C10 - Updates to the Declaration of Helsinki

CLICK HERE to view captioning for this session! 

The Declaration of Helsinki from the World Medical Association (WMA) is a foundational document for human research ethics. The first version was adopted in 1964, and has been amended eight times, most recently in October 2024. The principles described within the document have been embedded as an expectation for research conduct in ICH Good Clinical Practice Guidelines and International Committee of Medical Journal Editors (ICMJE) Publication Recommendations, as well as at many institutions. At the WMA Council meeting in April 2022, a workgroup was established to begin another revision. Following a global listening tour and two comment periods, the workgroup offered the revised Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Participants (see https://www.wma.net/policies-post/wma-declaration-of-helsinki/) to the WMA General Assembly and it was unanimously adopted in Helsinki, Finland in October. This session will provide an overview of the changes to the document with associated rationales and discuss its potential impact on research.