A guide to interpreting discordant systematic reviews

Systematic reviews are becoming prominent tools to guide health care decisions. As the number of published systematic reviews increases, it is common to find more than 1 systematic review addressing the same or a very similar therapeutic question. Despite the promise for systematic reviews to resolve conflicting results of primary studies, conflicts among reviews are now emerging. Such conflicts produce difficulties for decision-makers (including clinicians, policy-makers, researchers and patients) who rely on these reviews to help them make choices among alternative interventions when experts and the results of trials disagree. The authors provide an adjunct decision tool--a decision algorithm--to help decision-makers select from among discordant reviews.     

Reviewing Literature in Bioethics Research: Increasing Rigour in Non‐Systematic Reviews

The recent interest in systematic review methods in bioethics has highlighted the need for greater transparency in all literature review processes undertaken in bioethics projects. In this article, I articulate features of a good bioethics literature review that does not aim to be systematic, but rather to capture and analyse the key ideas relevant to a research question. I call this a critical interpretive literature review. I begin by sketching and comparing three different types of literature review conducted in bioethics scholarship. Then, drawing on Dixon‐Wood's concept of critical interpretive synthesis, I put forward six features of a good critical interpretive literature review in bioethics: answering a research question, capturing the key ideas relevant to the research question, analysing the literature as a whole, generating theory, not excluding papers based on rigid quality assessment criteria, and reporting the search strategy.     

New Notes

All citizens will make bioethics decisions as a result of today's biotechnology revolution. The decisions made require citizens to find possible acceptable solutions to dilemmas that have become public issues. In this activity, students practice making decisions in ethical dilemmas after evaluating the influences of their own ethical beliefs and learning five ethical systems (relativism, divine command, utilitarianism, deontology, and virtue). They also learn systematic strategies that are useful for approaching any ethical dilemma. Alternatives and adaptations are provided or suggested to accommodate different maturity levels.     

Ethics and Rationing Access to Dialysis in Resource‐Limited Settings: The Consequences of Refusing a Renal Transplant in the South African State Sector

Resource constraints in developing countries compel policy makers to ration the provision of healthcare services. This article examines one such set of Guidelines: A patient dialysing in the state sector in South Africa may not refuse renal transplantation when a kidney becomes available. Refusal of transplantation can lead to exclusion from the state‐funded dialysis programme. This Guideline is legally acceptable as related to Constitutional stipulations which allow for rationing healthcare resources in South Africa. Evaluating the ethical merit of the Guideline, and exploring the ethical dilemma it poses, proves a more complex task. We examine the actions of healthcare professionals as constrained by the Guideline. From a best interests framework, we argue that in these circumstances directing patient decision making (pressurising a patient to undergo renal transplantation) is not necessarily unethical or unacceptably paternalistic. We then scrutinise the guideline itself through several different ethical ‘lenses’. Here, we argue that bioethics does not provide a definitive answer as to the moral merit of rationing dialysis under these circumstances, however it can be considered just in this context. We conclude by examining a potential pitfall of the Guideline: Unwilling transplant recipients may not comply with immunosuppressive medication, which raises questions for policies based on resource management and rationing.     

Cutting red tape to manage public health threats: An ethical dilemma of expediting antibiotic drug innovation

Antibiotic resistance, arising when bacteria develop defences against antibiotics, is creating a public health threat of massive proportions. This raises challenging questions for standard notions in bioethics when suitable policy is to be characterized and justified. We examine the particular proposal of expediting innovation of new antibiotics by cutting various forms of regulatory ‘red tape’ in the standard system for the clinical introduction of new drugs. We find strong principled reasons in favour of such a lowering of the ethical standards of research and the clinical introduction of new antibiotic formulas. However, this support is undermined by pragmatic challenges owing to expected responses from stakeholders, creating uncertainty about which policies could actually be effectively implemented. We describe an underlying dilemma on how to rationally justify compromises between ideal ethical justification and pragmatic risks that needs to be further addressed in this light. We suggest a solution to this dilemma related to proposals of expediting antibiotic drug innovation.     

Don't Blame the ‘Bio’ — Blame the ‘Ethics’: Varieties of (bio) ethics and the challenge of pluralism

We tend to think that the difficulties in bioethics spring from the novel and alarming issues that arise due to discoveries in the new biosciences and biotechnologies. But many of the crucial difficulties in bioethics arise from the assumption we make about ethics. This paper offers a brief overview of bioethics, and relates ethical 'principlism' to 'ethical fundamentalism.' It then reviews some alternative approaches that have emerged during the second phase of bioethics and argues for a neo-Aristotelian approach. Misconceptions about ethical principles and ethical reasoning not only distort our views of the business of bioethics, but they also prevent us from facing up to the formidable problems posed by ethical pluralism in so-called liberal societies.     

Realizing responsibility. Institutional routines,critical intervention,and the “big” questions in the controversy over non-invasive prenatal testing in Germany

NIPT has become a matter of controversy in Germany over the past years, there is now a widespread concern that it raises fundamental social and ethical questions. Starting from the assumption that responsible governance requires governance actors to address these questions, the article examines how the main governance actors realized their responsibility in the sense of conceiving and performing it. Building on the pragmatic sociology of critique, we study how actors are doing responsibility within a given institutional and political context. We show that critical interventions disrupted institutional routines and caused governance actors to struggle with conflicting commitments of complying with institutional rules and exercising responsibility by taking social and ethical considerations into account. Whereas these conflicting commitments posed a predicament for political decision-makers, who solved it through shifting responsibility for social and ethical issues elsewhere, there was no such predicament for the producers; for them, routine and responsibility converged.     

Maximizing the value of systematic reviews in ecology when data or resources are limited

Systematic reviews provide a rigorous, repeatable and quantitative method for assessing and synthesizing all available empirical evidence to evaluate a specific research, management, or policy question. They are particularly well suited for evaluating the effectiveness of environmental management actions, and thus for underpinning evidence‐based adaptive natural resource management. However, their current utility may be limited in countries like Australia, where both the amount of research relative to land area and of well‐monitored, active land management for environmental purposes are relatively low. Based on our experience conducting two of the first ecological systematic reviews in Australia, we have developed a number of recommendations for conducting systematic reviews in situations where resources and/or primary research data are limited. We discuss potential modification or augmentation of most aspects of the systematic review process including selection of a review team, question formulation, search strategy, data analysis, and the communication of results, as well as the inherent tradeoffs between systematic thoroughness and available resources that are involved in these changes. We hope that our recommendations will encourage more ecologists to undertake systematic reviews even if primary research and resources to conduct the review appear to be limited, as even a modified systematic review can provide more defensible evidence‐based guidelines for management of natural resources.     

The Ethical and Legal Framework for the Decision Not to Resuscitate

Practicing physicians are frequently faced with the question of whether or not to institute cardiopulmonary resuscitation in case of cardiac or respiratory arrest in a patient in hospital. Medical training has usually not included any systematic analysis of this issue from either an ethical or a legal standpoint. Many physicians may be unaware that ethical and legal principles, as well as professional guidelines, exist to guide such decision making. In practice, physicians make this decision without the benefit of training in ethical analysis. The problem is especially acute in teaching hospitals when young physicians unacquainted with formal ethics or the law must often make decisions emergently. Studies show some discrepancy between ethical and legal principles and the actual decision making by physicians. For this reason, we recommend an approach that will enable physicians to make and implement decisions not to resuscitate that are consistent with current ethical and legal standards.     

Systems Bioethics and Stem Cell Biology

The complexities of modern science are not adequately reflected in many bioethical discussions. This is especially problematic in highly contested cases where there is significant pressure to generate clinical applications fast, as in stem cell research. In those cases a more integrated approach to bioethics, which we call systems bioethics, can provide a useful framework to address ethical and policy issues. Much as systems biology brings together different experimental and methodological approaches in an integrative way, systems bioethics integrates aspects of the history and philosophy of science, social and political theory, and normative analysis with the science in question. In this paper we outline how a careful analysis of the science of stem cell research can help to refocus the discussions related to the clinical applications of stem cells. We show how inaccurate or inadequate scientific assumptions help to create a set of unrealistic expectations and badly inform ethical deliberations and policy development. Systems bioethics offers resources for moving beyond the current impasse.     

An undignified bioethics: there is no method in this madness

In a recent article, Alasdair Cochrane argues for the need to have an undignified bioethics. His is not, of course, a call to transform bioethics into an inelegant, pathetic discipline, or one failing to meet appropriate disciplinary standards. His is a call to simply eliminate the concept of human dignity from bioethical discourse. Here I argue that he fails to make his case. I first show that several of the flaws that Cochrane identifies are not flaws of the conceptions of dignity he discusses but rather flaws of his, often problematic, understanding of such conceptions. Second, I argue that Cochrane's case against the concept of human dignity goes too far. I thus show that were one to agree that these are indeed flaws that require that we discard our ethical concepts, then following Cochrane's recommendations would commit us not only to an undignified bioethics, i.e. a bioethics without dignity, but to a bioethics without much ethics at all.     

Ethical pluralism without complementarity

Grinnell, Bishop, and McCullough (2002) have proposed extending Bohr's notion of complementarity from the realm of quantum physics to that of bioethics, arguing that many ethical disputes cannot in principle be resolved. On this view, we should give up the aim of reaching all-things-considered moral verdicts on a variety of disputed questions, settling instead for a holism of irreducibly complementary perspectives. I discuss a number of difficulties with this proposal, and argue that the desire for inclusiveness that motivates it is properly captured through a different approach to ethical pluralism already familiar in moral philosophy, which does allow for resolution.     

Assessment of the ethical review process in Sudan

The ethical review process is an important component of contemporary health research worldwide. Sudan started an ethical review process rather late in comparison with other countries. In this study, we evaluate the structure and functions of existing ethics review committees. We also explore the knowledge and attitudes of Sudanese researchers toward the ethical review process and their experience with existing ethics review committees. There are four ethics review committees in the country; these committees have no institutional regulations to govern their functions. Furthermore, Sudan also lacks national guidelines. Ethical reviews are carried out primarily for studies seeking international funding and are almost always governed by the funding agencies' requirements. Nearly half of respondents (46.3%) knew about the existence of research ethics committees in Sudan. Researchers reported a variety of experiences with the ethical review process; most of them were unable to define 'ethics committee'.     

Teaching global bioethics

We live in a world with enormous disparities in health. The life expectancy in Japan is 80 years; in Malawi, 40 years. The under-five mortality in Norway is 4/1000; in Sierra Leone, 316/1000. The situation is actually worse than these figures suggest because average rates tend to mask inequalities within a country. Several presidents of the IAB have urged bioethicists to attend to global disparities and to broaden the scope of bioethics. For the last six years I have tried to do just that. In this paper, I report and reflect on my attempts to teach bioethics in ways that address global health and justice. I then discuss ways to address key ethical issues in global health: the problem of inequalities; the nature of the duty to assist; the importance of the duty not to harm; the difference between a cosmopolitan and a political view of justice. I also discuss how teaching about global health may help to shift the emphasis in bioethics--from sensational cases to everyday matters, from autonomy and justice, and from access to healthcare to the social determinants of health. At the end of my paper, I reflect on questions that I have not resolved: how to delineate the scope of bioethics, whether my approach over-politicises bioethics, and how to understand the responsibilities of bioethicists.     

Semi-automated screening of biomedical citations for systematic reviews

Background  

Systematic reviews address a specific clinical question by unbiasedly assessing and analyzing the pertinent literature. Citation screening is a time-consuming and critical step in systematic reviews. Typically, reviewers must evaluate thousands of citations to identify articles eligible for a given review. We explore the application of machine learning techniques to semi-automate citation screening, thereby reducing the reviewers' workload.     

Head-counting vs. heart-counting: an examination of the recent case of the conjoined twins from Malta

This paper reexamines the recent case of the conjoined twins from Malta. Survival was said to be possible only through separation, which would actually leave only one twin alive. The parents refused to allow the killing of one to save the other, but the court ruled that this would amount to the neglect of innocent life. The article questions the assumption that the case is indeed a struggle between two people. Further, it questions the assumption that a conjoined twin's natural interest and wish is separation. Historical evidence shows that many conjoined twins do not wish for separation, even when it becomes a question of survival.The article concludes with a critical evaluation of the tendency in contemporary society and particularly in bioethics to regard ethical challenges as rivalry between individuals competing for scarce resources.     

The past, the future and the biology of memory storage

We here briefly review a century of accomplishments in studying memory storage and delineate the two major questions that have dominated thinking in this area: the systems question of memory, which concerns where in the brain storage occurs; and the molecular question of memory, which concerns the mechanisms whereby memories are stored and maintained. We go on to consider the themes that memory research may be able to address in the 21st century. Finally, we reflect on the clinical and societal import of our increasing understanding of the mechanisms of memory, discussing possible therapeutic approaches to diseases that manifest with disruptions of learning and possible ethical implication of the ability, which is on the horizon, to ameliorate or even enhance human memory.     

Parental virtue: a new way of thinking about the morality of reproductive actions

In this paper I explore the potential of virtue ethical ideas to generate a new way of thinking about the ethical questions surrounding the creation of children. Applying ideas from neo‐Aristotelian virtue ethics to the parental sphere specifically, I develop a framework for the moral assessment of reproductive actions that centres on the concept of parental virtue. I suggest that the character traits of the good parent can be used as a basis for determining the moral permissibility of a particular reproductive action. I posit three parental virtues and argue that we can see the moral status of a reproductive action as determined by the relationship between such an action and (at least) these virtues. Using a case involving selection for deafness, I argue that thinking in terms of the question ‘would a virtuous parent do this?’ when morally assessing reproductive action is a viable and useful way of thinking about issues in reproductive ethics.     

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.