David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Ezio Di Nucci
Jack Alan Reynolds
Learn more about PhilPapers
Science and Engineering Ethics 16 (4):675-691 (2010)
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|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
No references found.
Citations of this work BETA
No citations found.
Similar books and articles
Sara Vollmer & George Howard (2010). Statistical Power, the Belmont Report, and the Ethics of Clinical Trials. Science and Engineering Ethics 16 (4):675-691.
Mark Sheehan & Steve Clarke (2009). The Duty to Disclose Adverse Clinical Trial Results. American Journal of Bioethics 9 (8):24 - 32.
S. Matthew Liao, Mark Sheehan & Steve Clarke (2009). The Duty to Disclose Adverse Clinical Trial Results. American Journal of Bioethics 9 (8):24-32.
Bernard Lo & Lindsay Parham (2010). Resolving Ethical Issues in Stem Cell Clinical Trials: The Example of Parkinson Disease. Journal of Law, Medicine & Ethics 38 (2):257-266.
Maurie Markman (2004). The Research Misconception. International Journal of Applied Philosophy 18 (2):241-252.
Charles Weijer, Characterizing the Population in Clinical Trials: Barriers, Comparability, and Implications for Review.
Udo Schuklenk (2007). HIV Vaccine Trials: Reconsidering the Therapeutic Misconception and the Question of What Constitutes Trial Related Injuries. Developing World Bioethics 7 (3).
Emma R. M. Cohen, Jennifer M. O'neill, Michel Joffres, Ross E. G. Upshur & Edward Mills (2009). Reporting of Informed Consent, Standard of Care and Post-Trial Obligations in Global Randomized Intervention Trials: A Systematic Survey of Registered Trials. Developing World Bioethics 9 (2):74-80.
Jacek Spławiński & Jerzy Kuźniar (2004). Clinical Trials: Active Control Vs Placebo — What is Ethical? Science and Engineering Ethics 10 (1):73-79.
Jeremy Snyder, Cari L. Miller & Glenda Gray (2011). Relative Versus Absolute Standards for Everyday Risk in Adolescent HIV Prevention Trials: Expanding the Debate. American Journal of Bioethics 11 (6):5 - 13.
Jonathan Kimmelman (2004). Valuing Risk: The Ethical Review of Clinical Trial Safety. Kennedy Institute of Ethics Journal 14 (4):369-393.
Stanley H. Shapiro, Charles Weijer & Benjamin Freedman, Reporting the Study Populations of Clinical Trials. Clear Transmission or Static on the Line?
Stephanie J. Bird (2010). Responsible Research: What is Expected? Commentary On: “Statistical Power, the Belmont Report, and the Ethics of Clinical Trials”. Science and Engineering Ethics 16 (4):693-696.
Franklin G. Miller & Steven Joffe (2006). Evaluating the Therapeutic Misconception. Kennedy Institute of Ethics Journal 16 (4):353-366.
Added to index2010-12-13
Total downloads20 ( #176,683 of 1,789,824 )
Recent downloads (6 months)2 ( #315,587 of 1,789,824 )
How can I increase my downloads?