bluuebunny/crossref_metadata_2025 huggingface dataset:
Offering patients entry in clinical trials: preliminary study of the views of prospective participants.
Authors: Corbett F , Oldham J , Lilford R
Published: November 2008

OBJECTIVE: To ascertain attitudes to different methods of obtaining informed consent for randomised clinical trials (RCTs). DESIGN: Structured interviews with members of the public, medical secretaries and medical students. SETTING: The public were approached in a variety of public places. Medical secretaries and students were approached in their place of work. SUBJECTS: Fifty members of the public, 25 secretaries and 25 students. MAIN OUTCOME MEASURES: Views on RCTs were elicited, with particular emphasis on how subjects thought the concept of randomisation should be explained. Each participant was presented with descriptions of proposed clinical trials and asked to select his or her preference from a range of options. RESULTS: Written information was preferred over verbal information in 91% of replies. Most respondents (86%) would prefer to sign a consent form. Of the seven statements explaining randomisation, a significant difference was found in favour of explanations that were less explicit about the play of chance (ANOVA; p = 0.0004). Eighty-three per cent of participants thought that randomised trials were morally acceptable when there was no prior medical preference between treatments. However, over half (55%) thought they would find it upsetting to be offered entry in such a trial and a quarter thought the outcome of treatment might be adversely affected. CONCLUSIONS: Our results offer some support for the idea that "economy with truth" is less unsettling than a frank description of the stark reality of what randomisation means. It is a matter of debate as to whether, if we are correct, autonomy should have precedence over beneficence. The offer of entry in a clinical trial is likely to affect the experience of care for many people, especially if the process of randomisation is described explicitly. Potential participants should be given a detailed written explanation of the rationale for the trial and be asked to sign a consent form if they agree to take part.
Resuscitation decisions in the elderly: a discussion of current thinking.
Authors: Bruce-Jones P N
Published: November 2008

Decisions about cardiopulmonary resuscitation may be based on medical prognosis, quality of life and patients' choices. Low survival rates indicate its overuse. Although the concept of medical futility has limitations, several strong predictors of non-survival have been identified and prognostic indices developed. Early results indicate that consideration of resuscitation in the elderly should be very selective, and support "opt-in" policies. In this minority of patients, quality of life is the principal issue. This is subjective and best assessed by the individual in question. Patients' attitudes cannot be predicted reliably and surrogate decision-making is inadequate. Lay knowledge is poor. However, patients can use prognostic information to make rational choices. The majority welcome discussion of resuscitation and prefer this to be initiated by their doctors; many wish to decide for themselves. There is little evidence that this causes distress. The views of such patients, if competent, should be sought actively.
Ethical theory, ethnography, and differences between doctors and nurses in approaches to patient care.
Authors: Robertson D W
Published: November 2008

OBJECTIVES: To study empirically whether ethical theory (from the mainstream principles-based, virtue-based, and feminist schools) usefully describes the approaches doctors and nurses take in everyday patient care. DESIGN: Ethnographic methods: participant observation and interviews, the transcripts of which were analysed to identify themes in ethical approaches. SETTING: A British old-age psychiatry ward. PARTICIPANTS: The more than 20 doctors and nurses on the ward. RESULTS: Doctors and nurses on the ward differed in their conceptions of the principles of beneficence and respect for patient autonomy. Nurses shared with doctors a commitment to liberal and utilitarian conceptions of these principles, but also placed much greater weight on relationships and character virtues when expressing the same principles. Nurses also emphasised patient autonomy, while doctors were more likely to advocate beneficence, when the two principles conflicted. CONCLUSION: The study indicates that ethical theory can, contrary to the charges of certain critics, be relevant to everyday health care-if it (a) attends to social context and (b) is flexible enough to draw on various schools of theory.
Animal rights v animal research: a modest proposal.
Authors: Bernstein J
Published: November 2008

The practical problem of assuaging the opponents of animal research may be solved without formally addressing (or resolving) the underlying ethical questions of the debate. Specifically, a peaceful boycott of the "fruits" of animal research may lead to a wider cessation of such research, than, say, vocal or even violent protest. To assist those who might wish to participate in such a boycott- and, moreover, to critically inform them of the implications of their actions-1 offer a modest proposal: the use of an "animal research advance directive", a form which enumerates precisely which "fruits of research" are declined.
Research ethics committees at work: the experience of one multi-location study.
Authors: While A E
Published: November 2008

OBJECTIVES: To report the outcome of applications to 43 research ethics committees. SETTING: Four regional health authorities in England. FINDINGS: The research ethics committees varied considerably in their practices. The time lapse until notification of the outcome of the approval ranged from just under one week to 23 weeks with a mean of 8.6 weeks. Four research ethics committees failed to notify the research team of an outcome of their request for approval. CONCLUSION: A national research ethics committee is needed to review national and multi-location research studies in the light of the fragmented and variable practice of local research ethics committees.
The case of Medea--a view of fetal-maternal conflict.
Authors: Reid M C , Gillett G
Published: November 2008

Medea killed her children to take away the smile from her husband's face, according to Euripides, an offence against nature and morality. What if Medea had still been carrying her two children, perhaps due to give birth within a week or so, and had done the same? If this would also have been morally reprehensible, would that be a judgment based on her motives or on her action? We argue that the act has multiple and holistic moral features and that, in fact, there is no absolute principle, such as the right of the fetus to life, which governs our moral judgments about fetal-maternal conflicts. We suggest that they illustrate a pervasive feature of human moral discourse and can only be addressed by attending to a range of negotiable moral considerations which depend on particular features of each situation.
Authority, autonomy, responsibility and authorisation: with specific reference to adolescent mental health practice.
Authors: Sutton A
Published: November 2008

Standards for professional training and practice are defined by accrediting organisations or statutory bodies. These describe the arena in which the practitioner may speak with authority. The sphere of authorised practice is further delineated by the external resources available. Within this explicit framework, unconscious mental processes can affect the professional response in potentially adverse ways. This is particularly important in mental health practice. Professionals must be prepared to examine their own responses on this basis in order to enhance their knowledge of the patient and minimise the possibilities of the patient becoming the victim of the professional's own psychopathology. The maintenance of such a position in an institution or organisation requires a similar process within its structure in order to provide the necessary setting and define the limits of good practice. In this paper, the field of adolescent mental health is specifically examined.
Of persons and organisms: a reply to Howsepian.
Authors: Lockwood M
Published: November 2008

Howsepian has presented a number of thought experiments, which are designed to undermine my claim that our identity through time is grounded in the continued existence of those structures in our brains which directly underlie mental functioning. I argue that the conclusions which Howsepian draws from these thought experiments are mistaken, and that his discussion of them is vitiated, in particular, by his failure to distinguish between personal identity and the identity of the associated human organism.
Ethics and the GMC core curriculum: a survey of resources in UK medical schools.
Authors: Fulford K W , Yates A , Hope T
Published: November 2008

OBJECTIVES: To study the resources available and resources needed for ethics teaching to medical students in UK medical schools as required by the new GMC core curriculum. DESIGN: A structured questionnaire was piloted and then circulated to deans of medical schools. SETTING: All UK medical schools. RESULTS: Eighteen out of 28 schools completed the questionnaire, the remainder either indicating that their arrangements were "under review" (4) or not responding (6). Among those responding: 1) library resources, including video and information technology were found to be fairly well developed; 2) many schools had a good supply of handouts and sample cases for teaching; 3) most had a written syllabus, and 4) two-thirds examined in the subject. However, many schools indicated that there was an urgent need for: 1) full-time teachers (most ethics teaching is still by part-time and voluntary staff); funding for books and journals, and 3) additional teaching materials (including further case vignettes, handouts and sample exam questions). CONCLUSIONS: There has been a considerable overall improvement in resources for medical ethics teaching since the time of the last national survey (The Pond Report). However, provision varies widely from medical school to medical school. The particular needs identified were for full-time teachers, library resources and teaching materials. Wider use of existing organisations concerned with medical ethics could help to meet these needs.
The gift of blood in Europe: an ethical defence of EC directive 89/381.
Authors: Keown J
Published: November 2008

Article 3.4 of EC directive 89/381 requires member states to take "all necessary measures to promote Community self-sufficiency in human blood or human plasma" and, for this purpose, to "encourage the voluntary unpaid donation of blood and plasma". This paper presents an ethical case in support of the policy of voluntary, unpaid donation.
Medical futility and the social context.
Authors: Halliday R
Published: November 2008

The concept of medical futility has come to be seen in some quarters as a value-neutral trump card when dealing with issues of power and conflicting values in medicine. I argue that this concept is potentially useful, but only in a social context that provides a normative framework for its use. This social context needs to include a broad consensus about the purpose of medicine and the nature of the physician-patient relationship.
Organ transplant initiatives: the twilight zone.
Authors: Price D P
Published: November 2008

Assessments of the acceptability of new transplantation practices require a pinpointing of not only the meaning of death, but also the timing of death. They typically perceive elective ventilation as occurring just prior to death and non-heart-beating donor protocols as operative just after death. However, such practices in fact highlight the general vagueness and ambiguity surrounding these issues in both law and ethics. Supply-side dilemmas in transplantation lend real urgency to this "life or death" debate.
An analysis of CPR decision-making by elderly patients.
Authors: Sayers G M , Schofield I , Aziz M
Published: November 2008

Traditionally clinicians have determined their patients' resuscitation status without consultation. This has been condemned as morally indefensible in cases where not for resuscitation (NFR) orders are based on quality of life considerations and when the patient's true wishes are not known. Such instances would encompass most resuscitation decisions in elderly patients. Having previously involved patients in CPR decision-making, we chose formally to explore the reasons behind the choices made. Although the patients were not upset, and readily decided at the time of initial consultation, on later analysing the decision-making we found poor understanding of the procedure, poor recall of information given and in some cases evidence of harm. This may be attributed to impaired decision-making capacity of elderly hospitalised patients as previously shown, or to the discomfort precipitated by having to contemplate the apparent immediacy of cardiac arrest by these patients. We propose that subscribing to autonomy as a general principle needs to be balanced against particular cases where distress may be caused by, or result in, diminished competence and limited autonomy.
Partial and impartial ethical reasoning in health care professionals.
Authors: Kuhse H , Singer P , Rickard M , Cannold L , van Dyk J
Published: November 2008

OBJECTIVES: To determine the relationship between ethical reasoning and gender and occupation among a group of male and female nurses and doctors. DESIGN: Partialist and impartialist forms of ethical reasoning were defined and singled out as being central to the difference between what is known as the "care" moral orientation (Gilligan) and the "justice" orientation (Kohlberg). A structured questionnaire based on four hypothetical moral dilemmas involving combinations of (health care) professional, non-professional, life-threatening and non-life-threatening situations, was piloted and then mailed to a randomly selected sample of doctors and nurses. SETTING: 400 doctors from Victoria, and 200 doctors and 400 nurses from New South Wales. RESULTS: 178 doctors and 122 nurses returned completed questionnaires. 115 doctors were male, 61 female; 50 nurses were male and 72 were female. It was hypothesised that there would be an association between feminine subjects and partialist reasoning and masculine subjects and impartialist reasoning. It was also hypothesised that nurses would adopt a partialist approach to reasoning and doctors an impartialist approach. No relationship between any of these variables was observed.
May we practise endotracheal intubation on the newly dead?
Authors: Ardagh M
Published: November 2008

Endotracheal intubation (ETI) is a valuable procedure which must be learnt and practised, and performing ETI on cadavers is probably the best way to do this, although lesser alternatives do exist. Performing ETI on a cadaver is viewed with a real and reasonable repugnance and if it is done without proper authorisation it might be illegal. Some form of consent is required. Presumed consent would preferably be governed by statute and should only occur if the community is well informed and therefore in a position of being able to decline. Currently neither statute nor adequate informing exists. Endotracheal intubation on the newly dead may be justifiable according to a Guttman scale if the patient has already consented to organ donation and if further research supports the relevance of the Guttman scale to this question. A "mandated choice" with prior individual consent as a matter of public policy is the best of these solutions, however until such a solution is in place we may not practise endotracheal intubation on the newly dead.
Moral assessment of growth hormone therapy for children with idiopathic short stature.
Authors: Verweij M , Kortmann F
Published: November 2008

The prescription of growth hormone therapy for children who are not growth hormone deficient is one of the controversies in contemporary paediatric endocrinology. Is it morally appropriate to enhance the growth, by means of medical treatment, of a child wish idiopathic short stature? The medical, moral, and philosophical questions in this area are many. Data on the effects of human growth hormone (hGH) treatment will not on their own provide us with answers, as these effects have to be evaluated from a normative perspective. In this article we consider hGH treatment for children of idiopathic short stature from three normative perspectives: the goals of medicine, the good of the patient, and the public good. We argue that the prevention of psychological and social problems due to short stature (and not merely the enhancement of growth) should be the ultimate goal of medical treatment and research.
Teaching ethics using small-group, problem-based learning.
Authors: Tysinger J W , Klonis L K , Sadler J Z , Wagner J M
Published: November 2008

Ethics is the emphasis of our first-year Introduction to Clinical Medicine-1 course. Introduction to Clinical Medicine-1 uses problem-based learning to involve groups of seven to nine students and two facilitators in realistic clinical cases. The cases emphasize ethics, but also include human behaviour, basic science, clinical medicine, and prevention learning issues. Three cases use written vignettes, while the other three cases feature standardized patients. Groups meet twice for each case. In session one, students read the case introduction, obtain data from the written case or standardized patient, identify the case's ethical problems, formulate learning issues, discuss ways to resolve the moral conflicts, and assign research responsibilities. In session two, students discuss their assigned learning issues and specify and justify clinical actions to address the case's ethical dilemmas. Following three cases, groups write an essay discussing what they learned and describing how they would approach and resolve the case's learning issues.
"Goodbye Dolly?" The ethics of human cloning.
Authors: Harris J
Published: November 2008

The ethical implications of human clones have been much alluded to, but have seldom been examined with any rigour. This paper examines the possible uses and abuses of human cloning and draws out the principal ethical dimensions, both of what might be done and its meaning. The paper examines some of the major public and official responses to cloning by authorities such as President Clinton, the World Health Organisation, the European parliament, UNESCO, and others and reveals their inadequacies as foundations for a coherent public policy on human cloning. The paper ends by defending a conception of reproductive rights of "procreative autonomy" which shows human cloning to be not inconsistent with human rights and dignity.
Marginally effective medical care: ethical analysis of issues in cardiopulmonary resuscitation (CPR)
Authors: Hilberman M , Kutner J , Parsons D , Murphy D J
Published: November 2008

Outcomes from cardiopulmonary resuscitation (CPR) remain distressingly poor. Overuse of CPR is attributable to unrealistic expectations, unintended consequences of existing policies and failure to honour patient refusal of CPR. We analyzed the CPR outcomes literature using the bioethical principles of beneficence, non-maleficence, autonomy and justice and developed a proposal for selective use of CPR. Beneficence supports use of CPR when most effective. Non-maleficence argues against performing CPR when the outcomes are harmful or usage inappropriate. Additionally, policies which usurp good clinical judgment and moral responsibility, thereby contributing to inappropriate CPR usage, should be considered maleficent. Autonomy restricts CPR use when refused but cannot create a right to CPR. Justice requires that we define which medical interventions contribute sufficiently to health and happiness that they should be made universally available. This ordering is necessary whether one believes in the utilitarian standard or wishes medical care to be universally available on fairness grounds. Low-yield CPR fails justice criteria. Cardiopulmonary resuscitation should be performed when justified by the extensive outcomes literature; not performed when not desired by the patient or not indicated; and performed infrequently when relatively contraindicated.
Causing death or allowing to die? Developments in the law.
Authors: Ferguson P R
Published: November 2008

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.
Against medical ethics: a response to Cassell
Authors: Seedhouse David
Published: November 2008

This paper responds to Dr Cassell's request for a fuller explanation of my argument in the paper, Against medical ethics: a philosopher's view. A distinction is made between two accounts of ethics in general, and the philosophical basis of health work ethics is briefly stated. The implications of applying this understanding of ethics to medical education are discussed.
Changes in medical student attitudes as they progress through a medical course.
Authors: Price J , Price D , Williams G , Hoffenberg R
Published: November 2008

OBJECTIVES: To explore the way ethical principles develop during a medical education course for three groups of medical students--in their first year, at the beginning of their penultimate (fifth) year and towards the end of their final (sixth) year. DESIGN: Survey questionnaire administered to medical students in their first, fifth and final (sixth) year. SETTING: A large medical school in Queensland, Australia. SURVEY SAMPLE: Approximately half the students in each of three years (first, fifth and sixth) provided data on a voluntary basis, a total of 385 students. RESULTS: At the point of entry, minor differences were found between medical students and first year law and psychology students. More striking were differences between male and female medical students, suggesting early socialization had a substantial impact here. CONCLUSIONS: Results indicate that substantial changes in attitude have developed by the beginning of fifth year with little change thereafter. Gender difference persisted. Some difference in ethical attitudes were found when groups of different ethnic backgrounds were compared. The impact of a move to a graduate medical course, which gives high priority to ethics within a professional development domain, can now be evaluated.
An anthropological exploration of contemporary bioethics: the varieties of common sense.
Authors: Turner L
Published: November 2008

Patients and physicians can inhabit distinctive social worlds where they are guided by diverse understandings of moral practice. Despite the contemporary presence of multiple moral traditions, religious communities and ethnic backgrounds, two of the major methodological approaches in bioethics, casuistry and principlism, rely upon the notion of a common morality. However, the heterogeneity of ethnic, moral, and religious traditions raises questions concerning the singularity of common sense. Indeed, it might be more appropriate to consider plural traditions of moral reasoning. This poses a considerable challenge for bioethicists because the existence of plural moral traditions can lead to difficulties regarding "closure" in moral reasoning. The topics of truth-telling, informed consent, euthanasia, and brain death and organ transplantation reveal the presence of different understandings of common sense. With regard to these subjects, plural accounts of "common sense" moral reasoning exist.
Supply of medicines: paternalism, autonomy and reality.
Authors: Prayle D , Brazier M
Published: November 2008

Radical changes are taking place in the United Kingdom in relation to the classification of, and access to, medicines. More and more medicines are being made available over the counter both in local pharmacies and in supermarkets. The provision of more open access to medicines may be hailed as a triumph for patient autonomy. This paper examines whether such a claim is real or illusory. It explores the ethical and legal implications of deregulating medicines. Do patients benefit? What is the impact on pharmacists? Are the true beneficiaries of change largely the pharmaceutical industries?
Francis Galton: and eugenics today.
Authors: Galton D J , Galton C J
Published: November 2008

Eugenics can be defined as the use of science applied to the qualitative and quantitative improvement of the human genome. The subject was initiated by Francis Galton with considerable support from Charles Darwin in the latter half of the 19th century. Its scope has increased enormously since the recent revolution in molecular genetics. Genetic files can be easily obtained for individuals either antenatally or at birth; somatic gene therapy has been introduced for some rare inborn errors of metabolism; and gene manipulation of human germ-line cells will no doubt occur in the near future to generate organs for transplantation. The past history of eugenics has been appalling, with gross abuses in the USA between 1931 and 1945 when compulsory sterilization was practised; and in Germany between 1933 and 1945 when mass extermination and compulsory sterilization were performed. To prevent such abuses in the future statutory bodies, such as a genetics commission, should be established to provide guidance and rules of conduct for use of the new information and technologies as applied to the human genome.
Empirical examination of the ability of children to consent to clinical research.
Authors: Ondrusek N , Abramovitch R , Pencharz P , Koren G
Published: November 2008

This study examined the quality of children's assent to a clinical trial. In subjects younger than 9 years of age, understanding of most aspects of the study was found to be poor to non-existent. Understanding of procedures was poor in almost all subjects. In addition, voluntariness may have been compromised in many subjects by their belief that failure to complete the study would displease others. If the fact that a child's assent has been obtained is used to justify the exposure of that child to the potential harm of a non-therapeutic blood sample, the assent must be meaningful. In the nutrition study observed here, the quality of the assent of children younger than 9 years of age was very poor. The assent therefore did not provide a valid justification for requesting a blood sample from these children. This study indicates that most children younger than 9 years of age cannot be expected to consent or assent to clinical research in a meaningful way. The current age of 7 years for initiating assent (in addition to parental consent) is possibly not appropriate and should be reconsidered.
Bioethics of the refusal of blood by Jehovah's Witnesses: Part 1. Should bioethical deliberation consider dissidents' views?
Authors: Muramoto O
Published: November 2008

Jehovah's Witnesses' (JWs) refusal of blood transfusions has recently gained support in the medical community because of the growing popularity of "no-blood" treatment. Many physicians, particularly so-called "sympathetic doctors", are establishing a close relationship with this religious organization. On the other hand, it is little known that this blood doctrine is being strongly criticized by reform-minded current and former JWs who have expressed conscientious dissent from the organization. Their arguments reveal religious practices that conflict with many physicians' moral standards. They also suggest that a certain segment of "regular" or orthodox JWs may have different attitudes towards the blood doctrine. The author considers these viewpoints and argues that there are ethical flaws in the blood doctrine, and that the medical community should reconsider its supportive position. The usual physician assumption that JWs are acting autonomously and uniformly in refusing blood is seriously questioned.
The cost of refusing treatment and equality of outcome.
Authors: Savulescu J
Published: November 2008

Patients have a right to refuse medical treatment. But what should happen after a patient has refused recommended treatment? In many cases, patients receive alternative forms of treatment. These forms of care may be less cost-effective. Does respect for autonomy extend to providing these alternatives? How for does justice constrain autonomy? I begin by providing three arguments that such alternatives should not be offered to those who refuse treatment. I argue that the best argument which refusers can appeal to is based on the egalitarian principle of equality of outcome. However, this principle does not ultimately support a right to less cost-effective alternatives. I focus on Jehovah's Witnesses refusing blood and requesting alternative treatments. However, the point applies to many patients who refuse cost-effective medical care.
Mental incapacity: some proposals for legislative reform.
Authors: McHale J V
Published: November 2008

While the decision of the House of Lords in Re F in [1990] clarified somewhat the law concerning the treatment of the mentally incapacitated adult, many uncertainties remained. This paper explores proposals discussed in a recent government green paper for reform of the law in an area involving many difficult ethical dilemmas.
Transfusion-free treatment of Jehovah's Witnesses: respecting the autonomous patient's motives.
Authors: Malyon D
Published: November 2008

What makes Jehovah's Witnesses tick? What motivates practitioners of medicine? How is benevolent human behaviour to be interpreted? The explanation that fear of censure, mind-control techniques or enlightened self-interest are the real motivators of human conduct is questioned. Those who believe that man was created in "God's image", hold that humanity has the potential to rise above selfishly driven attitudes and actions, and reflect the qualities of love, kindness and justice that separate us from the beasts. A comparison of general medical ethics and disciplines, and those of the Jehovah's Witness community, is made in this context. The easy charge that frequent deaths result from refusal of blood transfusions is examined. The central source of antipathy towards Jehovah's Witnesses, namely the alleged imposition of extreme and even harmful refusal of blood therapy on our children is addressed. Of course, "...few dilemmas are likely to be resolved wisely or satisfactorily by a blinkered adherence to abstract principles alone. Solutions to most cases will be dictated by a combination of factors. The support of medical ethics by Jehovah's Witnesses, and their willingness to share in reasoned and ethical debate, while at the same time holding firm to their religious and conscientious principles are emphasised.
The commodification of human reproductive materials.
Authors: Resnik D B
Published: November 2008

This essay develops a framework for thinking about the moral basis for the commodification of human reproductive materials. It argues that selling and buying gametes and genes is morally acceptable although there should not be a market for zygotes, embryos, or genomes. Also a market in gametes and genes should be regulated in order to address concerns about the adverse social consequences of commodification.
Can unequal be more fair? Ethics, subject allocation, and randomised clinical trials.
Authors: Avins A L
Published: November 2008

Randomised clinical trials provide the most valid means of establishing the efficacy of clinical therapeutics. Ethical standards dictate that patients and clinicians should not consent to randomisation unless there is uncertainty about whether any of the treatment options is superior to the others ("equipoise"). However, true equipoise is rarely present; most randomised trials, therefore, present challenging ethical dilemmas. Minimising the tension between science and ethics is an obligation of investigators and clinicians. This article briefly reviews several techniques for addressing this issue and suggests that unbalanced randomisation, a technique rarely employed in current clinical trial practice, may be useful for enhancing the ethical design of human experimentation.
Selecting subjects for participation in clinical research: one sphere of justice.
Authors: Weijer C
Published: November 2008

Recent guidelines from the US National Institutes of Health (NIH) mandate the inclusion of adequate numbers of women in clinical trials. Ought such standards to apply internationally? Walzer's theory of justice is brought to bear on the problem, the first use of the theory in research ethics, and it argues for broad application of the principle of adequate representation. A number of practical conclusions for research ethics committees (RECs) are outlined. Eligibility criteria in clinical trials ought to be justified by trial designers. Research ethics committees ought to question criteria that seem to exclude unnecessarily women from research participation. The issue of adequate representation should be construed broadly, so as to include consideration of the representation of the elderly, persons with HIV, mental illness and substance abuse disorders in clinical research.
Relationships between various attitudes towards self-determination in health care with special reference to an advance directive.
Authors: Eisemann M , Richter J
Published: November 2008

OBJECTIVES: The subject of patient self-determination in health care has gained broad interest because of the increasing number of incompetent patients. In an attempt to solve the problems related to doctors' decision making in such circumstances, advance directives have been developed. The purpose of this study was to examine relationships between public attitudes towards patient autonomy and advance directives. SUBJECTS AND MAIN OUTCOME MEASURES: A stratified random sample of 600 adults in northern Sweden was surveyed by a questionnaire with a response rate of 78.2%. The subjects were asked about their wish for control of their health care, their concerns about health care, their treatment preferences in a life-threatening situation (both reversible and irreversible), and their attitudes towards the application of advance directives. RESULTS: Numerous relationships between various aspects of self-determination in health care (desire for control, fears of over-treatment, and choice of treatment level) in general and advance directives, in particular, were found. Those who wanted to have a say in their health care (about 94%) also mainly supported the use of an advance directive. CONCLUSIONS: The fact that almost 30% of the respondents were undecided concerning their personal use of advance directives points to a lack of knowledge and to the necessity of education of the public on these issues.
Do studies of the nature of cases mislead about the reality of cases? A response to Pattison et al.
Authors: Higgs R
Published: November 2008

This article questions whether many are misled by current case studies. Three broad types of style of case study are described. A stark style, based on medical case studies, a fictionalised style in reaction, and a personal statement made in discussion groups by an original protagonist. Only the second type fits Pattison's category. Language remains an important issue, but to be examined as the case is lived in discussion rather than as a potentially reductionist study of the case as text.
Genetic privacy: orthodoxy or oxymoron?
Authors: Sommerville A , English V
Published: November 2008

In this paper we question whether the concept of "genetic privacy" is a contradiction in terms. And, if so, whether the implications of such a conclusion, inevitably impact on how society comes to perceive privacy and responsibility generally. Current law and ethical discourse place a high value on self-determination and the rights of individuals. In the medical sphere, the recognition of patient "rights" has resulted in health professionals being given clear duties of candour and frankness. Dilemmas arise, however, when patients decline to know relevant information or, knowing it, refuse to share it with others who may also need to know. This paper considers the notions of interconnectedness and responsibility to others which are brought to the fore in the genetic sphere and which challenge the primacy afforded to personal autonomy. It also explores the extent to which an individual's perceived moral obligations can or should be enforced.
Can we learn from eugenics?
Authors: Wikler D
Published: November 2008

Eugenics casts a long shadow over contemporary genetics. Any measure, whether in clinical genetics or biotechnology, which is suspected of eugenic intent is likely to be opposed on that ground. Yet there is little consensus on what this word signifies, and often only a remote connection to the very complex set of social movements which took that name. After a brief historical summary of eugenics, this essay attempts to locate any wrongs inherent in eugenic doctrines. Four candidates are examined and rejected. The moral challenge posed by eugenics for genetics in our own time, I argue, is to achieve social justice.
Genetic screening with the DNA chip: a new Pandora's box?
Authors: Henn W
Published: November 2008

The ethically controversial option of genetic population screening used to be restricted to a small number of rather rare diseases by methodological limitations which are now about to be overcome. With the new technology of DNA microarrays ("DNA chip"), emerging from the synthesis of microelectronics and molecular biology, methods are now at hand for the development of mass screening programmes for a wide spectrum of genetic traits. Thus, the DNA chip may be the key technology for a refined preventive medicine as well as a new dimension of eugenics. The forthcoming introduction of the DNA chip technology into medical practice urgently requires an internationally consistent framework of ethical standards and legal limitations if we do not want it to become a new Pandora's box.
Persons and their copies.
Authors: McCarthy D
Published: November 2008

Is cloning human beings morally wrong? The basis for the one serious objection to cloning is that, because of what a clone is, clones would have much worse lives than non-clones. I sketch a fragment of moral theory to make sense of the objection. I then outline several ways in which it might be claimed that, because of what a clone is, clones would have much worse lives than non-clones. In particular, I look at various ideas connected with autonomy. I conclude that there is no basis to the claim that, because of what a clone is, clones would have much worse lives than non-clones. I therefore reject the claim that cloning human beings is morally wrong.
Equitable rationing of highly specialised health care services for children: a perspective from South Africa.
Authors: Landman W A , Henley L D
Published: November 2008

The principles of equality and equity, respectively in the Bill of Rights and the white paper on health, provide the moral and legal foundations for future health care for children in South Africa. However, given extreme health care need and scarce resources, the government faces formidable obstacles if it hopes to achieve a just allocation of public health care resources, especially among children in need of highly specialised health care. In this regard, there is a dearth of moral analysis which is practically useful in the South African situation. We offer a set of moral considerations to guide the macro-allocation of highly specialised public health care services among South Africa's children. We also mention moral considerations which should inform micro-allocation.
Genetically determined obesity in Prader-Willi syndrome: the ethics and legality of treatment.
Authors: Holland A J , Wong J
Published: November 2008

A central characteristic of people with Prader-Willi Syndrome (PWS) is an apparent insatiable appetite leading to severe overeating and the potential for marked obesity and associated serious health problems and premature death. This behaviour may be due to the effects of the genetic defect resulting from the chromosome 15 abnormalities associated with the syndrome. We examine the ethical and legal dilemmas that can arise in the care of people with PWS. A tension exists between a genetic deterministic perspective and that of individual choice. We conclude that the determination of the capacity of a person with PWS to make decisions about his/her eating behaviour and to control that behaviour is of particular importance in resolving this dilemma. If the person is found to lack capacity, the common law principles of acting in a person's "best interests" using the "least restrictive alternative" may be helpful. Allowing serious weight gain in the absence of careful consideration of these issues is an abdication of responsibility.
Research, ethics and conflicts of interest.
Authors: Little M
Published: November 2008

In this paper, I have tried to develop a critique of committee procedures and conflict of interest within research advisory committees and ethical review committees (ERCs). There are specific features of conflict of interest in medical research. Scientists, communities and the subjects of research all have legitimate stakeholdings. The interests of medical scientists are particularly complex, since they are justified by the moral and physical welfare of their research subjects, while the reputations and incomes of scientists depend on the success of their science. Tensions of this kind must at times produce conflict of interest. It is important to recognise that conflicts of interest may unwittingly lead to manipulation of research subjects and their lay representatives on research committees. It is equally important to recognise distinctions between the legal and moral aspects of conflict of interest. Some practical suggestions are made which may go some way towards resolving these difficulties. They indicate what might be needed to ensure the validity of ethical discourse, and to reduce the risks associated with conflict of interest.
Can the written information to research subjects be improved?--an empirical study.
Authors: Bjørn E , Rossel P , Holm S
Published: November 2008

OBJECTIVES: To study whether linguistic analysis and changes in information leaflets can improve readability and understanding. DESIGN: Randomised, controlled study. Two information leaflets concerned with trials of drugs for conditions/diseases which are commonly known were modified, and the original was tested against the revised version. SETTING: Denmark. PARTICIPANTS: 235 persons in the relevant age groups. MAIN MEASURES: Readability and understanding of contents. RESULTS: Both readability and understanding of contents was improved: readability with regard to both information leaflets and understanding with regard to one of the leaflets. CONCLUSION: The results show that both readability and understanding can be improved by increased attention to the linguistic features of the information.
Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical trial protocols on medicines.
Authors: Dal-Ré R , Espada J , Ortega R
Published: November 2008

OBJECTIVES: To review the characteristics and performance of research ethics committees in Spain in the evaluation of multicentre clinical trial drug protocols. DESIGN: A prospective study of 100 applications. SETTING: Forty-one committees reviewing clinical trial protocols, involving 50 hospitals in 25 cities. MAIN MEASURES: Protocol-related features, characteristics of research ethics committees and evaluation dynamics. RESULTS: The 100 applications involved 15 protocols (of which 12 were multinational) with 12 drugs. Committees met monthly (except one). They had a mean number of 12 members, requested a mean of six complete dossiers and nine additional copies of the protocol with a mean deadline of 14 days before the meeting. All applications were approved except three (two of the three were open-label long-term safety trials rejected by the same committee), which were approved by the other committees involved. The mean time from submission to approval was 64 days. The mean time from submission to arrival of the approval document at our offices was 85 days. Twenty-five committees raised queries for 38 of the 97 finally approved applications. Impact of evaluation fee, number of members, queries raised and experience of committees on timings were not statistically significant. CONCLUSION: Obtaining ethical approval is time-consuming. There is much diversity in the research ethics committees' performance. A remarkable delay (> 20 days) exists between the decision and the arrival of the written approval, suggesting administrative or organisational problems.
Ancient Chinese medical ethics and the four principles of biomedical ethics.
Authors: Tsai D F
Published: November 2008

The four principles approach to biomedical ethics (4PBE) has, since the 1970s, been increasingly developed as a universal bioethics method. Despite its wide acceptance and popularity, the 4PBE has received many challenges to its cross-cultural plausibility. This paper first specifies the principles and characteristics of ancient Chinese medical ethics (ACME), then makes a comparison between ACME and the 4PBE with a view to testing out the 4PBE's cross-cultural plausibility when applied to one particular but very extensive and prominent cultural context. The result shows that the concepts of respect for autonomy, non-maleficence, beneficence and justice are clearly identifiable in ACME. Yet, being influenced by certain socio-cultural factors, those applying the 4PBE in Chinese society may tend to adopt a "beneficence-oriented", rather than an "autonomy-oriented" approach, which, in general, is dissimilar to the practice of contemporary Western bioethics, where "autonomy often triumphs".
The ambiguity about death in Japan: an ethical implication for organ procurement.
Authors: McConnell J R
Published: November 2008

In the latter half of the twentieth century, developed countries of the world have made tremendous strides in organ donation and transplantation. However, in this area of medicine, Japan has been slow to follow. Japanese ethics, deeply rooted in religion and tradition, have affected their outlook on life and death. Because the Japanese have only recently started to acknowledge the concept of brain death, transplantation of major organs has been hindered in that country. Currently, there is a dual definition of death in Japan, intended to satisfy both sides of the issue. This interesting paradox, which still stands to be fully resolved, illustrates the contentious conflict between medical ethics and medical progress in Japan.