Justice in international clinical research

Debates about justice in international clinical research problematically conflate two quite different forms of obligation. International research ethics guidelines were intended to describe how to conduct biomedical research in a just manner at the micro or clinical level (within the researcher-participant interaction) but have come to include requirements that are clearly intended to promote justice at the global level. Ethicists have also made a variety of claims regarding what international research should contribute to global justice. This paper argues that the conflation of debates about justice at the micro and macro-levels has not only resulted in the placement of obligations upon the wrong actors but has also served to exclude relevant actors from the ethical picture. Suggestions for who should properly bear macro-level obligations of justice in international clinical research are offered. The paper further contends that, unlike researchers who violate informed consent requirements, no similar type of accountability exists for obligations of global justice, even for those obligation-bearers (incorrectly) identified by current ethics guidelines.     

GLOBAL HEALTH ETHICS FOR STUDENTS

As a result of increased interest in global health, more and more medical students and trainees from the 'developed world' are working and studying in the 'developing world'. However, while opportunities to do this important work increase, there has been insufficient development of ethical guidelines for students. It is often assumed that ethics training in developed world situations is applicable to health experiences globally. However, fundamental differences in both clinical and research settings necessitate an alternative paradigm of analysis. This article is intended for teachers who are responsible for preparing students prior to such experiences. A review of major ethical issues is presented, how they pertain to students, and a framework is outlined to help guide students in their work.     

A Framework to Link International Clinical Research to the Promotion of Justice in Global Health

How international research might contribute to justice in global health has not been substantively addressed by bioethics. Theories of justice from political philosophy establish obligations for parties from high‐income countries owed to parties from low and middle‐income countries. We have developed a new framework that is based on Jennifer Ruger's health capability paradigm to strengthen the link between international clinical research and justice in global health. The ‘research for health justice’ framework provides direction on three aspects of international clinical research: the research target, research capacity strengthening, and post‐trial benefits. It identifies the obligations of justice owed by national governments, research funders, research sponsors, and investigators to trial participants and host communities. These obligations vary from those currently articulated in international research ethics guidelines. Ethical requirements of a different kind are needed if international clinical research is to advance global health equity.     

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.     

Coronavirus Disease 2019 (COVID-19) Diagnostic Tools: A Focus on Detection Technologies and Limitations

The ongoing coronavirus disease (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) poses a severe threat to human health and the global economy and has resulted in overwhelming stress on health care systems worldwide. Despite the global health catastrophe, especially in the number of infections and fatalities, the COVID-19 pandemic has also revolutionized research and discovery with remarkable success in diagnostics, treatments, and vaccine development. The use of many diagnostic methods has helped establish public health guidelines to mitigate the spread of COVID-19. However, limited information has been shared about these methods, and there is a need for the scientific community to learn about these technologies, in addition to their sensitivity, specificity, and limitations. This review article is focused on providing insights into the major methods used for SARS-CoV-2 detection. We describe in detail the core principle of each method, including molecular and serological approaches, along with reported claims about the rates of false negatives and false positives, the types of specimens needed, and the level of technology and the time required to perform each test. Although this study will not rank or prioritize these methods, the information will help in the development of guidelines and diagnostic protocols in clinical settings and reference laboratories.     

Ethnicity and population structure in personal naming networks

Personal naming practices exist in all human groups and are far from random. Rather, they continue to reflect social norms and ethno-cultural customs that have developed over generations. As a consequence, contemporary name frequency distributions retain distinct geographic, social and ethno-cultural patterning that can be exploited to understand population structure in human biology, public health and social science. Previous attempts to detect and delineate such structure in large populations have entailed extensive empirical analysis of naming conventions in different parts of the world without seeking any general or automated methods of population classification by ethno-cultural origin. Here we show how 'naming networks', constructed from forename-surname pairs of a large sample of the contemporary human population in 17 countries, provide a valuable representation of cultural, ethnic and linguistic population structure around the world. This innovative approach enriches and adds value to automated population classification through conventional national data sources such as telephone directories and electoral registers. The method identifies clear social and ethno-cultural clusters in such naming networks that extend far beyond the geographic areas in which particular names originated, and that are preserved even after international migration. Moreover, one of the most striking findings of this approach is that these clusters simply 'emerge' from the aggregation of millions of individual decisions on parental naming practices for their children, without any prior knowledge introduced by the researcher. Our probabilistic approach to community assignment, both at city level as well as at a global scale, helps to reveal the degree of isolation, integration or overlap between human populations in our rapidly globalising world. As such, this work has important implications for research in population genetics, public health, and social science adding new understandings of migration, identity, integration and social interaction across the world.     

Food consumption trends and drivers

A picture of food consumption (availability) trends and projections to 2050, both globally and for different regions of the world, along with the drivers largely responsible for these observed consumption trends are the subject of this review. Throughout the world, major shifts in dietary patterns are occurring, even in the consumption of basic staples towards more diversified diets. Accompanying these changes in food consumption at a global and regional level have been considerable health consequences. Populations in those countries undergoing rapid transition are experiencing nutritional transition. The diverse nature of this transition may be the result of differences in socio-demographic factors and other consumer characteristics. Among other factors including urbanization and food industry marketing, the policies of trade liberalization over the past two decades have implications for health by virtue of being a factor in facilitating the ‘nutrition transition’ that is associated with rising rates of obesity and chronic diseases such as cardiovascular disease and cancer. Future food policies must consider both agricultural and health sectors, thereby enabling the development of coherent and sustainable policies that will ultimately benefit agriculture, human health and the environment.     

Clinical utility of ICD‐11 diagnostic guidelines for high‐burden mental disorders: results from mental health settings in 13 countries

In this paper we report the clinical utility of the diagnostic guidelines for ICD‐11 mental, behavioural and neurodevelopmental disorders as assessed by 339 clinicians in 1,806 patients in 28 mental health settings in 13 countries. Clinician raters applied the guidelines for schizophrenia and other primary psychotic disorders, mood disorders (depressive and bipolar disorders), anxiety and fear‐related disorders, and disorders specifically associated with stress. Clinician ratings of the clinical utility of the proposed ICD‐11 diagnostic guidelines were very positive overall. The guidelines were perceived as easy to use, corresponding accurately to patients’ presentations (i.e., goodness of fit), clear and understandable, providing an appropriate level of detail, taking about the same or less time than clinicians’ usual practice, and providing useful guidance about distinguishing disorder from normality and from other disorders. Clinicians evaluated the guidelines as less useful for treatment selection and assessing prognosis than for communicating with other health professionals, though the former ratings were still positive overall. Field studies that assess perceived clinical utility of the proposed ICD‐11 diagnostic guidelines among their intended users have very important implications. Classification is the interface between health encounters and health information; if clinicians do not find that a new diagnostic system provides clinically useful information, they are unlikely to apply it consistently and faithfully. This would have a major impact on the validity of aggregated health encounter data used for health policy and decision making. Overall, the results of this study provide considerable reason to be optimistic about the perceived clinical utility of the ICD‐11 among global clinicians.     

Women's health. The childbearing years and after.

Health and development planners have tended to see women primarily in context of their reproductive role. As a result, solutions to women''s health needs have been restricted to expanding and improving maternal and child health systems. There has recently been a major shift in direction, largely because of the influence of the world conference on population and development held in Cairo in 1994. Dr Guiseppe Benagiano, director of the special programme of research, development and research training in human reproduction based at the WHO, says, "We need to remind ourselves constantly that reproductive health is not simply a biomedical issue but one with serious implications for our general health and by extension, for all our efforts in human social and economic development." The 1993 world development report on health identified the lack of a clear strategy for engaging women in health care and suggested that child health services, prenatal care, treatment of sexually transmitted diseases, and family planning services should be provided jointly at convenient times. In an example of this, the Chilean Institute of Reproductive Medicine now offers integrated family planning services at the same time as child health services, and Thailand is experimenting with mobile health clinics to reach women in their homes. As the proportion of elderly women increases, old age is increasingly being seen as a female issue. With the impact of urbanisation and industrialisation, more of these women are living isolated lives, often suffering from chronic debilitating diseases. In his opening statement to the global commission on women''s health in April 1995 which focused on health conditions of women in old age, Dr Hiroshi Nakajima, the WHO''s director general, said: "Our goal should not be solely to extend lives in the physical sense, but to ensure that the added years are worth living."     

Addressing power asymmetries in global health: Imperatives in the wake of the COVID-19 pandemic

Seye Abimbola and co-authors argue for a transformation in global health research and practice in the post-COVID-19 world.

Summary points

• The Coronavirus Disease 2019 (COVID-19) pandemic, the Black Lives Matter and Women in Global Health movements, and ongoing calls to decolonise global health have all created space for uncomfortable but important conversations that reveal serious asymmetries of power and privilege that permeate all aspects of global health.
• In this article, we, a diverse, gender-balanced group of public (global) health researchers and practitioners (most currently living in the so-called global South), outline what we see as imperatives for change in a post-pandemic world.
• At the individual level (including and especially ourselves), we emphasise the need to emancipate and decolonise our own minds (from the colonial conditionings of our education), straddle and use our privilege responsibly (to empower others and avoid elite capture), and build “Southern” networks (to affirm our ownership of global health).
• At the organisational level, we call for global health organisations to practice real diversity and inclusion (in ways that go beyond the cosmetic), to localise their funding decisions (with people on the ground in the driving seat), and to progressively self-decentralise (and so, divest themselves of financial, epistemic, and political power).
• And at both the individual and organisational level, we emphasise the need to hold ourselves, our governments, and global health organisations accountable to these goals, and especially for governance structures and processes that reflect a commitment to real change.
• By putting a spotlight on coloniality and existing inequalities, the COVID-19 pandemic inspires calls for a more equitable world and for a decolonised and decentralised approach to global health research and practice, one that moves beyond tokenistic box ticking about diversity and inclusion into real and accountable commitments to transformative change.

     

Clinical guidelines contribute to the health inequities experienced by individuals with intellectual disabilities

ABSTRACT: BACKGROUND: Clinical practice guidelines are developed to improve the quality of healthcare. However, clinical guidelines may contribute to health inequities experienced by disadvantaged groups. This study uses an equity lens developed by the International Clinical Epidemiology Network (INCLEN) to examine how well clinical guidelines address inequities experienced by individuals with intellectual disabilities. METHODS: Nine health problems relevant to the health inequities experienced by persons with intellectual disabilities were selected. Clinical guidelines on these disorders were identified from across the world. The INCLEN equity lens was used as the basis for a purposedesigned, semistructured data collection tool. Two raters independently examined each guideline and completed the data collection tool. The data extracted by each rater were discussed at a research group consensus conference and agreement was reached on a final equity lens rating for each guideline. RESULTS: Thirty-six guidelines were identified, one of which (2.8%) explicitly excluded persons with intellectual disabilities. Of the remaining 35, six (17.1%) met the first criterion of the equity lens, identifying persons with intellectual disabilities at high risk for the specific health problem. Eight guidelines (22.9%) contained any content on intellectual disabilities. Six guidelines addressed the fourth equity lens criterion, by giving specific consideration to the barriers to implementation of the guideline in disadvantaged populations. There were no guidelines that addressed the second, third, and fifth equity lens criteria. CONCLUSIONS: The equity lens is a useful tool to systematically examine whether clinical guidelines address the health needs and inequities experienced by disadvantaged groups. Clinical guidelines are likely to further widen the health inequities experienced by persons with intellectual disabilities, and other disadvantaged groups, by being preferentially advantageous to the general population. There is a need to systematically incorporate methods to consider disadvantaged population groups into the processes used to develop clinical guidelines.     

Non-canonical aging model systems and why we need them

Aging is one of the greatest challenges for biomedical research in the developed world. The continuing increase in lifespan without accompanying increases in health span has extreme economic and societal implications for an aging society. The majority of adult-onset diseases such as cancer, cardiovascular disease, and Alzheimer's are a direct consequence of aging, and with changing demographics, more and more people are afflicted. If we knew how to slow down the negative effects of aging, we could delay or prevent all of these diseases at once. We therefore need to understand the underlying molecular mechanisms of aging and longevity so as to develop applications that ultimately improve health span.     

Global health inequalities and the need for solidarity: a view from the Global South

Although the world has experienced remarkable progress in health care since the last half of the 20th century, global health inequalities still persist. In some poor countries life expectancy is between 37‐40 years lower than in rich countries; furthermore, maternal and infant mortality is high and there is lack of access to basic preventive and life‐saving medicines, as well a high prevalence of neglected diseases, HIV/AIDS, tuberculosis, and malaria. Moreover, globalization has made the world more connected than before such that health challenges today are no longer limited within national or regional boundaries, making all persons equally vulnerable. Because of this, diseases in the most affluent countries are closely connected with diseases in the poorest countries. In this paper, we argue that, because of global health inequalities, in a situation of equal vulnerability, there is need for global solidarity not only as a means of reducing health inequalities, but also as a way of putting up a united force against global health challenges. We argue for an African approach to solidarity in which the humanity of a person is not determined by his/her being human or rational capacity, but by his/her capacity to live a virtuous life. According to this view of solidarity, because no one is self‐sufficient, no individual can survive alone. If we are to collectively flourish in a world where no individual, nation or region has all the health resources or protection needed for survival, we must engage in solidarity where we remain compassionate and available to one another at all times.     

Lymphatic filariasis in Papua New Guinea: interdisciplinary research on a national health problem

Bancroftian filariasis is a major public health problem in Papua New Guinea, where the level of transmission by the mosquito vector, human infection rates and clinical morbidity are among the highest in the world. Coordinated research efforts within the country, involving the disciplines of epidemiology, vector biology, immunology and genetics, have led to new insights into the ecology and pathogenesis of human lymphatic filariasis. Recent work using this knowledge base should be helpful in assessing local and global strategies aimed at eliminating Wuchereria bancrofti and in guiding research that will facilitate achievement of this goal.     

Global health and justice

In Australia, Japan, Sweden, and Switzerland, the average life expectancy is now greater than 80 years. But in Angola, Malawi, Sierra Leone, and Zimbabwe, the average life expectancy is less than 40 years. The situation is even worse than these statistics suggest because average figures tend to mask inequalities within countries. What are we to make of a world with such inequal health prospects? What does justice demand in terms of global health? To address these problems, I characterize justice at the local level, at the domestic or social level, and at the international or global level. Because social conditions, structures, and institutions have such a profound influence on the health of populations, I begin by focusing attention on the relationship between social justice and health prospects. Then I go on to discuss health prospects and the problem of global justice. Here I distinguish two views: a cosmopolitan view and a political view of global justice. In my account of global justice, I modify and use the political view that John Rawls developed in The Law of Peoples. I try to show why an adequate political account must include three duties: a duty not to harm, a duty to reconstruct international arrangements, and a duty to assist.     

基于文献计量的全球生物技术研究现状与发展趋势分析

采用文献计量分析方法,分析了全球生物技术研究领域的发展现状和趋势及其对中国生物技术研究发展的启示。研究结果表明:2019年我国在生物技术文献发表数量上已位列世界第一,但在生物技术文献的质量、学术影响力以及国际合作能力方面仍与欧美等发达生物技术国家存在一定差距,接着分析了全球生物技术研究的学科组成、各生物技术分支领域的研究交叉现状,最后分析了目前各生物技术细分领域的热点研究主题。针对当前我国面临的生物技术研究发展问题,我国应当注重研究成果质量,促进各学科间交叉融合,加强国际合作交流,顺应未来生物技术发展热点趋势。     

全球抗病毒药物研发进展与展望

病毒是危害人体健康的主要病原体之一,病毒感染和传播造成的传染性疾病严重威胁人类健康。目前,艾滋病、病毒性肝炎等发病率高、治愈率低的病毒性疾病仍在全球蔓延,流感病毒、冠状病毒等呼吸道病毒不断发生变异,2019年以来,新冠病毒引起的全球疫情对世界各国产生巨大影响,疫情走向还存在很大不确定性,开发安全有效的抗病毒药物成为应对病毒性疾病的重要手段。拟在总结全球抗病毒药物研发整体现状的基础上,分析抗艾滋病病毒、肝炎病毒、新冠病毒等重点领域的新药研发进展,提出抗病毒药物的发展建议,为未来研发更加高效的抗病毒药物提供指引和参考。     

昆虫对全球气候变暖的响应

过去的100年全球地表平均温度显著上升,全球气候变暖对生物的影响引起世界范围内的广泛关注。和其他生物一样,昆虫也受到了气候变暖的影响,如繁殖发育速度增快、遗传变异、种群多样性降低、分布区扩大、种群爆发、外来入侵、种群灭绝等等。全球变暖引起的昆虫响应对农林业以及人类健康存在潜在风险,因此本文主要从物候、分布区、生长发育及繁殖、形态、行为与生理、分子水平这些方面综述全球气候变暖背景下昆虫如何响应,并讨论了目前研究动态和未来的研究方向,意在为气候变化条件下昆虫科学管理策略(如种群监控、模型预测、风险评估、遗传多样性、抗性遗传等)提供指导意义。     

Development and evaluation of a self care program on breastfeeding in Japan: A quasi-experimental study

Background

When and how to wean breastfed infants exposed to HIV infection has provoked extensive debate, particularly in low-income countries where safe alternatives to breastfeeding are rarely available. Although there is global consensus on optimal infant-feeding practices in the form of guidelines, practices are sub-optimal in much of sub-Saharan Africa. Policy-makers and health workers face many challenges in adapting and implementing these guidelines.

Methods

This paper is based on in-depth interviews with five policy-makers and 11 providers of interventions to prevent mother-to-child transmission (PMTCT) of HIV, participant observations during clinic sessions and site visits.

Results

The difficulties with adapting the global infant-feeding guidelines in Malawi have affected the provision of services. There was a lack of consensus on HIV and infant-feeding at all levels and general confusion about the 2006 guidelines, particularly those recommending continued breastfeeding after six months if replacement feeding is not acceptable, feasible, affordable, sustainable and safe. Health workers found it particularly difficult to advise women to continue breastfeeding after six months. They worried that they would lose the trust of the PMTCT clients and the population at large, and they feared that continued breastfeeding was unsafe. Optimal support for HIV-infected women was noted in programmes where health workers were multi-skilled; coordinated their efforts and had functional, multidisciplinary task forces and engaged communities. The recent 2009 recommendations are the first to support antiretroviral (ARV) use by mothers or children during breastfeeding. Besides promoting maternal health and providing protection against HIV infection in children, the new Rapid Advice has the potential to resolve the difficulties and confusion experienced by health workers in Malawi.

Conclusions

The process of integrating new evidence into institutionalised actions takes time. The challenge of keeping programmes, and especially health workers, up-to-standard is a dynamic process. Effective programmes require more than basic resources. Along with up-to-date information, health workers need contextualized, easy-to-follow guidelines in order to effectively provide services. They also require supportive supervision during the processes of change. Policy-makers should ensure that consensus is carefully considered and that comprehensive perspectives are incorporated when adapting the global guidelines.