Initial goals
For 2014, the short-term organizational goals of the GA4GH are to establish an open and transparent structure with an executive and secretariat. Four Working Groups will produce standards and documents that will address the following areas: genomic data interoperability; security and privacy of data; ethics and regulatory issues; and clinical data. Relationships with cloud computing operators that provide distributed information platforms will allow the launch of transformative demonstration projects, first, to create the technical standards for data sharing and, second, to foster testing of processes for the global harmonization of ethics frameworks.
With respect to the first demonstration project, except for disease-based efforts such as, for example, the International Cancer Genome Consortium (ICGC, http://www.icgc.org/) and the International Rare Diseases Research Consortium(http://www.irdirc.org/), data are still siloed and international standards for informatics are missing or not up to scale. Although security and privacy technologies are increasingly sophisticated, more work needs to be done to create a system that recognizes data producers and managers. Internationally recognized systems for the proper identification of the provenance of bioresources and genomic and clinical data, as well as scientific attribution for accompanying analyses, are emerging [3, 4]. Cloud computing operators that agree to be platform development partners need to establish both common standards and tools, including the necessary software, as well as voluntary models of self-regulation and certification. The GA4GH will chiefly mobilize and catalyze these efforts to enable operators and working groups to develop and implement interoperable application program interfaces and technologies.
However, for the second demonstration project, the socio-ethical and legal regulatory challenges of such a global initiative may prove to be formidable. Indeed, although agreement on data standards and quality assurance can (hopefully) be reached with leading information technology centers, companies and data systems managers, consensus on even a standardized set of acceptable processes and procedures for ethical, legal and social implications (ELSI) using the core principles is not certain. Ethics harmonization (as opposed to standardization) may be achievable, however. To accomplish this, the GA4GH will have to maintain both a clear, shared vision and interactive, dynamic communication structures within a global membership that ranges from public and academic, private and patient organizations to policymakers [5]. Harmonizing ELSI tools across these members and countries will not be simple.