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Science and Engineering Ethics

, Volume 16, Issue 4, pp 675–691 | Cite as

Statistical Power, the Belmont Report, and the Ethics of Clinical Trials

  • Sara H. VollmerEmail author
  • George Howard
Article

Abstract

Achieving a good clinical trial design increases the likelihood that a trial will take place as planned, including that data will be obtained from a sufficient number of participants, and the total number of participants will be the minimal required to gain the knowledge sought. A good trial design also increases the likelihood that the knowledge sought by the experiment will be forthcoming. Achieving such a design is more than good sense—it is ethically required in experiments when participants are at risk of harm. This paper argues that doing a power analysis effectively contributes to ensuring that a trial design is good. The ethical importance of good trial design has long been recognized for trials in which there is risk of serious harm to participants. However, whether the quality of a trial design, when the risk to participants is only minimal, is an ethical issue is rarely discussed. This paper argues that even in cases when the risk is minimal, the quality of the trial design is an ethical issue, and that this is reflected in the emphasis the Belmont Report places on the importance of the benefit of knowledge gained by society. The paper also argues that good trial design is required for true informed consent.

Keywords

Statistical power Belmont Report RCR Ethical frameworks Ethical thinking Ethical reasoning Research oversight Research compliance Ethics of clinical trials 

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Copyright information

© Springer Science+Business Media B.V. 2010

Authors and Affiliations

  1. 1.Department of PhilosophyUAB Center for Ethics and Values in the SciencesBirminghamUSA
  2. 2.Department of BiostatisticsUniversity of Alabama at BirminghamBirminghamUSA

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