ALTERNATIVES TO NATIONAL AVERAGE INCOME DATA AS ELIGIBILITY CRITERIA FOR INTERNATIONAL SUBSIDIES: A SOCIAL JUSTICE PERSPECTIVE

Current strategies to address global inequities in access to life‐saving vaccines use averaged national income data to determine eligibility. While largely successful in the lowest income countries, we argue that this approach could lead to significant inefficiencies from the standpoint of justice if applied to middle‐income countries, where income inequalities are large and lead to national averages that obscure truly needy populations. Instead, we suggest alternative indicators more sensitive to social justice concerns that merit consideration by policy‐makers developing new initiatives to redress health inequities in middle‐income countries.     

HUMAN RIGHTS AND THE REQUIREMENT FOR INTERNATIONAL MEDICAL AID

Every year approximately 18 million people die prematurely from treatable medical conditions including infectious diseases and nutritional deficiencies. The deaths occur primarily amongst the poorest citizens of poor developing nations. Various groups and individuals have advanced plans for major international medical aid to avert many of these unnecessary deaths. For example, the World Health Organization's Commission on Macroeconomics and Health estimated that eight million premature deaths could be prevented annually by interventions costing roughly US$57 bn per year.
This essay advances an argument that human rights require high-income nations to provide such aid. The essay briefly examines John Rawls' obligations of justice and the reasons that their applicability to cases of international medical aid remains controversial. Regardless, the essay argues that purely humanitarian obligations bind the governments and citizens of high-income liberal democracies at a minimum to provide major medical aid to avert premature deaths in poor nations. In refusing to undertake such medical relief efforts, developed nations fail to adequately protect a fundamental human right to life.     

Putting placebo‐controlled trials in developing countries to the interpersonal justifiability test

This paper considers the ethics of placebo‐controlled trials in developing countries, where a treatment already exists but is not available due to the low local standard of care. Such trials would not be permitted in more developed nations where a higher standard of care is available. I argue that there are moral intuitions against such trials, but a further intuition that if the trials were aimed at producing treatment options for the developing world, that would be more permissible than if the trials were designed with the benefit of rich world people in mind. An approach based upon GA Cohen's work on interpersonal justifiability is suggested to allow us to explain these intuitions. Cohen's framework shows that these trials are ethically problematic because the inequality in healthcare provision between developing and developed nations that allows them to take place is at least partly the pharmaceutical corporations’ fault. Following Cohen's argument, this means the trials are non‐comprehensively justified. This allows for a more complete explanation of our intuitions than to consider such trials as cases of exploitation, because intuitions on the ethicacy of research can vary even when the exploitation relation remains the same. It is then established that there is good empirical evidence to believe that pharmaceutical corporations do fail the interpersonal justifiability test. The policy implications of this judgement are then considered, and it is suggested that the framework might be equally applicable to examining the permissibility of research conducted on vulnerable people within more developed nations.     

Ethics and Rationing Access to Dialysis in Resource‐Limited Settings: The Consequences of Refusing a Renal Transplant in the South African State Sector

Resource constraints in developing countries compel policy makers to ration the provision of healthcare services. This article examines one such set of Guidelines: A patient dialysing in the state sector in South Africa may not refuse renal transplantation when a kidney becomes available. Refusal of transplantation can lead to exclusion from the state‐funded dialysis programme. This Guideline is legally acceptable as related to Constitutional stipulations which allow for rationing healthcare resources in South Africa. Evaluating the ethical merit of the Guideline, and exploring the ethical dilemma it poses, proves a more complex task. We examine the actions of healthcare professionals as constrained by the Guideline. From a best interests framework, we argue that in these circumstances directing patient decision making (pressurising a patient to undergo renal transplantation) is not necessarily unethical or unacceptably paternalistic. We then scrutinise the guideline itself through several different ethical ‘lenses’. Here, we argue that bioethics does not provide a definitive answer as to the moral merit of rationing dialysis under these circumstances, however it can be considered just in this context. We conclude by examining a potential pitfall of the Guideline: Unwilling transplant recipients may not comply with immunosuppressive medication, which raises questions for policies based on resource management and rationing.     

Global Health Care Justice,Delivery Doctors and Assisted Reproduction: Taking a Note From Catholic Social Teachings

This article will examine the Catholic concept of global justice within a health care framework as it relates to women's needs for delivery doctors in the developing world and women's demands for assisted reproduction in the developed world. I will first discuss justice as a theory, situating it within Catholic social teachings. The Catholic perspective on global justice in health care demands that everyone have access to basic needs before elective treatments are offered to the wealthy. After exploring specific discrepancies in global health care justice, I will point to the need for delivery doctors in the developing world to provide basic assistance to women who hazard many pregnancies as a priority before offering assisted reproduction to women in the developed world. The wide disparities between maternal health in the developing world and elective fertility treatments in the developed world are clearly unjust within Catholic social teachings. I conclude this article by offering policy suggestions for moving closer to health care justice via doctor distribution.     

Why Restrictions on the Immigration of Health Workers Are Unjust

Some bioethicists and political philosophers argue that rich states should restrict the immigration of health workers from poor countries in order to prevent harm to people in these countries. In this essay, I argue that restrictions on the immigration of health workers are unjust, even if this immigration results in bad health outcomes for people in poor countries. I contend that negative duties to refrain from interfering with the occupational liberties of health workers outweighs rich states' positive duties to prevent harm to people in sending countries. Furthermore, I defend this claim against the objection that health workers in poor countries acquire special duties to their compatriots that render them liable to coercive interference.     

Cambodian patients' and health professionals' views regarding the allocation of antiretroviral drugs

The way Cambodian patients and health professionals judge the priority of HIV-infected patients in relation to the allocation of antiretroviral drugs was examined. Participants were either HIV-infected patients attending the HIV/AIDS Care and Support Centre for People Living with HIV/AIDS in Phnom Penh (29 females and 21 males) or members of the staff (9 physicians, 6 pharmacists and 15 health counsellors and health educators). They were presented with stories of a few lines depicting a patient's situation and were instructed to judge the extent to which the patient should be given priority for HIV drugs. The stories were composed according to a four within-subject factor design: (a) the patient's family responsibilities, (b) the severity of infection, (c) the time elapsed since the first consultation, and (d) the financial difficulties of the family. Most patients expressed the view that the drugs should be used for the patients who are most important from a familial point of view, namely, when the family contains small children and/or is already in a precarious financial condition.     

Acceptance and Perception of Nigerian Patients to Medical Photography

The aim of the study was to determine the acceptance and perception of Nigerian patients to medical photography. A self‐administered questionnaire was distributed among Nigerian patients attending oral and maxillofacial surgery and plastic surgery clinics of 3 tertiary health institutions. Information requested included patients' opinion about consent process, capturing equipment, distribution and accessibility of medical photographs. The use of non‐identifiable medical photographs was more acceptable than identifiable to respondents for all purposes (P = 0.003). Most respondents were favourably disposed to photographs being taken for inclusion in the case note, but opposed to identifiable photographs being used for other purposes most especially in medical websites and medical journals. Female respondents preferred non‐identifiable medical photographs to identifiable ones (P = 0.001). Most respondents (78%) indicated that their consent be sought for each of the outline needs for medical photography. Half of the respondents indicated that identifiable photographs may have a negative effect on their persons; and the most commonly mentioned effects were social stigmatization, bad publicity and emotional/psychological effects. Most of the respondents preferred the use of hospital‐owned camera to personal camera/personal camera‐phone for their medical photographs. Most respondents (67.8%) indicated that they would like to be informed about the use of their photographs on every occasion, and 74% indicated that they would like to be informed of the specific journal in which their medical photographs are to be published. In conclusion, non‐identifiable rather than identifiable medical photography is acceptable to most patients in the studied Nigerian environment. The use of personal camera/personal camera‐phone should be discouraged as its acceptance by respondents is very low. Judicious use of medical photography is therefore advocated to avoid breach of principle of privacy and confidentiality in medical practice.     

US IRBs confronting research in the developing world

Increasingly, US‐sponsored research is carried out in developing countries, but how US Institutional Review Boards (IRBs) approach the challenges they then face is unclear. METHODS: I conducted in‐depth interviews of about 2 hours each, with 46 IRB chairs, directors, administrators and members. I contacted the leadership of 60 IRBs in the United States (US) (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding), and interviewed IRB leaders from 34 (55%). RESULTS: US IRBs face ethical and logistical challenges in interpreting and applying principles and regulations in developing countries, given economic and health disparities, and limited contextual knowledge. These IRBs perceive wide variations in developing world IRBs/RECs' quality, resources and training; and health systems in some countries may have long‐standing practices of corruption. These US IRBs often know little of local contexts, regulations and standards of care, and struggle with understandings of other cultures' differing views of autonomy, and risks and benefits of daily life. US IRBs thus face difficult decisions, including how to interpret principles, how much to pay subjects and how much sustainability to require from researchers. IRB responses and solutions include trying to maintain higher standards for developing world research, obtain cultural expertise, build IRB infrastructure abroad, communicate with foreign IRBs, and ‘negotiate’ for maximum benefits for participants and fearing ‘worst‐case scenarios’. CONCLUSIONS: US and foreign IRBs confront a series of tensions and dilemmas in reviewing developing world research. These data have important implications for increased education of IRBs/RECs and researchers in the US and abroad, and for research and practice.     

The domestic struggle for traditional medical knowledge rights

In China, the local communities and various ethnic minorities still hold, sustain and develop traditional medicial knowledge (TMK), innovations, and practices within the original communities. TMK also has pharmaceutical option value, which has attracted interests in commercial use of TMK for pharmaceutical innovation in China. However, the increased use of TMK for non-traditional purposes might lead to a change in the customary treatment of TMK as common goods of relevant communities and peoples, and may lead to significant tension faced by both providers and users of TMK in China. We find there is a significant gap in literature analysing the phenonmenon of domestic biopolitics concerning TMK in China. Closely connected problem is the contradictory relationship between providers and users of TMK, especially between the indigenous and local communities, and corporate and industrial actors. Therefore, urgent research is needed to fill this literature gap.     

Racial classification regarding semen donor selection in Brazil

Brazil has not yet approved legislation on assisted reproduction. For this reason, clinics, hospitals and semen banks active in the area follow Resolution 1358/92 of the Conselho Federal de Medicina, dated 30 September 1992. In respect to semen donation, the object of this article, the Resolution sets out that gamete donation shall be anonymous, that is, that the donor and recipients (and the children who might subsequently be born) shall not be informed of each other's identity. Thus, since recipients are unaware of the donor's identity, semen banks and the medical teams involved in assisted reproduction become the intermediaries in the process. The objective of this article is to show that, in practice, this represents disrespect for the ethical principles of autonomy, privacy and equality. The article also stresses that the problem is compounded by the racial question. In a country like Brazil, where racial classification is so flexible and goes side by side with racist attitudes, the intermediary role played by semen banks and medical teams is conditioned by their own criteria of racial classification, which are not always the same as those of donors and semen recipients. The data presented in this paper were taken from two semen banks located in the city of São Paulo (Brazil). At the time of my research, they were the only semen banks in the state of São Paulo and supplied semen to the capital (São Paulo city), the state of São Paulo, and to cities in other Brazilian states where semen banks were not available.     

CURRICULUM GUIDE FOR RESEARCH ETHICS WORKSHOPS FOR COUNTRIES IN THE MIDDLE EAST

To help ensure the ethical conduct of research, many have recommended educational efforts in research ethics to investigators and members of research ethics committees (RECs). One type of education activity involves multi‐day workshops in research ethics. To be effective, such workshops should contain the appropriate content and teaching techniques geared towards the learning styles of the targeted audiences. To ensure consistency in content and quality, we describe the development of a curriculum guide, core competencies and associated learning objectives and activities to help educators organize research ethics workshops in their respective institutions. The curriculum guide is divided into modular units to enable planners to develop workshops of different lengths and choose content materials that match the needs, abilities, and prior experiences of the target audiences. The content material in the curriculum guide is relevant for audiences in the Middle East, because individuals from the Middle East who participated in a Certificate Program in research ethics selected and developed the training materials (e.g., articles, powerpoint slides, case studies, protocols). Also, many of the activities incorporate active‐learning methods, consisting of group work activities analyzing case studies and reviewing protocols. The development of such a workshop training curriculum guide represents a sustainable educational resource to enhance research ethics capacity in the Middle East.     

The Social Value of Knowledge and International Clinical Research

In light of the growth in the conduct of international clinical research in developing populations, this paper seeks to explore what is owed to developing world communities who host international clinical research. Although existing paradigms for assigning and assessing benefits to host communities offer valuable insight, I criticize their failure to distinguish between those benefits which can justify the conduct of research in a developing world setting and those which cannot. I argue that the justification for human subjects research is fundamentally grounded in the social value of knowledge, and that this value is context‐dependent in a manner which should inform our ethical evaluation of the conduct of research in specific settings. I propose a new framework for the assessment of research benefits assigned to developing world host communities, a natural implication of which is to limit the types of research projects which may permissibly be conducted in developing world settings.     

Patent Funded Access to Medicines

Instead of impeding access to essential medicines in developing countries, the essay explores why and how patents can serve as a source of funding for the much needed access to medicine. Instead of a weakening of patents, prolonged protection periods are suggested in circumstances where there is widespread lack of access. The revenues from extended patents are seen as a source of funding for drug donations to the least developed countries.     

PALLIATIVE CARE, PUBLIC HEALTH AND JUSTICE: SETTING PRIORITIES IN RESOURCE POOR COUNTRIES

Many countries have not considered palliative care a public health problem. With limited resources, disease-oriented therapies and prevention measures take priority. In this paper, I intend to describe the moral framework for considering palliative care as a public health priority in resource-poor countries. A distributive theory of justice for health care should consider integrative palliative care as morally required as it contributes to improving normal functioning and preserving opportunities for the individual. For patients requiring terminal care , we are guided less by principles of justice and more by the duty to relieve suffering and society's commitment to protecting the professional's obligation to uphold principles of beneficence, compassion and non-abandonment. A fair deliberation process is necessary to allow these strong moral commitments to serve as reasons when setting priorities in resource poor countries.     

Reporting of informed consent, standard of care and post-trial obligations in global randomized intervention trials: a systematic survey of registered trials

Objective:  Ethical guidelines are designed to ensure benefits, protection and respect of participants in clinical research. Clinical trials must now be registered on open-access databases and provide details on ethical considerations. This systematic survey aimed to determine the extent to which recently registered clinical trials report the use of standard of care and post-trial obligations in trial registries, and whether trial characteristics vary according to setting.
Methods:  We selected global randomized trials registered on http://www.clinicaltrials.gov and http://www.controlled-trials.com . We searched for intervention trials of HIV/AIDS, malaria, and tuberculosis from 9 October 2004, the date of the most recent version of the Helsinki Declaration, to 10 April 2007.
Results:  We collected data from 312 trials. Fifty-eight percent (58%, 95% CI  =  53 to 64) of trial protocols report informed consent. Fifty-eight percent (58%, 95% CI  =  53 to 64) of trials report active controls. Almost no trials (1%, 95% CI  =  0.5 to 3) mention post-trial provisions. Most trials measure surrogate outcomes. Twenty percent (20%, 95% CI  =  16 to 25) of trials measure patient-important outcomes, such as death; and the odds that these outcomes are in a low income country are five times greater than for a developed country (odds ratio (OR) 5.03, 95% CI  =  2.70 to 9.35, p  = < 0.001). Pharmaceutical companies are involved in 28% (CI  =  23 to 33) of trials and measure surrogate outcomes more often than nonpharmaceutical companies (OR 2.45, 95% CI  =  1.18 to 5.09, p  =  0.31).
Conclusion:  We found a large discrepancy in the quality of reporting and approaches used in trials in developing settings compared to wealthier settings.     

FAIR TRADE INTERNATIONAL SURROGACY

Since the development of assisted reproductive technologies, infertile individuals have crossed borders to obtain treatments unavailable or unaffordable in their own country. Recent media coverage has focused on the outsourcing of surrogacy to developing countries, where the cost for surrogacy is significantly less than the equivalent cost in a more developed country. This paper discusses the ethical arguments against international surrogacy. The major opposition viewpoints can be broadly divided into arguments about welfare, commodification and exploitation.
It is argued that the only valid objection to international surrogacy is that surrogate mothers may be exploited by being given too little compensation. However, the possibility of exploitation is a weak argument for prohibition, as employment alternatives for potential surrogate mothers may be more exploitative or more harmful than surrogacy. It is concluded that international surrogacy must be regulated, and the proposed regulatory mechanism is termed Fair Trade Surrogacy. The guidelines of Fair Trade Surrogacy focus on minimizing potential harms to all parties and ensuring fair compensation for surrogate mothers.