임상시험에 있어 전자동의(Electronic Informed Consent) 획득: 미국 지침에 따른 고려사항을 중심으로

Abstract

According to the international norms, the researcher who wants to conduct the clinical trial must obtain the informed consent from the research participant in order to protect their rights and welfare and to respect their autonomy. To obtain the informed consent appropriately, the researcher must provide the sufficient information and the detailed explanations about the research and allow adequate opportunity to ask questions before obtaining the informed consent. In Korea, these requirements are specified as the researcher’s legal liabilities both in the Pharmaceutical Affairs Act and in the Korean Good Clinical Practice. Recently, there has been a growing interest in the use of the electronic media and process for obtaining the informed consent since the electronic informed consent is convenient for delivering and storing the information. However, it is questionable whether the use of the electronic media and process for obtaining informed consent satisfies the legal and ethical requirements laid out in the domestic law and the international norms because these principles and standards within them are created on the premise that the informed consent could be obtained on paper. So, in this article, I identify the ethical issues surrounding the electronic informed consent that require the attention not only of the researcher but also of the Institutional Review Board. In particular, I analyze and comment on the guidance concerning the electronic informed consent prepared by the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration.