The need for continuing provision of beneficial experimental interventions after research is concluded remains a controversial topic in bioethics for research. Based on the principle of beneficence, justice as reciprocity, concerns about exploitation and fair benefits, participants should be able to have continuing access to benefits beyond the research period. However, there is no consensus about whether or not post-trial provision of beneficial interventions should be mandatory for participants from developing countries. This paper summarises recommendations from international and national guidelines. (...) Ethical principles and practical issues relating to post-trial provision are also discussed. In conclusion, post-trial provision is not necessary in all situations and a set of criteria are proposed to identify the situations that beneficial interventions should be provided beyond the research period. However, mandatory post-trial supply of beneficial experimental interventions should be assured for those who still need and are able to benefit from them but have no alternative access. Mandatory provision is based on universal bioethical principles such as beneficence and justice. Furthermore, difficulties associated with implementation of post-trial provision are not unmanageable. Careful advanced planning and a comprehensive partnership among relevant parties would be very helpful in solving these difficulties in practice, which therefore should not be taken as an excuse to escape post-trial responsibility. (shrink)

A property analysis of the U.K. Biobank reveals a new imagination of the genomic biobank as a national commonpool resource. U.K. Biobank's treatment of property and governance exhibit both strengths and weaknesses that may be instructive to genome project planners around the world.

Although scientific and commercial excitement about genomic biobanks has subsided since the biotech bust in 2000, they continue to fascinate life scientists, bioethicists, and politicians alike. Indeed, these assemblages of personal health information, human DNA, and heterogeneous capital have become and remain important events in the ethics and politics of the life sciences. For starters, they continue to reveal and produce the central scientific, technological, and economic paradigms so ascendant in biology today: genome, infotech, and market. Biobanks also illustrate what (...) might be called the new distributive politics of biomedical research. Within those politics, the commodification of persons – or at the very least, of their informational representations – has challenged the ontological, ethical, and political underpinnings of the social contract between researchers and their human research subjects. In brief, biobanks are unsettling relations between genes, tissue, medical records, and persons. But it is also clear that these relations are increasingly being restructured by new rights of control, access, exclusion, and use known as “property,” both material and intellectual. (shrink)

In biobanks, a broader model of consent is often used and justified by a range of different strategies that make reference to the potential benefits brought by the research it will facilitate combined with the low level of risk involved (provided adequate measures are in place to protect privacy and confidentiality) or a questioning of the centrality of the notion of informed consent. Against this, it has been suggested that the lack of specific information about particular uses of the samples (...) means that such consent cannot be fully autonomous and so is unethical. My answer to the title question is a definite ‘yes’. Broad consent can be informed consent and is justified by appeal to the principle of respect for autonomy. Indeed, I will suggest that the distinction between the various kinds of consent is not a distinction between kinds of consent but between the kinds of choice a person makes. When an individual makes a choice (of any kind) it is important that they do so according to the standards of informed consent and consistent with the choice that they are making. (shrink)

A medical profession which did not seek improved means to conquer disease would be condemned for dereliction of its duty, Members of the public will not accept the current state of the medical arts as finite but feel justified in expecting the development of more effective therapies for illness, and the promotion of improved means of preventive care.With this assertion, the distinguished academic, Bernard Dickens, places research firmly in the domain of the public interest. Foster agrees, saying that, “[t]o improve (...) medical care as much as we can, if not to perfect it, means that we have to accept the need for research.” Giesen adds a further emphasis to the search for medical advancements, saying that “freedom of research and scientific inquiry is, in itself, an important aspect of open societies.“. (shrink)

Amongst Professor Dickens’ extensive writings on medical law and medical jurisprudence are a host of distinguished contributions on the subject of the proper legal and ethical limits on human experimentation. As early as 1975, Professor Dickens was examining the legal aspects of human experimentation. A few years later he was promoting the responsibility of researchers to recognize and protect human rights in medical experimentation. In the last two decades, Professor Dickens has penned a rich flow of scholarly contributions on the (...) legal and ethical rights and duties in medical experimentation and the need to do better as a research community. His articles have considered a broad range of issues in medical experimentation including the imperative of voluntary consent, the ethical unacceptability of co-ercion or inducement of research participants, embryonic research, epidemiological research and the protection of vulnerable research participants, particularly children. (shrink)

Amongst Professor Dickens’ extensive writings on medical law and medical jurisprudence are a host of distinguished contributions on the subject of the proper legal and ethical limits on human experimentation. As early as 1975, Professor Dickens was examining the legal aspects of human experimentation. A few years later he was promoting the responsibility of researchers to recognize and protect human rights in medical experimentation. In the last two decades, Professor Dickens has penned a rich flow of scholarly contributions on the (...) legal and ethical rights and duties in medical experimentation and the need to do better as a research community. His articles have considered a broad range of issues in medical experimentation including the imperative of voluntary consent, the ethical unacceptability of co-ercion or inducement of research participants, embryonic research, epidemiological research and the protection of vulnerable research participants, particularly children. (shrink)

International transfers of human biological material (biospecimens) and data are increasing, and commentators are starting to raise concerns about how donor wishes are protected in such circumstances. These exchanges are generally made under contractual material transfer agreements (MTAs). This paper asks what role, if any, should research ethics committees (RECs) play in ensuring legal and ethical conduct in such exchanges. It is recommended that RECs should play a more active role in the future development of best practice MTAs involving exchange (...) of biospecimens and data and in monitoring compliance. (shrink)

In 2007, the Ethics and Governance Council of the UK Biobank commissioned a Report on ‘Concepts of Public Good and Pubic Interest in Access Policies’. This study considered the Biobank’s role as a ‘public good’ in respect to supporting and promoting health throughout society. However, the conditions under which access by third parties to UK Biobank are justified in the public interest have not been well considered. In this article, I propose to analyse the conditions that should allow such access. (...) My argument develops UK Biobank’s function as a ‘public good’ and in terms of its responsibilities as a public health institution; both to protect the rights of the participants and in having a role in reinforcing public goals. Although these two tasks may conflict, it is possible that resolute opposition to some third-party access demands—if properly justified in terms of a public interest—will be damaging to, rather than protective of, participants’ rights. To illustrate my argument, I consider the appropriate response to an extraordinary public emergency , such as a serious criminal investigation or disaster response, in terms of an ethical access policy. (shrink)

Deliberative democracy is now an influential approach to the study of democracy and political behaviour. Its key proposition is that, in politics, it is not only power that counts, but good discussions and arguments too. This book examines the interplay between the normative and empirical aspects of the deliberative model of democracy. Jürg Steiner presents the main normative controversies in the literature on deliberation, including self-interest, civility and truthfulness. He then summarizes the empirical literature on deliberation and proposes methods by (...) which the level of deliberation can be measured rather than just assumed. Steiner's empirical research is based in the work of various research groups, including experiments with ordinary citizens in the deeply divided societies of Colombia, Bosnia-Herzegovina and Belgium, as well as Finland and the European Union. Steiner draws normative implications from a combination of both normative controversies and empirical findings. (shrink)

Genetic research has moved from Mendelian genetics to sequence maps to the study of natural human genetic variation at the level of the genome. This past decade of discovery has been accompanied by a shift in emphasis towards the ethical principles of reciprocity, mutuality, solidarity, citizenry and universality.