Assessing the ethical implications of research into the prevention of bioterrorism

February 6, 2004

Brussels, 05 Feb 2004

With the Commission setting out proposals to establish an EU security research programme on 3 February, it is clear that many regard scientific and technological research as a key response to the perceived increased threat of global terror attacks.

In the case of bioterrorism, it is estimated that some 75 to 100 companies worldwide are engaged in research to develop vaccines and drugs designed to mitigate the effects of a biological attack. But such investigations raise serious ethical concerns, both in terms of the ultimate applications of the research results, and the methods used to validate the products.

To address these issues, the Commission hosted a conference on the ethical implications of research on bioweapons and prevention of bioterrorism, in Brussels on 3 and 4 February. The event gathered experts in various fields from around the world, and rather than acting as a conclusion to the debate, the conference was designed to stimulate an international dialogue on the issue.

According to Professor Emilio Mordini, the coordinator of an EU funded project on the bioethical implications of globalisation: 'Scientific understanding of living systems and how to manipulate them is expanding exponentially, fuelled by advances in computerisation [and] the global dispersion of bioscientific expertise [...]. Such discoveries will bring great benefit to humankind, but they will also allow the development of a new constellation of powerful bioweapons.'

'The distinction between good biology and its 'dark side' lies only in intent and application. With rare exceptions, it will be very difficult to sequester new bioscientific knowledge that might be applied to building biological weapons without simultaneously harming beneficial biomedical research and essential biodefence,' added Professor Mordini.

For Dr Charles Penn, from the UK centre for applied microbiology and research, the issue therefore becomes a question of risk versus benefit: 'A careful balance needs to be struck between freedom in research endeavour and cooperation, that are vital for us to realise public health benefits, and controls designed to prevent the misuse of material and knowledge.'

Even when such research is clearly designed to deliver benefits or security to society, there remain ethical issues to be addressed. The use of human subjects in clinical trials is regulated through international conventions, which state that participants must give their informed consent, and that the research should be approved through an independent ethical review process, taking into account the risks versus the benefits of performing the trial.

However, in a field as sensitive as biodefence, elements or even significant proportions of the research could be considered classified by the government or agency concerned. Given this reality, the conference was asked, should biodefence research be subject to the same ethical standards as ordinary clinical trials, and how should these standards be interpreted, given the need for secrecy and the difficulty in performing a risk-benefit analysis in a field as full of uncertainty as bioterrorism?

Participants appeared to unanimously agree that even in the case of classified biodefence research, the ethical standards that govern human medical trials should still apply. Moreover, it was noted that according to the Council of Europe's convention on human rights and biomedicine, even if a country is facing war or conflict, the defence of its economic well being, or a threat to national security, no exceptions are granted to these standards.

As Professor Reidar Lie, from the University of Bergen in Norway, pointed out though, the requirement to get a patient's informed consent is not the same as total disclosure. Only that information which could alter an individual's decision on whether or not to take part in a trial must be given, which, under many circumstances, will ensure that it isn't necessary to divulge classified information.

However, the issue of secrecy becomes more problematic when it comes to the review of the clinical trial by an independent ethics committee, said Professor Lie. 'With the necessary security clearance, the committee chairperson could decide if the research can be reviewed without needing to analyse classified information. If it can, fine, but if not, the trial must either be abandoned, or another solution found.'

A solution would be to establish a special ethics committee of experts with the necessary security clearance, said Professor Lie, but in this case 'how can the independence of the review be assured?' he asked.

The difficulty in finding definitive answers to this and other questions raised during the conference was clear to participants, but most were agreed on the necessity of maintaining an international dialogue on the issue in order to make any progress, and felt that discussions such as these would help to answer the challenges posed by this most scientific form of modern warfare.

CORDIS RTD-NEWS / © European Communities

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