Determining the Ethical and Legal Interests in Privacy and Data Protection for Research Involving the Use of Genetic Databases and Bio-banks
Project start date: January 2007
Project end date: December 2009
Funding awarded by: European Commission: EU, FP6-2003-Science and Society 9
About the project
The PRIVILEGED project was looking to determine the ethical and legal interests in privacy and data protection for research involving the use of genetic databases and biobanks. It was funded by the European Commission from 2007 to 2009, and had 32 member institutions from the European Union, European Economic Area and three non-European countries Israel, Japan and Taiwan. The Project was coordinated by Dr Mark Taylor based at the Sheffield Institute of Biotechnological Law and Ethics, School of Law, University of Sheffield, and David Townend based at the Faculty of Health, Medicine and Life Sciences, Department of Health, Ethics & Society, Maastricht University, with the help of partner institutions Biomedical Law Centre, University of Coimbra, Portugal and Department of Medical History and Ethics, Vilnius University, Lithuania.
The primary objectives of PRIVILEGED were organised through three workshops, reports, and publications. PRIVILEGED brought together the expertise of 45 national participants and their dialogues national, regional, and European/international levels. The dialogue between the participants was supported through organising them in three regions to explore whether there are significant differences in the social, cultural, and regulatory approaches to research into genetic information and biobanking. Each participant has produced a written national report in advance of each workshop, addressing guidance questionnaires. These reports form the basis of comparative Regional Reports prepared in advance of the workshops to assist the discussions, by the regional co-ordinators and principal investigators.
Advances in understanding of genetic information and the potentials of biobanking have enormous potentials for society. Public health research and planning, and the development of more effective therapies for the individual can take on radical new dimensions through the newly available information. At the same time, the information that can be disclosed about an individual can also be used, intentionally or unintentionally for economic and social discrimination (especially in insurance, employment and other access issues). At the same time that the scientific revolution has developed, the European understanding and acceptance of individual privacy has also advanced. Data protection is a major development for the safeguarding of fundamental rights and freedoms of individuals, especially privacy, and human rights find greater and more subtle acceptance across Europe. However, the development of these important safeguards still requires the consideration of many key questions about the meaning of privacy in relation to genetic information and about effective protection of legitimate rights.
In relation to genetic information and its use in research biobanking, a number of fundamental questions require research and consideration. What is the relationship between genetic information and the sample containing genetic information? Genetic information is unique, but it also has very close relationships to information about other people. How far can privacy protection in relation to genetic information focus on an individual rights system, and how far must the regulatory protections protect the rights of groups? How can this balance of interests be achieved effectively? Beyond this joint ownership, or common heritage consideration, what is the relation between the individual and genetic group and the broader community within which they live? What is the nature of a claim for a research exemption in this area? And, how far is the current data protection and privacy regulatory framework effective? How far does it reflect the interests already expressed by individuals in the published literature? What are the regulatory choices available for the regulation of this area?
PRIVILEGED (Privacy in Law, Ethics and Genetic Data) will make recommendations for research practice and public policy, including regulatory options at the national and European level, to promote the optimal relation between research using genetic data and bio-banks and ethical interests in privacy. The ethical interests in privacy are being explicated through survey, description and comparison of the alternative conceptions of privacy currently operating throughout the Europe and Israel, Japan and Taiwan, paying particular attention to the relative interests accorded an individual as a member of a group.
Our strategic objectives are:
- To identify, analyse and compare different ethical, cultural, and social concepts of privacy as engaged by research using genetic data and bio-banks; describing areas of common understanding and recognising significant points of difference within both the conceptions themselves and their relationship with research.
- To describe and compare Member State regulation of research using genetic data and bio-banks, with particular reference to data protection, and to evaluate the relationship between regulation (including associated strategies of compliance) and the ethical needs of privacy. To establish in what ways, and to what extent, data protection regulations may be either consistent or inconsistent with, or insufficient for, the protection of identified ethical interests in privacy.
- To make recommendations for research practice and policy at national and European level for the promotion of a harmonious relationship between research using genetic data and bio-banks and data protection and privacy interests as articulated at both national and European level.
The project was split into 3 stages:
National Privacy Perceptions: Stage 1