The sharing of scientific, genomic and health-related data for the purpose of research is of key importance in ensuring continued progress in our understanding of human health and wellbeing. New challenges raised by international, collaborative research require a principled and practical framework that brings together researchers, regulators, funders, patient groups, information technologists, and consortia to share data. Such a framework will facilitate global science and responsible research conduct.
This International Code of Conduct provides guidance for the responsible sharing of genomic and health-related data. In particular, it is guided by Article 27 of the 1948 Universal Declaration of Human Rights. Article 27 guarantees the rights of every individual in the world “to share in scientific advancement and its benefits”, to freely engage in responsible scientific inquiry, and at the same time “to the protection of the moral and material interests resulting from any scientific…production of which [a person] is the author.” Article 27 has been expanded by other enforceable international conventions and national laws, regulations, codes and policies set out in Appendix 1.
This Code establishes a set of foundational principles and guidelines for responsible research conduct and oversight of research data systems, guided by the enforceable human rights of privacy, non-discrimination, and procedural fairness. The Code also: (a) interprets the right to enjoy the benefits of scientific progress and its applications as being the right to engage in responsible scientific inquiry, access and share genomic and health-related data across the translation continuum, from basic research through practical applications; and (b) applies the right to benefit from the protection of the moral and material interests resulting from scientific productions to health-related research by developing rights for data producers.
The value of this Code is that it: offers political and legal dimensions that reach beyond the moral appeals of bioethics and provides a more robust governance framework for genomic and health-related data sharing; speaks to groups and institutions, not just individuals; stresses the progressive realization of duties, urging action by governments, industry, funders, and researchers to create an environment for responsibly sharing data; and fosters responsible research in health by offering stronger protection in critical areas.