<< Previous Section | < Previous Page | Next Page > | Next Section >> Bibliography (page 8 of 11) Warner, S. (2004). "The Tribulations of Clinical Trials: Efforts are afoot to improve the output of the drug research pipeline." the Scientist 18(8): 20-24.       An extremely informative brief review of the problems associated with bringing a drug from concept to approval. It includes looking at problem auras and suggests empirical processes. A considerable amount of factual information is presented succinctly. Weijer, C. M., P. (2003). "Rehabilitating Equipoise." Kennedy Inst Ethics Journal 13(2): 93-118. Winslow, R. (2005). What Makes a Drug Too Risky? There's No Easy Answer. Wall Street Journal: B1-B2. February 16, 2005       This is an intriguing news article that offers a society-based rather than empirical view of risk. With pulled medications like Vioxx and negative reports of SSRIs and other drugs dominating media, there is no easy answer on what constitutes a "safe" drug. The author argues because the risk is small, even if it is significant, the medications should be allowed because of their benefit. Mastroianni, A. C. and J. P. Kahn (2002). "Risk and Responsibility: Ethics, Grimes v Kennedy Krieger, and Public Health Research Involving Children." Am J Public Health 92(7): 1073-1076.       This article describes the Kennedy Krieger Institute study of lead reductions in low income housing in Baltimore that led to suits for lead exposure to children living in that housing. The Appeals Court decision sent the case back to the trial court with much criticism but the final disposition does not seem to have been reached. Lockwood, A. H. (2004). "Human Testing of Pesticides: Ethical and Scientific Considerations." Am J Public Health 94(11): 1908-1916.       The Environmental Protection Agency has not used the protections of the NIH and FDA in conducting trials to determine the risks associated with the use of individual pesticides. The author indicates that this cannot be ethically justified. Worthwhile reading. Changes are afoot. Wendler, D., L. Belsky, et al. (2005). "Quantifying the Federal Minimal Risk Standard: Implications for Pediatric Research Without a Prospect of Direct Benefit." JAMA 294(7): 826-832.       United States federal regulations allow institutional review boards (IRBs) to approve pediatric research that does not offer participants a "prospect of direct" benefit only when the risks are minimal or a "minor" increase over minimal. The federal regulations define minimal risks based on the risks "ordinarily encountered in daily life or during routine physical or psychological examinations or tests." In the absence of empirical data, IRB members may assume they are familiar with the risks of daily life and with the risks of routine examinations and tests and rely on their own intuitive judgment to make these assessments. Yet intuitive judgment of risk is subject to systematic errors, highlighting the need for empirical data to guide IRB review and approval of pediatric research. Current data reveal that car trips pose the highest risk of mortality ordinarily encountered by healthy children. On average, these risks are approximately 0.06 per million for children aged 14 years and younger, and approximately 0.4 per million for children aged 15 through 19 years. Riskier, but still ordinary, car trips pose an approximately 0.6 per million chance of death for children aged 14 years and younger and an approximately 4 per million chance of death for children aged 15 through 19 years. Participation in sports represents the upper end of the range of morbidity risks for healthy children. For every million instances of playing basketball, approximately 1900 individuals will sustain injuries, including 180 broken bones and 58 permanent disabilities. These findings suggest IRBs are implementing the federal minimal risk standard too cautiously in many cases. These data also raise the question of whether the federal minimal risk standard may sometimes fail to provide sufficient protection for children, prompting the need to consider alternative standards. << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 3 Quick Links Ethics and Study Design Introductory Ethics Design Appropriate Risk to Benefit Ratio Selection of Subject Populations Cases Bibliography Chapter 3 Download (PDF)