Ethical guidelines for conducting clinical trials have historically been based on a perceived therapeutic obligation to treat and benefit the patient-participants. The origins of this ethical framework can be traced to the Hippocratic oath originally written to guide doctors in caring for their patients, where the overriding moral obligation of doctors is strictly to do what is best for the individual patient, irrespective of other social considerations. In contrast, although medicine focuses on the health of the person, public health is (...) concerned with the health of the entire population, and thus, public health ethics is founded on the societal responsibility to protect and promote the health of the population as a whole. From a public health perspective, research ethics should be guided by giving due consideration to the risks and benefits to society in addition to the individual research participants. On the basis of a duty to protect the population as a whole, a fiduciary obligation to realise the social value of the research and the moral responsibility to distribute the benefits and burdens of research fairly across society, how a public health perspective on research ethics results in fundamental re-assessments of the proper course of action for two salient topical issues in research ethics is shown: stopping trials early for reasons of efficacy and the conduct of research on less expensive yet less effective interventions. (shrink)

: Recent controversial decisions to terminate several large clinical trials have called attention to the need for developing a sound ethical framework to determine when trials should be stopped in light of emerging efficacy data. Currently, the fundamental rationale for stopping trials early is based on the principle that equipoise has been disturbed. We present an analysis of the ethical and practical problems with the "equipoise disturbed" position and describe an alternative ethical framework based on the principle of nonexploitation. This (...) framework acknowledges the need for balancing the dual ethical obligations of clinical research, the protection of human subjects and the generation of new medical knowledge. Based on this framework, we put forward a proposal to make early stopping guidelines more stringent under specified conditions. The temporary withholding of apparent benefits in certain circumstances is justified by achieving a fair contract with the research participants, one that protects them from undue harm and exploitation while reducing the many uncertainties surrounding new investigational treatments that arise when trials are stopped prematurely. (shrink)

The analysis presented here lays out the ethical warrants for requiring community oversight of health research conducted in international settings. It reviews the inadequacies with the current standards of individual informed consent and research ethics committee review, and then, shows how a broader population-based public health perspective raises new demands on justice involving due consideration of the rights, harms and benefits to the community as a whole. As developed here, an ethical standard that requires community oversight of health research is (...) justified on three principled grounds: respect for community autonomy and their right to self-determination; due consideration of the consequences of the research for the community as a whole; and, a more complete understanding of human autonomy. The paper concludes with practical recommendations regarding the composition of Community Advisory Boards to ensure that they have legitimate decision-making authority in diverse socio-cultural contexts. (shrink)

Involuntary civil commitment to treatment for opioid use disorder prevents imminent overdose, but also restricts autonomy and raises other ethical concerns. Using the Kass Public Health Ethics Framework, we identified ICC benefits and harms. Benefits include: protection of vulnerable, underserved patients; reduced legal consequences; resources for families; and “on-demand” treatment access. Harms include: stigmatizing and punitive experiences; heightened family conflict and social isolation; eroded patient self-determination; limited or no provision of OUD medications; and long-term overdose risk. To use ICC ethically, (...) it should be recognized as comprising vulnerable patients worthy of added protections; be a last resort option; utilize consensual, humanizing processes; provide medications and other evidence-based-treatment; integrate with existing healthcare systems; and demonstrate effective outcomes before diffusion. ICC to OUD treatment carries significant potential harms that, if unaddressed, may outweigh its benefits. Findings can inform innovations for ensuring that ICC is used in an ethically responsible way. (shrink)

The study reports on the results of an empirical investigation of the education and recruitment processes used in HIV vaccine trials conducted in South Africa. Interviews were conducted with 21 key informants involved in HIV vaccine research in South Africa and three focus groups of community advisory board members. Data analysis identified seven major themes on the relationship between education and recruitment: the process of recruitment, the combined dual role of educators and recruiters, conflicts perceived by field staff, pressure to (...) achieve recruitment targets, problems in achieving comprehension, accountability and education as capacity building. The results raise ethical concerns about the adequacy of current informed consent processes in these settings. The study findings bear directly on current debates about issues of exploitation and the scope of moral responsibilities of researchers and funding agencies to assure that HIV clinical prevention research is conducted ethically. (shrink)

Public policies to reduce the extent of obesity in the United States have generated considerable public controversy. The paper examines the implications of proposed policies for the principles of justice and autonomy and key assumptions underlying the major contending positions with respect to the relative weight that should be assigned to them in balancing their respective claims. The analysis traces the crux of the debate regarding the ethical warrant for policies to restrict access to calorie-dense foodstuffs to two key issues: (...) the appeal to different and conflicting theories of justice, and the conflation of autonomy with negative liberty in public debates. After clarifying the ethically relevant characteristics of autonomy that merit defense, the paper concludes with a description of how the capabilities approach to justice may offer a more coherent ethical framework for developing and evaluating policies to address the current obesity epidemic. (shrink)

A letter to the editor from Howard Brody, David Buchanan, and Franklin G. Miller in response to the recent article by Erik Malmqvist Understanding Exploitation," March-April 2011).

The prelims comprise: Introduction Historical Background The Role of Health Research in Promoting Social Justice Justice in Setting Research Priorities Justice Concerns within the Research Context Case Study: The Investigation of Alternative Lead Abatement Procedures by the Kennedy Krieger Institute Conclusion Note References.

Dedicated to the late Gerard Béhague, this anthology offers perspectives on the evolving legacy of performance ethnography in socio-musical analysis and reflects the heritage but also contemporary trajectories of Béhague’s scholarly concerns. Prefaced by an essay outlining key developments in the ethnography of performance paradigm, the volume’s seven case studies portray snapshots of musical life in representative communities of the Americas, including the southwestern and Pacific United States, Puerto Rico, Bolivia, Chile, Cuba, and Ecuador. These studies pose anthropological inquiries into (...) the ontology of performance practice, the social power of poetic performativity, and the experience and embodiment of sound in place. (shrink)

As necessary austerity measures make major inroads into western health services, this paper investigates the philology of austerity and finds that there are two subtly similar yet importantly different derivations from the Latin and the Greek. The Latin austerus is an abstract term meaning dry, harsh, sour; whereas the Greek austeros has a more embodied and literal meaning of making the tongue dry. What seems an initially subtle difference between the metaphorical and the metonymic plays out as involving seriously different (...) outcomes between harsh economic measures and the literal effects on the people suffering under measures that actually make the tongue dry. The paper argues that between the trope and the literal that which Wittgenstein described as ‘a language game’ ensues wherein the metaphorical through a sleight of grammar is passed off as being real while, the literal effects on real people is downplayed as metaphorical ‘collateral damage’. The paper further argues that within this grammar that forces itself upon us, the game of capital is played out through what the author terms an austerity bargain that is levelled by the financial elites: healthy capitalism equals a healthy society. The paper then examines the six elements of the social determinants of health and what actually contributes to a healthy society. Rather than being under an individual threat of exclusion from what Marx termed a superabundance, the paper considers the irreducible differences between the game of capital's individualism, and, the social determinants of health's social inclusion, legitimization and that which Habermas termed public authentication. The paper concludes that not only do necessary austerity measures need to be critiqued but that they radically undermine what determines a healthy society. It follows also that the social determinants of health, radically undermine the bargain inherent for the privileged few within the game of capital. (shrink)

This paper is significant in its exploration of the experiences of children designated as ‘lower-attaining’ in British primary schooling. It is underpinned by Nancy Fraser’s conceptualisation of a global shift from government via nation-state welfare structures to governance through supra-national financialised neoliberalism. Within this context, we take the innovative path of investigating how ‘lower-attaining’ children explain perseverance with hard work at school within neoliberalism’s ‘cruel and cynical fiction’ of social mobility. Our extended interviews with 23 ‘lower-attaining’ children over two years (...) provide findings which indicate – with a startling vividness – that these particular children experienced loneliness at school and blamed themselves for being inadequate and inferior. Fear appeared to be an essential component of their schooling system and sometimes elicited from them anger as well as humiliation. In particular, these children feared being assessed and sorted according to attainment. We propose that these factors often led the ‘lower-attaining’ children to experience schooling as at least uncomfortable. And yet they came to accept as fact the fiction that they were inadequate; and to perceive that perseverance in conforming to schooling’s rules was their only chance of not slipping out of the race altogether. (shrink)

Patients with persistent pain who lack adetectable underlying disease challenge thetheories supporting much of biomedicalbody-mind discourse. In this context,diagnostic labeling is as inherently vulnerableto the same pitfalls of uncertainty that besetany other interpretative endeavour. The endpoint is often no more than a name ratherthan the discovered essence of a pre-existentmedical condition. In 1990 a Committee of theAmerican College of Rheumatology (ACR)formulated the construct of Fibromyalgia in anattempt to rectify a situation of diagnosticconfusion faced by patients presenting withwidespread pain. It was (...) proposed thatFibromyalgia existed as a ``specific entity'',separable from but curiously able to co-existwith any other painful condition. Epistemological and semiotic analyses ofFibromyalgia have failed to find any sign,clinical or linguistic, which coulddifferentiate it from other diffusemusculoskeletal pain states. The construct ofFibromyalgia sought to define a discernablereality outside the play of language and topass it off as a natural phenomenon. However,because it has failed both clinically andsemiotically, the construct also fails the testof medical utility for the subject inpersistent pain. (shrink)

Cancer chemoprevention trials test the efficacy of pharmaceutical agents in preventing cancer in at-risk research subjects who are neither patients diagnosed with the disease nor typical healthy volunteers. Such trials present unique challenges to investigators and IRB reviewers when evaluating risks and benefits, assessing informed consent, and compensating subjects. Investigators and IRBs should pay particular attention to the criteria used to define at-risk subjects and carefully assess the strength of the evidence supporting them, as this is critical to evaluating the (...) risk-benefit ratio. (shrink)