Equipoise and the Duty of Care in Clinical Research: A Philosophical Response to Our Critics 

Authors: Paul B. Miller ^a; Charles Weijer ^b

Affiliations:	a University of Toronto, Toronto, Ontario, Canada
	b University of Western Ontario, London, Ontario, Canada

DOI: 10.1080/03605310701255735

Publication Frequency: 6 issues per year

Published in: Journal of Medicine and Philosophy, Volume 32, Issue 2 March 2007 , pages 117 - 133

Subjects: Medicine: Medical Ethics; Ethics Philosophy: Medical Ethics;

Formats available: HTML (English) : PDF (English)

You have: FREE ACCESS

The circumstances under which this title is published have changed:

Reason for change: Changed Publisher
Now published by: Oxford University Press
Date of change: 2008

References

• 1. Arras, J. D. (2001) A method in search of a purpose: The internal morality of medicine. Journal of Medicine and Philosophy 26 , pp. 643-662. [informaworld]
• 2. Brody, H. and Miller, F. G. (2003) The clinician-investigator: Unavoidable but manageable tension. Kennedy Institute of Ethics Journal 13:4 , pp. 329-346. [ crossref ] [ csa ] [ pubmed ]
• 3. Buchanan, D. and Miller, F. G. (2005) Principles of early stopping of randomized trials for efficacy: A critique of clinical equipoise and an alternative nonexploitation framework. Kennedy Institute of Ethics Journal 15 , pp. 161-178. [ crossref ] [ csa ] [ pubmed ]
• 4. Cox, D., La Caze, M., & Levine, M. (Fall, 2005). 'Integrity,' in E. N. Zalta (Ed.), The Stanford Encyclopedia of Philosophy. [On-line]. Available: (First Accessed February 10, 2006; last accessed March 5, 2007)
• 5. Emanuel, E. J.,  Wendler, D. and Grady, C. (2000) What makes clinical research ethical?. Journal of the American Medical Association 283 , pp. 2701-2711. [ crossref ] [ pubmed ]
• 6. Emanuel, E. J. and Miller, F. G. (2001) The ethics of placebo-controlled trials — A middle ground. New England Journal of Medicine 345 , pp. 915-919. [ crossref ] [ csa ]
• 7. Feinberg, J. (1986) Harm to Self Oxford University Press , New York
• 8. Freedman, B. (1987) Equipoise and the ethics of clinical research. New England Journal of Medicine 317 , pp. 141-145.
• 9. Freedman, B.,  Fuks, A. and Weijer, C. (1992) Demarcating research and treatment: A systematic approach for the analysis of the ethics of clinical research. Clinical Research 40 , pp. 653-660. [ pubmed ]
• 10. Horng, S. and Miller, F. G. (2002) Is placebo surgery unethical?. New England Journal of Medicine 347 , pp. 137-139. [ crossref ]
• 11. Horng, S. and Miller, F. G. (2003) Ethical framework for the use of sham procedures in clinical trials. Critical Care Medicine 31:3 , pp. S126-S130. — (Supp.) [ crossref ] [ pubmed ]
• 12. Litton, P. and Miller, F. G. (2005) A normative justification for distinguishing the ethics of clinical research from the ethics of medical care. Journal of Law, Medicine & Ethics 33 , pp. 566-574. [ crossref ]
• 31. London, A. J. and Kadane, J. B. (2003) Sham Surgery and genuine standard of care: Can the two be reconciled?. American Journal of Bioethics 3:4 , pp. 61-64. [informaworld]
• 32. London, A. J. Benator, David (ed) (2006a) Sham Surgery and Reasonable Risks. Cutting to the Core: Exploring The Ethics of Contested Surgeries Rowman & Littlefield , New York
• 33. London, A. J. Steinbock, Bonnie (ed) (2006b) Clinical Equipoise: Foundational Requirement of Fundamental Error?. The Oxford Handbook of Bioethics Oxford, University Press , New York
• 13. Miller, F. G. (2003a) Sham surgery: An ethical analysis. American Journal of Bioethics 3:4 , pp. 41-48. [informaworld]
• 14. Miller, F. G. (2003b) Ethical issues in research with healthy volunteers: Risk-benefit assessment. Clinical Pharmacology & Therapeutics 74 , pp. 513-515.
• 15. Miller, F. G. (2004) Research ethics and misguided moral intuition. Journal of Law, Medicine & Ethics 32 , pp. 111-116. [ crossref ]
• 16. Miller, F. G. and Brody, H. (2001) The internal morality of medicine: An evolutionary perspective. Journal of Medicine and Philosophy 26 , pp. 581-599. [informaworld]
• 17. Miller, F. G. and Brody, H. (2002) What makes placebo-controlled trials unethical?. American Journal of Bioethics 2:2 , pp. 3-9. [informaworld]
• 18. Miller, F. G. and Brody, H. (2003) A critique of clinical equipoise: Therapeutic misconception in the ethics of clinical trials. Hastings Center Report 33:3 , pp. 19-28. [ crossref ] [ csa ]
• 19. Miller, F. G. and Rosenstein, D. (2003) The therapeutic orientation to clinical trials. New England Journal of Medicine 348 , pp. 1383-1386. [ crossref ]
• 20. Miller, F. G.,  Rosenstein, D. L. and DeRenzo, E. G. (1998) Professional integrity in clinical research. Journal of the American Medical Association 280 , pp. 1449-1454. [ crossref ] [ pubmed ]
• 21. Miller, F. G. and Shorr, A. F. (2002) Ethical assessment of industry-sponsored clinical trials. Chest 121 , pp. 1337-1342. [ crossref ] [ csa ] [ pubmed ]
• 22. Miller, F. G. and Silverman, H. J. (2004) The ethical relevance of the standard of care in the design of clinical trials. American Journal of Respiratory and Critical Care Medicine 169 , pp. 562-564. [ crossref ] [ csa ] [ pubmed ]
• 23. Miller, P. B. and Weijer, C. (2003) Rehabilitating equipoise. Kennedy Institute of Ethics Journal 13:2 , pp. 93-118. [ crossref ] [ csa ] [ pubmed ]
• 24. Miller, P. B. and Weijer, C. (2006a) The trust-based obligations of the state and physician-researcher to patient-subjects. Journal of Medical Ethics 32 , pp. 542-547. [ pubmed ] [ crossref ] [ csa ]
• 25. Miller, P. B. and Weijer, C. (2006b) Fiduciary obligation in clinical research. Journal of Law, Medicine & Ethics 34 , pp. 424-440. [ crossref ]
• 26. Miller, F. G.,  Wendler, D. and Wilfond, B. (2003) When do the federal regulations allow placebo-controlled trials in children?. Journal of Pediatrics 142 , pp. 102-107. [ crossref ] [ csa ]
• 27. Scanlon, T. M. (1998) What We Owe to Each Other Harvard University Press , Cambridge, MA
• 28. Silverman, H. J. and Miller, F. G. (2004) Control group selection in critical care randomized trials evaluating interventional strategies: An ethical assessment. Critical Care Medicine 32 , pp. 852-857. [ pubmed ] [ crossref ] [ csa ]
• 29. Weijer, C. (2000) The ethical analysis of risk. Journal of Law, Medicine & Ethics 28 , pp. 344-361. [ crossref ]
• 30. Weijer, C. and Miller, P. B. (2004) When are research risks reasonable in relation to anticipated benefits?. Nature Medicine 10 , pp. 570-573. [ pubmed ] [ crossref ] [ csa ]