演者：Jon F. Merz 先生
Department of Medical Ethics & Health Policy,
the University of Pennsylvania, USA
演題：Waivers of informed consent for research: a legal and historical review and consideration of emerging practice
Waivers of informed consent for research are broadly permitted by national regulations and international ethical codes, and there is movement to expand the use of waivers in clinical trials. In this talk, I summarize several threads of current research that explore the legal and policy background to the development of waivers in United States policy and regulation. I also describe several completed and on-going systematic reviews that raise questions about the frequency of use as well as the legal and ethical legitimacy of waivers. The potential for misuse is highlighted by specific cases. The purpose of the presentation is to spur a comparative discussion of relevant norms and regulations in Japan.
Baker FX, Merz JF. What gives them the right? Legal privilege and waivers of consent for research. Clinical Trials. 2018;15(6):579-86. ほか3報をまとめたものを発表予定