Background

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?