Recent Updates to the Declaration of Helsinki: A View from the U.S. Food and Drug Administration.

Abstract

This commentary provides the perspective of the U.S. Food and Drug Administration (FDA) on the World Medical Association's (WMA) recent updates to the Declaration of Helsinki, a foundational document in biomedical research ethics. We highlight the value of an enduring principles-based approach in permitting such ethical codes to retain relevance over time; explain the different role that such codes and FDA regulations play in assuring the rights, safety, and welfare of research participants; and outline key changes in the Declaration, including a welcome shift in how vulnerability in research participants should be evaluated and managed. In the context of the rapidly evolving use of technology, we encourage ongoing engagement of global regulators, ethicists, and the broader research community as WMA revisits ethical norms related to health databanks, biobanks, and the use of novel computational methods in biomedical research. Clinical research is global in nature, and ensuring ethical treatment of research participants and their communities requires our continued collective commitment.