Abstract

Human experimentation is imperative to the advancement of science; in order to confirm the efficacy and safety of a drug, clinical trials are necessary for approval by governing bodies such as the FDA. The availability of human subjects is essential to the survival of pharmaceutical companies and to biomedical innovation. With over 100,000 clinical trials currently being conducted, outsourcing from the US to developing countries has grown exponentially as pharmaceutical companies are pressed to find enough subjects. As patients in the US become harder to find, trials more costly, and regulations tighter, globalization of clinical trials is inevitable. Despite the many benefits of this globalization, such as providing a means of healthcare to underserved communities that would otherwise lack medical attention, the outsourcing of clinical trials has become problematic due to a combination of legal, ethical, and regulatory issues that have allowed for the exploitation of vulnerable populations. Target populations have often been from third world countries in which cost is cheaper, subjects are less informed, and regulations are more lenient. Through a comparison of clinical trials and a review of current ethical guidelines for pharmaceutical drug testing, such as the Declaration of Helsinki and those outlined by the National Bioethics Advisory Committee, a large disparity was revealed in the regulation of and adherence to ethical standards in US drug testing between domestic and international trials. The results indicate a need to revise the protocol for clinical trials on an international scale, specifically for developing countries. By strengthening the regulations of clinical trials as well as the legal consequences due to noncompliance to current guidelines, the inequality of ethical standards in domestic and international trials will be minimized.