David M. Shaw

Institutional review boards (IRBs) have a reputation for impeding research. This reputation is understandable inasmuch as many studies are poorly designed, exploit participants, or do not ask a relevant question , and it is entirely proper that IRBs should reject such proposals. However, IRBs also frequently reject or tamper with perfectly sound and relevant studies in the name of protecting participants from harm, in accordance with the widely accepted message that “clinical research is justified only when participants are protected from excessive risks”. Here, I argue that IRBs should never reject a study because it poses too high a risk to participants, and that their role should be confined to ensuring that risks and any potential benefits are fully explained to potential participants. Everyone should have the right to participate in research without paternalistic decisions about risk being made on their behalf.

This special issue of the Journal of Bioethical Inquiry focuses on global health and associated bioethical concerns. As a concept, global health broadens the focus from national public health situations to the international sphere and concerns itself with the health of all humans, but particularly those in developing countries who suffer from severe health inequalities. However, there is one sense in which global health is lacking: Its primary focus is on those currently alive and, in some cases, their offspring. But what about future generations, who may suffer from even more pronounced inequalities? In this editorial, we consider the bioethical implications of failing to adopt an intergenerational concept of global health.One of the major strengths of global health is its emphasis on disenfranchised populations who do not enjoy the advantages of the medical systems of developed countries. By drawing attention to the issues that affect billions of disadvantaged people around the world ..

One of the most fascinating issues in the emerging field of neuroethics is pharmaceutical cognitive enhancement (CE). The three main ethical concerns around CE were identified in a Nature commentary in 2008 as safety, coercion and fairness; debate has largely focused on the potential to help those who are cognitively disabled, and on the issue of “cosmetic neurology”, where people enhance not because of a medical need, but because they want to (as many as 25% of American students already use nootropic cognitive enhancers such as ritalin). However, the potential for CE to improve public health has been neglected. This paper examines the prospect of improving health outcomes through cognitive enhancement among sections of the population where health inequalities are particularly pronounced. I term this enhancement of the public's health through CE “neuroenhancing health”. It holds great promise, but raises several ethical issues. This paper provides an outline of these issues and related philosophical problems. These include the potential effectiveness of CE in reducing health inequalities; issues concerning autonomy and free will; whether moral enhancement might be more effective than cognitive enhancement in reducing health inequalities; and the problem of how to provide such CE, including the issue of whether to provide targeted and universal coverage.

Current General Medical Council guidelines state that any doctor who does not wish to carry out a non-therapeutic circumcision (NTC) on a boy must invoke conscientious objection. This paper argues that this is illogical, as it is clear that an ethical doctor will object to conducting a clinically unnecessary operation on a child who cannot consent simply because of the parents’ religious beliefs. Comparison of the GMC guidelines with the more sensible British Medical Association guidance reveals that both are biased in favour of NTC and subvert standard consent procedures. It is further argued that any doctor who does participate in non-therapeutic circumcision of a minor may be guilty of negligence and in breach of the Human Rights Act. In fact, the GMC guidance implies that doctors must claim conscientious objection if they do not wish to be negligent. Both sets of guidelines should be changed to ensure an objective consent process and avoid confusion over the ethics of NTC.

Almost all academics sigh at any mention of the REF. Preparing submissions for the Research Excellence Framework takes up a lot of effort, but is important because the REF determines a department's funding allocation from a finite pot of cash. As such, it is seen as a necessary evil by most staff. However, the REF poses ethical problems in addition to the stress it causes. As it stands, the REF is exacerbating a schism between research and teaching staff, encouraging deceptive attribution of authorship, and failing to give due credit (and cash) to deserving research. As such, the REF needs some serious refereeing.

Oncologists frequently have to break bad news to patients. Although they are not normally the ones who tell patients that they have cancer, they are the ones who have to tell patients that treatment is not working, and they are almost always the ones who have to tell them that they are going to die and that nothing more can be done to cure them. Perhaps the most difficult cases are those where further treatment is almost certainly futile, but there remains an extremely slim chance of yet more aggressive treatment having a near-miraculous effect. In such situations, it can be difficult for the oncologist to decide how to explain things to the patient, and how much to tell them. It can also be very difficult to achieve the correct balance between respecting the patient’s autonomy and not exposing them to harm. This paper examines an example of one such case and makes three suggestions. First, that respecting autonomy cannot be achieved by maximising information-sharing only to deny patients the chance to make decisions based on that information; second, that the simplistic application of the principles of nonmaleficence and respect for autonomy can lead to erroneous conclusions about the most ethical course of action; and third, that there is an extra reason, in addition to respecting patients’ autonomy, for attempting near-futile last-ditch interventions: when treating rare conditions, useful evidence can be generated that will benefit future patients.

Biobanks are vital for diagnostic, epidemiological and research purposes following radiation disasters, but there is a history of delays in this type of research and specifically in setting up important resources including tissue repositories following the rare occurrence of these events. Here, we argue that one key lesson from Chernobyl and Fukushima has still not been learned: it is essential to agree on a proactive international plan for a radiation disaster biobank and accompanying data collection before the next disaster occurs.

The importance of medical confidentiality is obvious to anyone who has ever been a patient, and protecting private information about patients is one of the key responsibilities of healthcare professionals. However, maintaining the confidentiality of patients who are incarcerated in prisons poses several ethical challenges. In this chapter we explain the importance of confidentiality in general, and the dilemmas that sometimes face doctors with regard to it, before describing some of the specific difficulties faced by prison doctors. Although healthcare professionals working in prisons have the same duty to respect confidentiality as those working in the wider community, the conflicts of interest caused by their dual loyalty to prisoners and to prison authorities can make it very difficult to strike the right balance between respecting confidentiality and protecting prisoners and third parties. We illustrate some of the dilemmas facing prison doctors with a series of case discussions before providing suggestions for resolving these difficult situations. Ideally, a combination of great ethical and legal sensitivity on the part of healthcare professionals and general respect for prisoners’ rights on the part of other prison staff enables most issues to be resolved without the need to compromise patients’ confidentiality.

Aim: While there is widespread agreement on the broad aspects of what constitutes a biobank, there is much disagreement regarding the precise definition. This research aimed to describe and analyse the definitions of the term biobank offered by various stakeholders in biobanking. Methods: Interviews were conducted with 36 biobanking stakeholders with international experience currently working in Switzerland. Results: The results show that, in addition to the core concepts of biological samples and linked data, the planned use of samples (including sharing) is held to be a key criterion. It also emerges that some researchers avoid the term in order to circumvent certain regulatory guidelines, including informed consent requirements. Conclusion: Developments in the field of biobanking will be complicated if researchers are unaware, or deny that their collection is a biobank. A clear definition of the term is therefore an important step towards fostering collaboration amongst researchers, enabling them to more easily identify potential sources of samples.

In two recent papers, Hugh McLachlan, Jacob Busch and Raffaele Rodogno have criticised my new perspective on euthanasia. Each paper analyses my argument and suggests two flaws. McLachlan identifies what he sees as important points regarding the justification of legal distinctions in the absence of corresponding moral differences and the professional role of the doctor. Busch and Rodogno target my criterion of brain life, arguing that it is a necessary but not sufficient condition and that it is not generalisable. In this paper I indicate flaws in all of these criticisms, and again suggest that my perspective does add something new to the debate.

IntroductionThis editorial introduces this special issue of the Journal of Bioethical Inquiry on global health by presenting an analysis of the ethical implications of the Glasgow effect, the curious phenomenon whereby inhabitants of Scotland’s largest city have substantially higher mortality rates than their counterparts in similar British cities, despite adjustment for factors such as socioeconomic status, obesity, smoking, drinking, and drug use. The Glasgow effect represents a health inequality that cannot currently be addressed, as its causes are as yet unidentified. As such, it raises several ethical issues. Parents may even have an ethical obligation to move their children away from Glasgow to prevent them being affected by the effect.The Glasgow effect is perhaps the most perplexing health inequality. It represents unfairness with an unknown cause and is composed of several different elements. The most basic fact is that socioeconomically disadvantaged people are worse of ..

Although homeopathy has received a great deal of criticism in recent years for unethical practices, Homeopaths without Borders (HWB) has gone almost entirely unmentioned in the medical literature. This is somewhat surprising, given that HWB are engaged in activity even more dubious than that of most homeopaths. HWB has quite a long history, and several different national associations; here, I focus on HWB Germany (HWBG) and HWB North America (HWBNA) and briefly describe some of their activities and their harmful effects.

Why devote an issue of an ethics journal to prison medicine? Why conduct ethics research in prisons in the first place? In this editorial, we explain why prison ethics research is vitally important and illustrate our argument by introducing and briefly discussing the fascinating papers in this special issue of the Journal of Bioethical Inquiry.Ethics is often regarded as a theoretical discipline. This is in large part due to ethics’ origin as a type of moral philosophy, which is frequently associated with armchair theorising about principles and virtues and seems to have little connection with the “real world.” However, medical ethics and bioethics are increasingly becoming empirical disciplines. The “empirical turn” in ethics has led to an explosion in field research in ethics that uses the empirical methods of sociology, anthropology, and the health sciences to investigate a variety of ethical issues. The results of such research are often of much more value than purely theoret.

This article provides an ethical critique of the Good Clinical Practice (GCP) and Declaration of Helsinki (DoH) documents. While the previous criticisms of GCP are entirely correct, there is much more wrong with the document than has previously been acknowledged, including a circular definition and an astonishing vagueness about ethical principles. In addition to its failure to provide adequate ethical protection of participants, the procedurally dense nature of GCP lends itself to a box-ticking culture where important ethical issues are overlooked because they are not ‘mentioned on the form’. In contrast, the DoH is a much more effective ethical document, but actually goes too far in one respect. It transpires that the best ethical guidelines for clinical research would be neither over-prescriptive in regard to particular ethical issues (as the DoH is) nor neglectful of them (as GCP is); correctly framed ethical principles will provide sufficient protection to participants while also ensuring a culture of ethicovigilance in clinical trials

[V]isibility is central to the shaping of political, medical, and socioeconomic decisions. Who will be treated—how and where—are the central questions whose answers are often entwined with issues of visibility … [and] the effects that media visibility has on the perception of particular bodies .In a documentary entitled Paris: The Luminous Years , writer Janet Flanner describes the intense friendship of Pablo Picasso and Georges Braque. Both were inspired by Paul Cézanne and his retrospective at the 1907 Salon d’Automne—which, according to Paris: The Luminous Years, marked in Janus-like fashion the end of the 19th and the beginning of the 20th centuries in art. Flanner tells of the frequent visits between the two painters, where they “talked and talked … two or three months that they just spent gabbling, gabbling.” And from their camaraderie and gabble emerged someth ..

In 2006, the Indian Council of Medical Research (ICMR) published its ‘Ethical guidelines for Biomedical Research on human participants’. The intention was to translate international ethical standards into locally and culturally appropriate norms and values to help biomedical researchers in India to conduct ethical research and thereby safeguard the interest of human subjects. Unfortunately, it is apparent that the guideline is not fit for purpose. In addition to problems with the structure and clarity of the guidelines, there are several serious omissions and contradictions in the recommendations. In this paper, we take a close look at the two key chapters and highlight some of the striking flaws in this important document. We conclude that ethics committees and national authorities should not lose sight of international ethical standards while incorporating local reality and cultural and social values, as focusing too much on the local context could compromise the safety of human subjects in biomedical research, particularly in India

A range of interventions in dying patients can improve both the possibility of successful organ donation and the likely long-term success of transplantation. The ethical and legal issues surrounding such interventions, which most frequently occur in the context of donation after circulatory determination of death, are complex, controversial and many remain unresolved. This is true with adults, but even more so with children, where the issue of organ donation and premortem interventions to facilitate it, are highly sensitive. Essentially, such interventions are being undertaken in dying children who cannot medically benefit from them, though arguments have been advanced that becoming a donor might be in a child's extended best interest. However, certain interventions carry a potential risk, although small, of direct harm and of course overall objections to child donation after circulatory determination of death per se are still expressed in the literature. But, unlike the case in critically ill adults, those giving permission for such interventions are normally able to fully participate in decision-making, and indeed to consent, to both donation and premortem interventions. We review the issue of the use of premortem interventions in dying children to facilitate organ donation, including decision-making and ethical justification. Individual interventions are then considered, including an ethical analyse of their use. Finally, we recommend an approach using a combination of welfare checklist strategy, coupled with the establishment of an agreed zone of parental discretion about individual interventions which might be used in dying children to increase the possibility of successful organ donation.

Many ethical issues are posed by public health interventions. Although abstract theorizing about these issues can be useful, it is the application of ethical theory to real cases which will ultimately be of benefit in decision-making. To this end, this paper will analyse the ethical issues involved in Childsmile, a national oral health demonstration programme in Scotland that aims to improve the oral health of the nation's children and reduce dental inequalities through a combination of targeted and universal interventions. With Scotland's level of dental caries among the worst in Europe, Childsmile represents one of the largest programmes of work aimed at combating oral health inequalities in the UK. The areas of ethical interest include several contrasting themes: reducing health inequalities and improving health; universal and targeted interventions; political values and evidence base; prevention and treatment; and underlying all of these, justice and utility.

In 2011 the Swiss government published a report on homeopathy. This report was commissioned following a 2009 referendum in which Swiss people decided that homeopathy and other alternative therapies should be covered by private medical insurance; before implementing this decision, the government wanted to establish whether homeopathy actually works. In February 2012 the report was published in English and was immediately proclaimed by proponents of homeopathy to be conclusive proof that homeopathy is effective. This paper analyses the report and concludes that it is scientifically, logically and ethically flawed. Specifically, it contains no new evidence and misinterprets previously debunked studies; it creates a new standard of evidence in order to make homeopathy appear effective and attempts to discredit randomised controlled trials as the gold standard of evidence; and almost all the authors have conflicts of interest, despite their claim that none exist. If anything, the report proves that homeopaths are willing to distort the evidence in order to support their beliefs, and its authors appear to have violated the Swiss Academies of Arts and Sciences principles governing scientific integrity.

In their recent paper in this journal, Heinz and colleagues accuse proponents of cognitive enhancement of making two unjustified assumptions. The first of these is the assumption that neuroenhancing drugs will be safe; the second is that research into cognitive enhancement does not pose particular ethical problems. Heinz and colleagues argue that both these assumptions are false. Here, I argue that these assumptions are in fact correct, and that Heinz and colleagues themselves make several assumptions that undermine their argument. Neuroenhancement does raise several ethical concerns, but safety and research in this area pose no unique difficulties.

Currently, any dentist in the UK who is HIV-seropositive must stop treating patients. This is despite the fact that hepatitis B-infected dentists with a low viral load can continue to practise, and the fact that HIV is 100 times less infectious than hepatitis B. Dentists are obliged to treat HIV-positive patients, but are obliged not to treat any patients if they themselves are HIV-positive. Furthermore, prospective dental students are now screened for hepatitis B and C and HIV, and are not allowed to enrol on Bachelor of Dental Surgery degrees if they are infectious carriers of these diseases. This paper will argue that: (i) the current restriction on HIV-positive dentists is unethical, and unfair; (ii) dentists are more likely to contract HIV from patients than vice versa, and this is not reflected by the current system; (iii) the screening of dental students for HIV is also unethical; (iv) the fact that dentists can continue to practise despite hepatitis B infection, but infected prospective students are denied matriculation, is unethical; and (v) that the current Department of Health protocols, as well as being intrinsically unfair, have further unethical effects, such as the waste of valuable resources on ‘lookback’ exercises and the even more damaging loss of present and future dentists. Regulation in this area seems to have been driven by institutional fear of public fear of infection, rather than any scientific evidence or ethical reasoning.

Homeopathy has been the subject of intense academic, media and public debate in recent months. Those opposed to the practice, which treats like with like by using ultra-dilute remedies, argue that it is an ineffective non-treatment that is not supported by evidence and should not be funded on the National Health Service. Its proponents claim that it is effective (although they disagree about whether it is more effective than placebo) and argue its use is appropriate for certain conditions. This paper examines homeopathy from the perspective of the four principal principles of medical ethics and two example cases. It transpires that homeopathic practice is in contravention of all four of these principles, and is by its very nature unethical.

Mandeville and colleagues describe a fascinating case where Facebook was used to warn potential contacts that their acquaintance had a communicable disease (Mandeville et al., 2013). They are correct that this case raises important issues about social media, confidentiality and the prevention of harm. However, they underestimate both the dangers of overcommunication via Wall and Timeline postings (and Twitter) and the potential utility of Facebook in cases like this one. Increased awareness of Facebook functionality will allow more accurate targeting of those at risk of infection, while also protecting the confidentiality of the index case

It is well known that prisoners’ human rights are often violated. In this chapter we examine whether guidelines can be effective in preventing such violations and in helping physicians resolve the significant conflicts of interest that they often face in trying to protect prisoners’ rights. We begin by explaining the role of clinical and ethical guidelines outside prisons, in the context of healthcare for non-incarcerated prisoners, and then the specific role of such guidelines within prisons, where the main concerns are ensuring respect for the principle of equivalence of care, and for a prisoner patient’s autonomy in health care decisions. After reviewing and analysing various national and international guidelines, we review the literature and assess whether the good practices set out in these guidelines actually translate into changes in professional behaviour and consequent benefits for prisoners. It emerges that physicians both outside and within prisons tend to be insufficiently familiar with the relevant guidelines, and that they too infrequently use the guidance to make decisions, preferring instead to use personal codes of conduct. Guidelines designed specifically for the prison context are important to ensure equivalence of care and should be better known by health care personnel and other professional groups working in prison. Further guidelines should be developed that describe challenging situations and provide concrete guidance as to how to deal with them.

Several bioethical topics received a great deal of news coverage here in Scotland in 2009. Three important issues with transatlantic connections are the swine flu outbreak, which was handled very differently in Scotland, England and America; the US debate over healthcare reform, which drew the British NHS into the controversy; and the release to Libya of the Lockerbie bomber, which at first glance might not seem particularly bioethical, but which actually hinged on the very public discussion of the prisoner’s medical records. On a national level, there have been attempts in both Scotland and England to change the law on assisted suicide, where success looks more likely than ever. This paper will discuss each of these issues, and hopefully raise awareness of how these issues were dealt with in the UK and its component countries.

It is highly probable that you have fallen victim to a spoiler at some point in your life. Perhaps you heard what the twist was in The Sixth Sensei before you saw it, or perhaps you have come across one of the now near-ubiquitous references in the media to Keyzer Soze, and thus had much of your enjoyment of The Usual Suspectsii ruined. Put simply, a spoiler is a piece of information that spoils your enjoyment of a film, usually by revealing a key plot detail. This paper argues that those working in the media and the public at large have an ethical obligation to avoid communicating spoilers if at all possible. Although this might seem like an unimportant moral issue (or not a moral issue at all) it transpires {SPOILER ALERT} that spoilers, particularly of the media variety, can have a significant cumulative antiutilitarian effect. This paper will feature less examples than is typical of a philosophical work, because the author wishes to avoid any spoilers.