Ethical Case Study Regarding Randomised Medical Trials in a Developing Country

Global Healthcare Ethics and the Randomised HIV Trial

Healthcare professional face a range of ethical issues in the pursuance of their vocation. In the context of HIV research and the conducting of research among vulnerable population, such as poor expectant mothers in developing countries, the compete of global health ethics should provide a foundation for the assessment of ethical practices, both in planning, undertaking, and reviewing the work (WHO, 2014; Stapleton et al., 2013). Global health ethics is an interdisciplinary field, which covers not only health research, but also issues such as the provision of healthcare, and development of health policy, with the aim of understanding the moral values which should be implemented at a global level, undertaken utilising a predominantly geographic approach to macro level health issues (Stapleton et al., 2013). In this context, global health ethics is primarily concerned with issues such as pandemics, the effects of natural disasters, poverty, and other health-related factors that affect large populations (Stapleton et al., 2013). The content approach may also be adopted towards global health ethics, with the health issues themselves are also considered, which combines both the macro level, and the micro level, and issues associated with medical ethics in terms of treatment (Stapleton et al., 2013; Pinto and Upshur, 2009).

It may be argued that the research study in Africa, Thailand, and the Dominican Republic, which took place in 1997 with sixteen randomised trials in developing countries, researching a drug to prevent HIV being transmitted from mothers to their unborn infants would come under the remit of global health ethics. HIV is certainly a global issue, with millions of people infected. The research tackled an issue which may help to improve health outcomes for thousands of people, by preventing the transmission of HIV in utero, therefore presenting disease, which is always better than treatment. However, the study was controversial as it included 17,000 pregnant women, and of the sixteen randomised trials, fifteen trials involved a placebo was used as a control.

The ethical dilemma presented in this case is the potential harm that could be created for the unborn children. The global health issue requires assessment of treatment, as a positive outcome may save thousands, if not millions, of children being born with HIV. This would have a significant impact on the lives of the individuals, as well as societies which suffer from high levels of HIV incidences. For research to be valid, it is necessary to compare a treatment against a control, which is usually a no treatment group, although this may also include existing established treatment as a comparison. Therefore, it may be argued there is need for the research which was conducted. However, the research design is controversial, with the utilisation of a placebo. General ethical approaches towards medical interventions usually seek to minimise the potential for harm. In this research, in fifteen of the trials, the control group received only placebos. The placebo should have no medical impact, and therefore mothers receiving this drug were receiving no treatment. This is controversial and three counts, firstly, the mothers themselves may be suffering as a result of taking a placebo, as alternative treatments may have been available. Secondly, the main subject of the treatment; the unborn children, are a particularly vulnerable population, and may have been placed at greater risk as a result of the research. Thirdly, the mothers participating in the study came from underdeveloped nations, where there are low levels of healthcare and low levels of education, so may not have completely understood the potential risks to themselves, as well as to their unborn children. Global health ethics is particularly concerned with the vulnerable populations, who suffer from an asymmetry of power and knowledge, which may negatively impact on the decision-making capabilities (Pinto and Upshur, 2009). A further controversial issue associated with this study is the way to place the developed nations, with arguments that this type of study design would not have been acceptable in the developed world, and was therefore an effective form of racism; placing the risk of the research on the poor developing nations, who subsequently failed to benefit from the research.

A number of different models have been developed to assess global health issues, Kass (2001), developed a model for public health interventions, which Pinto and Upshur, (2009), argue is suitable for application within the global health environment. Kass argued that ethics could be assessed by asking six questions, including the examination of the goals, questioning the effectiveness, assessing burdens who bears, as well as judging fairness in the way that was implemented. In this instance, the goals themselves may be laudable, and effectiveness of the study testing a drug against a control sample with an absence of any alternative treatment may be argued as effective. However, the burden of this research would invariably be felt by the unborn children, which could be argued as unfair, especially when the mothers may not have full knowledge regarding the risks they are taking by participating. In addition, you may also be judged as unfair in terms of implementation, as researchers may be leveraging the asymmetry of power present in the developing nations, an asymmetry that is less in the developed nations research more difficult to conduct.

If the research had been conducted in a developed nation, the application of the six questions may have been different. For example, the effectiveness goals would remain intact, but the fairness of implementation may be judged in a different manner, as those participating may have a greater level of knowledge and empowerment, choosing whether or not to participate. However, the burden of implementation of the study would remain on the unborn infants, who may benefit from the research if they receive the drug, but may also suffer as a result of receiving a placebo, or present with unknown side effects which manifest during the trial. Therefore, the main differential in undertaking the trial in a devout of the developing country, would be the increase knowledge and power of the potential sample, as well as increased public interest and influence from the media if an ethical research was discovered to take place, which also acts as a check and balance.