Q&A: What Do The Recent Updates To The Declaration Of Helsinki Mean For Clinical Trial Technology?

A conversation with Amanda Howley, Director of Services Solutions at Suvoda

The World Medical Association (WMA) has announced a significant, rare update to its cornerstone ethical document, the Declaration of Helsinki, which guides medical research involving human participants. This revision reflects a growing emphasis on patient-centered care and the evolving landscape of clinical research.

One of the most notable changes is a shift in terminology—from referring to individuals in studies as "human subjects" to "human participants." This subtle yet powerful change reflects a deeper respect for autonomy, dignity, and the essential role participants play in advancing medical knowledge. In addition, the updated Declaration formally acknowledges the role of digital technologies in clinical trials by explicitly validating the use of electronic documentation, including eConsent. The WMA is aligning ethical standards with modern research practices. These updates, along with others, mark a pivotal moment in the evolution of global research ethics.

If you're involved in clinical research, healthcare policy, or digital health innovation, now is the time to review the revised Declaration and consider how these changes may impact your work. Stay informed, stay ethical—explore the updated Declaration of Helsinki today.