| 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 2: August 26, Monday, 2024 | ||||
| Video recording | ||||
| Welcome Remarks from the representatives of organizers: Varvara Baroutsou, President of the International Federation of Associations of Pharmaceutical Physicians & Pharmaceutical Medicine (IFAPP) Elda Coelho Azevedo Bussinguer, President of the Brazilian Society of Bioethics (SBB) Dirceu Greco, Past President of the SBB | ||||
| Chieko Kurihara, Participation in WMA meeting in Washington DC: Taking forward bioethics and human rights, maximizing the impact of the NEW DoH 【Reading text】 | ||||
| Varvara Baroutsou, Collaboration with the WMA and the IFAPP’s perspective | ||||
| Ames Dhai, Access and Equity in Research: Justice, Vulnerability and Low-Resource Settings | ||||
| Diego Zanella, Ethical Reflections by the Brazilian Society of Bioethics on Research Ethics【Reading text】 | ||||
| Dirceu Greco, Ethics of Placebo-controlled Trials and Post-trial Access: International health research as a stepping-stone to universal public health care access | ||||
| Peter Lurie, Special comment | ||||
| Sarai Keestra, Revising the Declaration of Helsinki: Three Suggestions for Improvement | ||||
| 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. | ||||