Human rights law, on the other hand, identifies certain non-derogable rights from which no deviation is permitted, even in times of crisis. 7Д«ioethics builds on the basic principles of autonomy, beneficence, and justice, which are non-hierarchical and require careful balancing of factors such as potential risks and benefits.

Perhaps most importantly, applying complementary human rights principles can help provide guidance in situations where invoking bioethical principles alone leads to conflicting conclusions. 6 Harnessing the language of human rights also helps build power among disadvantaged groups, which fuels advocacy and organizing efforts to challenge exploitation. Examining the standard of care issue through a human rights lens helps draw attention to the obligations of the States that both sponsor and host the trials, including their obligations to regulate corporations, rather than focusing on the subject-researcher relationship. In this article, we argue that international human rights principles are relevant to the standard of care debate and help define a middle ground that recognizes the practical challenges involved in providing the best worldwide intervention while also setting a minimum standard of care for control groups. On the other hand, the unavailability of interventions in many developing countries often means the local standard of care is very limited or no care at all, creating a double standard in clinical trials involving the rich and the poor. Some argue that providing the best worldwide standard of care is simply not feasible in developing countries and may obstruct important research that could improve health conditions in those countries. The Declaration of Helsinki, which provides ethical principles for medical research involving human subjects, generally requires researchers to test new interventions against the вЂњbest proven intervention.вЂќ 4 The plain text of the Declaration does not clarify whether this means the best intervention available worldwide or the best intervention available locally. Specifically, there is a dispute over when the use of placebo or no intervention for the control group is permissible. One of the ongoing debates within bioethics related to the practice of вЂњoff-shoringвЂќ pertains to the standard of care owed to participants in clinical trials. 2 However, these same factors increase the risk that research subjects will be exploited, especially since nearly half of the clinical trials in developing trials escape review by an ethics committee. Affluent countries and multinational corporations now commonly conduct clinical trials in developing countries, a practice known as вЂњoff-shoring.вЂќ 1 The advantages of this practice for the sponsors of the trials are clear: it significantly reduces the cost of trials, sometimes as much as 90%, helps avoid the increasingly bureaucratic regulatory environment in many wealthy countries, and renders legal accountability extremely unlikely. Yet the rapid globalization of biomedical research in recent decades presents new challenges in preventing exploitation.

In fact, the principles that guide biomedical research ethics were developed in response to specific incidents of exploitation, including the infamous Tuskegee Syphilis Study. Protecting human dignity and preventing exploitation are core concepts in both bioethics and human rights. Through non-derogable rights, including the core obligations of the right to health, human rights law can help set a minimum standard of care. Introducing human rights law into this complex and longstanding debate adds a new and important perspective. Questions of justice are particularly relevant where limited resources mean that the local standard of care is no care at all. Some interpret the Declaration of Helsinki to mean that control groups should receive the best intervention available worldwide, while others interpret this and other international guidelines to mean the best local standard of care. For the past few decades, there has been intense debate in bioethics about the standard of care that should be provided in clinical trials conducted in developing countries.

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