims only in so far as the questions they address are at risk of being redefined by the phenomena mobilized in them, and who extends this ethos to elaborate an understanding of, even a test for, an adequate political theory and practice. I do so with reference to a recent research experiment in which I collaborated with social and natural scientists and people affected by flooding in the UK. (shrink)

The American Journal of Bioethics, Volume 12, Issue 6, Page 35-37, June 2012.

The remodel the structure of chromatin (RSC) nucleosome remodeling complex is a conserved chromatin regulator with roles in chromatin organization, especially over nucleosome depleted regions therefore functioning in gene expression. Recent reports in Saccharomyces cerevisiae have identified specificities in RSC activity toward certain types of nucleosomes. RSC has now been shown to preferentially evict nucleosomes containing the histone variant H2A.Z in vitro. Furthermore, biochemical activities of distinct RSC complexes has been found to differ when their nucleosome substrate is partially unraveled. (...) Mammalian BAF complexes, the homologs of yeast RSC and SWI/SNF complexes, are also linked to nucleosomes with H2A.Z, but this relationship may be complex and extent of conservation remains to be determined. The interplay of remodelers with specific nucleosome substrates and regulation of remodeler outcomes by nucleosome composition are tantalizing questions given the wave of structural data emerging for RSC and other SWI/SNF family remodelers. (shrink)

Canada is six years into a new era of legalized medical assistance in dying (MAiD). The law continues to evolve, following a pattern in which Canadian courts rule that legal restrictions on eligibility for MAiD are unconstitutional and Parliament responds by gradually expanding eligibility for MAiD. The central tension underlying this dialogue between courts and government has focused on two conceptions of how to best promote and protect the interests of people who are vulnerable by virtue of intolerable and irremediable (...) suffering due to an illness, disease, or disability. Do we, as a society, have a duty to protect vulnerable people from seeking certain medical procedures that are contrary to their interests, as those are perceived by others? Or do we have a duty to uphold their rights to autonomy, including the right to make choices within a range that may be constrained by many factors, some of which may be socially unjust? This is a recurrent problem in bioethics and medical law, which we explore through the lens of how Canadian courts and Parliament have grappled with defining eligibility for MAiD. (shrink)

Alfandre et al. helpfully outlines the case for attending to contingency planning as well as to crisis measures during a pandemic. The authors provides a helpful framework for reflecting on...

Name der Zeitschrift: Zeitschrift für Religionswissenschaft Jahrgang: 25 Heft: 1 Seiten: 132-158.

The COVID‐19 pandemic has reinforced the critical role of ethics and community engagement in designing and conducting clinical research during infectious disease outbreaks where no vaccine or treatment already exists. In reviewing current practices across Africa, we distinguish between three distinct roles for community engagement in clinical research that are often conflated: 1) the importance of community engagement for identifying and honouring cultural sensitivities; 2) the importance of recognising the socio‐political context in which the research is proposed; and 3) the (...) importance of understanding what is in the interest of communities recruited to research according to their own views and values. By making these distinctions, we show that current practice of clinical research could draw on anthropology in ways which are sometimes unnecessary to solicit local cultural values, overlook the importance of socio‐political contexts and wider societal structures within which it works, potentially serving to reinforce unjust political or social regimes, and threaten to cast doubt on the trustworthiness of the research. We argue that more discerning anthropological engagement as well as wider collaboration with other social scientists and those working in the humanities is urgently needed to improve the ethics of current biomedical and pharmaceutical research practice in Africa. (shrink)

ABSTRACT In this paper, I support the claim that placing certain restrictions on public access to possible new treatments is morally problematic under some exceptional circumstances. Very ill patients may find that all available standard treatments are unacceptable, either because they are ineffective or have serious adverse effects, and these patients may understandably be desperate to try something new even if this means stepping into the unknown. Faced with certain death, it is rational to want to try something new and (...) to chance a dire outcome. Restricting possible new treatments to research trials may put these treatments scientifically, geographically or economically out of reach of these patients. For those who can get access, research restrictions could weaken, though not necessarily eliminate, the value of consent participants of such trials are able to give. Some participants may therefore be exploited for scientific purposes in the name of public interest. There are nonetheless compelling reasons for keeping some restrictive regulation in this area. (shrink)

Unfortunately, cases like Mr. Turner’s are common, and likely to become more so in the near future, as the number of people aged 65 and older is expected to increase to about 74 million by 2030, an...

The rapid and dynamic nature of digital transformation challenges companies that wish to develop and deploy novel digital technologies. Like other actors faced with this transformation, companies need to find robust ways to ethically guide their innovations and business decisions. Digital ethics has recently featured in a plethora of both practical corporate guidelines and compilations of high-level principles, but there remains a gap concerning the development of sound ethical guidance in specific business contexts. As a multinational science and technology company (...) faced with a broad range of digital ventures and associated ethical challenges, Merck KGaA has laid the foundations for bridging this gap by developing a Code of Digital Ethics (CoDE) tailored for this context. Following a comprehensive analysis of existing digital ethics guidelines, we used a reconstructive social research approach to identify 20 relevant principles and derive a code designed as a multi-purpose tool. Versatility was prioritised by defining non-prescriptive guidelines that are open to different perspectives and thus well-suited for operationalisation for varied business purposes. We also chose a clear nested structure that highlights the relationships between five core and fifteen subsidiary principles as well as the different levels of reference—data and algorithmic systems—to which they apply. The CoDE will serve Merck KGaA and its new Digital Ethics Advisory Panel to guide ethical reflection, evaluation and decision-making across the full spectrum of digital developments encountered and undertaken by the company whilst also offering an opportunity to increase transparency for external partners, and thus trust. (shrink)

It has been consistently demonstrated that fear-relevant images capture attention preferentially over fear-irrelevant images. Current theory suggests that this faster processing could be mediated by an evolved module that allows certain stimulus features to attract attention automatically, prior to the detailed processing of the image. The present research investigated whether simplified images of fear-relevant stimuli would produce interference with target detection in a visual search task. In Experiment 1, silhouettes and degraded silhouettes of fear-relevant animals produced more interference than did (...) the fear-irrelevant images. Experiment 2, compared the effects of fear-relevant and fear-irrelevant distracters and confirmed that the interference produced by fear-relevant distracters was not an effect of novelty. Experiment 3 suggested that fear-relevant stimuli produced interference regardless of whether participants were instructed as to the content of the images. The three experiments indicate that even very simplistic images of fear-relevant animals can divert attention. (shrink)

This is the first in a series of five papers on the role, remit and function of research ethics committees which are intended to provide for REC members a broad understanding of the most important issues in research ethics and governance. The first considers the rationale for having ethics review by committee at all; seeking to explain why ethics committees, as we currently have them, are so important to the wider system of governing research.

Jansen and Wall suggest a new way of defending hard paternalism in clinical research. They argue that non-therapeutic research exposing people to more than minimal risk should be banned on egalitarian grounds: in preventing poor decision-makers from making bad decisions, we will promote equality of welfare. We argue that their proposal is flawed for four reasons.First, the idea of poor decision-makers is much more problematic than Jansen and Wall allow. Second, pace Jansen and Wall, it may be practicable for regulators (...) to uncover the values that a potential research participant holds when agreeing to enter a research project, so their claim that we must ban such research projects for all if we are to ban them for poor decision-makers looks to be unmotivated. Third, there seem to be cases where the liberty to enter the sort of research project Jansen and Wall discuss is morally weighty, and arguably should outweigh concerns of egalitarian distribution. Fourth, banning certain types of research, which seem on the face of it to offer an unfavourable risk-benefit ratio, would have unwelcome consequences for all clinical research, which Jansen and Wall do not recognize. (shrink)

This is the third in a series of five papers on the role, remit and function of research ethics committees which are intended to provide for REC members a broad understanding of the most important issues in research ethics and governance. This paper examines the role of ethics committees in balancing the social value of the research it reviews against the risks it imposes on those who take part. The ethics committee's role in assessing the social value of research goes (...) well beyond checking its scientific validity and this assessment may affect the risks ethics committees are prepared to ask of subjects not only for their own potential personal interests but importantly and inevitably in the name of science. However, their function is importantly restricted by the wider regulatory and governance environment in which they work. (shrink)

Most ethics committees which review research protocols insist that potential research participants reserve unconditional or absolute ‘right’ of withdrawal at any time and without giving any reason. In this paper, I examine what consent means for research participation and a sense of commitment in relation to this right to withdraw. I suggest that, once consent has been given (and here I am excluding incompetent minors and adults), participants should not necessarily have unconditional or absolute rights to withdraw.This does not imply (...) that that there should be a complete absence of rights, or, indeed, an abandonment of the right to withdraw. The point of this paper is to show that the supposed unconditional or absolute nature of these rights may be self‐defeating and so fail to respect the autonomy of participants. In addition, and on a more positive note, I suggest that, attaching certain conditions on the right to withdraw, may better respect the autonomy of these participants by underlining the idea that autonomy is more than mere whim or indifference to the fate of others. On the contrary, research staff are currently unable to ‘push’ participants, who may merely have logistical difficulties unrelated to the research itself, but who really want to stay the course, for fear of coercing them. Furthermore, researchers now try to ‘screen out’ people they think may be unreliable to protect the science of the study and so groups at risk of dropping out may be unfairly denied access to research treatments. I conclude that on‐going negotiation between the relevant parties could be on balance the only truly acceptable way forward but concede certain important limitations to take into account. (shrink)

Volume 20, Issue 9, September 2020, Page 39-41.

This is the fourth in a series of five papers on the role, remit and function of research ethics committees which are intended to provide for REC members a broad understanding of the most important issues in research ethics and governance. This paper explores the role of ethics committees in reviewing proposed conditions for recruiting human subjects and in checking the intended procedures for gaining consent. In so doing the paper will reiterate the conditions which are traditionally thought to make (...) consent valid, identify a number of limitations to meeting these conditions, and show when consent, however broadly construed or indeterminately focused, may be unnecessary. (shrink)

This is the second in a series of five papers on the role, remit and function of research ethics committees which are intended to provide for REC members a broad understanding of the most important issues in research ethics and governance. This paper examines the role of ethics committees in assessing the science of the research it reviews. While ethics committees are not specifically constituted to review the science of a project, they must nevertheless assess the social benefits of research (...) and, in this context, have an important role in checking that the science has been properly peer-reviewed. (shrink)

An introduction to the paragone -- The archetype of beauty : Narcissus and the birth of the beau idéal -- Pygmalion and Galatea : the battle between iconophobes and iconodules -- Salomé versus Medusa.

This article addresses the problem of writing the posthuman in educational research. Confronted by our own failures as educational researchers within posthuman and new materialist approaches, it seeks a more radical opening to Lather and St Pierre’s question: ‘If we give up “human” as separate from non-human, how do we exist? … Are we willing to take on this question that is so hard to think but that might enable different lives?’ We do this to enable different lives for the (...) planet in all of its manifestations, including its children of the Anthropocene. We begin with the insistent presence of mud in our deep hanging out in an early learning site and ask: what is mud, what does it do, where can mud lead us in its oozing at Grey Gums Preschool. From these explorations we include a scripted dialogue that was performed at a conference against a background of rolling images of the proliferation of mud’s play with children. We consider this scripted dialogue, and its performance, as data read in relati... (shrink)