Public Health, Biosecurity And Ethics

(Professor Margaret Somerville is the Samuel Gale Chair, Faculty of Law and Founder Director, McGill Centre for Medicine, Ethics and Law, McGill University, Montreal, Canada. She has extensively studied the wider legal and ethical aspects of medicine and life sciences. A widely published author, she has been an invited speaker at numerous international conferences on the ethical and legal aspects of science and society. She was the first recipient of the UNESCO’s Avicenna Prize for Ethics in Science (2004). She delivered the 2006 Massey Lectures entitled ‘The Ethical Imagination: ‘Journeys of the Human Spirit’, which was the basis of the new book of the same title, now available through www.amazon.ca.

FBAE thanks her for permitting to post this article, which is about life sciences and biotechnology and their societal concerns, on our website.)

Introduction

An ominous new word has crept into our general vocabulary: ‘biosecurity’. The term has special relevance to the life sciences and biomedical research and reflects a growing awareness that while rapid developments in these fields offer the potential for great benefits, the knowledge, tools, and techniques that enable scientific advances also can by accident produce unexpected results or be misused to cause deliberate harm through bioterrorism or, even, biowarfare, for instance, that waged through ‘planned epidemics’. The life sciences tragically could become the death sciences.

Any effort to address this ‘dual use’ dilemma must ultimately be international, since biotechnology research is a genuinely global enterprise. The international scientific community, in particular, has a key role to play in ensuring that efforts to manage the risks improve security and strengthen international collaboration to ensure non- maleficent use of scientific advances. There is an urgent need for an international consensus on the steps that must be taken to realize that goal. One such step is that throughout the world all persons and institutions associated with or involved in science or medicine - especially scientists, physicians, scientific institutions, international institutions (in particular, the World Health Organization), and others engaged in research and development in the life sciences-must be aware of their ethical obligations to prevent such a horrific transformation. To promote such awareness we need to understand, in a very general way, what ‘doing ethics’ requires; what is the role of people, whether ethicists or ethics committees, whose job it is to implement ethics in practice; and what instruments - for example, codes of ethics or laws - might help to ensure ethical behaviour.

What is ethics?

In everyday language ethics can be described as trying not to do the wrong thing in the sense of harming people, first do no harm, and, then, wherever possible, doing the right thing in the sense of benefiting people.

Ethics is about values, especially shared values, in particular those we adopt as our basic societal values - they are sometimes called norms. The nature of a value is not easy to define. The Oxford English Dictionary defines it within the context of ethics as: ‘That which is worthy of esteem for its own sake; that which has intrinsic worth’. Another way to describe values might be as ‘ethical organising principles’ - they are principles that we can use to guide us in deciding what is ethical and what is not. The issue we look at in this working paper is what values should govern science and scientists, especially those working in the life sciences, public health and epidemiology, in particular, when the science has potential not only for good, but also for harm.

An individual scientist’s good conscience is an essential guide, but it is not sufficient to ensure that science is carried out ethically. Moreover, because science is held on trust for society, societal values or norms must play an important role in governing science.

Doing ethics

The process of undertaking an ethical analysis is called ‘doing ethics’. An important methodology in doing ethics is engaging in ‘ethics talk’ or an ‘ethical conversation’ with all the people who should be involved in making a certain ethical decision.

Doing ethics consists, first, in identifying all the ethically relevant facts. Good facts are essential to good ethics. Second, we must identify the values that are in play in the situation. Sometimes we can do that for ourselves, other times, we need an ethicist to help us to identify the full range of those values. Third, we must see whether any of these values are in conflict; if they are not, we do not have an ethical dilemma because we can honour all of them. If there is conflict, however, we must prioritize our values and that is where we often do not agree. Not everybody gives the same weight to the same values or chooses the same order of priority when they are in conflict. Finally, and this is the most important aspect of doing ethics, we must justify the priority that we choose when not all values can be honoured. That justification is the essence of doing ethics.

The role of ethicists and ethics committees

As an ethicist it is quite common to encounter people (not uncommonly scientists) who fear what they see as interference by ethicists in their science. They often perceive ethicists as "moral police" telling them what not to do and as seriously curtailing what they see as their rights and freedoms. They often see ethicists as imposing their moral values, more or less in the guise of secular priests, and they rightly challenge why ethicists’ values should prevail when they are no more important or valuable than others’ values and especially when there is no consensus on which values should prevail.

People who are critical of ethicists are correct if ethicists are simply imposing their own personal, moral values. It is not their right to do that and not the role of an ethicist to make decisions that others should take. Rather, it is the role of an ethicist to help those

people who must make decisions about ethics to understand as fully as possible the nature of these decisions.

Making Ethics Decisions:

Identify
all ethically relevant facts.
Identify values.
Identify any conflicts of values.
Prioritize conflicting values.
Ethically justify the priority adopted.

That requires ethicists, first, to help people recognize that they might have an ethical problem - many ethical mistakes are made because people do not identify that there is a problem or, if they do recognize there is a problem, they mistakenly identify it as a public relations or communications issue and call in experts in these fields. That often substantially augments the seriousness and number of ethical issues present. ‘Spin doctoring’ an ethical issue is usually disastrous ethically. Often it means that what began as one ethical problem ends up as multiple ethical problems .

Second, once an ethical problem is identified, it is an ethicist’s job to help the people who must make a decision analyze it in such a way that they can access the necessary ethical insights. That requires, first, knowing as many facts as possible about the situation, including any uncertainties - that ‘good facts are essential to good ethics’ is a truism in ethics, but no less important because of that. Then, the ethicist must help people to identify the ethical issues those facts raise and the different values that could inform their decision. As explained above, the next step is to see whether any of the values, identified through this process as relevant, conflict - if they don’t there is no ethical problem, as all values can be honoured, it’s just a matter of ‘doing the right thing’.

If the values conflict, however, they must be prioritized. Ethicists do not agree on how we should go about doing that and, depending on which approach is used, what we regard as ethical or unethical can be radically different. There are two main camps of ethicists: utilitarians and principle-based or deontological ethicists. Utilitarians assess ethical acceptability by seeing if potential goods outweigh risks and harms; most commonly they assess that by searching for the greatest good for the greatest number of people. In stark contrast, principle based or deontological ethicists believe that some things are wrong no matter how much good could come from them and, therefore, must not be done. Their first consideration is whether any given course of conduct is, in itself, inherently wrong.

Ethics committees can be regarded as a composite ethicist. Their role and function is essentially the same as an ethicist’s. They do, however, have a further responsibility: they are the trustee of the public’s trust that science will be conducted and used ethically. Honouring that trust is central to the future good health of science. Individual scientists who breach it - as has happened in several high profile cases that have recently made front page headlines around the world - seriously damage not only themselves, but science as a whole.

To summarize the discussion so far: First, ’doing ethics’ is more than a matter of individual conscience, although individual conscience is an essential element in ‘doing ethics’. Second, ‘doing ethics’ is the systematic application of informed, structured and disciplined discernment to analysis of situations in relation to the ethical issues they raise and to decision making in these situations. And, third, sometimes some people need ethicists to help them to ‘do ethics’.

Basic presumption

Basic presumptions are the foundation stones from which we start an ethical analysis, or any other analysis or decision making. We cannot avoid such a starting point or the choice of what it will be. However, if we think about that reality at all, we usually take whatever basic presumption we use to ground our ethics analysis and decision making as a given, as self-evident. But, in fact, there is a choice to be made and that choice has a far from neutral effect on our ethical analysis and, consequently, a major impact on whether our decisions go one way or the other. Basic presumptions are important because they establish the ethical framework in which we ground our arguments.

There are four basic presumptions: ‘No’: we must not do this; ‘Yes’: there are no restrictions or conditions on what we want to do; ‘No, unless...’: no, we must not do it, unless we can justify it and these are the requirements for justification; and ‘Yes, but...’: yes, we may do it, but not if certain circumstances prevail. Most ethical analysis involves situations where we must choose to use either a ‘no, unless’ or a ‘yes, but’ analysis. You might think that it doesn’t matter which of those we favour and that is true where the ethical answer is relatively clear. But where we are equally doubtful about which of two courses of action to take, these two presumptions give polar opposite results. In such situations, a ‘no, unless’ presumption means we may not proceed - a good example of this approach is the precautionary principle used in environmental ethics, which requires those creating risks to the environment to show that it is reasonably safe to do so before proceeding. In contrast, a ‘yes, but’ presumption in the same circumstances means we may proceed until it becomes obvious that it is not reasonably safe to do so.

In democratic Western societies the basic presumption has been a ‘yes, but’ one, including in relation to science. That is consistent with those societies having ‘open legal systems’ - anything which is not prohibited is permitted - as compared with ‘closed legal systems’ - anything which is not permitted is prohibited. The major exception to using an open legal system in Western societies is the regulation of pharmaceuticals and medical devices - since major tragedies in the early 1960’s marketing and use is prohibited unless permission is given. One question now is whether certain science, for instance, that with serious ‘dual use’ potential (the potential for beneficial use, but also for great harm, such as bioterrorism), should be subject to a similar approach.

More specific basic presumptions relevant to undertaking scientific research also need to be identified and articulated. Among the most important of these are the integrity of scientists and scientific research and openness and transparency of scientific information.

Ethics education and research

Several national academies of science are also thinking about the value of inserting ethics education on life sciences research and public health ethics within their curricula. We should all encourage and assist them to do so. Education is the only successful way to convert ethics in theory to ethics in practice, to convert principles on paper to applied ethics in the everyday life of scientists, other researchers and professionals. Such education should be seen as an ongoing process, not merely a hurdle to be jumped that can then be disposed of. And research on the effectiveness of ethics education is needed; we have been far too complacent in assuming that all we need to do is to provide education and that will achieve the goals we hope for in terms of ensuring ethical conduct. Many recent events, such as fraud in the conduct of human embryo stem cell research, have shown us that we need to be much more involved on an on-going basis.

Research on ethics, itself, is also required. As science evolves so must the ethics that accompany it. In short, 1960’s ethics will not be adequate to govern 2006 science - indeed, even 1990’s ethics might not be. In carrying out research on ethics we should keep in mind that there is a world of difference in outcome between seeking an ethics that will allow us to use new technoscience as we wish to do - that is allowing technology to govern the substance of the ethics we articulate - and seeking an ethics to inform and govern technoscience. The latter is the ethical approach to doing ethics in science.

One frequent objection to applied ethics in the context of research, in general, is that it places too heavy a burden on research or even prevents essential research. For instance, it can be argued that ethics could have harmful impact on undertaking important public health or life sciences research. Sometimes that might be true, but such cases can be dealt with under legal and ethical doctrines of necessity, as justified exceptions to the general ethical and legal rules. However, ethical issues do not drop off the radar screen simply by ignoring or denying them and experience has shown that putting ethics into practice at the outset - embedding ethics in life sciences and public health research from its initiation - is likely to avoid far more problems than it creates and to benefit such research overall. In other words, rather than hindering research, good ethics can facilitate it.

The ethics of two specific topics public health and biosecurity is further analyzed below.

The Complementarity of Public Health and Biosecurity

Although no consensus has yet emerged on a code of ethics to govern the life sciences, there is wide agreement among researchers that a robust public health system is an essential safeguard against biological threats, whether natural, accidental or deliberate. Security and public health concerns now overlap, whereas traditionally they had been separate areas that elicited different kinds of policy responses. Strengthening the response to naturally occurring infectious diseases is needed to protect against the accidental and deliberate misuse of science. In short, promoting public health, biosafety, and biosecurity, on the one hand, and protecting against bioterrorism, on the other, are linked, complementary activities. That means that working out strategies to prevent or deal with natural, accidental or deliberate epidemics are consistent goals - whatever we do to reduce the risk of one is likely to reduce the risk of the other. This fact is ethically and legally relevant. It means that some measures that might not be justified for just a public health or just a biosecurity goal, may be justified if they promote both goals.

The insight, which arose largely out of trying to deal ethically with the HIV/AIDS crisis in its earliest days, that promotion of public health and respect for human rights were also complementary goals initially came as a surprise to many. Before that time, the ethical and legal issues that health lawyers and medical ethicists were called on to deal with in public health, usually involved breaches of human rights - whether of a person’s rights to liberty, privacy, confidentiality or inviolability (the right not to be touched without one’s consent) - in order to promote public health and protect the community. Traditionally, public health law is predicated on two state powers: the parens patriae power - the obligation and power of the state to look after those unable to look after themselves; and the police power - the obligation and power of the state to protect its citizens. Depending on how it is employed, the former power can be coercive and the latter is inherently coercive. But in contemporary constitutional law they are contained within certain limits by human rights and civil liberties law, so the idea of complementarity between promoting public health - which after all is what public health law seeks to do - and respecting human rights is not immediately obvious.

We might also benefit from considering a recently emerging concept called human ethics - the idea that we have an innate moral compass that is expressed in various ways - that can complement that of human rights. One way to look at instruments such as the Universal Declaration of Human Rights and Charters of Rights in various countries’ constitutions, is that they do not create the rights expressed in them; rather they are declarative of rights that pre-exist their declaration and which come from an intrinsic human morality. Legal positivists (those who reject Natural Law theory and believe that law is entirely the creation of the law makers) will hotly contest this view, which is all to the good in an ongoing ethics dialogue. Rights are always accompanied by responsibilities, so we also have human responsibilities. We can enrich our understanding and insights by regarding human rights, human responsibilities and human ethics as three complementary lenses that must all be used concurrently to give us the fullest possible perspective on issues that involve public health, biosecurity and ethics.

The future may also need to be anticipated when crafting present ethical responses. Contemplating potential new bioweapons raises deeply worrying possibilities for protection of public health that return us to the problem of how to ensure ethics in scientific research discussed in more detail below. For instance, "synthetic biology" involves the creation of living material from its DNA components, so that we can re-engineer life in the manner of our choosing. It is said that the technology making this possible will most likely become common within the next two years at a substantially reduced cost. Safeguards such as a moratorium on such developments or registering the equipment needed to implement them should be considered. In other words, preemptive measures not just reactive ones might be considered and these measures must be fashioned in an imaginative, innovative and broad manner.

But we must also recognize the dangers of over-regulation and paradoxically regulation, itself, can sometimes carry the same risks as those we are trying to minimize. For instance, requiring public scrutiny of all laboratories working with infectious organisms, could provide opportunities for terrorists to learn about or to obtain these organisms .

The past may also provide us with the deep wisdom that will be needed to ensure ethics in science and its use. There are ancient taboos on the use of ‘poison or plague’ as weapons or for warfare, and doing so has long been stigmatized in many cultures and prohibited by customary international law and international treaties. Might this be one reflection of an innate shared human morality the possibility which was raised earlier? The taboo is the companion to the sacred: that which we regard as sacred we protect with taboos. Traditionally the sacred has been associated with religion. But it has been proposed that it can also function in a secular context through a concept called the secular sacred . Contemporary societies which do not use religion as a direct basis for public policy still need to have access to a concept of the sacred in order to maintain respect for all life, in particular human life, and to find shared values.

We have lost both the concept of the sacred and of the taboo in relation to much conduct in our contemporary world, but we urgently need to re-find them in relation to the new possibilities opened up by the life sciences if we are to continue to ensure that they are not misused in horrific ways. The challenge is, as pointed out at the beginning of this working paper, no less than to prevent the life sciences from becoming the death sciences. That will require complex, multiple, varied, and integrated responses from a very wide variety of sources at individual, institutional, societal, and global levels. Above all, it will require integrity, honesty, trust, courage, and sometimes restraint. This is no small order at the level of international relations and cooperation.

The following part of this paper looks at the promises and pitfalls of a code of ethics to govern the life sciences as a way to prevent or reduce the misuse of that science.

A Code of Ethics for the Life Sciences

One way to raise the awareness of people in the life sciences to their ethical obligations is through national and international adoption of a code of ethics to govern research in the life sciences. Professor Ronald Atlas of the University of Louisville and past President of the American Microbiology Association and Margaret Somerville recently presented a proposed Code of Ethics for the Life Sciences in the journal Science . This proposal and the contents of the code have both met with strongly conflicting views. The scientific community increasingly recognizes that science itself is not a value-free activity and, therefore, the choice of what research to undertake and how to undertake it must be governed by ethical principles. But there is still a nucleus of scientists who oppose that concept, arguing that there must be no restrictions on the search for new knowledge, and that ethical principles only become relevant in the application of that knowledge.

Scientists’ reasons for holding such a view can range from cognitive (it won’t work), to emotional (fear that it will shut down science), philosophical (science is value free, it’s only its applications that need ethical guidance), misguided (scientists are ethical people and all that ethics requires is that they act in good conscience), monetary (it will bankrupt our company) and personal (it will ruin my career). But even those who question the value of a code agree that research in the life sciences, including biodefense research, must be conducted in a safe and ethical manner. Such assurance is essential to maintain the public trust, which, in turn, is essential for the continued support of research. Bodies speaking out publicly about this need for ethics include, the General Assembly of the World Medical Association in adopting the Washington Declaration on Biological Weapons , the British Medical Association , the US National Research Council , the British Parliament , and the Asia-Pacific Economic Cooperation (APEC) Leaders , among others .

There have been recurring debates since the tragic events of September 11, 2001, concerning what research should and should not be conducted and what information should and should not be disseminated in the open literature , , . That dialogue has generated calls for a code or codes of conduct to provide guidance for scientists, publishers, and others facing extremely difficult decisions in the context of the dual-use dilemma. The National Science Advisory Board for Biosecurity (NSABB) of the National Institutes of Health has been charged with developing such a code for professional organizations and institutions . In 2005, the Expert and State Parties Meeting of the Biological Weapons Convention (BWC) considered how to promote a common understanding of needed actions toward this end as well.

It needs to be recognized that a code of ethics alone is not a complete solution-that some, possibly even many, people will not comply with the code. But to ask whether a code will provide complete protection is the wrong question. The right question is whether society is better off with a code than without one. The argument put forward by Somerville and Atlas in their Science article is that society is better off with one.

Recognizing that deplorable past breaches of ethics have occurred despite the presence of a code relevant to the conduct in question, also presents another challenge, namely guarding against the cynicism or despair the breaches may evoke in relation to the capacity of a code of ethics to have any or a at least some protective effect. Hope is the antidote to cynicism that we need and there is new reason for optimism in this respect. Research in the philosophy of science shows that as long as a small clustered nucleus of ethical voices remains, ethics has a high probability of reasserting itself; but if those voices are lost, so is ethics-at least from that source , . Consequently ethics requires that we continue to try to be ethical ourselves and to encourage and to help others to do likewise. A code of ethics will help to set the normative standards for the behavior we must strive to have implemented as one of the necessary, although not alone sufficient, protections against bioterrorism.

A Code as the Basis for On-going ‘Ethics Talk’

Words matter. In constructing a code of ethics it needs to be recognized that language is not neutral and nowhere is the choice of language more important and difficult than in drafting provisions that can touch on some of our most profound and dearly-held moral values and beliefs. Codes of ethics unavoidably do that with the result that we may not always agree with each other about their provisions. But society cannot afford simply to walk away from a search for ethics in science because people cannot agree on what should or should not be included in a code of ethics. Rather, there is a need to establish a code and then use it as a basis to engage in an ongoing debate - that is, continue to foster "ethics talk" - because that is an important way in which ethics can move forward in conjunction with science as it advances . A code not only raises awareness of the need for ethics and provides some guidelines against which to judge the ethical acceptability of any given conduct, but also, functions as a teaching tool and provides less senior people, including students, with a means of raising ethical concerns, especially with respect to the conduct of those in authority. By actively supporting the creation and implementation of norms to govern the conduct of research and the communication of scientific information in the life sciences-including behavioral norms established through public discourse-national and global security can be enhanced.

The ancient Hippocratic Oath consists of particular provisions that apply in specific circumstances and, contrary to popular belief, does not explicitly articulate the mandatory injunction ‘first do no harm’. This is, however, the underlying general ethical principle on which all of the provision of the Oath are based and for which the Oath now stands. To reiterate its overall message: Physicians and Scientists must today, even more crucially than in the past, first do no harm-primum non nocere. And to paraphrase a provision in the modern Hippocratic Oath: Physicians and Scientists shall remember that they have a pact with society to advance knowledge and to apply that knowledge for the good of humanity. Scientists and scientific institutions must act responsibly to limit the potential misuse of scientific materials and information by potential bioweaponeers.

Elements of a Code to Counter Bioterrorism

So what are the critical elements that a code of ethics for the life sciences should include. It needs to be built upon ethically relevant facts and articulate the substantive and procedural principles of ethics that must govern its interpretation and application in any given circumstances. They include:

The power of science to result in harm, if it is not governed by strong ethical standards, has been vastly augmented, in particular, by advances in molecular biology and informatics and especially in the context of the life sciences;
Society has entrusted all people and institutions engaged in all aspects of science to undertake it in such a way as to show respect for life, in particular human life;
Safeguards are needed to ensure fulfillment of the public trust and the fiduciary obligations it engenders, and to protect against breach, in particular, to ensure that science is not used in the cause of bioterrorism or biowarfare;
Ethics must be embedded in all aspects of scientific research from its inception;
The standards of behavior embodied in a code of ethics will help to protect against the misuse of science, especially the life sciences;
Compliance with a code of ethics and adherence to its principles is both the individual and collective responsibility of all people engaged in all aspects of science;
A code of ethics will underline the importance of ethics reviews of proposed scientific research and the monitoring of on-going research, including by ensuring the ethics of involving humans or animals as research subjects;
A code of ethics can establish a basic presumption of openness and transparency of scientific information and knowledge, but can allow for exceptions, the use of which must be justified by the persons relying on them to maintain secrecy, when there is a real risk such information or knowledge could be used to do serious harm;
A code of ethics will support the protection of people who act in accordance with its requirements to bring breaches of ethics in scientific research or the misuse of science to the attention of relevant authorities or the public;
Scientists, physicians, other researchers and scientific institutions who fail to act ethically are at high risk of losing the respect of their peers and the respect and the trust of society as a whole, which would have harmful consequences, not only, for them, but also, for scientific research, all people and institutions engaged in science, and society.
Some breaches of ethics can concurrently constitute contravention of existing law and, because codes of conduct and ethical principles that are broadly accepted by one’s peers are often used by courts to establish legal standards, violations of this code could result in legal penalties as well as censures for breaches of ethics;
Persons with ethical or moral objections to participation in certain research need protection and support; and
A code of conduct based upon strong ethical principles will facilitate transmitting the values that must govern scientific research to trainees and students and provide them with both guidance for themselves and benchmarks against which to assess the conduct of their teachers and mentors.

            CODE OF ETHICS FOR THE LIFE SCIENCES

All persons and institutions engaged in any aspect of the life sciences must:
1. Work to ensure that their discoveries and knowledge do no harm:
        i) by refusing to engage in any research that is intended to facilitate, or that has a high probability
           of being used to facilitate bioterrorism or biowarfare; and
       ii) by never contributing to development, production, or acquisition of microbial or other biological
           agents or toxins, whatever their origin or method of production, of types or in quantities that
           cannot be justified on the basis that they are necessary for prophylactic, protective, therapeutic,
           or other peaceful purposes.
2. Work for ethical and beneficent advancement, development, and use of scientific knowledge.
3. Call to the attention of the public or appropriate authorities activities (including unethical research) that there are reasonable grounds to believe are likely to contribute to bioterrorism or biowarfare.
4. Seek to allow access to biological agents that could be used as biological weapons only to individuals who there are reasonable grounds to believe will not misuse them.
5. Seek to restrict dissemination of dual use information and knowledge to those who need to know in cases where there are reasonable grounds to believe that the information or knowledge could be readily misused through bioterrorism or biowarfare.
6. Subject research activities to ethics and safety reviews and monitoring to ensure that:
        i) legitimate benefits are being sought and that they outweigh the risks and harms; and
        ii) involvement of human or animal subjects is ethical and essential for carrying out highly
           important research.
7. Abide by laws and regulations that apply to the conduct of science unless to do so would be unethical, and recognize a responsibility to work through societal institutions to change laws and regulations that conflict with ethics.
8. Recognize all persons’ rights, without penalty, of conscientious objection to participation in research that they consider ethically or morally objectionable.
9. Faithfully transmit this code and the ethical principles upon which it is based to all who are or may become engaged in the conduct of science.

Applying a Code in Practice

A code of ethics is necessarily drafted at the level of general principles. This means that it needs to be supplemented with examples of its interpretation and practical application in a wide range of cases. As an on-line addendum to the Science article Somerville and Atlas considered several real life cases and showed how the individual provisions of the proposed Code of Ethics for the Life Sciences would apply, with particular reference to the responsibilities that devolve on various actors.

Responses to a Proposed Code of Ethics

One important function of any code of ethics, including one to counter bioterrorism, is to stimulate dialogue. Letters sent to Science in response to its publication of a proposed code of ethics to govern the life sciences attested that the code had caused people to think about the value of ethics and the need to act to protect science from misuse. These letters enriched the original discussion and opened up further major issues. The majority confirmed the view that codes are valuable and that ‘ethics talk’ involving the broadest possible range of participants is even more valuable.
Matters that were raised included that the values and ethical standards enshrined in a code of ethics must be reflective of a very broad spectrum of people that stretches well beyond those of a given profession and that the public must have a strong voice in deciding on these values and ethical standards. Ethics requires more than scientists just acting in good personal conscience, and the same is true of them acting collectively as a profession in good professional conscience. Rather, the broadest possible range of people and institutions must be involved in ethics decision making in relation to science for that decision making to be ethically acceptable.
Some of the ways in which we can engage people outside science and, in particular, the public, in setting values and ethical standards for the life sciences include the following:

Ethics review of all research, as is now the norm, must be undertaken by ethics committees that have a very broad-based membership.
Recognizing that the scientific professions hold science on trust for society, establishes that society has the final say as to what will and will not be allowed in terms of ethics.
Adopting a basic presumption of openness and transparency of scientific knowledge and information allows the public to monitor the ethics of science on an ongoing basis, as does the protection of ‘whistle blowers’.
An express duty to bring to the attention of the public or appropriate authorities activities that are unethical or could contribute to bioterrorism or biowarfare engages public participation in decision making about these activities.
Likewise, requiring protection and support for persons with ethical or moral objections to participation in certain research, and protecting their freedom of conscience, promotes public knowledge and involvement in the ethics of science.
And, we must encourage an on-going debate about contested values and beliefs, as a means of stimulating ‘ethics talk’, an important way in which ethics is developed and implemented in practice. It is widely accepted in ethics that this ‘talk must include the public and it merits stating expressly in the context of a WHO consultation that the ‘ethics talk’ we need must go beyond any one country to include broad international participation.

More specifically, as indicated above, providing protection for ‘whistleblowing’ is an essential element in implementing ethics in science. Sometimes difficulties can arise because the person or body to whom one would normally report has a conflict of interest. For example, one’s own government could (and would, unless procedures were put in place to avoid it) have a conflict of interest in receiving information about its own wrongdoing. In such cases, it would not be an appropriate authority to which to report. Who would be must be determined on a case-by-case basis and might include a role for other national authorities or international ones, as well as the public.

We do not need to reinvent the ethical wheel. For instance, medicine has considerable experience in developing ethical guidance in relation to both research and practice and we should use these developments as models. It is important to identify and build on all presently existing relevant resources. And those resources may also benefit from comparison with others. Moreover, ongoing monitoring of ethics as the research evolves is not only instructive ethically, but also, is required as part of ‘doing ethics’.

But experience has shown that professional specificity of ethical requirements is needed for scientists to personally identify with them and, as a result, apply them in practice. Consequently we also need statements about ethics and ethics research specific to the life sciences.
It’s not enough to have ethics on paper; ethics must be implemented in practice. An important example of the practical operationalization of a code of ethics is seen in Europe as a consequence of steps taken by the European Commission. We can learn much from the European experiential ethics knowledge that has resulted.
Whatever steps we take to implement ethics we will not instantiate a perfect system, but the right question is not whether we can find a perfect system, but whether we are better off with than without any measures that might be implemented to promote ethics. Critics of the formal implementation of ethics believe for instance that ‘imposing ethical standards ...will demonize the scientific community’ that scientists will not inadvertently ‘develop weapons through their benign research efforts’; and that ‘aggressive law enforcement and intelligence efforts’ are the only ways to counter bioterrorism and are not complemented by implementing ethics. It can be argued that such views are counter-productive in terms of ensuring ethical science and must be challenged. Ethics is integral to science, which means that unethical science is bad science, not just bad ethics. Like all elements of good science, ethics must be intentionally included. Scientists need support to fulfill their ethical responsibilities to help protect against the misuse of science by those who would do harm.

Sometimes scientists who are punished for breaches of ethics or law are seen as victims who are being unfairly persecuted. The Butlercase has been the focus of stark division within the scientific community. Thomas Butler, a highly respected scientist, apparently, had carried plague-containing material on a commercial airliner from Tanzania to the United States, had sent cultures back to Africa by air transport, and had transported cultures to laboratories within the United States-including government laboratories of the U.S. military and the CDC-all without obtaining the necessary authorizations. He was criminally charged with illegally transporting plague samples (involving illegal import, domestic transport, and export) and convicted. One group of scientists spoke out strongly in defence of Dr. Butler and supported him throughout his trial and pointed to his noble efforts to combat plague. Dr. Butler was, however, in breach of legal regulations governing the transport of pathogens and research on them. Unless to do so would be unethical, scientists and their colleagues must recognize their responsibility to comply with regulations and laws even if government officials and others encourage them to do otherwise and even if the intent of the research is noble.
The Butler case reminds us of some important truisms in ethics: that good facts are essential to good ethics; and that judging the ethics of certain situations can be highly complex, especially when the facts are in dispute, as the scientists who defended Dr Butler say they should be in hiscase. The disputes that have surrounded this case have raised very broad issues that range from the ethics of law enforcement agencies seeking to secure a successful prosecution of a scientist, to those of universities and their administrators seeking to secure funds for their institutions, in particular, when the administrators are in conflict of interest with respect to supporting faculty members and trying to ensure "damage control" with respect to the university’s reputation or liability. University and science administrators must also act ethically.

That brings us to the ethics of ethicists. Engaging in ethical analysis in real cases is an exercise of power and power must be exercised ethically. In short, ethicists must also be reminded that they must practice their profession - that is, ‘do ethics’ - ethically.

The basis on which societal-level trust is established has shifted in post-modern Western societies from blind trust - "trust me to make all the decisions, because I have knowledge, power and status that you don’t have, and I know what is best for you and will act in your best interests" to earned trust - "trust me because I will show that you can trust me and thereby earn your trust" . Earning trust requires openness, honesty and integrity. It is a continuing process not an event and, in particular, requires the sharing of information and the informed consent of those who give their trust. All of which means that the public has a critical role in deciding on the ethics that should govern the life sciences and that structures must be put in place to ensure and to show the public those ethics are consistently applied by scientists in practice. Dialogue and ethics talk with constituencies within and beyond the scientific community are critical to achieving that goal. Scientists must develop a manifest culture of responsibility to maintain the public trust upon which not only science, but also public safety and public health now depends.

Concluding Remarks

The search for ethics to govern the life sciences and public health, both nationally and internationally, is part of a complex ongoing process which will be the setting for diverse and sometimes strongly conflicting viewpoints. To successfully reduce the threat of bioterrorism and biowarfare, and to protect public health, especially on a global level, we all will need to engage across boundaries that have separated us in the past. Only by doing so can we seek to ensure that the promise of our unprecedented new scientific knowledge is fulfilled and its potential for unprecedented harm averted. Certainly, no one measure will be sufficient to ensure that science is not misused or public health put at risk or people’s rights not unjustifiably breached, but in conjunction with other measures, ethics and law properly used can contribute to the protection of people, the reduction of risks of serious harm, and the deterrence of bioterrorism and biowarfare.

The challenges in developing the measures we will need include having them reflect a balance between the necessary certainty and flexibility to be open to universal applicability transnationally, and opening up a critical international dialogue that will help define the boundaries that science must respect to protect against its misuse for bioterrorism and biowarfare and the safeguards needed to protect public health throughout the world. That that is the nature of the challenge makes clear how important the role of the World Health Organization will be in dealing with it.

Finally, we all are involved in many and various activities and, much as we take this consultation seriously, it is easy to slot it in as just one more professional activity. This consultation on research and development in the life sciences, public health and global security not only emphasizes the great benefits that such new knowledge and technologies may provide but also raise awareness on the potential for risks for public health. We must avoid being hysterical or fear-mongering, but we would be very remiss to underestimate the harm that could be unleashed. Let’s hope that with coordinated, international, sustained efforts we can ensure a future in which everyone can feel that ethics prevails, that public health is protected and, as a result, the fear of an ‘accidental, negligently caused or planned epidemic’ can be realistically reduced to a minimum.

Margaret Somerville,"Death Talk: The case against euthanasia and physician-assisted suicide", McGill-Queen’s University Press, 2002, chapter 22.
Stephen Heuser, "City cuts back on plan to regulate biolabs: Scientists feared loss of confidentiality", The Boston Globe, August 23, 2006.
Margaret Somerville, The Ethical Canary: Science, Society and the Human Spirit, Viking/Penguin, Toronto, 2000.
Margaret Somerville, The Ethical Imagination: Journeys of the Human Spirit, House of Anansi Press, Toronto, 2006.
Ibid.

World Medical Association Policy: "Declaration of Washington on Biological Weapons" (Document 17.400; 2002; http://www.wma.net/e/policy/bl.htm).
British Medical Association, Biotechnology, Weapons and Humanity (Harwood Academic Publishers, London, 1999).
Committee on Research Standards and Practice to Prevent the Destructive Application of Biotechnology, National Research Council, Biotechnology Research in an Age of Terrorism (National Academies Press, Washington, DC, 2004). http://books.nap.edu/catalog/10827.html
House of Commons. "Security of Research" (Select Committee on Science and Technology Eighth Report, 2003). www.publications.parliament.uk/pa/cm200203/cmselect/cmsctech/415/41515.htm
Asia-Pacific Economic Cooperation (APEC) Leaders' Statement on Health Security, http://www.apecsec.org.sg/apec/leaders__declarations/2003/2003_StmtHealthSecurity.htm (2003).
University of Exeter, "Biological weapons and codes of conduct," www.ex.ac.uk/codesofconduct/Chronology/
Supra note 10.
Supra note 11.
Editorial, Proc. Natl. Acad. Sci, U.S.A 100, 1464 (2003).
National Science Advisory Board for Biosecurity, www4.od.nih.gov/nsabb (last updated 3/4/2004)
G. Malinas, J. Bigelow in The Stanford Encyclopedia of Philosophy, E. N. Zalta, Ed. The Metaphysics Research Lab, Stanford, CA, 2004; http://plato.stanford.edu/archives/spr2004/entries/paradox-simpson/)
M. Nowak, R.M. May, K. Sigmund, Sci. Am., 50 (June 1995).
M. Somerville, The Ethical Canary: Science, Society and the Human Spirit (Viking, Toronto, 2000), pp. 1-21.

Supra note 6.
Ben Perman, "Using Ethics to Fight Bioterrorism", Letters, Science 2005; 309:1012-1017.
J. Katz, Silent World of Doctor and Patient, Free Press, New York, 1984.