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. (shrink)

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. (shrink)

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. (shrink)

The WHO Consultative Group on Equity and Universal Health Coverage published a comprehensive report titled “Making Fair Choices on the Path to Universal Health Coverage” detailing strategies that countries should adopt when moving towards providing healthcare coverage to the entire population. The report provides detailed guidelines on how to expand coverage to more people, what services should be covered, and how to prioritize these healthcare resources in achieving universal healthcare coverage. The main goal of this WHO report is to ensure (...) fair and equitable access for all population groups within a country during the implementation of UHC. In principle, the group’s approach is sound and fair, but we argue that each country must take into account its own unique situations in designing a pathway towards UHC. China has achieved near UHC but did so by an approach that would have been deemed completely unacceptable based on this group’s recommendations. In this article, we provide a brief review of the Chinese healthcare system and argue that the implementation of the recommendations in the report is not always feasible. We argue that there are alternate pathways towards achieving UHC and there are good reasons for China’s departure from the approach outlined by the WHO report. Nevertheless, we acknowledge substantial inequities still exist for various segments of the population and among the diverse areas of China in accessing healthcare services and make suggestions on how to reduce such inequities within the system. (shrink)