Reidar Lie

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

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

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

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.

In 2005 Japan completed its first census after the Personal Information Protection Law went into force in April 2005. The debate about the new law raised privacy concerns for the first time among the public. The news-media also provided several examples of possible lack of safeguards in the data collection of sensitive personal information required for the census. The result was the highest non-response rate ever for the Japanese census. Consequently, its accuracy and role as a source for the reliable national statistics for health/welfare policy-making is now critically threatened. In this paper we argue the necessity to adopt specific safeguards to protect personal data in any future census if the trend of increasing non-response rates is to be reversed. We provide some suggestions for such safeguards, and criticize the Japanese government’s response of focusing exclusively on the mechanism of data collection as a means of meeting the privacy challenge

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.

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.

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 ..

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.

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.