Clin Eval 48（1）2020

Opening Remarks

Presidential Symposium in the 40th Annual Scientific Meetingof the Japanese Society of Clinical Pharmacology and Therapeutics, 2019

International Collaborative Research and New Trends of Research Ethics

Opening Remarks:
The Declaration of Helsinki,
CIOMS guidelines, ICH Renovation
and New Trend of Research Ethics ＊1
Organized & Chaired by: Kazutaka Shimoda 1, Hiroshi Watanabe 2
Organized & Presented by: Chieko Kurihara 3（Wednesday, December 4, 2019, Keio Plaza Hotel Tokyo, Japan）＊1123

The symposium was held with the cooperation of the Mochida Memorial Foundation for Medical and Pharmaceutical Researchand Rinsho Hyoka Kankokai Inc. (Clinical Evaluation). Japanese version is included in Clinical Evaluation. 2020; 48(1). Otherrelated articles in this issue:
http://cont.o.oo7.jp/48_1/48_1contents_e.html
Professor & Chairman, Department of Psychiatry, Dokkyo Medical University School of Medicine; Meeting President of the 40th
Annual Scientific Meeting of the JSCPT; Current President of the JSCPT
Professor, Executive Director / Vice President, Hamamatsu University School of Medicine; Immediate Past President of theJSCPTNational Institutes for Quantum and Radiological Science and Technology− W1 −臨床評価48 巻 1 号

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Abstract
Here we publish the record of the Presidential Symposium of the 40th Annual Scientific Meeting of theJapanese Society of Clinical Pharmacology and Therapeutics (2019), entitled “International Collaborative
Research and New Trends of Research Ethics”. In this symposium two important guests were invited andpresented the lecturers on: (1) Historical development of the Declaration of Helsinki and immediatechallenges as well as future perspectives of research ethics, discussed by Dr. Otmar Kloiber, Secretary
General of the World Medical Association; (2) Implications of the International Ethical Guidelines for
Health-related Research Involving Humans by the Council for International Organizations of Medical
Sciences (CIOMS) and other international documents, discussed by Dr. Dirceu Greco, Professor Emeritus,
Infectious Diseases and Bioethics, Federal University of Minas Gerais, who is one of the working groupmembers of the 2016 version of the CIOMS guidelines. We explored relationship between these ethicalprinciples and recent perspectives of methodologies of clinical trial and clinical research, especiallysuggested in the ICH Renovation initiatives. The following points were specifically expected to be focused.
Patient-driven research and patient, public involvement (PPI) in clinical trials
Individual participant data (IPD) sharing and digital healthResearch in disaster situations
Social determinants of health and universal health coverage
Wellbeing of patients and physicians
Research involving the vulnerable
Placebo-controlled trial and post-trial access
The resulting findings from the lectures and discussions are recorded in this issue. We hope that thispublication contributes to grasping the latest trends of research ethics in the world and to find a direction
to go ahead in terms of clinical research infrastructure development and value generation both fromdomestic and global perspectives.
Key words
clinical pharmacology, research ethics, real world data, Declaration of Helsinki, CIOMS
Rinsho Hyoka（Clinical Evaluation）．2020；48（1）：W1−W8.［Epub ahead of the issue publication］− W2 −

Clin Eval 48（1）2020

Dr. Kazutaka Shimoda, M.D., Ph.D.
Professor & Chairman, Department ofPsychiatry, Dokkyo Medical University
School of Medicine;
Meeting President of the 40th Annual
Scientific Meeting of the JSCPT;
Current President of the JSCPT
Graduated from Shiga University of MedicalScience, received M.D.
1983‑1987 Shiga University of Medical Science,
Graduate School, majoring inPsychiatry and CNS Information
Control. Received Ph.D.
1987‑1990 Instructor, Department of Psychiatry,Shiga University of Medical Science
1988‑1990 Visiting Scientist from Japanese
Ministry of Education, Department ofPsychiatry, Brain & Development
Research Center, University of North
Carolina at Chapel Hill, NC, USA.
1995‑1996 Visiting Scientist from Japanese Society of Clinical Pharmacology, Department of ClinicalPharmacology, Huddinge University Hospital, Karolinska Institute, Sweden
2002‑2006 Associate Professor, Department of Psychiatry, Dokkyo Medical University
2007-present Chairman & Professor, Department of Psychiatry, Dokkyo Medical University

Dr. Hiroshi Watanabe, M.D., Ph.D.
Professor, Executive Director / Vice President,
Hamamatsu University School of Medicine;
Immediate Past President of the JSCPT
Graduated from Hokkaido University, received M.D.
1983‑ Started working as a cardiologist in
Hamamatsu University Hospital; received
PhD in 1988.
1989‑1991 Studied vascular biology as a research
fellow, Dusseldorf University, Germany.
2005‑ Professor of the Department of ClinicalPharmacology and Therapeutics inHamamatsu University School of Medicine
since, and now Executive Director/VicePresident, Hamamatsu University School ofMedicine.
2016‑2019, a cross-appointment with National
Center for Global Health and Medicine
as the Director of Center for ClinicalSciences.
2014‑2018 President of Japanese Society of Clinical Pharmacology and Therapeutics
Now a Program Officer of Japan Agency for Medical Research and Development (AMED)− W3 −

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Chieko Kurihara, National Institutes for Quantum andRadiological Science and Technology
Graduated Department of Economics, School of Political Science andEconomics, Waseda University
1984‑2000 Editorial, book writing, theatre works
1994‑2017 Rinsho Hyoka (Clinical Evaluation) (Since April of 2017,editorial member)2003‑2007 Researcher/Consultant, Center of Life Science and Society(CLSS)
2007‑Present National Institute of Radiological Sciences, (since 2016)
National Institutes for Quantum and Radiological Scienceand Technology (QST)
2019‑Present Specially-appointed Professor, Kanagawa Dental
University
Vice Chair, Certified Review Board, QST
Member, Ethics Working Group, International Federation of Associations of Pharmaceutical Physicians &Pharmaceutical Medicine (IFAPP)
Member, Task Group 109, Ethics in radiological protection for diagnosis and treatment, International Commission ofRadiological Protection (ICRP)On December 4, 2019, we hold an international symposium entitled “International Collaborative Researchand New Trends of Research Ethics” as the Presidential Symposium in the 40th Annual Scientific Meeting of
the Japanese Society of Clinical Pharmacology and Therapeutics, 2019, and its record is published here. In
this symposium we discussed the possibility of future revisions of the World Medical Association (WMA)’sDeclaration of Helsinki (DoH), responding recent trend of research involving human subjects. International
debate on the provisions of the DoH since around the year of 2000 until the latest revision in 2013 was also
reviewed. In addition, the International Ethical Guidelines for Health-related Research Involving Humans by
the Council for International Organizations of Medical Sciences (CIOMS) and other international ethicalnorms that play an important role same as the DoH were discussed. We deliberated in depth the recent trendsof methodology of clinical trial as well as research ethics, considering public health issues from the global
perspectives.
The World Medical Association’s “Declaration of Helsinki” was first adopted in 1964. After the latest
amendment in 2013 1), the 50th anniversary ceremony was held in 2014 2). In 2016, they adopted the Taipei
Declaration on Health Database and Biobanks, which complements the Declaration of Helsinki 3).
In this symposium, one of the invited lecturers, Dr. Otmar Kloiber, M.D., Ph.D., Secretary General, World
Medical Association, overviewed historical development of the WMA’s deontology and talked about thelatest trends of research ethics, including increasing interests in health database and biobanks responding
recent promotion of data-driven research; as well as positive and negative aspects of patient-driven research.
He also provided the WMA’s perspectives for next revision of the Declaration as well as critical issues andactivities which the WMA has been recently engaged in.
Meanwhile, the Council for International Organizations of Medical Sciences (CIOMS) produces anotherprominent international ethical guidelines for health-related research, the latest revision of which was in2016 4). It deals with emerging issues such as research in resource-limited environments, including disaster− W4 −

Clin Eval 48（1）2020【Invited lectures】“Declaration of Helsinki: Challenges and new trends ahead of us”
Dr. Otmar Kloiber, M.D., Ph. D., Secretary General, World Medical Association, Inc.
“The past, now and future of ethics of international health resarch as a stepping-stone to universal
public health care access”
Dr. Dirceu Greco, M. D., Ph. D., Professor Emeritus, Infectious Diseases and Bioethics,
Federal University of Minas Gerais; Chair, Brazilian Society of Bioethics (2017-2019)(Language: English)【Chairpersons】
Dr. Kazutaka Shimoda, M.D., Ph.D.
Professor & Chairman, Department of Psychiatry, Dokkyo Medical University School of Medicine;
Meeting President of the 40th Annual Scientific Meeting of the JSCPT;
Current President of the JSCPT
Dr. Hiroshi Watanabe, M.D., Ph.D.
Professor, Executive Director / Vice President, Hamamatsu University School of Medicine;
Immediate Past President of the JSCPT【Date and Venue】
Date: Wednesday, December 4, 2019 Time frame: 13:00-15:00
Venue: Keio Plaza Hotel Tokyo (Shinjuku, Tokyo, Japan) 4th Floor Room 4: Hana B【Cooperation】
Mochida Memorial Foundation for Medical and Pharmaceutical Research
Rinsho Hyoka Kankokai Inc. (Clinical Evaluation)− W5 −

臨床評価48 巻 1 号

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situations; research using online information and biobanks.
Another invited lecturer, Dr. Dirceu Greco, M.D., Ph.D., Professor Emeritus, Infectious Diseases andBioethics, Federal University of Minas Gerais, Brazil, is now the Chair of Brazilian Society of Bioethics,
2019-2021; Member and Vice-chair of International Bioethics Committee of United Nations Educational,
Scientific and Cultural Organization (UNESCO), 2018-2021; and worked as a member of Working Groupfor the 2016 revision of CIOMS guidelines for health research. He overviewed the past, present, future ofresearch ethics including international debate on the revision of the Declaration of Helsinki since 2000 version, and made important proposal toward universal healthcare access, as one of the fundamental humanrights, and establishment of the research ethics guidelines of international agreement 5).
Prior to the two invited lectures, Chieko Kurihara, one of the organizers, presented the latest trends ofresearch ethics in her presentation as Opening Remarks (Table 1), and provided a historical background,

Table 1 Recent trend of research ethics
ICH Renovation: IPD sharing, Real-world data⇒Mitigate the cost and ethical dilemma of “well-controlledcomparative clinical trials”
Promotion of “patient & public involvement (PPI)” by industries and governments; expanding patientinitiated research utilizing IoT gathering their own data.
Privacy issues associated with genome-wide analysis gathering big data and human samples; responsibilityof healthcare beneficiaries; ethics of AI development.
Ethical debate of studies in HIV/AIDS, then Ebola pandemic and in disaster/war conflict situations.
Collaborative studies toward Global Health; achievement of universal health coverage.

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Clin Eval 48（1）2020

most recent issues, and future perspective to be discussed more in depth, concerning the DoH and CIOMS
Guidelines. Regarding the discussions on the DoH, she also introduced related interviews and reports so far.
It includes Pros & Cons of placebo debate 6); 2000 revision of the DoH expanding the scope to studies onsamples and data and its philosophical bases 7); issues of 2002 note of clarification of the DoH 8); latest revision of the DoH in 2013 and 50th anniversary in 2014 with expanding view of research ethics 9, 10); the perspective of the United States Food and Drug Administration on scientific methodology and ethics of clinical
trial including placebo use 11); post-trial access, rejected “fair, additional benefit” and establishment of humanrights in developing worlds 12, 13); establishment of international consensus on ethics for health database andbiobanks by the WMA Taipei Declaration; discussions towards disaster medicine, Universal Health Coverageand global health 14〜18).
We hope that this record of the symposium will provide the readers a valuable opportunity to discuss new
trend of research ethics in accordance with ICH Renovation promoting digital health, as well as patientdriven research, research in disaster situations, facilitating global collaborative clinical trials and healthresearch.
References
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http://cont.o.oo7.jp/46_1/w29-w40.pdf(Published May 7, 2020)− W8 −