<< Previous Section | < Previous Page | Next Page > | Next Section >> Bibliography (page 1 of 11) Experimental Design Adrian, S. (2005). "Placebo effects in developmental disabilities: Implications for research and practice." Mental Retardation and Developmental Disabilities Research Reviews 11(2): 164-170.      The author discusses the importance of a placebo in the trial of secretin injections in autism research. She then elaborates on the "Hawthorne effect" and elaborates on the physiological consequences of placebos. A very worthwhile read. Carpenter, W. T., Jr., P. S. Appelbaum, et al. (2003). "The Declaration of Helsinki and Clinical Trials: A Focus on Placebo-Controlled Trials in Schizophrenia." Am J Psychiatry 160(2): 356-362.       This provides an excellent analysis of the placebo-control problem generated by the 2000 version of the Declaration of Helsinki as modified in 2001 and formally appeared in October 2002. It argues for the proper use of placebos and the benefits of having them in studies where numbers are important, failure to respond to current meds is widespread and in cases where the availability of standard Rx is problematic. Tishler, C. L. and S. Bartholomae (2003). "Repeat participation among normal healthy research volunteers: professional guinea pigs in clinical trials?" Perspectives in Biology and Medicine 46(4): 508-20.      The authors try to determine the amount of repeat volunteerism, motivation (altruism, money, obligation), ethical, and methodological problems and some suggestions. Richardson, L. (2005). "The ethics of research without consent in emergency situations." Mt Sinai J Med 72(4): 242-9.      This is an excellent review of the federal rule that permits research without consent in emergency situations. The detail about the limitations and the arguments about whether personal therapeutic benefit must be part of the process are discussed. http://www.mssm.edu/msjournal/72/724242.shtml Whitehead, J. (2004). "STOPPING CLINICAL TRIALS BY DESIGN." Nature Reviews Drug Discovery 3(11): 973.      This paper discusses the DSMB stopping rules which, he says, should be built into the design, before efficacy, lack of safety, or inevitably no evidence of benefit. If you belong to a DSMB or have one on your study this is very worthwhile reading. http://www.nature.com/nrd/journal/v3/n11/abs/nrd1553_fs.html Weijer, C. and P. B. Miller (2004). "When are research risks reasonable in relation to anticipated benefits?" Nat Med 10(6): 570.      The authors propose to use "component analysis" to assess risk vs. benefit in clinical research. The therapeutic components are assessed differently from the non-therapeutic. They use equipoise to justify the therapeutic component. http://www.nature.com/nm/journal/v10/n6/abs/nm0604-570.html ;jsessionid=00E29673439DE2E30C826750460B6D20 Morris, M. C., V. M. Nadkarni, et al. (2004). "Exception From Informed Consent for Pediatric Resuscitation Research: Community Consultation for a Trial of Brain Cooling After In-Hospital Cardiac Arrest." Pediatrics 114(3): 776-781.      Hypothermia may help treat cardiac arrest in children, but it must be applied quickly. A research project studying their potential benefit without prior consent was proposed to the community and substantial support was obtained but the results were far from unanimous. This study requires Federal approval as well. They concluded that making sure that prospective cardiac arrest parents be notified and allowed to decide whether to participate in advance but that timely consent was no feasible. http://pediatrics.aappublications.org/cgi/content/full/114/3/776 Roberts, L. W., T. D. Warner, et al. (2004). "Schizophrenia research participants' responses to protocol safeguards: recruitment, consent, and debriefing." Schizophrenia Research 67(2-3): 283. This report describes interview of patients with schizophrenia who were currently involved in a research program. They indicate that the participants understood that they were involved in research and that they had agreed voluntarily to participate although some degree of coercion was noted. This is a worthwhile report for anyone considering research with vulnerable populations. http://www.sciencedirect.com/science/article/B6TC2-48Y0DV3 -3/2/eaa1fedba809650b94c8231b368ecded << 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)