Abstract #301013


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JSM 2001 Abstract #301013
Activity Number: 284
Type: Invited
Date/Time: Wednesday, August 8, 2001 : 2:00 PM to 3:50 PM
Sponsor: Cmte on Scientific Freedom and Human Rights
Abstract - #301013
Title: Sample Size and the Nuremberg Code
Author(s): Linda Goldsmith*+ and Paul Simmons
Affiliation(s): University of Louisville and University of Louisville
Address: Carmichael Bldg. Room 109C, Louisville, Kentucky, 40292,
Keywords: sample size ; Nuremberg Code ; human rights ; medical ethics ; research ethics ; statistical power
Abstract:

In 1947 the Nuremberg Code was formulated during the trial of Nazi scientists accused of murder and torture in medical experiments in concentration camps during World War II (Shuster, 1998). Characterized as the most authoritative set of rules for the protection of human subjects in medical research, the Nuremberg Code has had a profound effect on the ethics of human experimentation, particularly in its requirement of informed consent of experimental subjects. The 10 principles of the Nuremberg Code deal with other ethical issues, and there are strong implications for correct sample size estimation. "Ethical Guidelines for Statistical Practice," approved by the American Statistical Association in 1999, calls for statisticians to "avoid the use of excessive or inadequate numbers of research subjects by making informed recommendations for study size." A recent article "Why 'underpowered' trials are not necessarily unethical" (S. J. L. Edwards, et al, 1997) will be analyzed with regard to subject equipoise, utility functions, meta-analysis, and the "implicit contract" with research subjects (Harrington, 2000).


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