インフォームド・コンセントにおける「非指示的」態度について

抄録

In the argument concerning informed consent, the concept of "non-directives" has been used as a protector of patients' self-determination. This concept is especially important for medical counselors. Ethical pradoxes arise when placebos are used both in medical experimentation and in a clinical setting. A placebo is a substance that the health care professional believes to be pharmacologically or biomedically inert for the condition being treated, the placebo effect sometimes be produced without nondisclosure, incomplete disclosure, or deception. Nevertheless, a placebo is less likely to be effective if used with the patient's knowledge. This raises the question of whether nondisclosure of placebo use is morally permissible. Most controlled trials are randomized clinical trials, which are generally preferred to observatinal or retrospective studies on grounds that their results have a higher degree of validity. Even if they had no preference for one treatment over the other, some patients may have refused conventional randomization because of its uncertainty. However, some critics suspect that disclosure of information became distorted, perhaps unconsciously, when the physician knew the assigned treatment in advance. Clearly, the process of obtaining informed consent under prerandomization merits unusually careful scrutiny to ensure adequate disclosure. On the other hand, a placebo is clinically given to a patient at the medical staffs' discretion without informing the patient about its use. The therapeutic use of placebo involves intentional deception or incomplete disclosure. This parodoxe is resolved when a patient has a chance to get a second-opinion.