包括同意を巡って : Informed Consentの拡張とその問題

抄録

Due to ever-pervasive gene studies and researches and the wide use of biobanks, the introduction of general consent is an urgent issue for promoting medical researches. However, in light of the conditions of IC, general consent is seen as an unorthodox or problematic consent form. This paper discusses the standards and forms that are required in order to respect the self-determination and protect the personal information of a subject(patient), and thereby presents a plausible argument for "a two-part consent process". Furthermore, this paper shows, using the Havasupai Case that some serious problems can be caused by communication gaps. To give general consent a definite form, it is not sufficient to take the consent's formal conditions into consideration; it is necessary to consider the role of medical coordinators. The stress is upon the need to create a common understanding and perception of the framework of medical studies shared by a subject(patient) and medical staff.