© 2003 by Oxford University Press
Journal of the National Cancer Institute, Vol. 95, No. 9, 636-637,
May 7, 2003
© 2003 Oxford University Press
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Growing Pains: Central Review Board Project Still Developing
| The first 150 words of the full text of this article appear below. |
During the 1970s, when the institutional review board (IRB) process was newly the law of the land, clinical trials done by a single investigator at a single institution were the norm. Todays trials, however, are more often enterprises in which networks of investigators at hundreds or even thousands of institutions collaborate.
Yet the rule still is, as it was originally, that every institution that plans to have patients on a trial must first have its own IRB review the protocolthe studys research planto be sure that it is ethically sound. Multicenter trials have made clinical trials more widely available and have other advantages as well. It stands to reason, for example, that therapies for adult cancers, in particular, would be more generalizable if the trials cast an even wider net. But there are barriers to trial expansion, and one is the local IRB approval requirement.
Perhaps no one is in
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E. J. Emanuel, A. Wood, A. Fleischman, A. Bowen, K. A. Getz, C. Grady, C. Levine, D. E. Hammerschmidt, R. Faden, L. Eckenwiler, et al. Oversight of Human Participants Research: Identifying Problems To Evaluate Reform Proposals Ann Intern Med, August 17, 2004; 141(4): 282 - 291. [Abstract] [Full Text] [PDF] |
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