Our “WMA Declaration of Helsinki”: Opinions and Proposals from Patient and Public for Research Ethics

Our “WMA Declaration of Helsinki”: Opinions and Proposals from Patient and Public for Research Ethics
Book Chapter
Chieko Kurihara, Keiko Inoue, Hiroto Kai, Katsura Suzuki, Haruko Saeki, Yoshikazu Funabashi, Noriko Kishi, Akemi Kuge, Toshie Murakami, Yoshiko Saito, Eiko Uchida, Naoki Tsutsumi, Kyoko Imamura
Ethical Innovation for Global Health, November 2023 [Springer]
Abstract
    The Declaration of Helsinki (DoH) was first issued in 1964 by the World Medical Association (WMA), addressed to physicians, and was amended nine times with the latest version being adopted in 2013. While it has been incorporated into research regulations in many countries and is well known to most researchers, most patients and the public see its title for the first time when they are requested to participate in medical research. We therefore formed a group composed mainly of patients and the public together with experts having perspectives of patients and the public. Our activity was intended to enhance our understanding of the DoH and to have it explained in our own language. In this way, patients and the public would be able to better comprehend its scope and contents.
This chapter is resulting from about 2 years of our monthly web-meetings, during COVID-19 pandemic. We found some discussion points not included in the current version of the DoH, such as the value of research aimed at Sustainable Development Goals (SDGs), patient and public involvement, multidisciplinary collaboration, shared decision-making founded on informed consent, patient-oriented research, diversity and fairness of research ethics committees, assuring the rights of those considered to be “vulnerable populations,” broad informed consent, dynamic consent, and social contract.
We hope that this chapter will contribute to the future revision of the DoH, as well as stimulate discussion for the international research ethics norms being under development, and that can be agreed to uniformly by all relevant stakeholders.