Reidar Lie

China has become a global player in the field of biosamples research and analysis of genetic data. The Beijing Genomics Institute is a genetics factory where enormous amounts of biosamples/data from all over the world are being analyzed. Most of the global bioethics discussions focused on research conducted by scientists from industrialized countries with subjects from poorer countries. Today, however, samples from industrialized nations are being analyzed in China on an unprecedented scale. This means that one should not just focus on bioethics developments in western countries, but also should pay attention to the situation in China. Under this era of rapid advancement in genomics, reassessing the conventionally accepted bioethical principles is strongly needed.

It has been suggested that focusing on procedures when setting priorities for health care avoids the conflicts that arise when attempting to agree on principles. A prominent example of this approach is “accountability for reasonableness.” We will argue that the same problem arises with procedural accounts; reasonable people will disagree about central elements in the process. We consider the procedural condition of appeal process and three examples of conflicts over coverage decisions: a patients’ rights law in Norway, health technologies coverage recommendations in the UK, and care withheld by HMOs in the US. In each case a process is at the center of controversy, illustrating the difficulties in establishing procedures that are widely accepted as legitimate. Further work must be done in developing procedural frameworks.

The application of genetic technologies in China, especially in the area of prenatal genetic testing, is rapidly increasing in China. In the wealthy regions of China, prenatal genetic testing is already very widely adopted. We argue that the government should actively promote prenatal genetic testing to the poor areas of the country. In fact, the government should prioritize resources first to make prenatal genetic testing a standard routine care with an opt-out model in these area. Healthcare professions would be required to inform pregnant women about the availability of genetic testing and provide free testing on a routine basis unless the parents choose not to do so. We argue that this proposal will allow parents to make a more informed decision about their reproductive choices. Secondarily, this proposal will attract more healthcare professionals and other healthcare resources to improve the healthcare infrastructures in the less-developed regions of the country. This will help to reduce the inequity of accessing healthcare services between in different regions of China. We further argue that this policy proposal is not practicing eugenics.

This article tries to present a broad view on the values and ethicalissues that are at stake in efforts to rationalize health policy on thebasis of economic evaluations (like cost-effectiveness analysis) andrandomly controlled clinical trials. Though such a rationalization isgenerally seen as an objective and `value free' process, moral valuesoften play a hidden role, not only in the production of `evidence', butalso in the way this evidence is used in policy making. For example, thedefinition of effectiveness of medical treatment or health care serviceis heavily dependent on dominant individual or social views about thegoals of the particular treatment or service. There is also a concernthat a reliance on EBM in health policy will occur at the expense ofwidely shared social values like equity and solidarity. Moreover, thereis a concern that when economic considerations and rational proceduresbecome more influential, various `outside' groups third parties likeinsurance companies and policy makers will get a stronger influence onmedical practice which may lead to a change in the patient-providerrelationship. The authors conclude that social values and patientpreference should be explicitly addressed when health policy making isbased on economic and other scientific evidence

This article presents a case study from the history of cardiology, namely, the development towards the acceptance of the coronary theory of angina pectoris. I show that the arguments which were considered decisive against the theory were not answered at the time the theory was accepted. I also point out that the experimental and practical success of the theory cannot be used to support the initial choice because, in the subsequent development, the field researchers became preoccupied with new questions and problems. In spite of this, there is a sense in which the field of angina research has progressed, but it remains a challenge to exactly characterise in what sense this is the case.

Background. Despite common recognition of joint responsibility for global health by all countries particularly to ensure justice in global health, current discussions of countries’ obligations for global health largely ignore obligations of developing countries. This is especially the case with regards to obligations relating to health financing. Bearing in mind that it is not possible to achieve justice in global health without achieving equity in health financing at both domestic and global levels, our aim is to show how fulfilling the obligation we propose will make it easy to achieve equity in health financing at both domestic and international levels. Discussion. Achieving equity in global health financing is a crucial step towards achieving justice in global health. Our general view is that current discussions on global health equity largely ignore obligations of Low Income Country governments and we recommend that these obligations should be mainstreamed in current discussions. While we recognise that various obligations need to be fulfilled in order to ultimately achieve justice in global health, for lack of space we prioritise obligations for health financing. Basing on the evidence that in most LICs health is not given priority in annual budget allocations, we propose that LIC governments should bear an obligation to allocate a certain minimum percent of their annual domestic budget resources to health, while they await external resources to supplement domestic ones. We recommend and demonstrate a mechanism for coordinating this obligation so that if the resulting obligations are fulfilled by both LIC and HIC governments it will be easy to achieve equity in global health financing. Summary. Although achieving justice in global health will depend on fulfilment of different categories of obligations, ensuring inter- and intra-country equity in health financing is pivotal. This can be achieved by requiring all LIC governments to allocate a certain optimal per cent of their domestic budget resources to health while they await external resources to top up in order to cover the whole cost of the minimum health opportunities for LIC citizens.

In this issue, Alex London and Kevin Zollman provide an analysis of an influential approach to the ethics of international research, known as the “fair benefits” approach. According to them, the fair benefits approach suffers from a fatal flaw: it is either too vague to be useful, or worse, is internally inconsistent. The fair benefits approach was developed based on a presentation I gave at a workshop organized in Malawi in March 2001 by the National Institutes of Health Clinical Center’s Department of Bioethics. In this presentation, I made what I still think is a valid point, which was accepted by the diverse group of participants and formed the basis of the subsequent publications: One should not ..

In rapidly evolving medical fields where the standard of care or prevention changes frequently, guidelines are increasingly likely to conflict with what participants receive in research. Although guidelines typically set the standard of care, there are some cases in which research can justifiably deviate from guidelines. When guidelines conflict with research, an ethical issue only arises if guidelines are rigorous and should be followed. Next, it is important that the cumulative evidence and the conclusions reached by the guidelines do not eliminate the need for further research. Even when guidelines are rigorous and the study still asks an important question, we argue that there may be good reasons for deviations in three cases: (1) when research poses no greater net risk than the standard of care; (2) when there is a continued need for additional evidence, for example, when subpopulations are not covered by the guidelines; and (3) less frequently, when clinical practice guidelines can be justified by the evidence, but practitioners disagree about the guidelines, and the guidelines are not consistently followed as a result. We suggest that procedural protections may be especially useful in deciding when studies in the third category can proceed

This is a discussion of the reaction to the recent research article publication in the journal Protein & Cell by a group of scientists at Sun Yat-sen University using the CRISPR/Cas9 technique on editing non-viable human zygotes. Many commentators condemned the Chinese scientists for overstepping ethical boundaries long accepted in Western countries and accused China of having lax regulations on genomic research in general. We argue that not only did this research follow strict ethical standards and fully comply with current regulations, but China also has a well-developed regulatory framework governing such research comparable to many developed countries. We see the reactions among Western commentators as a misunderstanding of the current situation and an expression of a lack of willingness to acknowledge China as an equal partner in the international debate about proper limits to the development of new biotechnologies.

Background: Sharing of tissue samples for research and disease surveillance purposes has become increasingly important. While it is clear that this is an area of intense, international controversy, there is an absence of data about what researchers themselves and those involved in the transfer of samples think about these issues, particularly in developing countries. Methods: A survey was carried out in a number of Asian countries and in Egypt to explore what researchers and others involved in research, storage and transfer of human tissue samples thought about some of the issues related to sharing of such samples. Results: The results demonstrated broad agreement with the positions taken by developing countries in the current debate, favoring quite severe restrictions on the use of samples by developed countries. Conclusions: It is recommended that an international agreement is developed on what conditions should be attached to any sharing of human tissue samples across borders

All health care systems face problems of justice and efficiency related to setting priorities for allocating a limited pool of resources to a population. Because many of the central issues are the same in all systems, the United States and other countries can learn from the successes and failures of countries that have explicitly addressed the question of health care priorities. We review explicit priority setting efforts in Norway, Sweden, Israel, the Netherlands, Denmark, New Zealand, the United Kingdom and the state of Oregon in the US. The approaches used can be divided into those centered on outlining principles versus those that define practices. In order to establish the main lessons from their experiences we consider the process each country used, criteria to judge the success of these efforts, which approaches seem to have met these criteria, and using their successes and failures as a guide, how to proceed in setting priorities. We demonstrate that there is little evidence that establishment of a values framework for priority setting has had any effect on health policy, nor is there evidence that priority setting exercises have led to the envisaged ideal of an open and participatory public involvement in decision making.

The World Medical Association’s revised Declaration of Helsinki endorses the view that all trial participants in every country are entitled to the worldwide best standard of care. In this paper the authors show that this requirement has been rejected by every national and international committee that has examined this issue. They argue that the consensus view now holds that it is ethically permissible, in some circumstances, to provide research participants less than the worldwide best care. Finally, the authors show that there is also consensus regarding the broad conditions under which this is acceptable

Ethical issues related to comparative effectiveness research, or research that compares existing standards of care, have recently received considerable attention. In this paper we focus on how Ethics Review Committees should evaluate the risks of comparative effectiveness research. We discuss what has been a prominent focus in the debate about comparative effectiveness research, namely that it is justified when “nothing is known” about the comparative effectiveness of the available alternatives. We argue that this focus may be misleading. Rather, we should focus on the fact that some experts believe that the evidence points in favor of one intervention, whereas other experts believe that the evidence favors the alternative. We will then introduce a case that illustrates this point, and based on that, discuss how ERCs should deal with such cases of expert disagreement. We argue that ERCs have a duty to assess the range of expert opinions and based on that assessment arrive at a risk judgment about the study under consideration. We also argue that assessment of expert disagreement is important for the assignment of risk level to a clinical trial: what is the basis for expert opinions, how strong is the evidence appealed to by various experts, and how can clinical trial monitoring affect the possible increased risk of clinical trial participation.

This paper gives an account of theory structure in the biomedical sciences with particular emphasis on cardiology. Rather than regarding theories as axiomatizable sets of statements (the so-called received view), theories are regarded as answers to questions which are accepted as legitimate and interesting by scientists within a field of investigation at a given time. This account of theory structure is used to distinguish between theories which are quite liable to be revised during the course of scientific investigation, here called theories within the field, and theories which are more securely established, here called theories of the field. These latter theories can also be regarded as patterns of reasoning which are applied again and again to answer the questions of the field. It is argued that the distinction proposed in this paper fits our intuitive understanding of what it means for a theory to be securely established within a field of research. Several examples are given which show the problems of justifying clinical intervention solely on the basis of theories within the field.

Decision analysts sometimes use the results of clinical trials in order to evaluate treatment alternatives. I discuss some problems associated with this, and in particular I point out that it is not valid to use the estimates from clinical trials as the probabilities of events which are needed for decision analysis. I also attempt to show that an approach based on objective statistical theory may have advantages over commonly used methods based on decision theory. These advantages include the recognition of uncertain data, the introduction of a third alternative, namely suspension of judgement, and the possibility of modifying the choice of probabilities based on a clinical trial with reference to other available knowledge. I have not, however, shown in detail how this modification is done, but I think the concept is sufficiently promising to be applied to an actual clinical decision problem.

There is a growing interest in comparison of international health care data with the hope that such studies will enable individual systems to learn from other systems. Such comparisons, however, presuppose that there exist common criteria for evaluating health care systems. The main thesis of this paper is that these comparative studies are misleading because they employ inappropriate operationalizations of these criteria because the operarionalizations are based upon mistaken global conceptualizations of the criteria in question. The essay provides a methodological critique of what has been done and sets a new agenda for future research

The term “globalization” was popularized by Marshall McLuhan in War and Peace in the Global Village. In the book, McLuhan described how the global media shaped current events surrounding the Vietnam War [1] and also predicted how modern information and communication technologies would accelerate world progress through trade and knowledge development. Globalization now refers to a broad range of issues regarding the movement of goods and services through trade liberalization, and the movement of people through migration. Much has also been written on the global effects of environmental degradation, population growth, and economic disparities. In addition, the pace of scientific development has accelerated, with both negative and positive implications for global health. Concerns for national health transcend borders, with a need for shared human security and an enhanced role for international cooperation and development [2]. These issues have significant bioethical implications, and thus a renewed academic focus on the ethical dimensions of public health is needed. Future developments in science and health policy also require a firm grounding in bioethical principles. These core principles include beneficence; nonmaleficence ; respect for persons and human dignity ; and attention to equity and social justice. According to the World Health Organization [3], global ethical approaches should monitor and update ethical norms for research, as necessary; anticipate ethical implications of advances in science and technology for health; apply internationally accepted codes of ethics; ensure that agreed standards guide future work on the human genome; and ensure that quality in health systems and services is assessed and promoted.

The main topic of this article is Otto Frank's forgotten notion of the pressure-volume diagram of the cardiac ventricle as a means to assess the external mechanical work of the heart. Developed by Frank at the end of the 19th century, this idea was reenvisioned as pressure-volume area about 70 to 80 years later by Hiroyuki Suga. This notion now serves as a perspective for defining cardiac contractility and thus enabling the controlled clinical application of cardiac assist devices. We begin our discussion, however, with the work of Ernest H. Starling, whose dominant influence on the thinking of cardio-physiologists led to a neglect of some of the fundamental insights of Frank's...

In this paper, the author argues that the requirement to conduct randomised clinical trials to inform policy in cases where one wants to identify a cheaper alternative to known effective but expensive interventions raises an important ethical issue. This situation will eventually arise whenever there are resource constraints, and a policy decision has been made not to fund an intervention on cost effectiveness grounds. It has been thought that this is an issue only in extremely resource poor settings. This paper gives an example from the United Kingdom illustrating that this is also a problem faced by richer countries

Obligations of global justice rest mainly on the global rich but also to a lesser extent on the global poor. The governments of poor countries are obliged to fulfill requirements of non-aggression, good governance and decency, along with all other requirements which facilitate the achievement of global justice. So far, obligations of poor countries seem to be taken as given yet the behavior of governments in poor countries and occurrences therein attest to the contrary;this suggests a need to mainstream these obligations in discussions about global justice. If poor countries do not live up to these requirements obstacles arise to the realization of global justice; and they act unjustly in relation to citizens of rich countries which provide them with aid. Uganda is taken as a case in point.

Background: Although health is a right of all individuals without any distinction, the realisation of this right has remained very difficult for the marginalised populations of poor countries. Inequitable distribution of health opportunities globally is a major factor in explaining why this is the case. Whereas the Protection, Promotion and Fulfilment of the health rights of poor country citizens are a joint responsibility of both domestic and external governments, most governments flout their obligations. So far disproportionate effort has been dedicated to reaffirming and interpreting these obligations as opposed to investigating the fundamental question regarding why these obligations have nevertheless remained largely unfulfilled. Further the normative question regarding what ought to be done about the shortcomings of current obligations has been largely ignored. Methods: We conduct a critical content analysis of existing literature on efforts towards the realisation of the health rights of marginalised populations in our attempt to ascertain their capacity to guarantee basic health opportunities to marginalised populations. In our analysis we treat issues of ‘health rights’ and ‘justice in global health’ as having unity of purpose – guaranteeing basic health opportunities to the marginalised populations. Results: We identify two sets of reasons for the failure of present obligations for global distributive justice in general: a set of ‘superficial reasons’ and a set of ‘fundamental reasons’ which account for the superficial reasons. Discussion: In order to overcome these reasons we propose a strategy which consists in specifying a number of minimum and less-demanding obligations for both external and domestic governments to guarantee to all individuals a certain threshold of health goods and services. We argue that these minimum obligations can be freely accepted and fully complied with or enforced with “a thin system of enforcement” without significant threat to national sovereignty and autonomy. Conclusion: The futility of countries’ obligations for the health rights of the global poor as is the case with global distributive injustice is because of lack of political will to specify and enforce such obligations. Minimum obligations should be specified and enforced with a “thin system” which is consistent with principles of national sovereignty and autonomy.

Introduction Stored human samples and the establishment of biobanks are increasing in the world. Along with this there are the questions of ethics that arise such as the correct method of obtaining informed consent for research on stored samples and the policies involved in collaborative research using collected samples. This study is an attempt to evaluate the researchers, academics and policy makers' views on these ethical aspects. Methods This was an anonymised study involving a Sri Lankan population of researchers, ethics committee members, and policy makers. A self administered questionnaire was utilised as the study instrument. The questionnaire captured four major areas of interest: demographic characteristics of respondents, their attitudes on informed consent policy, their opinion on rights of collaborating researchers, their attitudes on dealing with international differences in regulatory frameworks. Results The study included 55 responders with 40/55 agreeing that donors should receive the option of giving informed consent for future research, with 31/55 considering multiple- type consent options most appropriate. Regarding the issue of shared samples in collaborative research majority agreed that source country ethics review committee approval was necessary 53/55. Conclusion The study concludes that sample donors should be given the option of giving advance consent to unspecified future research provided that future research is approved by an ethics committee. In collaborative research, it is necessary to involve ethics committees from donor countries in the research approval process

It is a remarkable fact about the development of medical ethics from the 1960s until today that there has been a dramatic shift from a position where it was taken for granted that the physician knows best, to a position where much greater emphasis is put on the patient’s treatment preferences. This shift is evident with regard to physician attitudes towards disclosing a cancer diagnosis. For example, in 1961, a survey of cancer physicians showed that almost 90% of the physicians reported that their usual policy was not to tell their patients that they had cancer . The survey was repeated in 1979, and it showed a complete reversal in attitudes over this 20-year period. 90% reported that their usual policy was to tell their patients that they had cancer .One common way of justifying the new approach is to claim that patients have a right to make their own treatment decisions, referring to the basic value of patient autonomy. However, it is immediately obvious that physicians should not respect all choices made by patients. Consider the following case: A thirty-eight-year-old man with mild upper respiratory infection suddenly developed severe headache, stiff neck, and high fever. He went to an emergency room for help. The diagnosis was pneumococcal meningitis, a bacterial meningitis almost always fatal if not treated. If treatment is delayed, permanent neurological damage is likely. A physician told the patient that urgent treatment was needed to save his life and forestall brain damage. The patient refused to consent to treatment saying he wanted to be allowed to die .Very few, if any, physicians would respect this person’s treatment choice. The reason is that this patient is not competent to make his own decisions. Respect for autonomy only requires that the choices of patients who are competent to make their own decisions are honoured. Judgements about which patients are competent to make their own decisions therefore become crucial