An ethics-based approach to global child health research.

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When the international health research community recently opened its eyes to the ethical dilemmas raised by clinical drug trials in developing countries, the focal point was the study of antiretroviral therapy to reduce the incidence of maternal-fetal transmission of human immunodeficiency virus (HIV) (1). A heated debate in the literature dealt mainly with the fact that the control arm of trials in Asia and Africa involved HIV-infected mothers who received a placebo, instead of an antiretroviral regimen that had already been proven to reduce vertical transmission of HIV and was the standard of care in the United States. Many were appalled by the implication that thousands of infants were knowingly left at high risk of becoming infected with a deadly virus (2). The fact that the health of children was at stake in this controversy should not be overlooked as an incidental detail. Children are a vulnerable population in even the richest parts of the world, yet the role of foreign-sponsored health research involving children in the poorest regions is a particularly pressing issue that should be addressed by the paediatric research community in a timely and meaningful manner. Ethical considerations are integral to all health research throughout the world (3). Research involving children has historically been discouraged on ethical grounds, and was essentially barred by the Nuremberg Code (1949) (4). However, there is growing recognition of the ethical imperative to include children in research studies (5), particularly in light of evidence that child health research is not only beneficial, but that the absence of paediatric research can be harmful (6). There is likewise the obligation to adhere to ethical guidelines to protect the safety, human rights and cultural integrity of the children, their families and their communities. However, simultaneously enhancing both the inclusion and protection of children in research may create an apparent dilemma for paediatric researchers (7). There is some evidence that paediatric researchers have not universally emphasized the importance of ethical considerations, suggested by the finding that 40% of paediatric research studies published in five major American journals in 1999 did not document ethical approval (8), with even lower rates of approval documented in recent surgical paediatric publications (9). Yet the reality is that ‘protection’ and ‘inclusion’ can be mutually supportive goals when they exist within the context of an ethics-based approach to global child health research. The current development of cross-national paediatric research initiatives should therefore be guided by a formal discussion of bioethics. A proactive ethical approach to global child health research serves children in two broad ways. First, adherence to ethical principles leads to the development of a set of rational and relevant priorities and objectives. Second, promoting ethics ensures that observational or interventional methodologies are consistent with the customs and needs of the specific population with whom the investigators are working, and are mindful of the reality within which the community exists. Going beyond mere approval by an institutional review board or adherence to international guidelines (10), ethical research aims to reduce health inequities, by serving to benefit primarily the population from which the study participants are recruited, and benefit secondarily all children on a global scale through the transposition of the acquired knowledge.