| Co-organized by The Brazilian Society of Bioethics; International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP); Clinical Evaluation Inc.; The 129th Pharmaceutical Study Group Supported by The Japan Association for Bioethics | ||||
| ●Day 1: August 5, Monday, 2024 | ||||
| Video recording | ||||
| Dirceu Greco, Welcome Remarks from the Past President of the Brazilian Society of Bioethics | ||||
| Kotone Matsuyama, Welcome Remarks from Varvara Baroutsou, the President of the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP), and presentation on commitment of the Ethics Working Group of the IFAPP | ||||
| Takeo Saio, Overview of the revision process of the 2024 Declaration of Helsinki: Part 1 - focusing on placebo study 【Reading text】 | ||||
| Chieko Kurihara, Overview of the revision process of the 2024 Declaration of Helsinki: Part 2 - General descriptions and some highlights 【Reading text】 | ||||
| Kyoko Imamura, Introduction of the Japanese Institute for Public Engagement (Ji4pe) | ||||
| Yoshiko Saito, Patient and public opinions to the revision of the Declaration of Helsinki: Our proposals to the WMA 【Reading text】 | ||||
| Fernando Hellmann, In defense of the most vulnerable research participants 【Reading text】 | ||||
| Laís Alves de Souza Bonilha, Experience of CONEP to facilitate Ethical Research | ||||
| Background and objectives of the webinar | ||||
| The World Medical Association (WMA)’s Declaration of Helsinki (DoH), ethical principles for research 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; promoting inclusion and protection of vulnerable people; research in low-resource settings including disaster situations; access to interventions proven to be effective; and the most controversial issue of the condition of placebo-controlled trials when proven intervention exists (including consistency with CIOMS 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 rights of research participants in the context of bioethics. | ||||