The Law of Clinical Testing with Human Subjects
Temple University - Beasley School of Law
BAYESIAN METHODS AND ETHICS IN A CLINICAL TRIAL DESIGN, Joseph B. Kadane, ed., John Wiley & Sons, Inc., 1996
This chapter focuses on the 'undeveloped' law of treatment assignment in clinical trials with human subjects. Treatments in clinical trials are regularly assigned randomly, and randomization is regularly assumed to meet all legal and ethical requirements. Hence, there are not many decisions discussing the issue, and none seriously formulates rules or standards, or questions randomization. However, a new treatment assignment methodology was developed in the 1990s that introduces some individualized considerations into the assignment of treatments without compromising the ability of a clinical trial to yield useful results (explained briefly at page 238 of the chapter and in detail in the rest of the book). This raised some basic and long-ignored legal and ethical questions. Assigning treatments randomly seems to violate the basic duty of physicians to determine and administer the best treatment for the patient. And the apparently common practice of not adequately informing clinical trial subjects that their treatments will be assigned randomly also violates the duties of physicians. Courts are probably applying some unarticulated version of malpractice law, which emphasizes customary practices and recognizes specialties, but this body of law seems ill-designed and inappropriate for determining the circumstances in which a physician may deviate from what is best for the patient to find out what works best. To allow treatment assignment by the flip of a coin is to suspend, not apply, malpractice law. The chapter, from an interdisciplinary study and book on the new methodology for treatment assignment based in statistics, ethics, philosophy, and clinical practice as well as law, Baysian Methods and Ethics in a Clinical Trial Design, concludes that a body of law on clinical testing should be developed, and finds that new methodologies that allow consideration of individual characteristics and histories are legally and ethically preferable.
Keywords: clinical trial, human subject, malpractice, consent, law, ethicsAccepted Paper Series
Date posted: June 9, 2009 ; Last revised: October 4, 2010
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