Ethical Basis

Although enlarged upon elsewhere in this book, two ethical principles guiding informed consent are those of autonomy and equipoise. Autonomy is the concept that the patient is an individual who is under no duress, whether subtle or obvious, actual or inferred, and is competent to make a choice according to his/her free will. Clinical trials conducted on persons in custody, or on subordinate soldiers, may both violate the patient's autonomy. Equipoise is the concept that the investigator, and those sponsoring the trial, are truly uncertain as to the outcome of the study; in practical terms, this is a guarantee to the patient that an unreasonable hazard cannot result from unfavourable random ization because the treatment options are not known to be unequally hazardous.

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