The 2024 Declaration of Helsinki:
Taking Forward Bioethics and Human Rights
Co-organized by The Brazilian Society of Bioethics (SBB); International
Federation of Associations of Pharmaceutical Physicians andPharmaceutical Medicine (IFAPP); Clinical Evaluation Inc.; The 129th
Pharmaceutical Study Group
Supported by The Japan Association for Bioethics (JAB)
Cooperation: Japanese Association of Pharmaceutical Medicine(JAPhMed); Japanese Institute for Public Engagement (Ji4pe); ClinicalResearch Risk Management Study Group
共催：ブラジル生命倫理学会、国際製薬医学会（IFAPP）、臨床評価刊行会、第 129 回くすり勉強会
後援：日本生命倫理学会
協力：日本製薬医学会（JAPhMed）、医療開発基盤研究所（Ji4pe）、臨床研究リスク管理研究会

Monday, 5, 26, August 2024 Zoom webinar
Brazil 8:00-11:00; US Washington DC 7:00-10:00;
Japan 20:00-23:00; CET/South Africa 13:00-16:00
Registration required, free of charge：登録必須・無料
https://forms.gle/hWcumg8WiVGJUoQU6

Background and objectives
The World Medical Association (WMA)’s Declaration of Helsinki (DoH), ethical principles forresearch involving humans, was first adopted in 1964 and last amended in 2013. It is currently in the
final stage of the next revision, with the adoption proposed to be in October 2024. Critical topics
which have been discussed thus far in the WMA’s regional meetings and twice during public
consultations are: involvement and protection of patients and community in research; promotinginclusion and protection of vulnerable people; research in low-resource settings including disastersituations; access to interventions proven to be effective; and the most controversial issue of thecondition of placebo-controlled trials when proven intervention exists (including consistency withCIOMS guidelines). Linking of the issues with the WMA Declaration of Taipei on Health Databases
and Biobanks is also an important topic to promote data-driven research.
This symposium will provide an overview of the revision process of the WMA, from an external
perspective (including the view with some collaborative relationship with the WMA), and consider
the direction ahead from the perspective of the cornerstone for the protection of the dignity and rightsof research participants in the context of bioethics.

背景と目的
世界医師会による人を対象とする研究の倫理原則であるヘルシンキ宣言は、1964 年に初版が採択され、最新改訂は 2013 年である。現在、12024 年 10 月の改訂版採択に向けた最終段階にある。世界医師会の地域会議と 2 回のパブリックコンサルテーションでは、コミュニティや患者の研究への参画とその保護、弱者の研究組み入れ推進とその保護、低資Page 1 of 3

源環境・災害状況下での研究、試験終了後に有効性が証明された介入へのアクセス、そして最も論争を喚起してきたプラセボ対照試験の許容条件（CIOMS 指針との整合性）などが重要な争点となっている。ヘルスデータベースとバイオバンクについての台北宣言との関係性もデータ駆動型研究を推進する上で重要課題である。
本シンポジウムでは、第三者的な立場（協力関係を持つ場合を含む）から、世界医師会における改訂状況を概観し、今後の研究倫理の潮流の方向性を検討するとともに、研究参加者の尊厳と人権の保護のために必要な基軸を、生命倫理学の観点から明らかにする。
* All of presentations are panelists’ personal view, not of affiliations, not explanation from WMA’sside, unless there is specific reference.

Panelists (titles in blue are tentative)
1) Dirceu Greco, M.D., Ph.D., Professor Emeritus of Infectious Diseases and Bioethics at the Schoolof Medicine, Federal University of Minas Gerais, Brazil; Past President of the Brazilian Societyof Bioethics, Member of the UNESCO International Bioethics Committee; Associate Member ofthe World Medical Association
Ethics of placebo-controlled trials and post-trial access: Brazilian experience
2) Elda Coelho Azevedo Bussinguer, J.D. PhD (Bioethics). Full Professor at the Faculty of Law ofVitória (FDV), Brazil; President of the Brazilian Society of Bioethics
Welcome from Brazilian Society of Bioethics on the Declaration of Helsinki3) Diego Zanella, PhD (Phylosophy), Professor of Bioethics, Universidade Franciscana, Brazil,Member of the Board Brazilian Society of Bioethics
Perspectives from Brazilian Society of Bioethics on the Declaration of Helsinki
4) Laís Alves de Souza Bonilha, PhD (Local Health Development). Associate Professor at
the Federal Univertity of Mato Grosso do Sul, Brazil; Coordinator of the CONEP (BrazilianNational Commission on Ethics in Research)
Experience of CONEP to facilitate Ethical Research5) Varvara Baroutsou, M.D., Ph.D., President of the International Federation of Associations ofPharmaceutical Physicians & Pharmaceutical Medicine (IFAPP), Consultant in Internal Medicine
and in Pharmaceutical Medicine, Athens, Greece
Collaboration with the WMA and IFAPP’s perspective6) Kotone Matsuyama, PhD. Professor, Department of Health Policy and Management, Nippon
Medical School, Member of the Japan Association for Bioethics; Chair of Ethics Working Groupof the International Federation of Associations of Pharmaceutical Physicians and PharmaceuticalMedicine (IFAPP)
Commitment of the Ethics Working Group of the IFAPP
7) Chieko Kurihara, BA, Specially-appointed Professor, Kanagawa Dental University; Vice-chairof Certified Review Board, National Institute for Quantum Science and Technology; Member ofthe Japan Association for Bioethics; Member of Ethics Working Group of the International
Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)
Overview of the revision process of the 2024 Declaration of Helsinki (1)8) Takeo Saio, M.D., Department of Internal Medicine and Psychiatry, Fuji Toranomon Orthopedic
Hospital; Member of the Japan Association for Bioethics; Associate Member of the World
Medical Association
Overview of the revision process of the 2024 Declaration of Helsinki (2)Page 2 of 39) Yoshiko Saito, Master of School Design, Breast cancer survivor; Fellow Member of the Japan
Association for Bioethics
Patient and public opinions to the revision of the Declaration of Helsinki: our proposals to theWMA10) Ames Dhai, MBChB., LLM., Ph.D., Professor Bioethics, School of Clinical Medicine, Universityof the Witwatersrand, Specialist Ethicist at South African Medical Research Council,Johannesburg, South Africa; Past Chairperson of the UNESCO International Bioethics
Committee; South African Medical Association
Access and Equity in Research: Justice, Vulnerability and Low-Resource Settings
背景となる出版
Background publications●日本生命倫理学会 COVID-19 タスクフォース・ブラジル生命倫理学会 共催企画
Co-organized by the COVID-19 Task Force, Japan Association for Bioethics & Brazilian
Society of Bioethics
 COVID-19 と生命倫理 Part 3：パンデミックと研究倫理－民主主義，プラセボ，試験終了後
アクセス
http://cont.o.oo7.jp/49sup38/49sup38contents.html
 （英語版）
COVID-19 and bioethics Part 3: Pandemic and research ethics－Democracy, placebo andpost-trial access
http://cont.o.oo7.jp/49sup38/49sup38contents_e.html
 COVID-19 と生命倫理 Part 1 ブラジル生命倫理学会勧告 No. 01/2020 と直面する課題
http://cont.o.oo7.jp/48_3/ab-p551.pdf
 （英語版）
COVID-19 and bioethics: Part1 Ethical Challenges and COVID-19:
The Recommendation No. 01/2020 of the Brazilian Society of Bioethics (SBB)
http://cont.o.oo7.jp/48_3/p661-84.pdf
今回のオーガナイザーによる関連テーマの出版●Recent collaborative publications by co-organizers
 Kurihara C, Greco D, Dhai A, editors. Ethical innovation for global health: pandemic,democracy and ethics in research. Springer; 2023.
https://link.springer.com/book/10.1007/978-981-99-6163-4
 Kurihara C, Baroutsou V, Becker S, Brun J, Franke-Bray B, Carlesi R, Chan A, Collia
LF, Kleist P, Laranjeira LF, Matsuyama K, Naseem S, Schenk J, Silva H and KerpelFronius S. Linking the Declarations of Helsinki and of Taipei: Critical Challenges ofFuture- Oriented Research Ethics. Front. Pharmacol. 2020. 11: 579714.
doi: 10.3389/fphar.2020.579714
https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2020.579714/full Kurihara C, Kerpel-Fronius S, Becker S, Chan A, Nagaty Y, Naseem S, Schenk J,Matsuyama K, Baroutsou V. Declaration of Helsinki: ethical norm in pursuit of common
global goals. Front Med (Lausanne). 2024 Apr 2; 11: 1360653.
doi: 10.3389/fmed.2024.1360653. PMID: 38628806; PMCID: PMC11019506
https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1360653/fullPage 3 of 3