ETHICAL ISSUES IN FORENSIC PSYCHIATRIC RESEARCH ON MENTALLY DISORDERED OFFENDERS

This paper analyses ethical issues in forensic psychiatric research on mentally disordered offenders, especially those detained in the psychiatric treatment system. The idea of a 'dual role' dilemma afflicting forensic psychiatry is more complicated than acknowledged. Our suggestion acknowledges the good of criminal law and crime prevention as a part that should be balanced against familiar research ethical considerations. Research aiming at improvements of criminal justice and treatment is a societal priority, and the total benefit of studies has to be balanced against the risks for research subjects inferred by almost all systematic studies. Direct substantial risks must be balanced by health benefits, and normal informed consent requirements apply. When direct risks are slight, as in register-based epidemiology, lack of consent may be counter-balanced by special measures to protect integrity and the general benefit of better understanding of susceptibility, treatment and prevention. Special requirements on consent procedures in the forensic psychiatric context are suggested, and the issue of the relation between decision competence and legal accountability is found to be in need of further study. The major ethical hazard in forensic psychiatric research connects to the role of researchers as assessors and consultants in a society entertaining strong prejudices against mentally disordered offenders.     

Incorporating Science,Technology, Fairness,and Accountability in Environmental,Health, and Safety Decisions

The Precautionary Principle is in sharp political focus today because (1) the nature of scientific uncertainty is changing and (2) there is increasing pressure to base governmental action on more “rational” schemes, such as cost-benefit analysis and quantitative risk assessment, the former being an embodiment of ‘rational choice theory’ promoted by the Chicago school of law and economics. The Precautionary Principle has been criticized as being both too vague and too arbitrary to form a basis for rational decision making. The assumption underlying this criticism is that any scheme not based on cost-benefit analysis and risk assessment is both irrational and without secure foundation in either science or economics. This paper contests that view and makes explicit the rational tenets of the Precautionary Principle within an analytical framework as rigorous as uncertainties permit, and one that mirrors democratic values embodied in regulatory, compensatory, and common law. Unlike other formulations that reject risk assessment, this paper argues that risk assessment can be used within the formalism of tradeoff analysis—a more appropriate alternative to traditional cost-benefit analysis and one that satisfies the need for well-grounded public policy decision making. This paper will argue that the precautionary approach is the most appropriate basis for policy, even when large uncertainties do not exist, especially where the fairness of the distributions of costs and benefits of hazardous activities and products are a concern. Furthermore, it will offer an approach to making decisions within an analytic framework, based on equity and justice, to replace the economic paradigm of utilitarian cost-benefit analysis.     

Multidisciplinary Research: Strategies for Assessing Chemical Mixtures to Reduce Risk of Exposure and Disease

The Precautionary Principle is founded on the use of comprehensive, coordinated research to protect human health in the face of uncertain risks. Research directed at key data gaps may significantly reduce the uncertainty underlying the complexities of assessing risk to mixtures. The National Institute of Environmental Health Sciences (NIEHS) has taken a leadership rôle in building the scientific infrastructure to address these uncertainties. The challenge is to incorporate the objectives as defined by the Precautionary Principle with the knowledge gained in understanding the multifactorial nature of gene-environment interactions. Through efforts such as the National Center for Toxicogenomics, the National Toxicology Program, and the Superfund Basic Research Program, NIEHS is translating research findings into public health prevention strategies using a 3-pronged approach: (1) identify/evaluate key deviations from additivity for mixtures; (2) develop/apply/link advanced technologies and bioinformatics to quantitative tools for an integrated science-based approach to chemical mixtures; (3) translate/disseminate these technologies into useable, practical means to reduce exposure and the risk of disease. Preventing adverse health effects from environmental exposures requires translation of research findings to affected communities and must include a high level of public involvement. Integrating these approaches are necessary to advance understanding of the health relevance of exposure to mixtures.     

Commentary: The Rôle of Toxicology in Prevention and Precaution

Advocates of the Precautionary Principle have recently called for a “new science” to support the goals of precaution-based environmental and occupational health policy. While much attention has been given to epidemiology, the evidentiary science most relevant to precaution, or prevention, is toxicology. Opportunities for enhancing the rôle of toxicology in public policy must consider current biases in the field. Thus, rather than a “new science,” advocates for change should focus upon ensuring that current scientific methods are appropriate and that interpretations of scientific data are accurate.     

Implications of the Precautionary Principle: Is it a Threat to Science?

Scientific research is of proven value to protecting public health and the environment from current and future problems. We explore the extent to which the Precautionary Principle is a threat to this rôle for science and technology. Not surprisingly for a relatively simple yet still incompletely defined concept, supporters of the Precautionary Principle come from different viewpoints, including a viewpoint that is at least uneasy with the rôle of science, and particularly its use in risk assessment. There are also aspects of the Precautionary Principle that inherently restrict obtaining and using science. The Hazardous Air Pollutant (HAP) provisions in the US Clean Air Act Amendments are an example of the Precautionary Principle, which both shifted the burden of proof so that the onus is now on showing a listed compound is harmless, and required maximum available control technology (MACT) instead of a primarily risk-based approach to pollution control. Since its passage in 1990 there has been a decrease in research funding for studies of HAPs. Other potential problems include that once MACT regulations are established, it may be difficult to develop new technological approaches that will further improve air pollution control; that by treating all regulated HAPs similarly, no distinction is made between those that provide a higher or lower risk; and that there is a perverse incentive to use less well studied agents that are not on the existing list. As acting on the Precautionary Principle inherently imposes significant costs for what is a potentially erroneous action, additional scientific study should be required to determine if the precautionary action was successful. If we are to maximize the value of the Precautionary Principle to public health and the environment, it is crucial that its impact not adversely affect the potent preventive rôle of science and technology.     

Comparison of Bayesian-Utilitarian and Maximin Principle Approaches

The Precautionary Principle implies the adoption of a set of rules aimed at avoiding possible future harm associated with suspected, but not ascertained, risk factors. Several philosophical, economical and societal questions are implied by precaution-based public health decision making. The purpose of the present paper is to specify the scope of the principle examining the notion of uncertainty involved, and the implication of different approaches to the decision making process. The Bayesian-utilitarian approach and the approach based on the maximin principle will be considered, and the different meaning of prudence in the two settings will be discussed. In a Bayesian-utilitarian approach the small number of attributable cases will end up in a low average expected value, easily regarded as acceptable in a cost-benefit analysis. In a maximin approach, on the other hand, the issue will be to consider the high etiologic fraction of a rare disease in the highest category of exposure. In the light of the aforementioned cautions in interpretation, the core difference between the two approaches has to do with the choice between averaging knowledge or equitably distributing technological risks.     

The Precautionary Principle: Implications for Risk Management Strategies

The European Commission has published a Communication on the Precautionary Principle and a White Book on Governance. These provide us (as research civil servants of the Commission) an institutional framework for handling scientific information that is often incomplete, uncertain, and contested. But, although the Precautionary Principle is intuitively straightforward to understand, there is no agreed way of applying it to real decision-making. To meet this perceived need, researchers have proposed a vast number of taxonomies. These include ignorance auditing, type one-two-three errors, a combination of uncertainty and decision stakes through post-normal science and the plotting of ignorance of probabilities against ignorance of consequences. Any of these could be used to define a precautionary principle region inside a multidimensional space and to position an issue within that region. The rôle of anticipatory research is clearly critical but scientific input is only part of the picture. It is difficult to imagine an issue where the application of the Precautionary Principle would be non-contentious. From genetically-modified food to electro-smog, from climate change to hormone growth in meat, it is clear that: 1) risk and cost-benefit are only part of the picture; 2) there are ethical issues involved; 3) there is a plurality of interests and perspectives that are often in conflict; 4) there will be losers and winners whatever decision is made. Operationalisation of the Precautionary Principle must preserve transparency. Only in this way will the incommensurable costs and benefits associated with different stakeholders be registered. A typical decision will include the following sorts of considerations: 1) the commercial interests of companies and the communities that depend on them; 2) the worldviews of those who might want a greener, less consumerist society and/or who believe in the sanctity of human or animal life; 3) potential benefits such as enabling the world's poor to improve farming; 4) risks such as pollution, gene-flow, or the effects of climate change. In this paper we will discuss the use of a combination of methods on which we have worked and that we consider useful to frame the debate and facilitate the dialogue among stakeholders on where and how to apply the Precautionary Principle.     

Major Concerns in Developing Countries: Applications of the Precautionary Principle in Ecuador

Ecuador is a Latin American country with one of the biggest biodiversities. At the same time, social and environmental problems are also big. Poverty, political and social problems as well as questions like old transport systems, imported hazards from industrialized countries and lack of information and weak health care systems are the framework of this situation. The most common problems are the use of heavy metals in many activities without safety and health protection, a low technological oil production during two decades, intensive use of pesticides in agriculture, and some other chemical risks. A limited capacity to develop prevention strategies, reduced technical and scientific skills, and the absence of a reliable information and control system, lead to a weak response mechanism. The Precautionary Principle could help to stimulate prevention, protection and to have a new tool to improve the interest in environment and health problems. Reinforcing the presence of international organizations like WHO and ILO, establishing bridges among scientific organizations from developed and developing countries and introducing the Precautionary Principle in the legislation and daily practices of industry and agriculture could lead to an improvement in our environment and health.     

LINKING INTERNATIONAL RESEARCH TO GLOBAL HEALTH EQUITY: THE LIMITED CONTRIBUTION OF BIOETHICS

Health research has been identified as a vehicle for advancing global justice in health. However, in bioethics, issues of global justice are mainly discussed within an ongoing debate on the conditions under which international clinical research is permissible. As a result, current ethical guidance predominantly links one type of international research (biomedical) to advancing one aspect of health equity (access to new treatments). International guidelines largely fail to connect international research to promoting broader aspects of health equity – namely, healthier social environments and stronger health systems. Bioethical frameworks such as the human development approach do consider how international clinical research is connected to the social determinants of health but, again, do so to address the question of when international clinical research is permissible. It is suggested that the narrow focus of this debate is shaped by high‐income countries' economic strategies. The article further argues that the debate's focus obscures a stronger imperative to consider how other types of international research might advance justice in global health. Bioethics should consider the need for non‐clinical health research and its contribution to advancing global justice.     

The Precautionary Principle and Statistical Approaches to Uncertainty

The central challenge from the Precautionary Principle to statistical methodology is to help delineate (preferably quantitatively) the possibility that some exposure is hazardous, even in cases where this is not established beyond reasonable doubt. The classical approach to hypothesis testing is unhelpful, because lack of significance can be due either to uninformative data or to genuine lack of effect (the Type II error problem). Its inversion, bioequivalence testing, might sometimes be a model for the Precautionary Principle in its ability to ‘prove the null hypothesis.’ Current procedures for setting safe exposure levels are essentially derived from these classical statistical ideas, and we outline how uncertainties in the exposure and response measurements affect the No Observed Adverse Effect Level (NOAEL), the Benchmark approach and the “Hockey Stick” model. A particular problem concerns model uncertainty: usually these procedures assume that the class of models describing dose/response is known with certainty; this assumption is however often violated, perhaps particularly often when epidemiological data form the source of the risk assessment, and regulatory authorities have occasionally resorted to some average based on competing models. The recent methodology of Bayesian model averaging might be a systematic version of this, but is this an arena for the Precautionary Principle to come into play?     

Methodologic Implications of the Precautionary Principle: Causal Criteria

Applying the Precautionary Principle to public health requires a re-evaluation of the methods of inference currently used to make claims about disease causation from epidemiologic and other forms of scientific evidence. In current thinking, a well-established, near-certain causal relationship implies highly consistent statistically significant results across many different studies, large relative risk estimates, extensive understanding of biological mechanisms and dose-response relationships, positive prevention trial results, a clear temporal relationship between cause and effect, and other conditions spelled out in terms of the widely-used causal criteria. The Precautionary Principle, however, states that preventive measures are to be taken when cause and effect relationships are not fully established scientifically. What evidentiary conditions, as reflected in the causal criteria, will be certain enough to warrant precautionary preventive action? This paper argues that minimum evidentiary requirements for causation need to be articulated if the Precautionary Principle is to be successfully incorporated into public health practice. Two precautionary changes to criteria-based methods of causal inference are examined: reducing the number of criteria and weakening the rules of inference accompanying the criteria. Such changes point in the direction of identifying minimum evidentiary conditions, but would be premature without better understanding how well current methods of causal inference work.     

Adjusting Scientific Practices to the Precautionary Principle

In most discussions of the Precautionary Principle, it is implicitly assumed that we are at a point near risk neutrality, so that the principle aims at moving away from risk neutrality in the direction of more risk-averse behavior. In this paper it is argued that actual decision-making in environmental issues is often on the opposite, risk taking, side of risk neutrality. A minimal version of the Precautionary Principle consists in moving from such a position in the direction of risk neutrality. Some methods for achieving this are discussed, such as less consensus-seeking scientific procedures, requirements that scientific committees identify less probable but serious scenarios, interpretative presumptions, and supplementary statistical measures for type II errors.     

Ecological Risk Assessment and the Precautionary Principle

The Precautionary Principle, generated during the late 1980s as a unifying principle for regulating discharge of hazardous material into the North Sea, has been broadened to include a shifting of the burden of proof to the proponent of a proposed activity, adoption of a more holistic assessment process, and encompassing all environmental management decisions, not just pollution prevention activities. We argue that the Precautionary Principle remains a management philosophy, not a substitute for risk assessment. Risk assessment is a tool for organizing information used in environmental management decisions. However, increasing attention to reducing the Type II error of risk assessment studies would significantly reduce the skepticism with which many view the risk assessment process. A critical review of default assumptions used in risk assessments, inclusion of indirect effects within an ecologically relevant spatial/temporal framework, and better communication between risk assessors and risk managers also would enhance the acceptability of the process. Risk assessment can provide a sound basis for management decisions regardless of the underlying philosophies of environmental conservation or utilitarianism, but only if the inherent biases in the risk assessment assumptions are acknowledged explicitly throughout the assessment and management processes.     

Teaching global bioethics

We live in a world with enormous disparities in health. The life expectancy in Japan is 80 years; in Malawi, 40 years. The under-five mortality in Norway is 4/1000; in Sierra Leone, 316/1000. The situation is actually worse than these figures suggest because average rates tend to mask inequalities within a country. Several presidents of the IAB have urged bioethicists to attend to global disparities and to broaden the scope of bioethics. For the last six years I have tried to do just that. In this paper, I report and reflect on my attempts to teach bioethics in ways that address global health and justice. I then discuss ways to address key ethical issues in global health: the problem of inequalities; the nature of the duty to assist; the importance of the duty not to harm; the difference between a cosmopolitan and a political view of justice. I also discuss how teaching about global health may help to shift the emphasis in bioethics--from sensational cases to everyday matters, from autonomy and justice, and from access to healthcare to the social determinants of health. At the end of my paper, I reflect on questions that I have not resolved: how to delineate the scope of bioethics, whether my approach over-politicises bioethics, and how to understand the responsibilities of bioethicists.     

Commentary: Barriers and Opportunities to Changing the Research Agenda to Support Precaution and Primary Prevention

Conceptual research to define the Precautionary Principle and its rôle in science, science policy, and public health is making substantial progress. In September 2001, participants at the International Summit on Science and the Precautionary Principle developed a vision for science to address the complexity of contemporary health risks in a way that could lead to more precautionary, preventive decisions under uncertainty. Its components include: (1) a more effective linkage between research on hazards and research on primary prevention; (2) increased use of interdisciplinary approaches including better integration of qualitative and quantitative data; (3) innovative methods for analyzing cumulative and interactive effects, populations and systems and vulnerable sub-populations; (4) systems for continuous monitoring to avoid unintended consequences of actions and to identify early warnings of risks; (5) more comprehensive techniques for analyzing and communicating hazards and uncertainties; and (6) a more dynamic interface between science and policy. This article addresses barriers and opportunities to the practical application of this vision for science. Scientists in many fields have recognized the need for innovative approaches and tools to address increasingly complex, uncertain risks of a global scale. While opportunities to apply precautionary concepts in the research agenda exist, public health scientists must be cognizant of current and emerging barriers in the research agenda that balance the research focus on characterizing proximate causal mechanisms of disease, to the detriment of research and policy to support primary prevention.     

Implementing the Precautionary Principle: Rigorous Science and Solid Ethics

The Precautionary Principle came out of European efforts to clean-up and protect marine ecosystems in the 1980s. Since then, several North American activities have elaborated on this approach in U.S. environmental programs. Unfortunately, US organizations and agencies have not developed strategies and guidelines for implementing the Precautionary Principle in either statutory or voluntary environmental programs. Recent interest in this approach from some members of the scientific, non-profit, and regulatory communities highlights the need to understand the history and conceptual basis of the Precautionary Principle. In this paper we address several of these issues. First, we summarize the pertinent US history of the Precautionary Principle. Next, we describe the scientific framework for the principle. Finally, we make the case that this provides unique opportunities for scientists to obtain meaning in their work by fulfilling what has been called the new Social Contract.     

EPIDEMIOLOGY AND SOCIAL JUSTICE IN LIGHT OF SOCIAL DETERMINANTS OF HEALTH RESEARCH

The present article identifies how social determinants of health raise two categories of philosophical problems that also fall within the smaller domain of ethics; one set pertains to the philosophy of epidemiology, and the second set pertains to the philosophy of health and social justice. After reviewing these two categories of ethical concerns, the limited conclusion made is that identifying and responding to social determinants of health requires inter-disciplinary reasoning across epidemiology and philosophy. For the reasoning used in epidemiology to be sound, for its scope and (moral) purpose as a science to be clarified as well as for social justice theory to be relevant and coherent, epidemiology and philosophy need to forge a meaningful exchange of ideas that happens in both directions.     

The Precautionary Principle in the Information Society

The Precautionary Principle aims to anticipate and minimize potentially serious or irreversible risks under conditions of uncertainty. Thus it preserves the potential for future developments. It has been incorporated into many international treaties and pieces of national legislation for environmental protection and sustainable development. However the Precautionary Principle has not yet been applied systematically to novel Information and Communication Technologies (ICTs) and their potential environmental, social, and health effects. In this article we argue that precaution is necessary in this field and show how the general principle of precaution can be put in concrete terms in the context of the information society. We advocate precautionary measures directed towards pervasive applications of ICT (Pervasive Computing) because of their inestimable potential impacts on society.     

Justice and Surgical Innovation: The Case of Robotic Prostatectomy

Surgical innovation promises improvements in healthcare, but it also raises ethical issues including risks of harm to patients, conflicts of interest and increased injustice in access to health care. In this article, we focus on risks of injustice, and use a case study of robotic prostatectomy to identify features of surgical innovation that risk introducing or exacerbating injustices. Interpreting justice as encompassing matters of both efficiency and equity, we first examine questions relating to government decisions about whether to publicly fund access to innovative treatments. Here the case of robotic prostatectomy exemplifies the difficulty of accommodating healthcare priorities such as improving the health of marginalized groups. It also illustrates challenges with estimating the likely long‐term costs and benefits of a new intervention, the difficulty of comparing outcomes of an innovative treatment to those of established treatments, and the further complexity associated with patient and surgeon preferences. Once the decision has been made to fund a new procedure, separate issues of justice arise at the level of providing care to individual patients. Here, the case of robotic prostatectomy exemplifies how features of surgical innovation, such as surgeon learning curves and the need for an adequate volume of cases at a treatment centre, can exacerbate injustices associated with treatment cost and the logistics of travelling for treatment. Drawing on our analysis, we conclude by making a number of recommendations for the just introduction of surgical innovations.