<< Previous Section | < Previous Page | Next Page > | Next Section >> Bibliography (page 11 of 11) Nelson, R. M. and L. F. Ross (2005). "In Defense of a Single Standard of Research Risk for all Children." The Journal of Pediatrics 147(5): 565.      This editorial is devoted to the idea that it is possible to develop a single standard of research risk for children and propose that the NIH develop such a standard -- as they suggest. http://www.sciencedirect.com/science/article/B6WKR-4HJGM1S-K /2/2ae919b789b8571af0b5b352217a36b0 Wendler, D. and E. J. Emanuel (2005). "What is a "Minor" Increase over Minimal Risk?" The Journal of Pediatrics 147(5): 575.      In response to JAMA 2004; 291: 476-2 the authors try to develop ethical guidelines whereby IRBs may approve research on children that could be considered a "minor increase over minimal risk." very well worth reading. See editorial. http://www.sciencedirect.com/science/article/B6WKR-4HJGM1S-S /2/a07a87d7e4cc5383a47886354cfdba0b Wendler, D. and H. Forster (2004). "Why we need legal standards for pediatric research." The Journal of Pediatrics 144(2): 150.      This commentary discusses the implications of the Grimes case for legal liability of investigators carrying out research on children. They consider implications of 50 states writing different laws in the vein of them recently enacted Maryland law and warn investigators that their legal protections are slim. http://www.sciencedirect.com/science/article/B6WKR-4BKDKPD-R /2/003af6fbbdec811277c88f21a245f739 Ross, L. F. (2003). "Do healthy children deserve greater protection in medical research?" The Journal of Pediatrics 142(2): 108.      This commentary points out that the term "minimal risk" as utilized in reviewing research in children fails to distinguish between healthy and sick children, suggesting that for some reviewers, sick children can be exposed to more risk because they have already been exposed to greater risk. The author raises further questions as to the risks children can ethically be subject to. http://www.sciencedirect.com/science/article/B6WKR-48166F1 -8/2/d289d9d96eb89d1094062a3c7d466b34 Kimmelman, J. (2004). "Valuing risk: the ethical review of clinical trial safety." Kennedy Inst Ethics Journal 14(4): 369-93.      This very thoughtful theoretical paper considers risk assessments by IRBs and finds that they are too limited in that they are largely limited to technical evaluation of prior data. They usually are undetermined at the time of IRB consideration. At the same time, committees give less consideration to differing definition of risk of various populations and how they would attribute risk. This is very worthwhile, especially for IRB members. Buchanan, D. and F. G. Miller (2005). "Principles of early stopping of randomized trials for efficacy: a critique of equipoise and an alternative nonexploitation ethical framework." Kennedy Inst Ethics Journal 15(2): 161-78.      Early stopping of clinical trials for efficacy has become increasingly common. The usual reason given is that we can't expose subjects receiving the alternative treatment to inferior care since efficacy been proven, i.e. equipoise has been lost. The problem is that many such decisions leave the research incomplete. The author addresses the situation and proposes a new stricter standard that takes into greater account the generation of new knowledge. Required reading for NSMB members. << 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)