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

International access to and sharing of biospecimens is critical to answer important questions about complex diseases, and to ensure the diversity in biospecimen collection necessary to advance science and develop therapies that benefit all. However, many challenges exist. These include the lack of harmonized ethical, legal, and policy frameworks regarding secondary uses of biospecimens and associated data; regulatory and policy hurdles; and differences in cultural perspectives and practices across regional and national jurisdictions.In this manuscript, a set of ethical principles is presented with the intent to address some of these challenges by ensuring better alignment in ethical practices related to biobanking and the global use of human biospecimens. In addition, these principles could serve as a basis for promoting more consistency among national regulations and policies. The ultimate goal is to develop an international framework for global biospecimen and data sharing.