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

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

02 April 2024 | Chieko Kurihara, Sandor Kerpel-Fronius, Sander Becker, Anthony Chan, Yasmin Nagaty, Shehla Naseem, Johanna Schenk, Kotone Matsuyama and Varvara Baroutsou
The World Medical Association's Declaration of Helsinki (DoH) is undergoing revision to align with current ethical standards and global health goals. The authors propose several amendments to enhance the ethical framework for human research. Key recommendations include promoting data-driven research with broad informed consent and dynamic consent to ensure participant rights and data sharing for open science. Risk minimization in placebo-controlled trials and post-trial access to effective interventions for all are emphasized. A future-oriented research framework for co-creation with stakeholders is also recommended. The DoH should clarify its relationship with the Declaration of Taipei (DoT), which addresses data privacy and governance in health databases. Broad informed consent, allowing participants to understand and manage their data use, is crucial. Dynamic consent mechanisms, enabling participants to control data use over time, should be integrated into research protocols and ethics reviews. Individual participant data sharing and result registration in public databases are essential for transparency and ethical responsibility. The DoH should recognize "social value" as a key ethical criterion, ensuring research benefits society. Post-trial access to effective interventions is vital, especially in low- and middle-income countries, to prevent injustice and ensure equitable healthcare access. The ethical responsibility of physicians to inform participants of clinically significant results, even without marketing authorization, must be upheld. Post-trial access should be recognized as an international ethical obligation, not just an ideal. In conflict zones and natural disasters, access to investigational treatments must be prioritized, with ethical guidelines adaptable to changing circumstances. The DoH should promote interdisciplinary collaboration, patient and public involvement in research, and inclusive study participation to ensure diverse perspectives. Research ethics committees must be diverse and transparent in their appointments. The DoH should evolve to reflect the changing landscape of research, emphasizing the ethical responsibility of all stakeholders in promoting global health and well-being. The revised DoH should incorporate these principles to guide ethical research practices globally.The World Medical Association's Declaration of Helsinki (DoH) is undergoing revision to align with current ethical standards and global health goals. The authors propose several amendments to enhance the ethical framework for human research. Key recommendations include promoting data-driven research with broad informed consent and dynamic consent to ensure participant rights and data sharing for open science. Risk minimization in placebo-controlled trials and post-trial access to effective interventions for all are emphasized. A future-oriented research framework for co-creation with stakeholders is also recommended. The DoH should clarify its relationship with the Declaration of Taipei (DoT), which addresses data privacy and governance in health databases. Broad informed consent, allowing participants to understand and manage their data use, is crucial. Dynamic consent mechanisms, enabling participants to control data use over time, should be integrated into research protocols and ethics reviews. Individual participant data sharing and result registration in public databases are essential for transparency and ethical responsibility. The DoH should recognize "social value" as a key ethical criterion, ensuring research benefits society. Post-trial access to effective interventions is vital, especially in low- and middle-income countries, to prevent injustice and ensure equitable healthcare access. The ethical responsibility of physicians to inform participants of clinically significant results, even without marketing authorization, must be upheld. Post-trial access should be recognized as an international ethical obligation, not just an ideal. In conflict zones and natural disasters, access to investigational treatments must be prioritized, with ethical guidelines adaptable to changing circumstances. The DoH should promote interdisciplinary collaboration, patient and public involvement in research, and inclusive study participation to ensure diverse perspectives. Research ethics committees must be diverse and transparent in their appointments. The DoH should evolve to reflect the changing landscape of research, emphasizing the ethical responsibility of all stakeholders in promoting global health and well-being. The revised DoH should incorporate these principles to guide ethical research practices globally.
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