Scientists, lawyers, data protection specialists and ethicists gathered to explore the many and varied aspects of research using human biobanks and the consequences of regulatory measures for the practice of such research, as well as to consider the need for a Biobank Act together with politicians, patients’ representatives and other interested parties.
The speakers and discussants all agreed with the Ethics Council’s main recommendations – namely, that donors should be more securely protected than at present from the risks of misuse of their data, that public trust in the operation of biobanks should be nurtured, and that medical research should at the same time be facilitated by relaxing the restrictions on the use of samples for specific purposes only.
It was stated that the Ethics Council’s recommendations on the determination of permissible uses, the involvement of ethics commissions, quality assurance and transparency not only constituted favourable initial steps, but were in part already standard practice. Opinions differed on the extent to which collections limited in terms of content and time, used, say, for the purposes of academic theses, should be treated in the same way as large-scale biobanks.
A vigorous debate took place on the issue of the possible need for a statutory requirement of biobank secrecy in order to strike an appropriate balance between the interests of donors and researchers. Those working in the field, in particular, pointed out that, while biobank secrecy offered donors and scientists greater protection, it had the disadvantage of a possible increase in administrative costs for research projects and of impeding international cooperation.
No consensus was reached in the ensuing discussion as to whether statutory regulation was necessary at all or whether self-regulation within the world of research on the basis of the existing legislation was sufficient. The idea of self-regulation was supported by TMF’s recommendations and approaches to data protection, as well as by other considerations.
Human biobanks are collections of samples of human bodily substances, such as tissues, blood or DNA, that are linked electronically to personal data and, in particular, health-related information concerning their donors. They perform a vital function in investigation of the causes and mechanisms of many diseases and their treatment, and are an indispensable aid to biomedical research. Specific ethico-legal challenges are presented by a large number of new trends in biobank research, especially as regards their quantitative and qualitative expansion, their increasing interconnectedness and internationalization, and their privatization and commercialization.
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