Global Pulse Blog

It is a laudable goal to advance innovation in medicine, and the recently released results from the experimental HIV vaccine seem promising yet, with the growing trend of conducting clinical trials abroad and the corresponding increase in research subjects being drawn from developing nations, scientists, physicians, regulators and ethicists must strive to balance beneficence and justice and uphold their professional obligations. Large pharmaceutical companies and investigators based in developed nations are increasingly outsourcing clinical research trials to developing nations. The most commonly cited reasons for this globalization of clinical trials include decreased costs, stream-lined subject recruitment, international harmonization of research guidelines, the development of contract research organizations specializing in global trials and a rapidly expanding global market. While there may be identifiable benefits for the pharmaceutical industry, this trend towards looking to third world nations for research populations raises notable ethical concerns and has public health, economic and regulatory implications for the frequently vulnerable populations living there. Commonly, there is minimal regulatory oversight of clinical trials conducted in developing nations, resulting in a lack of knowledge about research conduct, ethical standards and data quality for many of these studies. Furthermore, there has been much debate over the appropriate content and interpretation of international research guidelines such as the Declaration of Helsinki as applied to international trials.

Past trials investigating HIV vaccines broach many ethical dilemmas. Several controversial experiments of HIV vaccines have taken place around the world. In 1987, an experimental HIV vaccine was given to healthy children in Zaire before any animal trials had been completed, based on an argument that this was justified given the gravity of the local circumstances. In another trial, researchers conducting a placebo-controlled preventative HIV vaccine trial in Thailand failed to provide intravenous drug using subjects with clean needles, the best proven method for preventing HIV in this population, and did not provide antiretroviral therapy to subjects who became infected during the course of the trial, arguing that this was the standard of care the subjects would have received had they not been enrolled in the trial. Not only does this trial raise concerns about relativising standards of care and exploiting vulnerable populations, but it also brings up the concept of therapeutic misconception. Inevitably many trial subjects, believing that the vaccine trial is therapeutic, will become newly infected with the HIV virus.

While advances and innovations in modern medicine build out of a foundation of clinical research and these advances lead to medical treatments to benefit many, it is important to scrutinize the path which brings these interventions into mainstream scientific medicine. The growing practice of taking clinical trials abroad to developing countries raises several important questions which must be thoughtfully discussed and addressed. Is it appropriate to apply the same regulatory standards and ethical guidelines employed for clinical trials conducted within the United States to trials taking place in developing nations, a decidedly diverse context? How do factors which shape the nature of the health care delivery systems of developing nations impact the conduct of clinical trials in these nations? How do the socioeconomic, cultural, ecological and genetic environments of the subject population affect the results of clinical trials and impact whether this data is generalizable to populations where the treatment will be most commonly utilized? What are the unique ethical challenges which arise when clinical trials are conducted abroad, enrolling vulnerable subjects from developing nations? Reflective, professional, responsible action is needed to address these questions, ensure ethical, quality research conduct and protect vulnerable populations.