The 2024 Revision of the Declaration of Helsinki: Key Updates

The Declaration of Helsinki, first adopted by the World Medical Association (WMA) in 1964, has long served as a foundation for ethical guidelines in medical research involving human participants. Over the years, it has undergone several revisions to adapt to the evolving landscape of medical research and to address emerging ethical challenges. The latest revision, approved on October 19, 2024, marks a significant milestone in the ongoing effort to safeguard the rights and well-being of research participants.

The 2024 revision of the Declaration of Helsinki continues to emphasize the fundamental ethical principles that have guided medical research for decades. These principles include:

•  Respect for Participants: The updated declaration underscores the importance of treating research participants with dignity and respect. The term "participants" replaces "subjects" to reflect this commitment.
• Informed Consent: The necessity of obtaining informed consent from all participants remains a key matter of ethical research. The new version introduces the concept of "expanded informed consent," allowing for the secondary use of health data and biological samples under certain conditions.
• Ethical Oversight: The role of Research Ethics Committees (RECs) is further highlighted, with an emphasis on their responsibility to ensure that research protocols are ethically sound and that participants' rights are protected.
• Beneficence and Non-Maleficence: Researchers are reminded of their duty to maximize potential benefits and minimize potential harms to participants.
• Justice and Equity: The updated declaration calls for greater attention to justice and equity in research, particularly in the inclusion and protection of vulnerable individuals, groups and communities.

The 2024 revision introduces several new elements and modifications to address contemporary challenges in medical research:

• Further Inclusion of Patients in the Research: Patients and healthy volunteers are more deeply included in research, with their cultural values, quality of life, and perspectives taken into account.
• Sustainability and Environmental Considerations: For the first time, the declaration addresses the environmental impact of medical research, urging researchers to minimize waste and consider ecological sustainability.
• Electronic Informed Consent: The introduction of electronic informed consent aims to streamline the consent process while ensuring that participants are fully informed and their rights are protected.
• Post-Trial Access to Medication: Researchers and sponsors are now required to provide access to investigational medications for participants who benefit from them. Exceptions to this requirement must be approved by an ethics comitte.