The World Medical Association (WMA) has announced the adoption of the 2024 Revision of the Declaration of Helsinki (DoH).
The Declaration of Helsinki is a statement of ethical principles for medical research involving humans, including research on identifiable human material and data. It was developed in 1964 by the WMA and is regarded as the most important document in the history of research ethics.
The Declaration’s principles inform our work every day and help guide us in our strategy to make it easy to do research that people can trust. The latest revised DoH is the result of a global consultation. The HRA responded to both the first and second phase of the consultation, with input from members of the HRA’s public involvement network and members of NHS Research Ethics Committees, developed in consultation with the UK’s Four Nations Policy Leads Group. You can read a summary of our feedback here.
The revision process was designed to be collaborative, transparent, and inclusive. The changes to the DoH were informed by regional and topical meetings spread over two and a half years, where issues were discussed by local and international experts and engaged audiences with diverse opinions.
These comprehensive revisions enhance the ethical framework of medical research by promoting inclusivity, protecting participant rights, and addressing contemporary challenges such as data privacy and global health emergencies.
Summary of Key Changes to the 2024 Declaration of Helsinki
- terminology update: the term "subjects" has been replaced with "participants" throughout the document to respect the rights and agency of individuals involved in research. Gender-neutral language has also been adopted.
- inclusive applicability: the Declaration now addresses all individuals, teams, and organisations involved in medical research, not just physicians. This change acknowledges the interdisciplinary nature of modern research and holds all researchers to the same ethical standards.
- participant engagement: new provisions emphasise meaningful engagement with research participants and their communities before, during, and after studies. This recognises participants as partners in the research process.
- distributive and global justice: researchers are now called upon to carefully consider how the benefits, risks, and burdens of research are distributed, addressing issues of equity and justice on a global scale.
- vulnerability and inclusion: significant revisions acknowledge that vulnerability is contextual and dynamic. The Declaration promotes fair and responsible inclusion of vulnerable populations, balancing the harms of inclusion and exclusion while providing adequate support.
- protections for vulnerable groups: specific protections remain for particularly vulnerable individuals (e.g., incarcerated persons or those unable to consent), including requirements that research address their health needs and that they benefit from the outcomes.
- data and biobanking: paragraph 32 has been rewritten to address informed consent for the collection, processing, storage, and secondary use of biological materials and data. It also recognises situations where obtaining consent for unforeseen secondary research is impracticable, requiring ethics committee approval in such cases.
- reference to Declaration of Taipei: the updated Declaration cross-references the WMA Declaration of Taipei, providing detailed guidelines on the governance of health databases and biobanks, especially for data collected for multiple and indefinite uses.
- public health emergencies: a new paragraph asserts that ethical principles must be fully upheld even during public health emergencies, emphasising that urgency should not compromise ethical standards.
- unproven interventions: revisions clarify the use of unproven interventions aimed at alleviating suffering, ensuring they are not used to bypass ethical protections or evade rigorous clinical trials.
- environmental sustainability and research integrity: modifications strengthen commitments to environmental sustainability, promote rigorous study designs to prevent research waste, and underscore the importance of scientific integrity.
- ethics committees: the Declaration now insists on sufficient resources and strengthened independence for research ethics committees to ensure they can effectively oversee research practices.
- participant preferences: new language calls for considering participants' previously expressed preferences and values when consent is obtained from legally authorised representatives on their behalf.