<< Previous Section | < Previous Page | Next Page > | Next Section >> Bibliography (page 5 of 11) Dickert, N. and C. Grady (1999). "What's the Price of a Research Subject? Approaches to Payment for Research Participation." N Engl J Med 341(3): 198-203.       The article discusses the ethics of paid research subjects in terms of three models of payment: market, wage-payment, and reimbursement. Though all have their advantages, the authors conclude the wage-payment model is superior. Although it may be the most ethical, it does not seem as effective in recruiting research subjects. Some interesting analyses of the differences are provided. http://content.nejm.org/cgi/content/full/341/3/198 Enserink, M. (2000). "BIOETHICS: Helsinki's New Clinical Rules: Fewer Placebos, More Disclosure." Science 290(5491): 418-419.       The article breaks the approval of the Declaration of Helsinki and shows its contradictions to current FDA guidelines. An interesting summary with a basic, but well thought out argument. Federman, D. D. (2003). "Minimizing Risk in Clinical Research." Ann Int Med 139(1): 71-72.       This important editorial identifies the three pillars of protecting individuals from harm in randomized, controlled trials: the evolution of published ethics papers, most notably the Belmont Report, the IRB, and the informed consent process. It points out that each process is fallible and constantly evolving, giving way to litigation against lapses in protection and a constantly improving system. Freedman, B., Ph.D. (1987). "Equipoise and the ethics of clinical research." N Engl J Med 317(3): 141-145.       Freedman proposes that justification of clinical research either requires genuine uncertainty on the part of the principal investigator as to the efficacy or safety of the various trial arms, or (his new idea) that uncertainty of professionals as a whole as to the advantages of one or another arm justifies research even if the PI is convinced of the advantage of one of the arms. He suggests that this will make more research meet ethical standards. As will be seen, continuing of discussion of equipoise is taking place. Gale, E. A. M. (2001). "Lessons from the glitazones: a story of drug development." The Lancet 357(9271): 1870. This report deals with the troglitizone story, which is pretty interesting but somewhat old hat in the face of new problems with Cox 2 inhibitors and SSRIs. Grant, G., O. Guyton, et al. (1999). "Creating effective research compliance programs in academic institutions." Acad Med 74(9): 951-71.       This somewhat outdated paper discusses the creation of a voluntary compliance program in research institutions to assure adherence to federal regulations. Because of differing rules among research institutions it would seem to be a good idea; however, it might significantly decrease trust in academic research and place a burden on the IRB process. Hellman, S. and D. Hellman (1991). "Sounding Board: Of Mice But Not Men." N Engl J Med 324(22): 1585-9. Hrobjartsson, A. and P. C. Gotzsche (2001). "Is the Placebo Powerless?- An Analysis of Clinical Trials Comparing Placebo with No Treatment." N Engl J Med 344(21): 1594-1602.       This empirical meta-analysis reviewed studies in which placebo was one arm of the trial. The placebos could be pills, manipulations, or conversations. They were able to study 114 such trials. They found that the placebo had little to no effect when the results were binary whether the outcome was subjective or objective. With continuous outcomes there were placebo effects but they diminished with increasing sample size. In the treatment of pain the placebo demonstrated a reduction in pain intensity of 6.5 mm on a 100-mm visual-analogue scale. This study generated a lot of comment on the trial use of placebos for lack of efficacy. There is also much thought deriding the use of placebos when effective therapies are present except under exceptional circumstances. Kodish, E., M. Eder, et al. (2004). "Communication of Randomization in Childhood Leukemia Trials." JAMA 291(4): 470-475.       This empirical study of children with leukemia and their parents tried to determine the degree of understanding of the concept of randomization (to new treatment and standard treatment arms). Most children with persistent leukemia end up in clinical trials. They found that only 50% of parents had an understanding of the concept of randomization. Having a nurse present and more complete explanation of the details of the research increased the percentage of the parents who understood the concept. leukemia trials. << 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)