The University of California, Santa Cruz, is among more than 150 leading health care, research, and disease advocacy organizations that together involve colleagues in more than 40 countries that have formed an international alliance dedicated to enabling secure sharing of genomic and clinical data—the Global Alliance for Genomics and Health. CBSE director David Haussler is one of eight organizing committee members, along with David Altshuler from the Broad Institute of Harvard and MIT; Peter Goodhand and Thomas Hudson from the Ontario Institute for Cancer Research; Brad Margus from the A-T Children's Project; Betsy Nabel from Brigham and Women's Hospital; Charles Sawyers from Memorial Sloan-Kettering; and Michael Stratton from Wellcome Trust Sanger Institute.
This non-profit global alliance works to develop a common data sharing framework, enabling learning from data while protecting participant autonomy and privacy.
Why? The cost of genome sequencing has fallen one-million fold, and more and more people are choosing to make their genetic and clinical data available for research, clinical, and personal use. However, interpreting these data requires an evidence base for biomedicine that is larger than any one party alone can develop, and that adheres to the highest standards of ethics and privacy. These organizations recognize that the public interest will be best served if we work together to develop and promulgate standards (both technical and regulatory) that make it possible to share and interpret this wealth of information in a manner that is both effective and responsible.
What is the alliance? Technological advances have led to large-scale collection of data on genome sequencing and clinical outcomes, with great promise for medicine. In late January 2013, fifty colleagues from eight countries met to discuss the current challenges and opportunities in genomic research and medicine, and how these groups could work together to foster medical progress. They concluded that the greatest need was a common framework of international standards designed to enable and oversee how genomic and clinical data are shared in an effective, responsible, and interpretable manner. They envisioned a trusted and authoritative international partnership, intended to include leading healthcare providers, research institutions, disease advocacy groups, life science and information technology companies, and others, to facilitate this.
The commitment. Each organization (listed below) has signed a non-binding letter of intent, pledging to work together to create a not-for-profit, inclusive, public-private, international, non-governmental organization (modeled on the World Wide Web Consortium, W3C) that will develop this common framework. They have committed to furthering innovation by supporting the creation of open technology standards to support the development of interoperable information technology platforms that will embody these principles and accelerate progress in biomedicine. The aim is that ultimately data will be stored in platforms built using the interoperable standards. Whether participants and organizations put all or some data into these or other platforms will be their own decision, but the common vision for the platforms is not that they will be a shared repository for data; rather, the platforms will enable sharing and learning regardless of where data are stored.
In signing the letter of intent, the organizations have committed to the global alliance's core principles:
- Respect for the data sharing and privacy preferences of participants
- Transparency of governance and operations
- Accountability to best practices in technology, ethics, and public outreach
- Inclusivity in partnering and building trust among stakeholders
- Collaboration to share data and information to advance human health
- Innovation to develop an ecosystem that accelerates progress
- Agility to act swiftly to benefit those suffering with disease
Member organizations recognize that when discussions occur about sharing large amounts of data, important questions about ethics and privacy naturally arise. Accordingly, members have committed to work together to establish a framework so that participants will have the right to share genomic and clinical information to advance human health as broadly or narrowly as they are comfortable with, including not at all.
Next steps. Thus far, the letter of intent has been signed by healthcare providers, disease advocacy organizations, research funders, and biomedical research institutions—all dedicated to improving human health. Now, they are inviting other organizations—for-profit as well as not-for-profit—to join in forming the alliance, building on many ongoing efforts around the world to address these opportunities and challenges that would be impossible working alone.