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Ted Shotter's founding of the London Medical Group (LMG) 50 years ago in 1963 had several far reaching implications for medical ethics, as other papers in this issue indicate. Most significant for the joint authors of this short paper was his founding of the quarterly Journal of Medical Ethics (JME) in 1975, with Alastair Campbell as its first editor-in-chief. In 1980 Raanan Gillon began his 20-year editorship (after which 5-year appointments extendable for up to 2 further years were instituted!). Gillon was succeeded in 2001 by Julian Savulescu, followed by John Harris and Soren Holm in 2004, with Julian Savulescu starting his second and current term in 2011. In 2000 an additional special edition of the JME, Medical Humanities (MH), was published, under the founding joint editorship of Martyn Evans and David Greaves. In 2003 Jane Macnaughton succeeded David Greaves as joint editor. Deborah Kirklin, under whose auspices MH became an independent journal, took over in 2008, and she was succeeded in 2013 by Sue Eckstein. This short paper offers reminiscences and reflections from the two journals’ various editors. From the start the JME was committed to clearly expressed reasoned discussion of ethical issues arising from or related to medical practice and research. In particular, both Edward Shotter and Alastair Campbell, each a cleric (one Anglican, the other Presbyterian), were at pains to make clear that the JME was not a religious journal and that it had no sort of partisan axe to grind. Campbell's appointment as founding editor was something of a surprise, as the original intention had been to appoint a medical doctor, who (‘up to the elbows in blood’) could be expected to know medical practice from the inside. However, in 1972 Campbell, a Joint Secretary of the Edinburgh Medical Group, had published Moral dilemmas in medicine . …

It is a common feature of debates on the regulation of reproductive medicine to find law portrayed as a crude form of intervention consisting in the imposition of inflexible rules on doctors and medical researchers. This paper argues that this view must be replaced by a more accurate assessment of the law's potential role in the regulation of reproductive medicine. From an analysis of the White Paper on human fertilisation and embryology, and in particular the proposed Statutory Licensing Authority, the author contends that far from being an inflexible method of regulation law can foster discussion and compromise.

Worldwide there are currently over 1200 research studies being performed on the topic of COVID-19. Many of these involve children and adults over age 65 years. There are also numerous studies testing investigational vaccines on healthy volunteers. No research team is exempt from the pressures and speed at which COVID-19 research is occurring. And this can increase the risk of honest error as well as misconduct. To date, 33 papers have been identified as unsuitable for public use and either retracted, withdrawn, or noted with concern. Asia is the source of most of these manuscripts (n=19; 57.6%) with China the largest Asian subgroup (n=11; 57.9%). This paper explores these findings and offers guidance for responsible research practice during pandemics.

Scholarly inquiry into medical ethics should inform and guide those involved in making challenging ethical decisions.1 It should strive to be integral to the work of health care professionals and health care institutions2 and clinical relevance seems essential for this to happen. To acknowledge the importance of clinical relevance for medical ethics, the Journal of Medical Ethics has introduced a regular Clinical Ethics section at the beginning of each issue. Papers that we think are likely to be of particular interest and relevance to clinicians will be placed in this section of the journal. One way in which a paper can be framed for a more clinical audience is by organising it around a scenario that healthcare professions might face. The paper published in this issue’s Clinical Ethics section considers a dilemma about whether an egg donor should be contacted to help diagnose a condition that the resulting child might have.3 While egg donation has become more common, the complexities presented by this scenario might appear removed from those which most health professionals face. However, the way in which genomics is becoming incorporated into healthcare means that the issues this scenario raises are relevant to all healthcare professionals. The spread of genomics into practice means that the …

In his classic paper, 'Why abortion is immoral', Don Marquis argues that what makes killing an adult seriously immoral is that it deprives the victim of the valuable future he/she would have otherwise had. Moreover, Marquis contends, because abortion deprives a fetus of the very same thing, aborting a fetus is just as seriously wrong as killing an adult. Marquis' argument has received a great deal of critical attention in the two decades since its publication. Nonetheless, there is a potential challenge to it that seems to have gone unnoticed. A significant percentage of fetuses are lost to spontaneous abortion. Once we bring this fact to our attention, it becomes less clear whether Marquis can use his account of the wrongness of killing to show that abortion is the moral equivalent of murder. In this paper, I explore the relevance of the rate of spontaneous abortion to Marquis' classic anti-abortion argument. I introduce a case I call Unexpected Death in which someone is about to commit murder, but, just as the would-be murderer is about to strike, his would-be victim dies unexpectedly. I then ask: what does Marquis' account of killing imply about the moral status of what the would-be murderer was about to do? I consider four responses Marquis could give to this question, and I examine what implications these responses have for Marquis' strategy of using his account of the wrongness of killing an adult to show that abortion is in the same moral category.

Robert Sparrow argues that because of women's longer life expectancy philosophers who advocate the genetic modification of human beings to enhance welfare rather than merely supply therapy are committed to favouring the selection of only female embryos, an implication he deems sufficiently implausible to discredit their position. If Sparrow's argument succeeds, then philosophers who advocate biomedical moral enhancement also seem vulnerable to a similar charge because of men's greater propensity for various forms of harmful wrongdoing. This paper argues there are various flaws in Sparrow's argument that render it unsuccessful. The paper also examines whether dimorphism reduction is a more desirable outcome than male elimination, thereby further illustrating the difficulties besetting the distinction between therapy and enhancement.

Background Medical research so flawed as to be retracted may put patients at risk by influencing treatments. Objective To explore hypotheses that more patients are put at risk if a retracted paper appears in a journal with a high impact factor (IF) so that the paper is widely read; is written by a ‘repeat offender’ author who has produced other retracted research; or is a clinical trial. Methods English language papers (n=788) retracted from the PubMed database between 2000 and 2010 were evaluated. Only those papers retracting research with humans or freshly derived human material were included; 180 retracted primary papers (22.8%) met inclusion criteria. Subjects enrolled and patients treated were tallied, both in the retracted primary studies and in 851 secondary studies that cited a retracted primary paper. Results Retracted papers published in high-IF journals were cited more often (p=0.0004) than those in low-IF journals, but there was no difference between high- and low-IF papers in subjects enrolled or patients treated. Retracted papers published by ‘repeat offender’ authors did not enrol more subjects or treat more patients than papers by one-time offenders, nor was there a difference in number of citations. However, retracted clinical trials treated more patients (p=0.0002) and inspired secondary studies that put more patients at risk (p=0.0019) than did other kinds of medical research. Conclusions If the goal is to minimise risk to patients, the appropriate focus is on clinical trials. Clinical trials form the foundation of evidence-based medicine; hence, the integrity of clinical trials must be protected.

This paper responds to DW Brock's technically strong case for the use of human embryonic stem cells in medical research. His main issue in this context is the question of whether it is moral to destroy viable human embryos. He offers a number of reasons to support his view that it is moral to destroy them, but his use of conceptual arguments is not adequate to secure his position. The purpose and scope of this paper is wholly concerned with his arguments rather than with the conclusion that it is justifiable to destroy human embryos. The author proceeds through his variety of arguments and offers reasons for rejecting them. The author concludes that Brock has not shown that it is moral to destroy viable human embryos.

I am very grateful to the five commentators for taking the time to respond to my article ‘The Active Recruitment of Health Workers: A Defense’.1 I have learned a great deal from each of their commentaries, and I am sorry to say that I will be unable to address all their important comments and criticisms in detail. In this response, I will focus on replying to the commentators’ major objections. In my paper, I suggested that the emigration of health workers from poor countries might not have harmful effects on health outcomes in general, or may only have relatively small negative effects in a wide range of cases. Several commentators challenge my analysis. Carwyn Rhys Hooper suggests that it is prima facie plausible that the emigration of health workers causes harm, and that there is insufficient evidence to reject this claim.2 Gilian Brock3 and Iain Bassington4 argue that my paper failed to consider the full range of possible harms that the active recruitment of health workers brings about. These commentators are correct in that we need more evidence about the effects of migration, and that it may be too soon to arrive at the all-things-considered judgment that the emigration of health workers does not generally enable serious harm. Nonetheless, I believe that the active recruitment of health workers is still permissible. For one thing, I am less confident than Brock that the empirical research on skilled migration clearly establishes that the migration of skilled professionals causes harm to sending countries. There is a sizable body of empirical research that is inconsistent with many of Brock's claims. It is not obvious that the emigration of skilled workers depletes human capital in the sending country.5 ,6 In fact, there is evidence that the opportunity to emigrate …

Nineteen ninety-six saw the publication of a major Dutch survey into euthanasia in the Netherlands. This paper outlines the main statistical findings of this survey and considers whether it shows that voluntary euthanasia is under effective control in the Netherlands. The paper concludes that although there has been some improvement in compliance with procedural requirements, the practice of voluntary euthanasia remains beyond effective control.

This paper responds to DW Brock's technically strong case for the use of human embryonic stem cells in medical research. His main issue in this context is the question of whether it is moral to destroy viable human embryos. He offers a number of reasons to support his view that it is moral to destroy them, but his use of conceptual arguments is not adequate to secure his position. The purpose and scope of this paper is wholly concerned with his arguments rather than with the conclusion that it is justifiable to destroy human embryos. The author proceeds through his variety of arguments and offers reasons for rejecting them. The author concludes that Brock has not shown that it is moral to destroy viable human embryos.

Several cases which have been considered by the courts in recent years have highlighted the legal dilemmas facing doctors whose decisions result in the ending of a patient's life. This paper considers the case of Dr Cox, who was convicted of attempting to murder one of his patients, and explores the roles of motive, diminished responsibility and consent in cases of "mercy killing". The Cox decision is compared to that of Tony Bland and Janet Johnstone, in which the patients were in a persistent vegetative state. In all three cases, the doctors believed that their patients' quality of life was so poor that their continued existence was of no benefit to them, and decided that their lives should not be unduly prolonged, yet the doctor who was prosecuted was the one whose dying patient had requested that her death be hastened. The paper examines the law's seemingly contradictory approaches to such cases.

What renders some mentally disordered patients incapable of informed consent to medical interventions? It is argued that a patient is incapable of giving informed consent owing to mental disorder, if a mental disorder prevents a patient from understanding what s/he consents to; if a mental disorder prevents a patient from choosing decisively; if a mental disorder prevents a patient from communicating his/her consent; or if a mental disorder prevents a patient from accepting the need for a medical intervention. This paper holds that a patient's capacity to give informed consent should be assessed clinically by using these conditions necessary for informed consent, and should be assessed specifically for each intervention and specifically at the time when the consent has to be given. The paper considers patients' incapacity to give informed consent to treatment, to give informed consent to be examined clinically, and to give informed consent to participate in research.

Background Clinical papers so flawed that they are eventually retracted may put patients at risk. Patient risk could arise in a retracted primary study or in any secondary study that draws ideas or inspiration from a primary study. Methods To determine how many patients were put at risk, we evaluated 788 retracted English-language papers published from 2000 to 2010, describing new research with humans or freshly derived human material. These primary papers—together with all secondary studies citing them—were evaluated using ISI Web of Knowledge. Excluded from study were 468 basic science papers not studying fresh human material; 88 reviews presenting older data; 22 case reports; 7 papers retracted for journal error and 23 papers unavailable on Web of Knowledge. Overall, 180 retracted primary papers (22.8%) met the inclusion criteria. Subjects enrolled and patients treated in 180 primary studies and 851 secondary studies were combined. Results Retracted papers were cited over 5000 times, with 93% of citations being research related, suggesting that ideas promulgated in retracted papers can influence subsequent research. Over 28 000 subjects were enrolled—and 9189 patients were treated—in 180 retracted primary studies. Over 400 000 subjects were enrolled—and 70 501 patients were treated—in 851 secondary studies which cited a retracted paper. Papers retracted for fraud (n=70) treated more patients per study (p Conclusions Many patients are put at risk by retracted studies. These are conservative estimates, as only patients enrolled in published clinical studies were tallied.

Ellie Anderson had always known that she wanted to have children. Her mother, Louise, was aware of this wish. Ellie was designated male at birth, but according to news sources, identified as a girl from the age of three. She was hoping to undergo gender reassignment surgery at 18, but died unexpectedly at only 16, leaving Louise grappling not only with the grief of losing her daughter, but with a complex legal problem. Ellie had had her sperm frozen before starting hormone treatment, specifically so that she would retain the chance of becoming a parent after her gender reassignment. Ellie had considered what might happen to the sperm if she died and was adamant that her children should be brought into the world. She made her mother promise to ensure that this would happen. But according to UK law, Ellie’s mother has no legal right to retain her sperm, or to use it to fulfil Ellie’s wishes. In this paper, we raise several key ethical questions on this case, namely: does a refusal to bring Ellie’s children into the world wrong her posthumously? Is Ellie’s mother morally entitled to use her daughter’s sperm as Ellie wished? Should the fact that Ellie was a minor at the time of her death or the fact that she was transgendered undermine her wish to have children? Can Ellie become a parent posthumously? We consider how these complex ethical questions could be approached.

Don Marquis has put forward a non-religious argument against abortion based on what he claims is a morally relevant similarity between killing adult human beings and killing fetuses. He asserts that killing adults is wrong because it deprives them of their valuable futures. He points out that a fetus's future includes everything that is in an adult's future, given that fetuses naturally develop into adults. Thus, according to Marquis, killing a fetus deprives it of the same sort of valuable future that an adult is deprived of in being killed and this makes abortion seriously wrong. Commentators have raised a number of objections to Marquis's argument, to which he has satisfactorily responded. In this paper, difficulties with Marquis's argument that have not been considered by previous commentators are pointed out. A main thesis of this paper is that Marquis does not adequately defend his argument against several important objections that he himself has raised. These new considerations support the view that Marquis's argument is unsuccessful.

Background: Authors are required to describe in their manuscripts ethical approval from an appropriate committee and how consent was obtained from participants when research involves human participants. Objective: To assess the reporting of these protections for several study designs in general medical journals. Design: A consecutive series of research papers published in the Annals of Internal Medicine , BMJ , JAMA , Lancet and The New England Journal of Medicine between February and May 2003 were reviewed for the reporting of ethical approval and patient consent. Ethical approval, name of approving committee, type of consent, data source and whether the study used data collected as part of a study reported elsewhere were recorded. Differences in failure to report approval and consent by study design, journal and vulnerable study population were evaluated using multivariable logistic regression. Results: Ethical approval and consent were not mentioned in 31% and 47% of manuscripts, respectively. 88 (27%) papers failed to report both approval and consent. Failure to mention ethical approval or consent was significantly more likely in all study designs (except case–control and qualitative studies) than in randomised controlled trials (RCTs). Failure to mention approval was most common in the BMJ and was significantly more likely than in The New England Journal of Medicine . Failure to mention consent was most common in the BMJ and was significantly more likely than in all other journals. No significant differences in approval or consent were found when comparing studies of vulnerable and non-vulnerable participants. Conclusion: The reporting of ethical approval and consent in RCTs has improved, but journals are less good at reporting this information for other study designs. Journals should publish this information for all research on human participants.

Cancer screening programmes cause harm to individuals via overdiagnosis and overtreatment, even where they confer population-level benefit. Screening thus appears to violate the principle of non-maleficence, since it entails medically unnecessary harm to individuals. Can consent to screening programmes negate the moral significance of this harm? In therapeutic medical contexts, consent is used as a means of rendering medical harm morally permissible. However, in this paper, I argue that it is unclear that the model of consent used within therapeutic medicine can be applied unproblematically to preventive medicine. Invitation to screening changes the pragmatic norms and expectations of the patient–doctor encounter such that two key principles of consent may be violated. First, the pragmatics of a medical invitation are such that patients may fail to be adequately informed, since patients appear to assume medical invitations are made with their best interests in mind, even where information to the contrary is outlined. Second, screening invitations may place pressure on patients; in the context of a medical encounter, to make an invitation to screening may constitute an inducement to accept. In order to be sure that a patient’s consent to a screening invitation is valid, we must make clear to patients that their decision to accept screening may be shaped not only by how information about screening is presented, but by the pragmatic form of the invitation itself.

This paper considers the ethical issues raised by xenotransplantation under four headings: interfering with nature; effects on the recipient; effects on other humans; and effects on donor animals. The first two issues raise no insuperable problems: charges of unnaturalness are misguided, and the risks that xenotransplantation carries for the recipient are a matter for properly informed consent. The other two issues raise more serious problems, however, and it is argued that if we take seriously the risk of transferring new infectious agents from animal to human populations and the interests of donor animals, then a moratorium on xenotransplantation is called for. The paper finds that the recent Nuffield Council and Department of Health reports on xenotransplantation are insufficiently cautious in the conclusions that they draw from these considerations.

This paper argues that doctors ought to make all things considered value judgments about what is best for their patients. It illustrates some of the shortcomings of the model of doctor as 'fact-provider'. The 'fact-provider' model fails to take account of the fact that practising medicine necessarily involves making value judgments; that medical practice is a moral practice and requires that doctors reflect on what ought to be done, and that patients can make choices which fail to express their autonomy and which are based on mistaken judgments of value. If doctors are properly to respect patient autonomy and to function as moral agents, they must make evaluations of what their patients ought to do, all things considered. This paper argues for 'rational, non-interventional paternalism'. This is a practice in which doctors form conceptions of what is best for their patients and argue rationally with them. It differs from old-style paternalism in that it is not committed to doing what is best.

Ethical controversy over transplantation of human fetal tissue has arisen because the source of tissue is induced abortions. Opposition to such transplants has been based on various arguments, including the following: rightful informed consent cannot be obtained for use of fetal tissue from induced abortions, and fetal tissue transplantation might result in an increase in the number of abortions. These arguments were not accepted by the National Institutes of Health (NIH) Human Fetal Tissue Transplantation Research Panel. The majority opinion of the panel stated that abortion and fetal tissue use are entirely separate issues, and that tissue use is ethically acceptable because it can be morally insulated from the issue of abortion. In support of this view, panel members and others have replied to the arguments put forward by opponents of fetal tissue use. However, replies to the two arguments mentioned above have been unsatisfactory, and the shortcomings of those replies are identified herein. Examination of the arguments pro and con suggests that fetal tissue use cannot be completely insulated from the issue of abortion. Thus, in seeking an ethical justification for fetal tissue transplantation we must consider reasons other than those put forward by the NIH panel. In this paper it is argued that whatever wrong is involved in using fetal tissue from induced abortions must be balanced against the benefits for patients, and it is on this basis that fetal tissue transplantation can be ethically justified.The source of human fetal tissue used in transplantation is induced abortion and as such an ethical controversy has arisen. There are 2 arguments against transplantation of human fetal tissue: rightful informed consent is not possible to obtain and this procedure could lead to more abortions. These arguments were not accepted by the National Institute for Health's (NIH) Human Fetal Tissue Transplantation Research Panel. The panel issued a majority opinion that transplantation of human fetal tissue and abortion are different and distinct issues and as such it is morally insulated from abortion. This does not serve as an adequate reply to the above 2 arguments against it. Careful examination of the issues involved shows that transplantation of human fetal tissue can not be totally morally insulated from abortion. Therefore, in order to justify fetal tissue transplantation other considerations must be used. The conclusion of this paper is that whatever wrong is involved with transplantation of fetal tissue from induced abortion must be balanced against the benefits of the patients, and it is on this basis that fetal tissue transplantation can be justified.

Clinical trials in emergency situations present unique challenges, because they involve enrolling individuals who lack capacity to consent in the context of acute illness or injury. The US Department of Health and Human Services and Food and Drug Administration regulations allowing an Exception from Informed Consent (EFIC) in these circumstances contain requirements for community consultation, public disclosure and restrictions on study risks and benefits. In this paper, we analyse an issue raised in the regulations that has received little attention or analysis but is ethically complex. This challenge is when to solicit and honour objections to EFIC trial enrolment, including from non-legally appointed representatives. We address novel questions involving whose objections should be honoured, what level of understanding is necessary for objections to be considered valid and how hard investigators should work to offer an opportunity to object. We present a set of criteria that provide conceptual and practical guidance. We argue that objections should be honoured if they undermine one of the key assumptions that allows for the permissibility of EFIC trials: that individuals would likely not object to enrolment based on their values or preferences. We then clarify the practical implications of this approach through examination of three cases of refusal in an EFIC study.

In July 2018, the Nuffield Council of Bioethics released its long-awaited report on heritable genome editing (HGE). The Nuffield report was notable for finding that HGE could be morally permissible, even in cases of human enhancement. In this paper, we summarise the findings of the Nuffield Council report, critically examine the guiding principles they endorse and suggest ways in which the guiding principles could be strengthened. While we support the approach taken by the Nuffield Council, we argue that detailed consideration of the moral implications of genome editing yields much stronger conclusions than they draw. Rather than being merely ‘morally permissible’, many instances of genome editing will be moral imperatives.

This paper addresses the just distribution of vaccines against the SARS-CoV-2 virus and sets forth an ethical framework that prioritises frontline and essential workers, people at high risk of severe disease or death, and people at high risk of infection. Section I makes the case that vaccine distribution should occur at a global level in order to accelerate development and fair, efficient vaccine allocation. Section II puts forth ethical values to guide vaccine distribution including helping people with the greatest need, reducing health disparity, saving the most lives and promoting narrow social utility. It also responds to objections which claim that earlier years have more value than later years. Section III puts forth a practical ethical framework to aid decision-makers and compares it with alternatives.

Institutional review boards (IRB) normally require of a morally defensible clinical trial that any trial participant will benefit from the inquiry, or at least not be exposed to a significant risk of having their prospects worsened by participating. Stage 1 HIV cure trials tend not to meet this requirement. Does that show them to be morally indefensible? Utilitarian thinking about this question supports a negative answer. But one might reasonably expect a Kantian moral theory to support the conclusion that exposing trial participants to a significant risk of their prospects being worsened by their participation to be morally indefensible, on grounds that this would be a clear case of using a person as a mere means. In this paper, I argue, drawing on Kantian contractualist thinking, that requiring the risk/benefit ratio for participants be positive if a trial is to be morally defensible does not in fact gain any support from Kantian thinking about morality.

In this paper, I examine two key arguments advanced by the Human Fertilization and Embryology Authority (HFEA) and the Nuffield Council justifying anonymous mitochondrial donation, even though the 'right to know' is recognised in standard gamete donation. I argue that the two arguments they offer, what I call the argument from genetic connection and the argument from personal characteristics, are unsuccessful. However, I provide additional reasons for why recognising the right to know in gamete donation but not in mitochondrial donation may be justified. I further argue that the status quo in the UK, which is to not recognise a right to know in mitochondrial donation, is provisionally acceptable.

This article is a response to Thomas David Riisfeldt’s paper entitled ‘Weakening the ethical distinction between euthanasia, palliative opioid use and palliative sedation’. It is shown that as far as euthanasia and palliative sedation are concerned, Riisfeldt has not established that a common ground, or a similarity, between the two is the relief of suffering. Quite the contrary, this is not characteristic of euthanasia, neither by definition nor from a clinical point of view. Hence, the argument hinges on a conceptually and empirically erroneous premise and is accordingly a non-starter. This article has been accepted for publication following peer review, and the Version of Record can be accessed online at http://dx.doi.org/10.1136/medethics-2019-105457

In their paper Chris Gyngell, Hilary Bowman-Smart and Julian Savulescu offer a careful analysis of the Nuffield Council on Bioethics report, Genome Editing and Human Reproduction: social and ethical issues but they challenge us to go further still.i I want to suggest that, although their analysis is clear and accurate, its rather ‘molecular’ approach neglects the overall arc and orientation of the report. Furthermore, their conclusions about prospective parents’ reproductive obligations lack sensitivity to the proper evaluative context and offer littlein the way of policy prescriptions. A neglected aspect of the report is the dialectical relation of the three sets of considerations through which it advances: those relating to the individuals directly involved, the wider society in which they live, and the future of human being in general. In particular, Gyngell et al .’s analysis does not attend to how the second principle advanced in the report (that of solidarity and social justice) interacts with the first (that of the welfare of the future person). It also ignores an important implication of the refusal of a final synthesis (which would be that heritable genome editing – HGE – is categorically at odds with the interests of humanity), namely, to inaugurate a continual process of reflection between the first two sets of considerations. And it therefore inevitably glosses over practical questions of the mode and venue for this reflection. Something that has not been well understood in the reception …

We are printing, by kind permission of the Law Commission, two sections of the report of the Law Commission on injuries to unborn children. This report was the result of a request to the Law Commission by the Lord Chancellor at the time (Lord Hailsham of Saint Marylebone) to advise on `what the nature and extent of civil liability for antenatal injury should be9. The Law Commission followed its usual practice in such circumstances of consulting various bodies and obtaining expert advice on the subject and then embodying the results in a working paper (Working Paper No. 47 - injuries to unborn children) published on 19 January 1973, which preceded their report (Cmnd 5709). Meanwhile a Royal Commission is considering much wider issues of civil liability for injury (including antenatal injury) but the terms of reference for the Law Commission were much narrower and confined to the position of children injured before birth. In the section relating to the present law the report makes it clear that it is probable that liability under the common law already exists. The Scottish Law Commission has also issued a report (Cmnd 5371). They were given different terms of reference and came to somewhat different conclusions. We are printing from this long report the paragraphs discussing the medical background and the summary of recommendations. As will be evident on reading the paragraphs on the medical background to injuries to the unborn child, events are moving very rapidly, particularly in the study of congenital defects and the effects of drugs but the problems of proof present great difficulty. Other causes of injury to the unborn child are better known to the general public: for example, those following the illness, infection and disease of the mother during pregnancy, injury caused in attempted termination of pregnancy and the risks resulting from the mother9s condition. The summary of the recommendations sets out very clearly the legal position of the unborn child, as the Law Commission sees it, arising from injury before birth, the final conclusion being that `legislation is desirable9. These extracts from the report, apart from their intrinsic interest, lead on to the paper by Mr Kennedy and Dr Edwards in which they set out their criticisms of it, and provide quick references to the original document.

This paper is not about the medical condition of AIDS. Nor is it about the history of the condition since it was first reported in Atlanta, Georgia in 1981. It looks rather, at the catalogue of legislative and other legal responses to the spread of AIDS. The paper analyses the AIDS condition in its historical context. The hysteria accompanying the outbreak of AIDS is contrasted with the similar hysteria associated with other previous epidemics experienced in Australia over the past two centuries. The paper categorises the responses of lawmakers to the condition, according to the approach taken; from 'full blast', through 'moderate heat' to 'low key' or an attempt to avoid or minimise legal intervention. It is suggested that the appropriate response should depend upon such factors as the present magnitude of the condition, its likely future course, the availability of cures and protections against its spread and objectives being sought by intervention. Unless these factors are taken into account gross over-reaction can occur, causing social disruption and much personal injustice.Justice Kirby, president of the Court of Appeal of the Supreme Court of New South Wales and former chairman of the Australian Law Reform Commission, discusses the responses of lawmakers in Australia and other countries to the AIDS outbreak in the context of reactions to previous epidemics. He categorizes the measures proposed as "full blast" (e.g., travel restrictions; universal testing for AIDS virus antibodies; national ID cards; quarantine); "moderate heat" (compulsory detention or reporting of AIDS patients; shutting down of homosexual clubs and baths; testing of employees or other groups; registering of prostitutes; criminal penalties for "knowingly" spreading the virus); or "low key" (condoms and "safe sex" education; discouraging blood donation by persons at risk). Favoring a generally restrained approach, he cautions that overreaction can be counterproductive and can lead to social disruption and injustice.

Research ethics committees, while in many ways an excellent innovation, do have some drawbacks. This paper examines three of these. The first problem of such committees is that their approval of specific projects in their own institutions acquires intrinsic value. The second problem relates to the possible devolution of responsibility from the investigator to the committee. The committee approves, the investigator feels relieved of some responsibility and things can be done to patients which neither the committee nor the investigator might countenance if they had sole responsibility. The third problem arises directly from the bureaucratic nature of the committee itself. And one consequence of the resulting rigid guidelines is the insistence, by most committees, on the written consent of patients. Demanding this can, in some circumstances, mean giving the patient very disturbing information. The paper suggests that in patients with a fatal disease where trials compare two accepted therapies committees dispense with written consent. There is a commentary on this paper by Dr D J Weatherall of the Nuffield Department of Clinical Medicine, University of Oxford.

Professor Austin explores four main areas in this paper. First of all he outlines the physical development of sex differentiation in the embryo. He develops this by describing the clinical manifestations of abnormality which can appear at that stage. Professor Austin points out that there are relatively few people with abnormalities and that those who do show homosexual tendencies are not noticeably different from the norm in terms of their sexual equipment and hormone levels. It is much more likely that their psychological and social development has a greater influence in differentiating them sexually. The last section of the paper is a synopsis of society's reactions to homosexuality or bisexuality which term in Professor Austin's opinion is more accurate and descriptive of the condition.

A primary goal of clinical practice is to respect patient autonomy. To promote this goal for patients who have lost the ability to make their own decisions, commentators recommend that surrogates make their treatment decisions based on the substituted judgment standard. This standard is commonly interpreted as directing surrogates to make the decision the patient would have made in the circumstances, if the patient were competent. However, recent commentators have argued that this approach--attempting to make the decision the patient would have made if competent--is theoretically problematic, practically infeasible, and ignores the interests of the patient's family and loved ones. These commentators conclude that the substituted judgment standard should be revised significantly, or abandoned altogether. While this response would avoid the cited problems, it also would require substantial changes to clinical practice and would raise significant problems of its own. The present paper thus considers the possibility that the criticisms do not point to problems with the substituted judgment standard itself; instead, they point to problems with the way it is most commonly interpreted. This analysis suggests that the substituted judgment standard need not be dramatically revised or abandoned. Instead, it should be interpreted in a way that effectively promotes respect for the autonomy of incompetent patients. The 'endorsed life' interpretation described here helps clinicians and surrogates to achieve this important goal. To clarify this approach, we explain how it differs from three other recently proposed alternatives to the standard interpretation of the substituted judgment standard.

This paper reviews the ethical literature on conflicts between health professionals and parents about medical decision-making for children. We present the results of a systematic review which addressed the question 'when health professionals and parents disagree about the appropriate course of medical treatment for a child,under what circumstances is the health professional ethically justified in overriding the parents' wishes?’ We identified nine different ethical frameworks that were put forward by their authors as applicable across various ages and clinical scenarios. Each of these frameworks centred on a different key moral concept including harm,constrained parental autonomy, best interests, medically reasonable alternatives, responsible thinking and rationality.

Animal use in medical research is widely accepted on the basis that it may help to save human lives and improve their quality of life. Recently, however, objections have been made specifically to the use of animals in scientific investigation of human obesity. This paper discusses two arguments for the view that this form of animal use, unlike some other forms of animal-based medical research, cannot be defended. The first argument leans heavily on the notion that people themselves are responsible for developing obesity and so-called ‘lifestyle’ diseases; the second involves the claim that animal studies of obesity9s causes and therapies distract attention from preventive efforts. Drawing on both empirical data and moral reasoning, we argue that the relevant attributions of responsibility and claims about distraction are not plausible, and that, therefore, there is no reason to single out the use of animals in obesity research as especially problematic.

This paper discusses the issue of ‘post-birth abortion’ from an applied perspective. Three hypothetical situations where a newborn considered as a ‘potential person’ is at risk of being killed are proposed to highlight the potential controversial outcomes of post-birth abortion. The internal consistency of the argument proposed by Giubilini and Minerva to morally justify newborn killing is contested as well. Finally, an alternative moral strategy based on the precautionary principle and excluding any distinction between potential and actual persons is proposed as rational.

This paper examines the ethico-legal problems regarding the right to refuse treatment in Turkey's healthcare system. We discuss these problems in the light of a recent case that was directly reported to us. We first summarise the experience of a chronically dependent patient (as recounted by her daughter) and her family during their efforts to refuse treatment and receive palliative care only. This is followed by a summary of the legal framework governing the limits of the right to refuse treatment in Turkey. With the help of this background information on the legal framework, we re-examine the ethico-legal aspects of the case and explain the underlying reasons for the problems the family and the patient experienced. Finally, we conclude that Turkey's legal framework relating to the right to refuse treatment needs to be clarified and amended in accordance with international conventions and fundamental human rights.

Termination of pregnancy after a certain gestational age and following prenatal diagnosis, in many nations seem to be granted with a special status to the extent that they by law have to be discussed within a predominantly medical context and have physicians as third parties involved in the decision-making process ('indication-based' approach). The existing legal frameworks for indication-based approaches, however, do frequently fail to provide clear guidance for the involved physicians. Critics, therefore, asked for professional ethics and professional institutions in order to provide normative guidance for the physicians in termination of pregnancy on medical grounds. After outlining the clinical pathway in an indication-based approach and the involved types of (clinical) judgements, this paper draws upon different understandings of professional ethics in order to explore their potential to provide normative guidance in termination of pregnancy on medical grounds. The analysis reveals that professional ethics will not suffice-neither as a set of established norms nor as internal morality-in order to determine the normative framework of indication-based approaches on termination of pregnancy. In addition, there seem to be considerable inconsistencies regarding the target and outcome between prenatal testing on the one hand and following termination of pregnancy on the other hand. A source of morality external to medicine has to be the basis of evaluation if a consistent and workable normative framework for termination of pregnancy and prenatal testing should be established.

The common objection to opt-out systems of postmortal organ procurement is that they allow removal of a deceased person's organs without their actual consent. However, under certain conditions it is possible for ‘silence’—failure to register any objection—conventionally and/or legally to count as genuine consent. Prominent conditions are that the consenter should be fully informed about the meaning of his or her silence and that the costs of registering dissent should be insignificant. This paper explicates this thesis and discusses some possible objections to it: (1) it cannot possibly be guaranteed that each citizen is aware of the meaning of silence; and (2) the system is slightly manipulative because it exploits a common defect in autonomous decision-making.

Poor medication adherence in patients with a psychosis is associated with relapse. It has been proposed that outcomes might be improved by using financial incentives for treatment adherence (FITA). However, a strong moral intuition against this practice has been found. This paper examines the ethics of FITA. Three arguments are presented, which if accepted would severely restrict or even prohibit the practice. These are based on (1) "incommensurable values", where FITA denigrates an aspect of "respect for the person", (2) "exploitation", where unfair advantage is taken of the patient, and (3) "fairness", where it is difficult to draw a line between those who should and should not be offered payment. A number of practical impediments are also considered.

More than 40 primary studies, and three recent systematic reviews and meta-analyses, have shown a clear association between pharmaceutical industry funding of clinical trials and pro-industry results. Industry sponsorship biases published scientific research in favour of the sponsors, a result of the strong interest commercial sponsors have in obtaining favourable results. Three proposed remedies to this problem are widely agreed upon among those concerned with the level of sponsorship bias: financial disclosure, reporting standards and trial registries. This paper argues that all of these remedies either fail to address the mechanisms by which pharmaceutical companies' sponsorship leads to biased results-design bias, multiple trials with predictable outcomes, fraud, rhetorical effects and publication bias-or else only inadequately address those mechanisms. As a result, the policies normally proposed for dealing with sponsorship bias are unable to eliminate it. Only completely separating public clinical research from pharmaceutical industry funding can eliminate sponsorship bias.

The introduction of conscience clauses after the 1973 US Supreme Court decision in Roe v. Wade allowed physicians and nurses to opt out of medical procedures, particularly abortions, to which they were morally opposed. In recent years pharmacists have requested the same consideration with regard to dispensing some medicines. This paper examines the pharmacists' role and their professional and moral obligations to patients in the light of recent refusals by pharmacists to dispense oral contraceptives. A review of John Rawls's concepts of the "original position" and the "veil of ignorance", along with consideration of the concept of compartmentalisation, are used to assess pharmacists' requests and the moral and legal rights of patients to have their prescriptive needs met.

In healthcare, a tension sometimes arises between the injunction to do as much good as possible with scarce resources and the injunction to rescue identifiable individuals in immediate peril, regardless of cost (the "Rule of Rescue"). This tension can generate serious ethical and political difficulties for public policy makers faced with making explicit decisions about the public funding of controversial health technologies, such as costly new cancer drugs. In this paper we explore the appropriate role of the Rule of Rescue in public resource allocation decisions by health technology funding advisory bodies such as the National Institute for Health and Clinical Excellence. We consider practical approaches to operationalising the Rule of Rescue from Australia and the UK before examining the relevance of individual moral imperatives to public policy making. We conclude that that whilst public policy makers in a humane society should facilitate exceptional departures from a cost effectiveness norm in clinical decisions about identified individuals, it is not so obvious that they should, as a matter of national public policy, exempt any one group of unidentified individuals within society from the rules of opportunity cost at the expense of all others.

The process of obtaining informed consent to participate in a clinical study presents many challenges for research conducted in a population of patients with schizophrenia. Morally valid, informed consent must include information sharing, decisional capacity, and capacity for voluntarism. This paper examines the unique features of schizophrenia that may threaten each of these elements of informed consent, and it proposes additional safeguards in the process of gaining informed consent from individuals with schizophrenia in order to maximise the decision‐making potential of this patient population.

The scope of embryo research in the UK has been expanded by the Human Fertilisation and Embryology (Research Purposes) Regulations 2001. Two advisory bodies--the Chief Medical Officer's Expert Group and the House of Lords' Select Committee--presented various arguments in favour of embryo research. One of these is the view that, just as lottery tickets have relatively little value before the draw because of the low probability of their being the winning ticket, early embryos have relatively little value because of the presumed low probability that they will mature into more developed embryos. This (first) argument from probability is questioned in this paper, as well as the contention that allowing embryo destruction is incompatible with the view that embryos have full moral status. Although I challenge Savulescu's view that early embryos should be entered into a lottery in which they are subjected to the probability of being destroyed (the second argument from probability), a revised version of Thomson's analogy of the famous violinist defies the view that the position that the embryo has full moral status is incompatible with qualified support for embryo destruction.

Lifelong smokers lose on average a decade of life vis-à-vis non-smokers. Globally, tobacco causes about 5–6 million deaths annually. One billion tobacco-related deaths are predicted for the 21st century, with about half occurring before the age of 70. In this paper, we consider a complete ban on the sale of cigarettes and find that such a ban, if effective, would be justified. As with many policy decisions, the argument for such a ban requires a weighing of the pros and cons and how they impact on different individuals, both current and future. The weightiest factor supporting a ban, we argue, is the often substantial well-being losses many individuals suffer because of smoking. These harms, moreover, disproportionally affect the disadvantaged. The potential gains in well-being and equality, we argue, outweigh the limits a ban places on individuals’ freedom, its failure to respect some individuals’ autonomous choice and the likelihood that it may, in individual cases, reduce well-being.

Guidelines around the world require children to provide assent for their participation in most research studies. Yet, little further guidance is provided on how review committees should implement this requirement, including which children are capable of providing assent and when the requirement for assent may be waived on the grounds that the research offers participating children the potential for important clinical benefit. The present paper argues that the assent requirement is supported by the importance of allowing children who are capable to make their own decisions. This suggests children are capable of assent when they become able to understand the research in question. While development varies across individual children, existing data suggest most children develop this ability by approximately age 14. Until instruments are developed to assess the assent capacity of individual children, this age should be used as the threshold for assent. In addition, the importance of protecting children from harm suggests that the sustained dissent of all children, including those who are unable to provide assent, should be respected. While the assent requirement may be waived when research participation offers the potential for important medical benefit that is unavailable outside the research context, analysis suggests that children's sustained dissent should be respected in all cases.

Most of us want to have children. We want them to be healthy and have a good start in life. One way to achieve this goal is to use preimplantation genetic diagnosis (PGD). PGD enables people engaged in the process of in vitro fertilisation (IVF) to acquire information about the genetic constitution of an early embryo. On the basis of this information, a decision can be made to transfer embryos without genetic defects to the uterus and terminate those with genetic defects.1 However, is it morally acceptable to use PGD to reduce the probability of children with severe genetic diseases being born? Is the current routine use of PGD in public healthcare services to select against severe genetic diseases like anencephaly, spina bifida, cystic fibrosis and Down’s syndrome morally acceptable? These are complex questions involving a range of difficult ethical issues—for instance, critical discussions about the morality of embryo research and embryo termination.2 They also involve awkward conceptual issues concerning such matters as the meaning of words such as “disability”3 and “severe” in “severe genetic diseases”,4 which will not be discussed here. In this paper I examine an argument which aims to show that efforts to prevent the birth of severely disabled children using PGD are morally unacceptable. Essentially, this argument appeals to our concern for disabled people and the belief that PGD, through a slippery slope process, will have bad consequences for them. I conclude that the argument is problematic for a number of reasons. But before I examine the argument itself, it will be helpful to separate two types of slippery slope argument since these involve different kinds of reasoning. Many of the arguments against PGD point to the bad consequences it can be expected to have for disabled people. Central to all these …

The legalization of physician assisted suicide (PAS) in Oregon and physician assisted death (PAD) in The Netherlands has revitalized the debate over whether and under what conditions individuals should be able to determine the time and manner of their deaths, and whether they should be able to enlist the help of physicians in doing so. Although the change in the law is both dramatic and recent, the basic arguments for and against have not really changed since the issue was debated by Glanville Williams and Yale Kamisar nearly 50 years ago. In this paper, the author argues in favour of Kamisar's consequentialist framework. Any change in law and social policy should not be based solely on individual cases, heart wrenching though these may be. Instead, we need to assess the need for PAS, and weigh this against the risks of mistake and abuse.