Clin Eval 49 Suppl XXXVIII 2021

Proceedings

COVID-19 and bioethics Part 3：

Pandemic and research ethics− Democracy, placebo and post-trial access ＊1
Lecturers: Day 1

Chieko Kurihara 1 Specially-appointed Professor, Kanagawa Dental University, Japan
Ruth Macklin Distinguished University Professor Emerita at Albert Einstein College of Medicine

in New York City, the United StatesPeter Lurie Center for Science in the Public Interest, Washington, DC, the United States
Ulf Schmidt Professor of Modern History, University of Hamburg, Germany

Lecturers: Day 2Ames Dhai 2 Professor of Bioethics, University of the Witwatersrand, Johannesburg, South Africa
Tammam Aloudat Managing Director, Global Health Center, Graduate Institute of International

Development Studies, Geneva, Switzerland
Professor Emeritus, Infectious Diseases and Bioethics, Federal University ofMinas Gerais, Brazil
Francis P. Crawley Executive Director of the Good Clinical Practice Alliance – Europe (GCPA)
and Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), Leuven, Belgium
Dirceu Greco 3

Special guests

Ramin Parsa-Parsi Workgroup Chair of the 2013 revision of the Declaration of Helsinki, World

Medical Association; German Medical Association

Otmar Kloiber Secretary General, World Medical Association

Discussants

Rihito Kimura 4 Professor Emeritus of Bioethics, Waseda University, Japan
Sandor Kerpel-Fronius 5 Professor of Clinical Pharmacology, Semmelweis University, Hungary

Moderators

Takeo Saio 6 COVID-19 Task Force, Japan Association for Bioethics
Kyoko Imamura 7 Past President of the International Federation of Associations ofPharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) and former President of theJapanese Association of Pharmaceutical Medicine (JAPhMed)

Co-organized by the COVID-19 Task Force, Japan Association for Bioethics and the Brazilian Societyof Bioethics
Supported by the Japanese Association of Pharmaceutical Medicine (JAPhMed) and the International
Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)
Cooperation: Clinical Evaluation; Bioethics Policy Study Group; Pharmaceutical Study Group;
Clinical Research Risk Management Study Group(Friday, 4 and Friday, 11, June, 2021, Webinar by Zoom system)＊1

This is a record of the webinar, of which related information and video-recorded version is available at:
http://cont.o.oo7.jp/sympo/covidandbioethics.html
Japanese translation is published in this journal issue: http://cont.o.oo7.jp/49sup38/49sup38contents.html

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別冊2021

Abstract
In the 1990s, the HIV/AIDS pandemic raised substantial discussions of research ethics, mainly a longlasting debate on placebo-controlled clinical trials and post-trial access after the establishment of safe andeffective interventions. In 2019, some argued that this debate was outdated and that we should drive
ourselves forward to a new trend of research ethics. Just at this occasion, the world was confronted with
the COVID-19 pandemic. In this webinar we have discussed to explore what is the internationally agreed
ethical standard on placebo-controlled clinical trial and post-trial access considering the COVID-19situation.
The invited speakers and special guests who took historically critical roles in the above discussion
made presentations and engaged in debate exploring and clarifying local and global situations. The
discussion provided insights into (1) future direction for possible revisions of the paragraphs in the World
Medical Associationʼs Declaration of Helsinki on placebo use and post-trial access; and (2) emphasizedneed for global, collaborative efforts for structural reformation of the mechanisms of research anddevelopment to correct inequity and to achieve access to necessary medicines for all who need it.
Key words
The Declaration of Helsinki, COVID-19, human rights, global health, clinical trial, placebo, post-trial access［Epub ahead of the issue publication］
Rinsho Hyoka（Clinical Evaluation）．2021；49 Suppl XXXVIII：9−109．

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COVID-19 Task Force, Japan Association for Bioethics; Working Group on Ethics, International Federation of Associations ofPharmaceutical Physicians and Pharmaceutical Medicine (IFAPP); National Institutes for Quantum and Radiological Science andTechnology
Founder of the Steve Biko Centre for Bioethics, University of the Witwatersrand, Johannesburg, South Africa; Member and Vicechair of International Bioethics Committee of United Nations Educational, Scientific and Cultural Organization (UNESCO)(2018-2021)
Chair of the Brazilian Society for Bioethics (2019-2021); Member and Vice-chair of International Bioethics Committee of United
Nations Educational, Scientific and Cultural Organization (UNESCO) (2018-2021)
Faculty Affiliate, Kennedy Institute of Ethics, Georgetown University; Past President, Japan Association for Bioethics (2009-2012);
President , Keisen University (2006-2012)
Chair of the Working Group on Ethics of the International Federation of Associations of Pharmaceutical Physicians andPharmaceutical Medicine (IFAPP) (2014-2021)
Department of Internal Medicine and Psychiatry, Fuji Toranomon Orthopedic Hospital
Project Professor, Social Cooperation Program of IT Healthcare, The Graduate School of Pharmaceutical Sciences, The Universityof Tokyo; Japanese Institute for Public Engagement− 10 −