Nuffield Council on Bioethics

Informed consent requirements for conducting research with human participants are set by institutional review boards (IRBs) following established guidelines. Despite this, researchers continue to face challenges in seeking and obtaining informed consent. This study discusses researchers' views of such problems in Lebanon and Qatar, which vary in research regulation. We conducted in-depth interviews with 52 academic researchers from various fields of research in both countries and analyzed them using thematic analysis. Important disjunctions emerged between IRB requirements and actual practice. Variations in obtaining informed consent were affected by the research context, type of research, and the prevalent cultural norms and values. Regulatory systems and guidelines for informed consent do not necessarily ensure ethical research conduct. Implications for improvement are presented.

“It is not ethical to conduct research on children.” This comment is typical of objections in the past to studies with children. The continuing legacy of this viewpoint is that today's evidence base for the care provided to children is not as strong as it could be. Thankfully, however, this is now changing. We have learnt that, rather than protecting children and young people from research, we need to protect them through research and there is now a strong recognition of the need for ethically and scientifically robust ways to conduct relevant clinical research with children.1 The recent Nuffield Council on Bioethics report Children and clinical research: ethical issues is helping the continued evolution of this thinking.2 This article summarises some of its main findings and recommendations. The report examined the question: how can we ethically undertake the research needed to ensure their healthcare services are safe and effective, given that research often involves burdens and risks? Moreover, what role should children, young people and parents themselves play in influencing how research studies are carried out, and how can their voices help influence the wider research agenda? There were 19 key recommendations (summary; http://nuffieldbioethics.org/wp-content/uploads/Children-and-clinical-research-key-recommendations.pdf). The Nuffield Council on Bioethics explored these issues through an expert Working Party, supported by a stakeholder group involving young people and parents. Throughout the project, input was sought widely from young people, parents and professionals concerned with clinical research, in the UK and beyond. Views and experiences were sought through web-based surveys, an open ‘call for evidence’ and face-to-face meetings; through school projects in the UK and Kenya; and through networks of research professionals. While the focus of the report and its concrete recommendations are targeted primarily on the UK, they sought to ensure that the ethical analysis and conceptual recommendations had as …

Although the responsibility for health debate has intensified in several ways between Norman Daniels’ 1985 Just healthcare and Just health: meeting health needs fairly of 2008, comparatively little space is dedicated to the issue in Just health, and Daniels notes repeatedly that his account “says nothing about personal responsibility for health”.Daniels considers health responsibility mainly in a particular luck-egalitarian version which he rejects because of its potentially unfeasible, penalising and inhumane character. But I show that he nonetheless acknowledges and endorses explicitly other dimensions of health responsibility.I develop a wider, more nuanced and less punitive concept of health responsibility, which expands Daniels’ brief consideration and is compatible with the overall approach set out in Just health. In its application to preventative medicine and health promotion in particular, the concept is suited to support and complement the notion that “health is special”, which is central in Just health.The concept of health responsibility as co-responsibility specifies the subjects and objects of health responsibilities. It permits the attribution of responsibility without blame and disconnects the question of assigning responsibility from decisions about entitlement to treatment or different status in prioritisation decisions. This approach secures conceptual plausibility and clarity of the concept of health responsibility, is of use in policy making, and can help reduce political tensions.

In his recent Beveridge lecture, Julian LeGrand highlighted a significant shift in social and public health policy over the past sixty years. In 1948, the task for the new British welfare state was to deal with the five “giants of too little”: too little income, work, education, housing, and health care. While there is no reason for complacency, the United Kingdom has made significant progress in these areas. But new giants have emerged: the “giants of too much.” Excessive consumption of alcohol, tobacco, and food have significantly affected both population health and health care budgets. In this issue of the Report, Erika Blacksher deals with one of the giants of excess—childhood obesity. Two central points emerge from Blacksher’s clear summary of the evidence. First, childhood obesity has serious shortand long-term consequences, affecting not only children’s “current and future health but also their evolving and future liberty as adults.” Between 40 and 77 percent remain obese as adults, and poor adulthood health is highly correlated with low socioeconomic status and educational attainment. Second, the social gradient in health means that childhood obesity is not distributed equally across socioeconomic groups. As many as one in three children of socioeconomically disadvantaged groups are obese, with higher levels in particular ethnic groups.

In October 2005, the United Nations Educational, Scientific and Cultural Organization adopted the Universal Declaration on Bioethics and Human Rights (UDBHR). A concept of central importance in the declaration is that of “human dignity”. However, there is lack of clarity about its scope, especially concerning the question of whether prenatal human life has the same dignity and rights as born human beings. This ambiguity has implications for the interpretation of important articles of the delcaration, including 2(c), 4, 8, 10 and 11. The paper applies relevant provisions of the UDBHR to specific cases, addresses problems of internal consistency and considers attempts at clarifying the scope of “human dignity” by the negotiating parties. An analysis of the important relationship between the UDBHR and the Universal Declaration of Human Rights, to which the UDBHR refers in its title and elsewhere, shows that because of a crucial emphatic asymmetry, a broad reading according to which the UDBHR must be understood to ascribe human rights and dignity to prenatal life is untenable. However, the view that the UDBHR confers human rights and dignity on humans from the moment of birth onwards is robust and defensible. This conclusion is important for a proper understanding of the declaration and its use, as stated in Articles 1(2) and 22, the latter urging states “… to give effect to the principles … in this declaration”. Similarly, it has implications for the use of the declaration in the wider context of bioethics-related law and policy, as well as in academic and other discussions where increasing reference to the UDBHR is likely.

Appeals to personal responsibility for health are controversial in many countries, especially in those that have publicly funded healthcare systems. In Germany, personal responsibility has traditionally been a focal point in the statutory health-insurance scheme. The most recent healthcare reform under the motto 'prevention before treatment, rehabilitation, and long-term care' came into force on 1 April 2007 through the Gesetz zur Stärkung des Wettbewerbs in der gesetzlichen Krankenversicherung (GKV-WSG--"Law to strengthen competition among providers of statutory health-insurance scheme"). In significant parts, the law has given further emphasis to the role of personal responsibility. Implications of three important changes are discussed: (1) insured persons may no longer claim free treatment for complications arising from certain 'lifestyle choices'; (2) chronically ill and cancer patients face more stringent compliance requirements or face higher co-payments; and (3) insured persons may cash 'no-claim bonuses' if over at least one year they do not require hospitalisation or prescription medicines. Previous emphasis on personal responsibility has had relatively broad support in Germany. The long-term acceptability of the new measures will depend on several factors, including the structural and financial impact on different providers of statutory health insurance, and the capacities and opportunities of different groups in society to make use of the new provisions.