Declaration of Helsinki: ethical norm in pursuit of common global goals

Chieko Kurihara; Sandor Kerpel-Fronius; Sander Becker; Anthony Chan; Yasmin Nagaty; Shehla Naseem; Johanna Schenk; Kotone Matsuyama; Varvara Baroutsou

doi:10.3389/fmed.2024.1360653

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. eCollection 2024.

Authors

Chieko Kurihara^#^{1

2}, Sandor Kerpel-Fronius^#^{2

3}, Sander Becker^#^{2

4}, Anthony Chan^#^{2

5}, Yasmin Nagaty^#^{2

6}, Shehla Naseem^#^{2

7}, Johanna Schenk^#^{2

8}, Kotone Matsuyama^#^{2

9}, Varvara Baroutsou^#²

Affiliations

¹ Kanagawa Dental University, Yokosuka, Japan.
² Ethics Working Group of International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP), Woerden, Netherlands.
³ Department of Pharmacology and Pharmacotherapy, Semmelweis University, Budapest, Hungary.
⁴ Consultants in Pharmaceutical Medicine, Dover Heights, NSW, Australia.
⁵ Pfizer Healthcare Ireland, Dublin, Ireland.
⁶ The Middle East Association of Pharmaceutical Medicine Professionals, Cairo, Egypt.
⁷ Academic and Research College of Family Medicine, Karachi, Pakistan.
⁸ PPH plus GmbH & Co. KG, Hochheim am Main, Germany.
⁹ Department of Health Policy and Management, Nippon Medical School, Tokyo, Japan.

^# Contributed equally.

Abstract

The World Medical Association's Declaration of Helsinki is in the process of being revised. The following amendments are recommended to be incorporated in pursuit of the common goal of promoting health for all. 1. Data-driven research that facilitates broad informed consent and dynamic consent, assuring participant's rights, and the sharing of individual participant data (IPD) and research results to promote open science and generate social value. 2. Risk minimisation in a placebo-controlled study and post-trial access to the best-proven interventions for all who need them. 3. A future-oriented research framework for co-creation with all the relevant stakeholders.

Keywords: Declaration of Helsinki; data-driven research; health for all; placebo; post-trial access; stakeholder involvement.

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This support was received for article publication charges granted by the IFAPP.