International Ethical Principles for Banking and Secondary Research Use of Human Biospecimens and Associated Data: The Seattle Principles

The secondary research use of human biospecimens and associated clinical data is essential to scientific advances by industry and academia, but is governed by a patchwork of differing national regulations and characterized by uncertainty in applicable ethical principles.  In a just-published paper in Journal of Law, Medicine and Ethics, a group of international experts in biobanking regulation and operations – including Mark Barnes from Ropes & Gray – sets forth a comprehensive set of ethical and operational principles for secondary research using banked biospecimens and related data.  The “Seattle Principles” – so named because they were first presented at the annual meeting in Seattle in 2023 of the primary international biobanking society, the International Society for Biological and Environmental Repositories (ISBER) – were later presented and discussed at various international meetings, including the 2024 UN General Assembly Science Summit and the Asian-Pacific Open Forum.  This paper could be used to inform internal industry and academic institution policies on secondary research uses of human biomaterials and data.