In the twenty-first century, technological advances have meant that whole genome sequencing and other ‘omics data are available in unprecedented quantities. Extracting the optimal benefit from biological big data sets requires sharing digitised information at the global level. However, mechanisms of participant consent for this level of data sharing remain static, paper-based, and organised around national boundaries and legal frameworks. Dynamic consent (DC) is a concept, and a specific project, designed to meet the needs of the twenty-first century biobanking and data sharing. At the heart of DC is a digital portal that connects researchers and participants, facilitating two-way communication of information to stimulate a more engaged, informed and scientifically literate participant population where individuals can tailor and manage their own consent preferences. The technical architecture of DC includes components that can securely encrypt sensitive data and allow participant consent preferences to travel with their data and samples when they are shared with third parties. In addition to improving transparency and public trust, this system benefits researchers by streamlining recruitment and enabling more efficient recontact of participants. DC is dynamic because it can rapidly respond to changes in regulatory or legal requirements, requests for additional data collection and novel applications of the data as new technologies and research questions arise. Our work on DC has been developed in collaboration with a number of biobanks and patient registries based in Oxford, UK. In this talk we report on our progress to date and describe the challenges and benefits of implementing the DC platform.
About the Seminar Series
The rapidly-declining cost of genomic sequencing promises many breakthroughs in our understanding of genetic predisposition to disease and for the development of medical treatments more precisely tailored to the individual patient. Much of this genomic data will end up in databases maintained by research and healthcare organisations (and increasingly by commercial “personal genomics” companies) which will have the ethical and legal responsibilities for preserving the privacy of such sensitive information. Unfortunately, recent research suggests that it is much more difficult than was first imagined to preserve the privacy of such information. Many existing methods for “de-identifying” or “anonymising” such data have been shown to be fragile: correlation of information from genomic databases, electronic health records and public sources such as genealogy and residence databases can often lead to surprisingly accurate inferences about the identities of individuals. If such information were to becomes widely available, it might compromise the ability of individuals to obtain health and life insurance, and might influence employment and even personal relationship decisions. Such information leakage might also well have a significant chilling effect on the public’s willingness to participate in research and clinical studies.
We are organising a series of seminars, funded by the Balliol Interdisciplinary Institute, to examine the current state of information privacy in this domain, and to look in particular at several questions:
To what extent can technology keep up with the arms race between “hackers” and data curators? Will recent advances in cryptography, database security architectures and “privacy preserving” data mining methods mitigate the risks, now and in the future?
What is the current state of legislation and regulation in this domain, and how is it likely to evolve in the face of developing attacks on privacy? Who actually owns and has control over genomic (and related health) data and its uses? Are there significant national and cultural differences which need to be taken into account (especially when data storage may transcend jurisdictional boundaries e.g. when data are stored in commercial “clouds”)?
To what extent does the appearance of patient-centric disease management portals such as PatientsLikeMe mitigate the concerns about privacy? Will patients’ altruistic urge to share information about themselves, their disease and their interactions with the healthcare system outweigh their concerns about their personal privacy? What is the appropriate balance between the public good which results from data sharing and the potential private loss?
What changes need be made to informed consent protocols to ensure that both researchers and donors fully understand and accept the risks associated with data collection and use?
If, as Scott McNealy (former CEO of Sun Microsystems) once said “Privacy is dead ñ get used to it,” and privacy is doomed to lose the arms race, what is the impact likely to be on public attitudes towards, and expectations of, personal genomic privacy? In a world where people are willing to commit intimate personal information to Facebook, should we even worry about the consequences of loss of genomic privacy? Or should we rather be addressing the issues inherent in completely open sharing of such information?
Answers to some or all of the above questions would have a profound impact on the practice of scientific research and medicine. A clear analysis of the risks, methods for mitigating those risks, and, alternatively, of the consequences of a deliberate policy of transparency, will help policy makers to develop realistic approaches to public education about, and the setting of guidelines for future research on, and exploitation of, personal genomic information.
About the speakers
Dr Jane Kaye D.Phil., L.L.B. is the Director of the Centre for Law, Health and Emerging Technologies at Oxford: HeLEX at the University of Oxford. She obtained her degrees from the Australian National University (BA); University of Melbourne (LLB); and University of Oxford (DPhil). She was admitted to practice as a solicitor/barrister in 1997 and is a member of the University of Oxford’s Faculty of Law. She is also on a number of international expert committees and scientific advisory boards and was on the UK Ethics and Confidentiality Committee of the National Information Governance Board for Health and Social Care. Her team are leading on the Dynamic Consent project and she is one of the leaders in the ELSI 2.0 Global Initiative. She is currently a member of the Nuffield Council Bioethics Working Group on Biodata. Her research focuses on the relationships between law, ethics and the emerging technologies in health including genomics.