What Are Some of the ELSI Challenges of International Collaborations Involving Biobanks,Global Sample Collection,and Genomic Data Sharing and How Should They Be Addressed?

Though genomic data sharing and international research collaborations have become increasingly pervasive, as evidenced by numerous data sharing policies, consortia announcements and data access agreements, several ethical, legal, and social (ELSI) challenges adversely affect these collaborations and resultant scientific progress. We discuss three and offer a way forward.

First, data privacy frameworks, both in laws and policies, differ widely across locations and increasingly are outdated. Some jurisdictions legally permit international sharing of data for research purposes, but many others still do not, making international data exchange between researchers difficult, if not impossible, to achieve. Many frameworks were developed to protect personal data such as genomic and health-related data within single jurisdictions only. Such frameworks are not fit for purpose in emerging large-scale international collaborations and research platforms like biobanks. Rather than enabling socially beneficial scientific research while protecting individuals from real harm, data privacy frameworks too often cause inefficient data flow, significant costs, and delays at the expense of research progress and human health.

Second, the nature and scope of consent continues to plague researchers and regulators alike. What constitutes “proper” consent is unsettled in regulatory circles. The scope of the right to transfer data to third parties and the scope of (future) research allowed remain open questions. Consequently, failure to obtain “proper” consent, which generally means specific and explicit consent, can impede important data sharing and scientific research. At the same time, laws and regulations provide little coherent guidance as to when consent may be waived or made “broad”. Broad consent allows for unspecified future research subject to ethics approval. Research organizations often use divergent consent forms or clauses, many of which were not designed for international collaborations and data sharing. For their part, research ethics committees interpret consent forms in wildly different ways. Together, the incoherent approach prevents researchers from readily sharing or accessing genomic data for certain projects.

Third, there has been insufficiently innovative governance to effectively shape solutions for data sharing. International collaborations lack the harmonized systems, procedures, and tools to responsibly steer genomic research and data sharing activities. Governance frameworks contain divergent recommendations in key areas and reflect different ethical perspectives; they promote differing systems for collecting and processing data and/or samples. Interpreting these governance frameworks can be difficult, much less in an internationally interoperable manner. A consequence is that some research platforms may institute overly restrictive data access conditions, while others may want to promote data sharing yet still face organizational or individual resistance to such sharing.

To overcome these challenges, in June 2013, a broad and diverse coalition of leading health and research organizations came together to accelerate progress in science and medicine through global data sharing. The Global Alliance for Genomics and Health (www.genomicsandhealth.org) was created as an international umbrella organization to develop and promulgate harmonized approaches (both technical and regulatory) for the effective and responsible sharing of genomic and clinical data across jurisdictions. With over 200 international members from more than 25 countries, the Global Alliance is uniquely situated to bring together various stakeholders for open dialogue about improving international collaborations and data sharing.

Moreover, the Global Alliance's Regulatory and Ethics Working Group has actively implemented a harmonized approach to improve international collaborations and data sharing by developing a Framework for Responsible Sharing of Genomic and Health-Related Data. The Framework is incorporated by reference into a Constitution endorsed by Global Alliance members. Collaborative input in developing the Framework has been provided from individuals as well as biomedical, patient advocacy, and ethical, policy and legal organizations, committees, and projects from all regions of the world. These include the Public Population Project in Genomics and Society (P3G), the International Cancer Genome Consortium (ICGC), H3Africa, the Biobank Standardisation and Harmonisation for Research Excellence project (BioSHaRE), the International Society for Biological and Environmental Repositories (ISBER), and the International Rare Disease Research Consortium (IRDiRC).

The unique value of the Framework is that it highlights, and is guided by, international human rights such as privacy, non-discrimination and procedural fairness. In particular, the Framework is guided by Article 27 of the 1948 Universal Declaration of Human Rights (http://www.un.org/en/documents/udhr/). A seldom referenced section of the Declaration, Article 27 guarantees the rights of every individual in the world “to share in scientific advancement and its benefits” (including 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.” Building on Article 27, the Framework interprets the right of all people to share in the benefits of scientific progress and its applications as being the duty of data producers and users to engage in responsible scientific inquiry and to access and share genomic and health-related data across the translation continuum, from basic research through practical applications. It recognizes the rights of data producers and users to be recognized for their contributions to research, balanced by the rights of those who donate their data. In addition to being founded on the right of all citizens in all countries to the benefits of the advancements of science, and on the right of attribution of scientists, it also reinforces the right of scientific freedom. Through its human rights positioning and international endorsement, the Framework provides a principled and practical framework for the responsible sharing of genomic and health-related data among multiple international organizations.

In addition, to better address the specific ELSI challenges of privacy, consent, accountability, and governance, the Framework will be elaborated by subsequent issue-specific Policies, and in so doing, elucidate the various core elements of responsible data sharing. The Framework and its Policies, particularly if endorsed and implemented by organizations and regulatory authorities across various jurisdictions, could be used in genomic research projects around the world, whether or not they are Global Alliance-inspired. Acknowledging diversity of legal and ethical approaches and being responsive to emerging issues, both the Framework and its Policies can serve as a potential model and provide leadership for international research collaborations. Indeed, through its international collaboration, sharing of best practices, and cross-pollinating of ideas and learning, the Global Alliance serves as a powerful case study of how to overcome some of the most pressing ELSI challenges.