<< Previous Section | < Previous Page | Next Page > | Next Section >> Bibliography (page 1 of 2) (2003). "American Society of Clinical Oncology Policy Statement: Oversight of Clinical Research." Journal of Clinical Oncology 21(12): 1-10. Burman, W., R. Reves, et al. (2001). "Breaking the camel's back: multicenter clinical trials and local institutional review boards." Ann Int Med 134(2): 152-7.       This article, which has become historical by now descried the lack of capacity of currently constituted IRBs to handle the increasing protocol load and also evaluate safety reports from large randomized clinical trials in a timely fashion. The rapidly rising number of multicenter clinical trials had put unprecedented stress on the institutions that was compounded by an increasing number of IRB investigations, often leading to publicly announced closures of major academic institutions' clinical research programs. They proposed a systematic investigation of the entire clinical research review process. This was carried out by the Institute of Medicine. Cairns JA, Hallstrom A, et al. (2001). "Should all trials have a Data Safety and Monitoring Committee?" Am Heart J 141(1): 156-63.       This paper reviews development of DSM boards and explains the rationale for having their oversight. It reviews their functions and activities and ends by proposing a set of standards for appointment and charter of a DSMB. Drazen, J. M. (2002). "Institutions, Contracts, and Academic Freedom." N Engl J Med 347(17): 1362-1363.       This editorial discusses contracting rules for clinical research carried out in academic institutions, focusing on insisting on the freedom to publish results no matter what they reveal. Friedrich, M. J. (2005). "Neuroscience Becomes Image Conscious as Brain Scans Raise Ethical Issues." JAMA 294(7): 781-783. Gamache, V. (2003). "Increasing Presence of Data Monitoring Committees." Center Watch 10(4): 1, 8-11.       This paper reports on the rise of Data and Safety Monitoring Boards as a further mechanism to oversee clinical research. Since then they have become almost ubiquitous. Russo, E. (2000). "Monitoring Human Subjects and Clinical Trials." The Scientist: 6.      This news report indicates that IRBs are inadequate to monitor research even though they were given that mandate. Slutsky, A. S. and J. V. Lavery (2004). "Data Safety and Monitoring Boards." N Engl J Med 350(11): 1143-1147. (2003). "American Society of Clinical Oncology Policy Statement: Oversight of Clinical Research." J Clin Oncol 21(12): 2377-2386.      These are the 2003 American Society of Clinical Oncology rules and proposals for clinical research. These include centralized IRBs, standardized forms, and making informed consent documents more directed at informing about the study. They also promote more institutional support and education in ethical clinical research. http://www.jco.org/cgi/content/full/21/12/2377 Andrews, J. (2006). "Research in the ranks: vulnerable subjects, coercible collaboration, and the hepatitis E vaccine trial in Nepal." Perspect Biol Med 49(1): 35-51.      The military are vulnerable subjects because requesting participation in research is, in itself, coercive. The example of the hepatitis E vaccine trial employing the Royal Nepal Army demonstrates the vulnerability of the soldiers. http://muse.jhu.edu/journals/perspectives_in_biology_and_medicine/v049/49.1andrews.html Hahn, S., P. R. Williamson, et al. (2002). "Investigation of within-study selective reporting in clinical research: follow-up of applications submitted to a local research ethics committee." Journal of Evaluation in Clinical Practice 8(3): 353-359.      By comparing the initial protocol with the results and analysis of a small group of studies in Reading, U.K., the authors found that the primary objective was often not given and the analysis differed from that proposed. These results, if extrapolated, would indicate huge biases in clinical research. http://www.blackwell-synergy.com/doi/abs/10.1046/j.1365-2753.2002.00314.x << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 6 Quick Links Monitor Research Cases Bibliography Chapter 5 Download (PDF)