<< Previous Section | < Previous Page | Next Page > | Next Section >> Bibliography (page 3 of 11) Iltis, A. S. (2005). "Stopping trials early for commercial reasons: the risk-benefit relationship as a moral compass." J Med Ethics 31(7): 410-414.      Drug trials are very carefully designed. They are approved because they have a favorable risk to benefit ratio. The authors argue that when companies stop trials for commercial reasons rather than matters of safety or efficiency they change the risk to benefit analysis unfavorable and, in doing, violate research ethics. This is an interesting and useful article. http://jme.bmjjournals.com/cgi/content/full/31/7/410 Tishler, C. L. and S. Bartholomae (2002). "The recruitment of normal healthy volunteers: a review of the literature on the use of financial incentives." J Clin Pharmacol 42(4): 365-375.      The authors review studies that currently exist regarding the impact of financial incentives to healthy volunteers and discuss the "coercive" impacts of large payments. It sounds a lot like paternalism to me in that the arguments assume that people would violate their interests should they volunteer primarily for money. Who is to say what is in someone's best interests but the person? http://jcp.sagepub.com/cgi/content/abstract/42/4/365 Grady, C. (2005). "Payment of clinical research subjects." J. Clin. Invest. 115(7): 1681-1687.      The author analyzes the details of payment for participation in clinical research, mainly in support of appropriate payments. http://www.jci.org/cgi/content/abstract/115/7/1681 Bennett, C. L., J. R. Nebeker, et al. (2005). "The Research on Adverse Drug Events and Reports (RADAR) Project." JAMA 293(17): 2131-2140.      This report highlights the productivity of the RADAR (Research on Adverse Drug Events and Reports). The team identified and tried to quantitate 16 adverse reaction to approved drugs that were previously unknown. This study highlights the weaknesses of the adverse event reporting system (or non-system), It lends support toward enhancing the FDA's capacity to utilize the AE reporting system and the huge advantages inherent in developing a national database using electronic medical records. http://jama.ama-assn.org/cgi/content/full/293/17/2131 Miller, F. G. and H. Brody (2003). "A critique of clinical equipoise. Therapeutic misconception in the ethics of clinical trials." Hasting Center Report 33(3): 19-28.      This sophisticated article argues that research differs from clinical medicine and that the concept of equipoise contains within it a "therapeutic misconception." Very worthwhile arguments are made in the context of an excellent review. Steinbrook, R. (2005). "Gag Clauses in Clinical-Trial Agreements." N Engl J Med 352(21): 2160-2162.      This report discusses the evils of contracts with clinical research sponsors in which the investigator doesn't see all of the data before agreeing to publication. http://content.nejm.org/cgi/content/extract/352/21/2160 Friedrich, M. J. (2005). "Neuroscience Becomes Image Conscious as Brain Scans Raise Ethical Issues." JAMA 294(7): 781-783.      This brief perspective points to ethical dilemmas generated by FMRI in practice but especially in research. Findings can be interpreted to violate privacy by revealing emotions that one would normally hide. Furthermore, the very act of doing FMRI would reveal unexpected findings of variable clinical significance in 2-8% of scans. How to deal with these raises additional ethical dilemmas the handling of which is very variable. http://jama.ama-assn.org/cgi/content/full/294/7/781 Franck, L. (2005). "Research with newborn participants: doing the right research and doing it right." J Perinatal and Neonatal Nursing 19(2): 177-86.      This paper discusses the role of the neonatal nursing team in determining what research is ethical in the NICU and how the rights of the infants need to be protected. << 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)