Biodefence, broadly understood as efforts to prevent or mitigate the damage of a bioterrorist attack, raises a number of ethical issues, from the allocation of scarce biomedical research and public health funds, to the use of coercion in quarantine and other containment measures in the event of an outbreak, to efforts to extend international arms control regimes to biological weapons. In response to the US bioterrorist attacks following 9–11, significant US policy decisions were made to spur scientific enquiry in the name of biodefence. These decisions in turn led to a number of critical institutional changes within the US federal government agencies governing scientific research, both at government laboratories and academic research centres. Subsequent science policy discussions have focused largely on ‘the dual use problem’: how to preserve the openness of scientific research while preventing research undertaken for the prevention or mitigation of biological threats from being used to cause harm by non-state terrorists or aggressive dictators. On this characterisation of ‘the dual use problem’, biomedical scientists must consider whether and, if so, to what extent the commitment to ‘open science’ ought to be compromised.

Although the term ‘open science’ is unfortunately broad, the main idea, as Robert Merton and others have noted, is that the scientific enterprise is characterised by a commitment to costless or low cost information sharing, understood as an element of the more basic commitment to the accumulation of knowledge through collective effort.1 ,2 The chief justification of openness is that it contributes to the production of scientific knowledge. Our aim is to join others in the bioethics literature in shifting the ethical debate over biodefence away from a simple framing of the problem as one of dual use, by making clear how a dual use framing distorts the debate about bioterrorism and truncates discussion of the moral issues.3–5 To advance the debate further we offer an alternative framing rooted in social epistemology and institutional design theory, better to inform policy deliberation over the full range of ethical challenges raised by the biodefence enterprise.

Reframing the dual use issue

Framing the ethical concerns of biodefence as predominantly a problem of dual use is inadequate for at least two reasons. First, the reference to ‘the dual use problem’ is misleading. As others have noted there are at least two distinct dual use problems.6 Furthermore, measures to cope with one may be inadequate for coping with—or may even exacerbate—the other. Biodefence research might be used not only by non-state terrorists or aggressive dictators, but also by any state that has or contemplates developing an offensive bioweapons programme.

It is important to understand that even states that have no aggressive intentions may have an incentive to develop offensive bioweapons. Fear of not having offensive bioweapons when others have them can motivate a self-defensive offensive bioweapons arms race, as existed between the USA and the former Soviet Union during the cold war.7 ,8 States not intent on aggression may conclude that, as with nuclear weapons, a ‘balance of terror’ is necessary for their security. Scientists and ordinary citizens should thus be concerned not only that biodefence research may be used to develop offensive bioweapons by non-state terrorists or by ‘outlaw states,’ but also by their own governments. Furthermore, it is not enough that a country refrains from seeking to use biodefence research to develop offensive weapons. Unless other countries have adequate assurance that this is so, a self-defensive bioweapons arms race may occur. Clarity and candor would be better served if ambiguous talk about ‘the dual use problem’ were abandoned and replaced with ‘the dual use problems’ or by explicit references to ‘dual use problem 1’ and ‘dual use problem 2:’

DU1: Research undertaken for prevention or mitigation of biological threats being used to cause harm by non-state terrorists or aggressive state actors.

DU2: Research used to develop offensive bioweapons by one's own government.

Second, it is not the case that measures to cope with the dual use problem(s) would be the first instance in which biomedical scientists are faced with the problem of a conflict between the values that underlie the norms of ‘open science’ and other important values. The norms of openness have never been absolute, nor should they be, because the values that underlie them are not absolute but instead must be balanced against other important values. Two examples should suffice to make this simple but crucial point: intellectual property and privacy protections for human research subjects. What sorts of items should count as intellectual property and how extensive the rights to control their uses should be are complex matters on which there is much disagreement; but if there is any room at all for intellectual property in the scientific research enterprise, then the norms of ‘open science’ cannot be absolute, because intellectual property rules constrain the dissemination of knowledge by limiting access to items (such as gene sequences) whose use is necessary for gaining knowledge. Similarly, ethical concerns about privacy quite properly limit the freedom of researchers to exchange information about human subjects. So, openness is not and has never been an absolute value. The current processes by which scientific knowledge is produced already reflect a compromise between openness and other values.

Recognising these two deficiencies in the dual use framing of biodefence has two important implications. First, one should not assume that policy measures crafted to cope with dual use problem 1 will be effective for coping with dual use problem 2. For example, omitting certain steps in the creation of a deadly virus from a publication might render the publication useless to a non-state terrorist group or to the relatively poorly trained or under-resourced bioweapons researchers of a so-called ‘outlaw state’, but the better trained, better resourced bioweapons researchers of a ‘great power’ might be able to fill in the gaps. What is more, some measures to mitigate the risks of dual use 1 might actually increase the risks of dual use 2. For example, a government-appointed national advisory board charged with vetting research to prevent it from being used by non-state terrorists or ‘outlaw states’ might officially or unofficially channel information to its own government's bioweapons researchers while increasing the value of the information to them by preventing others from getting access to it. Second, and more fundamentally, once we understand that the norms of ‘open science’ and the values that underlie them are not absolute, it becomes evident that the dual use problems should be reconceived as one aspect of a larger optimisation problem: how can policy, broadly understood, help shape the scientific enterprise in such a way as to give due weight both to its distinctive role in producing knowledge and to other relevant values, including, but not restricted to, the reduction of both dual use risks?

Just what values ought to be included in the optimisation project and how they ought to be weighted, are of course, difficult, contested questions. The central point is that an overly simplistic assumption that the problem is how to balance the two competing values of biosecurity and open science diverts public discussion from the other important values at stake. In the dual use policy discussions to date, we have seen two examples of this error: (1) failure to consider adequately the impact of biodefence research on the ethical use of human and non-human animals in research; and (2) failure to account for the opportunity costs of biodefence research vis-à-vis efforts to reduce the burden of infectious disease among the world's poor.

Few would dispute that the protection of human and non-human animal subjects also ought to be taken into account in the design of the enterprise of producing scientific knowledge. Yet, when ‘the dual use problem’ (meaning dual use problem 1) occupies centre stage, it is the interests of only two parties that are likely to be strongly represented: scientists who fear constraints on the pursuit of knowledge, and government officials whose worst nightmare is a bioterrorist attack that could have been prevented. Therefore, one of the dangers of an overly simplistic framing of the ethics of biodefence is that it largely ignores or arbitrarily discounts values that have been central to the research ethics debate since its inception: the protection of research subjects, both human and non-human. Special attention ought to be given to the need for protecting research subjects against risk in the testing or use of experimental vaccines in the event of an outbreak, or in the process of ‘emergency preparedness’. In this regard, the ethics of research ought to be nearer the centre of the biosecurity debate.

Similarly, as May has argued, it is important to consider the opportunity costs of investments in biodefence research.4 In particular, it can be argued that concerns about distributive justice ought to be given some weight in policies affecting the production of scientific knowledge, for example, by devising policies to provide greater incentives for research that is likely to yield results (such as a vaccine for malaria) that will help meet the special needs of the world's worst-off people.9 ,10 In biodefence discussions, if ‘the dual use problem’ is treated as central, consideration of this value, if it occurs at all, tends to be almost an afterthought.

To counter this tendency, some have appealed to yet a third sense of the term ‘dual use’, what might be called the ‘dual use opportunity’: the prospect that research undertaken for biodefence may contribute, or might be made to contribute, to the alleviation of the burden of disease among the world's worst-off people. This possibility was discussed, for example, at the Bioethics and Biodefense Meeting, 5 February 2007, at the Johns Hopkins School of Advanced International Studies. This meeting was sponsored by the Southeast Regional Center for Excellence for Emerging Infections and Biodefense and co-sponsored by the Johns Hopkins University Berman Bioethics Institute, the University of Minnesota Center for Bioethics, and the University of Washington Department of Medical History and Ethics. The idea is that knowledge for responding to bioterrorist attacks may also be valuable for responding to naturally occurring infectious disease outbreaks, many of which disproportionately affect poor populations, and that biodefence policy should take this fact into account.

Unfortunately, concerns about distributive justice have not been incorporated into the biodefence debate in any serious or systematic fashion. For example, in recent debates concerning the US government investments in global health, including HIV and the President's Emergency Plan for AIDS Relief, at no time were the trade-offs vis-à-vis renewed investments in biodefence research funding mentioned.11 For example, monies that are allocated to anthrax studies are not available for developing new antimalarial drugs.12 ,13 Keeping the biodefence allocation decisions out of transparent debate has masked the opportunity costs of the massive biodefence effort. It is critical to ask, however, what research or health investments might we forego in order to continue funding biodefence research?

The point is not that concerns of distributive justice or the protection of research subjects ‘trump’ security concerns, nor is it to deny that under exceptional circumstances they should be accorded less weight than they ordinarily have. Instead, it is that there should be a vigorous debate about the ethical justification for reducing the threshold for acceptable risk in the process of consent for experimental vaccines, and for increasing the use of non-human primates in biodefence research. Such a debate requires discussion of multiple values, each of which has substantial weight. An ethically responsible policy approach cannot simply assume that in effect the only two values at stake are ‘open science’ and biosecurity, because efforts to reconcile these two values may have serious consequences for the pursuit of other important values. To summarise, it is not simply that there are two dual use problems, not one (as well as a ‘dual use opportunity’); the more fundamental conclusion is that the dual use problems (and ‘the dual use opportunity’) are only aspects of a larger optimisation problem.

The idea of optimisation is crucial because it emphasises that the task is not to maximise the realisation of any one value (such as protection against bioterrorism), or to achieve an acceptable trade-off between just two values (such as ‘open science’ and biosecurity), but rather to achieve an overall outcome that gives due weight to all relevant values. The optimisation framing opens the door to discussions of values, such as giving some priority to a more equitable distribution of the benefits of scientific research or the protection of research subjects, that otherwise might be ignored or indefensibly discounted as a result of focusing exclusively on the trade-off between ‘open science’ and biosecurity. Notice that we use the term ‘optimisation’ here in a broad sense; there is no assumption that all competing values can be fully quantified and subjected to a definitive maximising calculation. Rather, the point is that there are multiple values that must each be given due consideration in an attempt to make an all-things-considered judgement about what to do. In many cases, optimising will require judgement, not just calculation.

The optimisation framing is also useful for dispelling the view, promoted by the political rhetoric of the ‘war against terror’ (as in all putative national emergencies), that the goal is to maximise risk reduction, that is, to reduce the risk of harm (in this case harm due to the rapid spread of infectious disease) to zero. Maximal, as opposed to optimal risk reduction is irrational and the attempt to achieve it is unethical because efforts to achieve it come at the expense of other important values.

It might be objected that in times of national emergency, such as the so-called ‘war on terror’, the goal is not to optimise across a plurality of values, but to seek a proper balance of only two dominant values: biosecurity and ‘open science’. The idea here would be that in current conditions other values can and ought to be ignored, because the stakes are so high. The unargued and highly problematical assumptions behind this objection are: (1) that in circumstances of extraordinary risk of bioterrorism, biosecurity and ‘open science’ are values of much greater value than all other relevant values combined; (2) that the only way to secure those two values is to proceed as if no other values existed; and (3) that the circumstances of extraordinary risk—risk sufficient to justify such an abandonment of the optimisation approach—can be reliably ascertained. Not one of these three assumptions has been explicitly defended by those who place ‘the (first) dual use problem’ at centre stage of the debate on biodefence.

It may be difficult to ascertain when conditions justify abandoning the optimisation approach and disregarding values we otherwise agree are of great importance. This point warrants elaboration. Institutions, preeminently, government institutions, shape beliefs about what constitutes an emergency and about when a state of emergency exists. Institutional agents sometimes have strong incentives to encourage a blurring of the line between preparing for an emergency and the occurrence of an emergency. Political leaders, whose roles give them opportunities for shaping public perceptions, have incentives to foster the belief that an emergency exists, because it is generally assumed that emergencies require extraordinary powers and reduce the requirements of transparency as a condition for the legitimacy of political authority. In brief, once people become convinced that we are in an emergency, they are more willing to accept the view that ordinary moral norms and the standard checks and balances of democratic constitutional government do not apply, or apply with less force—that the government should be given a ‘free hand’, and that criticism of the government is inappropriate, dangerous and even disloyal.14

So whether we are in fact in an emergency is a matter of great importance. Presumably scientific knowledge should play some role in determining the magnitude and probability of the risks that are judged to constitute an emergency and therefore in determining whether a state of emergency exists.

Although good facts are relevant to determining whether an emergency exists, a ‘state of emergency’ is not a natural fact to be discovered by empirical methods. The statement that a state of emergency exists is a political act, grounded in an evaluation of how serious certain risks are, with the added implication that the ordinary moral, political and legal rules do not apply. If this is the case, then a thorough investigation of alternative institutional arrangements for achieving biodefence at acceptable costs—when all relevant moral costs are considered—cannot take the distinction between emergency and non-emergency situations for granted, but must consider the possibility that scientific institutions can play an important role in providing a check on the tendency of government leaders to be too ready to declare an emergency. Furthermore, there is a tendency, as we have seen in the USA since the 9–11 attacks, for institutions implemented in a state of emergency to become permanent; arguably we have remained in a chronic state of emergency, or heightened alert, for a decade. So, once again we come to the same conclusion: it is a mistake to think that the only values to be balanced are biosecurity and ‘open science’. Reduction of the risk of erroneous judgements about the state of emergency, and more generally the risk of abuse of government power, should also be taken into account.

There has been another unclarity in the policy discussions over biodefence policy, particularly concerning the dissemination of scientific findings. Sometimes the assumption is that the solution is to formulate guidelines to help individuals engage in risk–benefit assessments regarding the dissemination of particular research results, when the assumption is that the risk is that of ‘dual use’ (ie, dual use 1) and the benefit is ‘open science’. Those who advocate such risk–benefit assessment also propose that a number of different parties, who in fact occupy quite different roles, including the scientific researchers themselves, scientific journal editors and perhaps government officials as well, should follow the same risk–benefit assessment guidelines and apply them to the same thing, namely, the dissemination of particular research results.15–19

Such proposals overlook the importance of the division of labour in a reasonable response to the optimisation problem. Better outcomes might be achieved if different agents, depending on their institutional roles, engage in different activities, following different guidelines. For example, it could be argued that government officials should not engage directly in the risk–benefit assessment of particular research results, but instead should be responsible for ensuring the accountability of the risk–benefit assessment procedures of other agents, including editors of scientific journals. According to this way of thinking, government officials might well employ some form of risk–benefit analysis, but they would apply it to the evaluation of risk–benefit assessments of particular research results by other agents, not to the act of disseminating or withholding particular research results. Similarly, it could be argued that scientists could assess the risks and benefits of disseminating their research more accurately if they did not attempt actual risk–benefit assessments of it, but instead employed guidelines that include reliable proxies for risk–benefit calculations. The idea that the best way of achieving a favourable balance of benefits over costs is not always to act on the maxim ‘maximise benefits over costs’ is familiar from discussions of indirect utilitarianism.20

While it is correct to say that a proper response to ‘the dual use problem(s)’ will include a role for risk–benefit analysis, determining which agents should apply such analysis to which actions is a complex matter. More precisely, it is a problem of institutional design.