02 April 2024 | Chieko Kurihara, Sandor Kerpel-Fronius, Sander Becker, Anthony Chan, Yasmin Nagaty, Shehla Naseem, Johanna Schenk, Kotone Matsuyama, and Varvara Baroutou
The article discusses the ongoing revision of the World Medical Association's (WMA) Declaration of Helsinki (DoH), emphasizing the need to incorporate amendments that align with global goals of promoting health for all. Key recommendations include:
1. **Data-Driven Research**: Emphasizing broad informed consent, dynamic consent, and the sharing of individual participant data (IPD) and research results to promote open science and social value.
2. **Risk Minimization in Placebo-Controlled Studies**: Ensuring risk minimization in placebo-controlled trials and post-trial access to proven interventions for all who need them.
3. **Future-Oriented Research Framework**: Promoting co-creation with interdisciplinary teams, patients, the public, and other stakeholders to ensure ethical and socially responsible research.
The authors highlight the importance of adapting the DoH to address emerging challenges, such as the use of real-world data, the ethical implications of placebo-controlled trials, and the need for equitable access to interventions, especially in low- and middle-income countries. They also stress the need for inclusive and diverse participation in research, ethical review processes, and the recognition of research participants as partners in co-creation. The article concludes by advocating for a revised DoH that reflects these modern ethical norms and principles.The article discusses the ongoing revision of the World Medical Association's (WMA) Declaration of Helsinki (DoH), emphasizing the need to incorporate amendments that align with global goals of promoting health for all. Key recommendations include:
1. **Data-Driven Research**: Emphasizing broad informed consent, dynamic consent, and the sharing of individual participant data (IPD) and research results to promote open science and social value.
2. **Risk Minimization in Placebo-Controlled Studies**: Ensuring risk minimization in placebo-controlled trials and post-trial access to proven interventions for all who need them.
3. **Future-Oriented Research Framework**: Promoting co-creation with interdisciplinary teams, patients, the public, and other stakeholders to ensure ethical and socially responsible research.
The authors highlight the importance of adapting the DoH to address emerging challenges, such as the use of real-world data, the ethical implications of placebo-controlled trials, and the need for equitable access to interventions, especially in low- and middle-income countries. They also stress the need for inclusive and diverse participation in research, ethical review processes, and the recognition of research participants as partners in co-creation. The article concludes by advocating for a revised DoH that reflects these modern ethical norms and principles.