Jan Helge Solbakk

Genetics: The human variome project

An ambitious plan to collect, curate, and make accessible information on genetic variations affecting human health is beginning to be realized.

Between the needy and the greedy: the quest for a just and fair ethics of clinical research

The acceleration of the market globalisation process over the last three decades has internationalised clinical research and influenced both the way in which it is funded and the development and application of research practices. In addition, in recent years international multicentre randomised clinical trials have become the model par excellence for research on new medicines. The neoliberal model of globalisation has induced a decline in state power, both with regard to establishing national research for health priorities and to influencing the development of adequate ethical guidelines to protect human beings that participate in multinational research. In this respect, poor and low-income countries, which lack sustainable control and review systems to deal with the ethical and methodological challenges of complex studies conducted by researchers from affluent countries and funded by large multinational pharmaceutical companies, are particularly vulnerable. The aim of the present paper is to explore critically some of the actual and possible ethical pitfalls of globalisation of clinical research and propose mechanisms for turning transnational clinical research into a more cooperative and fairer enterprise.

Analogical Reasoning in Handling Emerging Technologies: The Case of Umbilical Cord Blood Biobanking

How are we individually and as a society to handle new and emerging technologies? This challenging question underlies much of the bioethical debates of modern times. To address this question we need suitable conceptions of the new technology and ways of identifying its proper management and regulation. To establish conceptions and to find ways to handle emerging technologies we tend to use analogies extensively. The aim of this article is to investigate the role that analogies play or may play in the processes of understanding and managing new technology. More precisely we aim to unveil the role of analogies as analytical devices in exploring the “being” of the new technology as well the normative function of analogies in conceptualizing the characteristics and applications of new technology. Umbilical cord blood biobanking will be used as a case to investigate these roles and functions.

Hidden risks associated with clinical trials in developing countries

The academic literature in research ethics has been marked in the past decade by a much broader focus on the need for the protection of developing communities subjected to international clinical trials. Because of the proximity of the revision of the Declaration of Helsinki, completed in October 2008, most papers have addressed the issue of a double standard of care following the use of placebo. However, other no less important issues, such as interactions between the lifestyles structures of low-income communities and the efficiency of risk-minimising procedures also deserve attention. The purpose of this paper is to discuss forms of uncertainty involved in clinical trials in poor and low-income countries that are not addressed by conventional methods of risk assessment. Furthermore, the increase in size of risks that are identified by conventional assessment methods will be addressed. Besides, the difficulty in properly applying risk-minimising procedures will be discussed. Finally, this paper proposes the involvement of research ethics committees in the risk evaluation process and the establishment of national ethics evaluation systems.

Ethical endgames: broad consent for narrow interests; open consent for closed minds.

The ongoing legal and bioethics debates on consent requirements for collecting, storing, and utilizing human biological material for purposes of basic and applied research—that is, genomic research biobanking—have already managed to pass through three ostensibly dissimilar stages

Consent to Biobank Research: One Size Fits All?

Express informed consent has become a standard requirement in research related to human beings, so also in biobank research. However, it has been argued extensively that this approach is inappropriate for biobank research and that it seriously hampers beneficial research. This chapter analyses biobank research to see whether it has particular features that require exceptional regulation. The conclusion drawn is that biobank exceptionalism is not defensible. Nevertheless, it is acknowledged that certain types of biobank research challenge so many of the traditional approaches in research ethics that alternative approaches need to be pursued. Four alternatives to informed consent are explored: broad consent, the confidentiality/privacy approach, submission to the researcher, and conditioned authorization. Pros and cons related to all of them indicate that a contextual approach has to be taken; one size does not fit all. The question in biobank research is not “to consent or not to consent”, but how to protect and promote the interests of individuals contributing to research at the same time as benefiting society and future patients.

Ethics Report on Interspecies Somatic Cell Nuclear Transfer Research

This report considers whether research involving the creation of human-animal interspecies somatic cell nuclear transfer (iSCNT) embryos raises new ethical issues, and if so, whether it requires additional or special criteria and oversight distinct from research on human-animal chimeras.

Stem cells: Triple genomes go far

A technique called somatic-cell nuclear transfer has been applied to human oocytes, resulting in the generation of personalized stem cells, albeit genetically abnormal ones. Two experts discuss the biomedical significance of this work and the ethical issues surrounding the use of human oocytes in research. See Article p.70

Rationing at the bedside: Immoral or unavoidable?

Although most theorists of healthcare rationing argue that rationing, including rationing that takes place in the physician–patient relationship (“bedside rationing”) is unavoidable, some health professionals strongly disagree. In a recent essay, Vegard Bruun Wyller argues that bedside rationing is immoral and thoroughly at odds with a sound view of the physician–patient relationship. We take Wyller to be an articulate exponent of the reluctance to participate in rationing found among some clinicians. Our essay attempts to refute the five crucial premises of his argument yet build on his genuine insights. In our analysis, Wyller’s critique of bedside rationing is instructive both for harbouring some very common misconceptions that must be exposed and refuted, but also for offering important words of caution. In particular, bedside rationing must be performed in ways that do not harm the physician–patient relationship. Read irenically, Wyller’s critique is a reminder of what must not be lost in our painful endeavour to update the ethics of medicine to encompass the unavoidability of rationing.

In the Ruins of Babel: Pitfalls on the Way toward a Universal Language for Research Ethics and Benefit Sharing

At the end of a paper on international research ethics published in the July-August 2010 issue of the Hastings Center Report, London and Zollman argue the need for grounding our duties in international medical and health-related research within a broader normative framework of social, distributive, and rectificatory justice. The same goes for Thomas Pogge, who, in a whole range of publications during the past years, has argued for a human-rights-based approach to international research. In a thought-provoking paper in the June 2010 issue of the American Journal of Bioethics, Angela J. Ballantyne argues that “the global bioethics priority” in medical and health-related research ethics today is how to do research fairly in an unjust world.