title: The pharmaceutical industry's responsibility for protecting human subjects of clinical trials in developing nations.
abstract: Pharmaceutical companies increasingly perform clinical trials in developing nations. Governments of host nations see the trials as a way to provide otherwise unaffordable medical care, while trial sponsors are drawn to those countries by lower costs, the prevalence of diseases rare in developed nations, and large numbers of impoverished patients. Local governments, however, fail to police trials, and the FDA does not monitor trials in foreign countries, resulting in the routine violation of international standards for the protection of human subjects. This Note proposes independent accreditation of those institutions involved in clinical trials--the institutional review boards which oversee trial protocol; the organizations, such as pharmaceutical companies, which sponsor the trials; and the research organizations that conduct the trials. Accreditation, similar to that used in the footwear and apparel industries, would increase the transparency of pharmaceutical trials and would enable the United States government and consumers to hold trial sponsors accountable for their actions.
authors.affiliation: Columbia Journal of Law and Social Problems, Columbia University, USA.
authors.forename: Finnuala
authors.initials: F
authors.lastname: Kelleher
mesh_terms: D000068:Accreditation; D003906:Developing Countries; D004345:Drug Industry / Q000191:economics; D028744:Ethics Committees, Research; D033161:Government Regulation; D017408:Guidelines as Topic; D006805:Human Experimentation / Q000331:legislation & jurisprudence* / Q000592:standards*; D006806:Human Rights; D006801:Humans; D007258:Informed Consent; D017712:Peer Review, Research; D035842:Research Subjects; D012926:Social Control, Formal; D012941:Social Responsibility; D014481:United States; D014486:United States Food and Drug Administration