Trust in the Doctor-Patient Relationship in Chinese Public Hospitals: Evidence for Hope.

Purpose: Trust is an essential component in a successful health care relationship. Doctor-patient trust involves the subjects of both sides, including the direction of patients' trust in physicians (patients' perception) and physicians' trust in patients (physicians' perception). This study aims to assess the status quo and explore suggestions for improving trust between doctors and patients. Patients and Methods: In May 2018, we collected data from six representative hospitals in Beijing, China, including 610 questionnaires (310 physicians and 300 patients). Participants were Chinese-speaking, age 14 and older, who expressed their opinions clearly. Kruskal-Wallis H-test and Wilcoxon rank sum test were used to analyze the difference in the trust scores of the responses. Results: Based on the doctor and patient characteristics, the data show that inpatients are trusted more than outpatients, and patients who often visit the clinic are more doubtful of doctors. The family trust is the highest, and social trust is the lowest. In general, the degree of trust between doctors and patients is good, but the score of physicians (Mean=3.87; SD=0.79) is lower than that of patients (Mean=4.05; SD=0.76). Physicians' evaluation of the degree of trust tends to be more negative than patients'. Conclusion: In spite of recent negative press reports, there remains a high degree of trust between patients and doctors in Beijing. Despite this, one should not be complacent. We need to explore the root cause of the trust between doctors and patients from a deeper perspective to promote better medical services to meet the health needs of patients.

Allocating a COVID-19 Vaccine: Balancing National and International Responsibilities.

Policy Points In this paper we propose a middle-ground policy for the distribution of an effective COVID-19 vaccine, between a cosmopolitan approach that rejects entirely nation-state priority and unbridled vaccine nationalism that disregards obligations to promote an equitable global allocation of an effective vaccine over time. Features of the COVAX partnership, a collaboration among the Global Alliance for Vaccines and Immunizations (GAVI), the Coalition for Epidemic Preparedness Innovations (CEPI), and the World Health Organization (WHO) to develop and distribute COVID-19 vaccines make it an appropriate framework for a middle-ground policy.

The Internet Hospital as a Telehealth Model in China: Systematic Search and Content Analysis.

BACKGROUND: The internet hospital is an innovative organizational form and service mode under the tide of internet plus in the Chinese medical industry. It is the product of the interaction between consumer health needs and supply-side reform. However, there has still been no systematic summary of its establishment and definition, nor has there been an analysis of its service content. OBJECTIVE: The primary purpose of this study was to understand the definition, establishment, and development status of internet hospitals. METHODS: Data on internet hospitals were obtained via the Baidu search engine for results up until January 1, 2019. Based on the results of the search, we obtained more detailed information from the official websites and apps of 130 online hospitals and formed a database for descriptive analysis. RESULTS: By January 2019, the number of registered internet hospitals had expanded to approximately 130 in 25 provinces, accounting for 73.5% of all provinces or province-level municipalities in China. Internet hospitals, as a new telehealth model, are distinct but overlap with online health, telemedicine, and mobile medical. They offer four kinds of services-convenience services, online medical services, telemedicine, and related industries. In general, there is an underlying common treatment flowchart of care in ordinary and internet hospitals. There are three different sponsors-government-led integration, hospital-led, and enterprise-led internet hospitals-for which stakeholders have different supporting content and responsibilities. CONCLUSIONS: Internet hospitals are booming in China, and it is the joint effort of the government and the market to alleviate the coexistence of shortages of medical resources and wasted medical supplies. The origin of internet hospitals in the eastern and western regions, the purpose of the establishment initiator, and the content of online and offline services are different. Only further standardized management and reasonable industry freedom can realize the original intention of the internet hospital of meeting various health needs.

Issues and Challenges Associated with Data-Sharing in LMICs: Perspectives of Researchers in Thailand.

Data-sharing helps advance scientific research and assures the benefits of research data are maximized. Previous work has highlighted ethical challenges, especially in low- and middle-income countrie (LMIC) countries. This study examined the views of researchers in a middle-income country, Thailand, regarding the most important data-sharing challenges. The target researchers worked in biomedical and related research. The survey was distributed to 38 academic and health-science institutes, 18 university hospitals, 84 nonuniversity hospitals, and 22 research institutes across Thailand; 229 researchers in clinical/basic and social/behavioral sciences, and pubxxlic health/policy participated. Thai researchers were less concerned with informed consent and the feasibility of conducting research and sharing data, focusing on the importance of safeguards when handling data, including transfer to others, and possible lack of control over subsequent data use. The respondents felt that researchers should decide what types of project data are shareable and which data are likely useful to the scientific community. They were more concerned with appropriate acknowledgment and protecting the legal rights of the primary data collectors and providers. Although they had concerns about data access conditions, they rated sharing sufficient data and metadata to reproduce the analysis of the primary outcomes as highly important. These results are important for future efforts of the LMIC countries to develop efficient data-sharing frameworks and establish institutional data access committees. They highlight the importance, for the sustainability and fairness of these efforts, to ensure that parties in LMIC countries receive appropriate credit and are involved in determining where/when/how their data may be used.

Conducting human challenge studies in LMICs: A survey of researchers and ethics committee members in Thailand.

Questions have been raised over the acceptability of conducting human challenge studies in low and middle income countries (LMICs). Most of these concerns are based on theoretical considerations and there exists little data on the attitudes of stakeholders in these countries. This study examines the view of researchers and REC members in Thailand regarding the design and conduct of challenge studies in the country. A questionnaire was developed based on ethical frameworks for human challenge studies. The target respondents included those who had experience with health-related research at universities, non-university hospitals, and research institutes. A total of 240 respondents completed the on-line survey. In general, the respondents felt that the ethical issues raised by human challenge studies in LMICS do not differ significantly from those in high income countries, including: scientific rationale, safety, appropriate risks, and robust informed consent process. In contrast, issues that have been described as important for human challenge studies in LMICs were rated as having lower importance, including: a publicly available rationale, national priority, and community engagement. Responses did not vary significantly between researchers in different fields, nor between researchers and REC members. These findings provide an important perspective for assessing existing frameworks for human challenges studies in LMICs.

Ethical issues in human germline gene editing: a perspective from China.

The ethical issues associated with germline gene modification and embryo research are some of the most contentious in current international science policy debates. In this paper, we argue that new genetic techniques, such as CRISPR, demonstrate that there is an urgent need for China to develop its own regulatory and ethical framework governing new developments in genetic and embryo research. While China has in place a regulatory framework, it needs to be strengthened to include better compliance oversight and explicit criteria for how different types of research should be reviewed by regulatory authorities. We also document a variety of opinions about the new technologies among the public, scholars, and policy makers. China needs to develop its own regulations in coordination with other countries; but it is unlikely that an international consensus will be achieved in this area, given the existing differences in regulations between countries. We should aim at harmonization, not necessarily complete consensus, and the perspective from China is vital when international norms are developed and harmonized. Chinese policy makers and researchers need to be aware of the international discussions, at the same time as the international community is aware of, and accommodates, Chinese positions on important policy options.

Should a Country Follow WHO's Guidelines on the Pathway to Universal Health Coverage? A Case Illustration with the Chinese Healthcare System.

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 (UHC). 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.

Comparative effectiveness research: what to do when experts disagree about risks.

BACKGROUND: 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 (ERCs) should evaluate the risks of comparative effectiveness research. MAIN TEXT: 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(s). 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. CONCLUSION: 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.

Understanding the futility of countries' obligations for health rights: realising justice for the global poor.

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.

No ethical divide between China and the West in human embryo research.

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.

Eugenics and Mandatory Informed Prenatal Genetic Testing: A Unique Perspective from China.

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.

Reassessing Diagrams of Cardiac Mechanics: From Otto Frank and Ernest Starling to Hiroyuki Suga.

This article explores the importance of diagrams in the history of the understanding of cardiac function, by comparing Ernest Starling's famous "Law of the Heart" (1918) with the mathematically based view of cardiac mechanics put forward by Otto Frank (1897). Whereas Frank's diagrams gained influence in German cardio-physiological publications, they were widely unknown abroad until 1969, when Hiroyuki Suga began to present similar approaches for warm-blooded animals as Frank had done for the frog. Suga succeeded in correlating the pressure volume area (PVA)-a composite of Frank's work loop plus the area of remaining potential energy-with the oxygen consumption of the beating heart. With the concept of time-varying elastance as an index of cardiac contractility, Suga's approach became attractive for clinical applications, and Daniel Burkhoff and colleagues were able to use these insights for real-time, interactive simulations of the cardiovascular system. Such tools can be used for exploring basic hemodynamic principles and, thanks to technical developments of miniature pumps within the same time frame (Καιρός, the "right moment," or "the opportune"), to test the effects of device-based treatment for heart failure. These outcomes confirm that old analyses of the heart's activity may still be useful today.

Obligations of low income countries in ensuring equity in global health financing.

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 (LIC) 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. Although achieving justice in global health will depend on fulfillment 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.

A Survey of Scientist and Policy Makers' Attitudes Toward Research on Stored Human Biological Materials in Sri Lanka.

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 (73%) agreeing that donors should receive the option of giving informed consent for future research, with 31/55 (56%) 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 (96%). 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.

Following the giant's paces-governance issues and bioethical reflections in China.

BACKGROUND: 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. DISCUSSION: In this paper, we will analyze the case of BGI in the context of the Chinese regulatory system in order to identify methods to regulate genetic research more effectively and to strengthen BGI's role in international collaborative research projects. Three main issues concerning sample collection and samples/data management are addressed. Firstly, an ambiguous definition of research, which does not specifically include biosamples/data, when applied to genetic research, may cause confusion and leave loopholes in governance. Secondly, the current regulations do not provide sufficient guidelines on the details of what information to present to prospective subjects, and how to combine informed consent with strategies of re-consent, withdrawal and feedback from research. Finally, the existing regulations do not adequately address issues of genetic privacy and data protection. SUMMARY: Bioethical issues related to genetic research in China may be partially due to the nature of genetic research and partially stems from the strategy of simply adopting general international guidelines into the Chinese context without detailed considerations of the local needs. However, there are no perfect readymade ethical solutions for everyone; every country faces different open questions and challenges behind what appears to be unified guidelines. Given the importance of China in international genetic research, other countries ought to be concerned about the bioethical developments in China. China should also have a substantive discussion with the international community on bioethics issues.

Aiming at a moving target: research ethics in the context of evolving standards of care and prevention.

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.

A randomized controlled trial of short and standard-length consent forms for a genetic cohort study: is longer better?

BACKGROUND: Although the amount of detail in informed consent documents has increased over time and the documents have therefore become very long, there is little research on whether longer informed consent documents actually result in (1) better informed research subjects or (2) higher consent rates. We therefore conducted an add-on randomized controlled trial to the Takashima Study, a prospective Japanese population-based genetic cohort study, to test the hypothesis that a shorter informed consent form would satisfy both of the above goals. METHODS: Standard (10 459 words, 11 pages) and short (3602 words, 5 pages) consent forms in Japanese were developed and distributed using cluster-randomization to 293 potential cohort subjects living in 9 medico-social units and 288 subjects in 8 medico-social units, respectively. RESULTS: Few differences were found between the 2 groups with regard to outcome measures, including participants' self-perceived understanding, recall of information, concerns, voluntariness, trust, satisfaction, sense of duty, and consent rates. CONCLUSIONS: A short informed consent form was no less valid than a standard form with regard to fulfilling ethical requirements and securing the scientific validity of research.

What counts as reliable evidence for public health policy: the case of circumcision for preventing HIV infection.

BACKGROUND: There is an ongoing controversy over the relative merits of randomized controlled trials (RCTs) and non-randomized observational studies in assessing efficacy and guiding policy. In this paper we examine male circumcision to prevent HIV infection as a case study that can illuminate the appropriate role of different types of evidence for public health interventions. DISCUSSION: Based on an analysis of two Cochrane reviews, one published in 2003 before the results of three RCTs, and one in 2009, we argue that if we rely solely on evidence from RCTs and exclude evidence from well-designed non-randomized studies, we limit our ability to provide sound public health recommendations. Furthermore, the bias in favor of RCT evidence has delayed research on policy relevant issues. SUMMARY: This case study of circumcision and HIV prevention demonstrates that if we rely solely on evidence from RCTs and exclude evidence from well-designed non-randomized studies, we limit our ability to provide sound public health recommendations.