By Daisy Liu
In comparison to animal trials, experiments in humans pose enormous questions of ethics that are difficult and tricky to navigate. At the same time, they provide data at a level of statistical significance that its animal counterparts cannot hope to attain. Thus, despite the many challenges, clinical trials remain one of the most important stages of drug and therapy development. Partially in response to the increasing unwillingness of citizens in developed nations to participate in clinical trials, companies and research teams have set their sights internationally when choosing populations on which to conduct their tests. However, this generates the problem of exploitation, especially when there is a large power imbalance between the host population and the foreign scientists.
In particular, the question of value is one that must be addressed—is it ethical to conduct a trial for treatment on a population if they stand to gain little from its development?
First, it is easier to have the procedures for a clinical trial approved in a developing nation versus a developed one due to its comparatively loose restrictions around what constitutes ethical design. In practice, this would usually manifest as a recognition of what constitutes right or a wrong action within the legislative semantics that simultaneously lacks measures to monitor and enforce adherence to declared principles. As seen in past tragedies such as the Tuskegee and Guatemala Syphilis Experiments, the lack of strict oversight with regards to ethics can have truly horrific consequences for those involved. The research involved the deliberate infection of close to 1,500 prisoners, sex workers, soldiers, and children with STIs as part of an experiment in which they were enrolled without their consent. Thus, scientists must be exceedingly careful and check themselves regularly to ensure that their experiments do not cause harm to the communities and individuals with which they are working.
Due to the existence of key barriers and the multi-dimensional nature of exploitation, a previously healthy host population-research interaction can quickly become dysfunctional. Of the long list, cultural differences leading to difficulties in obtaining informed consent and a lack of understanding among local populations of more sophisticated medical procedures are particularly difficult to overcome. In many cases, creative solutions will have to be explored such as the substitution of medical terms with analogous concepts (e.g. vaccines as “training for the body to fight disease” instead of simply describing it as a form of prophylaxis). Note that this still involves modifying the concept itself to some degree. Indeed, it is important to recognise that perfect translation and conversion of the idea between languages without the creation of new terms is almost impossible. The value of the meaning that is lost, then, is something that approval boards and ethics committees must judge for themselves.
Outside of the ethical implications of clinical trials in developing countries, scientists must be wary of the strain that their experiments may place on healthcare systems in the community. Oft over-burdened, they may not be able to handle the extra strain of any injury resulting from research participation. This would require an examination of grant funds and other resources that the team may have to ensure that all participants are sufficiently cared for if the unexpected occurs.
If the above is done correctly, both sides - researchers and the subject community - will stand to benefit from the trial.
Ultimately, despite their many ethical implications and difficulties, clinical trials in developing countries can be used to help foster local research capacity by forming partnerships between foreign and local institutions. To this end, the goal would be the development research initiatives that, for the time being, remain largely externally funded but are largely driven by the knowledge and needs of the host population. In areas of high disease burden, this would mean that treatments are developed in a way that best fits the population that is in highest demand of it rather than requiring further trials to ensure local efficacy. The HIV vaccine clinical trials in South Africa constitute a particularly relevant example. Additionally, the creation of a local research agenda would likely increase the incentive for governments and local research institutes to create and adhere to appropriate ethical procedures, if not for moral reasons but for increasing the legitimacy of their discoveries on the international stage. In this way, clinical trials in developing countries are bridges over which they can cross to access the international medical community.
Human testing in any location must be approached with caution and respect for the ethical guidelines. Many times the requisite experience and insight were bought with human suffering in poorly executed clinical trials. Problems remain today that scientists and ethics boards struggle to solve. However, despite the challenges, clinical trials are an indispensable stage in the drug and therapy development process. More recently, considerations have been made for the experiments to serve as a development tool, fostering cooperation between institutions in developing countries that may be aware of local issues but simply lack the resources to take meaningful action. Thus, so long as appropriate care is taken, their involvement in clinical trials can prove invaluable to the development of the country’s scientific community.