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

REFERENCES

• Arras , J. D. 2001 . A method in search of a purpose: The internal morality of medicine . Journal of Medicine and Philosophy , 26 : 643 – 662 .
   PubMed Web of Science ®Google Scholar
• Brody , H. and Miller , F. G. 2003 . The clinician-investigator: Unavoidable but manageable tension . Kennedy Institute of Ethics Journal , 13 ( 4 ) : 329 – 346 .
   PubMed Web of Science ®Google Scholar
• 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 : 161 – 178 .
   PubMed Web of Science ®Google Scholar
• Cox, D., La Caze, M., & Levine, M. (Fall, 2005). ‘Integrity,’ in E. N. Zalta (Ed.), The Stanford Encyclopedia of Philosophy. [On-line]. Available: http://plato.stanford.edu/archives/fall2005/entries/integrity/ (First Accessed February 10, 2006; last accessed March 5, 2007)
   Google Scholar
• Emanuel , E. J. , Wendler , D. and Grady , C. 2000 . What makes clinical research ethical? . Journal of the American Medical Association , 283 : 2701 – 2711 .
   PubMed Web of Science ®Google Scholar
• Emanuel , E. J. and Miller , F. G. 2001 . The ethics of placebo-controlled trials — A middle ground . New England Journal of Medicine , 345 : 915 – 919 .
   PubMed Web of Science ®Google Scholar
• Feinberg , J. 1986 . Harm to Self , New York : Oxford University Press .
   Google Scholar
• Freedman , B. 1987 . Equipoise and the ethics of clinical research . New England Journal of Medicine , 317 : 141 – 145 .
   PubMed Web of Science ®Google Scholar
• 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 : 653 – 660 .
   PubMedGoogle Scholar
• Horng , S. and Miller , F. G. 2002 . Is placebo surgery unethical? . New England Journal of Medicine , 347 : 137 – 139 .
   PubMed Web of Science ®Google Scholar
• Horng , S. and Miller , F. G. 2003 . Ethical framework for the use of sham procedures in clinical trials . Critical Care Medicine , 31 ( 3 ) : S126 – S130 . (Supp.)
   Web of Science ®Google Scholar
• 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 : 566 – 574 .
   PubMed Web of Science ®Google Scholar
• 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 ) : 61 – 64 .
   PubMed Web of Science ®Google Scholar
• London , A. J. 2006a . “ Sham Surgery and Reasonable Risks ” . In Cutting to the Core: Exploring The Ethics of Contested Surgeries , Edited by: Benator , David . New York : Rowman & Littlefield .
   Google Scholar
• London , A. J. 2006b . “ Clinical Equipoise: Foundational Requirement of Fundamental Error? ” . In The Oxford Handbook of Bioethics , Edited by: Steinbock , Bonnie . New York : Oxford, University Press .
   Google Scholar
• Miller , F. G. 2003a . Sham surgery: An ethical analysis . American Journal of Bioethics , 3 ( 4 ) : 41 – 48 .
   PubMed Web of Science ®Google Scholar
• Miller , F. G. 2003b . Ethical issues in research with healthy volunteers: Risk-benefit assessment . Clinical Pharmacology & Therapeutics , 74 : 513 – 515 .
   PubMed Web of Science ®Google Scholar
• Miller , F. G. 2004 . Research ethics and misguided moral intuition . Journal of Law, Medicine & Ethics , 32 : 111 – 116 .
   PubMed Web of Science ®Google Scholar
• Miller , F. G. and Brody , H. 2001 . The internal morality of medicine: An evolutionary perspective . Journal of Medicine and Philosophy , 26 : 581 – 599 .
   PubMed Web of Science ®Google Scholar
• Miller , F. G. and Brody , H. 2002 . What makes placebo-controlled trials unethical? . American Journal of Bioethics , 2 ( 2 ) : 3 – 9 .
   PubMed Web of Science ®Google Scholar
• 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 ) : 19 – 28 .
   PubMed Web of Science ®Google Scholar
• Miller , F. G. and Rosenstein , D. 2003 . The therapeutic orientation to clinical trials . New England Journal of Medicine , 348 : 1383 – 1386 .
   PubMed Web of Science ®Google Scholar
• Miller , F. G. , Rosenstein , D. L. and DeRenzo , E. G. 1998 . Professional integrity in clinical research . Journal of the American Medical Association , 280 : 1449 – 1454 .
   PubMed Web of Science ®Google Scholar
• Miller , F. G. and Shorr , A. F. 2002 . Ethical assessment of industry-sponsored clinical trials . Chest , 121 : 1337 – 1342 .
   PubMed Web of Science ®Google Scholar
• 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 : 562 – 564 .
   Web of Science ®Google Scholar
• Miller , P. B. and Weijer , C. 2003 . Rehabilitating equipoise . Kennedy Institute of Ethics Journal , 13 ( 2 ) : 93 – 118 .
   PubMed Web of Science ®Google Scholar
• 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 : 542 – 547 .
   PubMed Web of Science ®Google Scholar
• Miller , P. B. and Weijer , C. 2006b . Fiduciary obligation in clinical research . Journal of Law, Medicine & Ethics , 34 : 424 – 440 .
   PubMed Web of Science ®Google Scholar
• Miller , F. G. , Wendler , D. and Wilfond , B. 2003 . When do the federal regulations allow placebo-controlled trials in children? . Journal of Pediatrics , 142 : 102 – 107 .
   PubMed Web of Science ®Google Scholar
• Scanlon , T. M. 1998 . What We Owe to Each Other , Cambridge, MA : Harvard University Press .
   Google Scholar
• 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 : 852 – 857 .
   PubMed Web of Science ®Google Scholar
• Weijer , C. 2000 . The ethical analysis of risk . Journal of Law, Medicine & Ethics , 28 : 344 – 361 .
   PubMed Web of Science ®Google Scholar
• Weijer , C. and Miller , P. B. 2004 . When are research risks reasonable in relation to anticipated benefits? . Nature Medicine , 10 : 570 – 573 .
   PubMed Web of Science ®Google Scholar