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Ethics and sample size.

Peter Bacchetti1, Leslie E Wolf, Mark R Segal

  • 1Division of Biostatistics, Department of Epidemiology and Biostatistics, School of Medicine, Box 0560, University of California, San Francisco, CA 94143, USA. peter@biostat.ucsf.edu

American Journal of Epidemiology
|January 6, 2005
PubMed
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Smaller studies may be more ethical than larger ones. This research suggests that the value per participant decreases as study size increases, challenging the notion that low statistical power automatically makes a study unethical.

Area of Science:

  • Biomedical Ethics
  • Clinical Research Methodology

Background:

  • A common belief in research is that studies with inadequate statistical power (often defined as <80% or 90%) are unethical.
  • This perspective often overlooks the ethical balance between participant burden and the study's potential value.

Purpose of the Study:

  • To analyze how sample size affects the ethical acceptability of research studies.
  • To re-evaluate the relationship between participant burden, study value, and sample size in ethical research.

Main Methods:

  • The study examines the ethical balance by comparing projected participant burden with expected clinical or scientific value.
  • It analyzes how this balance shifts as sample size increases, considering value proportional to statistical power or inversely proportional to confidence interval width.
Keywords:
Biomedical and Behavioral Research

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Main Results:

  • Participant burden per person remains constant regardless of sample size.
  • Study value increases at a slower rate than sample size, leading to a decline in value per participant as studies grow larger.
  • Smaller studies demonstrate a more favorable ratio of projected value to participant burden.

Conclusions:

  • Ethical research participant treatment does not hinge on achieving conventional statistical power thresholds (80% or 90%).
  • Lower statistical power does not inherently render a study unethical.
  • This analysis focuses solely on ethical acceptability, not research optimality; larger studies may still be preferred for non-ethical reasons.