The inclusion of children in research gives rise to a difficult ethical question: What justifies children's research participation and exposure to research risks when they cannot provide informed consent? This question arises out of the tension between the moral requirement to obtain a subject's informed consent for research participation, on the one hand, and the limited capacity of most children to provide informed consent, on the other. Most agree that children's participation in clinical research can be justified. But the ethical (...) justification for exposing children to research risks in the absence of consent remains unclear. One prevalent group of arguments aims to justify children's risk exposure by appealing to the concept of benefit. I call these ‘benefit arguments’. Prominent versions of this argument defend the idea that broadening our understanding of the notion of benefit to include non-medical benefits helps to justify children's research participation. I argue that existing benefit arguments are not persuasive and raise problems with the strategy of appealing to broader notions of benefit to justify children's exposure to research risk. (shrink)

Within the world of pharmacology, the male body has traditionally been taken as the biological norm. Coupled with this, concern about danger to the unborn foetus has meant that, until very recently, ‘women of childbearing potential’ were routinely excluded from most of the early phases of clinical drug testing. Consequently, most drugs tested during Phase I trials were initially carried out on healthy male volunteers. During subsequent phases when drugs were tested on patients, women remained largely under-represented. As a result, (...) some drugs prescribed for women have later been discovered to be lacking in efficacy, and women are more likely to suffer adverse drug reactions than men. The exclusion of women during the early phases of clinical drug trials has now been lifted and drugs are currently being more widely tested on women. This paper examines the differing political and ethical positions adopted by the pharmaceutical industry, drug regulators, pharmacologists, women's groups and patient activists in relation to the exclusion and inclusion of women in clinical drug trials. (shrink)

Non-therapeutic research on children raises ethical concerns. Such research is not only conducted on individuals who are incapable of providing informed consent. It also typically involves some degree of risk or discomfort, without prospects of medically benefiting the participating children. Therefore, these children seem to be instrumentalized. Some ethicists, however, have tried to sidestep this problem by arguing that the children may indirectly benefit from participating in such research, in ways not related to the medical intervention as such. It has (...) been argued, for example, that non-therapeutic pediatric research does not instrumentalize the children enrolled since it has the prospects of furthering their moral development. We argue that this argument is far too undeveloped to be taken seriously. (shrink)

In 2010, President Obama instructed the Presidential Commission for the Study of Bioethical Issues to enquire into research carried out by the US Public Health Service in Guatemala between 1946 and 1948. These studies entailed the deliberate inoculation of unconsenting prisoners, mental asylum patients and soldiers, with venereal disease. There was also evidence of deception and secrecy. The Commission’s report describes the research as heinous, egregious, unconscionable and unjustifiable, and identified those responsible as morally blameworthy. However, this article argues that (...) the Commission was deficient in its historical analysis, and failed to appreciate particular disease and temporal factors that might cast the research in a slightly different light. This is not to exculpate the researchers, but rather to critique the Commission’s analysis. The straightforward narrative woven by the Commission does not accurately reflect the muddy ethical waters of the time, nor the utilitarian ethos that pervaded particular research agendas. The creation of a facile story denies to us a proper understanding of why events unfolded as they did, and as a consequence a potential lack of comprehension of those elements that might prevent unethical and harmful research practices from being conducted in the future. (shrink)

A patient's informed consent is required by the Nuremberg code, and its successors, before she can be entered into a clinical trial. However, concern has been expressed by both patients and professionals about the beneficial or detrimental effect on the patient of asking for her consent. We examine advantages and drawbacks of popular variations on consent, which might reduce the stress on patients at the point of illness. Both informed and uninformed responses to particular trials, and trials in general, are (...) discussed. The selection by doctors of patients, to whom entry to trials will be offered, is explored. (shrink)

In debate over the ethics of deceptive experiments in American psy chology, commentators often provide an inaccurate history of these experiments. This happens especially where writers portray experi mental deception as a necessary accompaniment to human experiments, rather than a conscious choice based on values attached to persons and scientific inquiry. Compounding the error, commentators typically give a misleading portrayal of psychologists' attitudes and procedures. Commentators frequently cite Stanley Milgram's work in the 1960s as a harbinger of changed attitudes towards (...) deception, and suggest that today's psychologists abide by more enlightened ethical practices. It is difficult to find evidence to support this portrayal. (shrink)

Research on doctor-patient communication has characterized such interactions as being asymmetrical. The present article tries to shift emphasis away from the different orientations individuals bring to the communicative setting and attempts to highlight the different orientations ("voices") within a given individual. We draw on an in-depth analysis of discourse between a 2 l-year-old man who can be ascribed the roles of both patient and potential research subject and an interviewer who acts in both the role of medical staff and researcher. (...) Focusing our analysis on a limited number of linguistic forms (pronouns and demonstratives), it is argued that the use of the same form for different referents signals a conflation of two voices - the voice of health care ("caring") and the voice of "research." Furthermore, we argue that the voice of research is most likely to be interpreted by the patient/research subject within the framework of curing. As such, the present article promotes a shift in emphasis from different institutional - and as such often assumed to be preexisting - orientations between the communicating parties to differing orientations within the individual that cannot help but be misconstrued in terms of the curing voice. Our conclusion focuses on the ethical and discourse analytic implications of analyzing voices in a discussion. (shrink)

The application of human right frameworks is an increasingly important part of efforts to accelerate progress in global mental health. Much of this has been driven by several influential legal and policy instruments, most notably the United Nations’ Convention on the Rights of Persons with Disabilities, as well as the World Health Organization’s QualityRights Tool Kit and Mental Health Action Plan. Despite these significant developments, however, much more needs to be done to prevent human rights violations. This chapter focuses on (...) a critical component of this broader challenge, which is the question of how best to regulate and reduce the use of coercive measures. The recent literature on coercion in psychiatry – which addresses involuntary commitment, seclusion, restraint, and forced medication – represents a useful resource that can help guide tractable solutions in global mental health. These issues are evaluated from the perspective of global health governance, and several general recommendations are made in order to improve monitoring and enforcement, provide guidance for domestic legislative reform, and strengthen health systems. (shrink)