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This concluding chapter briefly highlights the main results of the preceding chapters and poses some vital questions that are still unanswered in the field of human tissue research: How can the regulatory efforts of Member states be translated to the supranational level of the European Union and the Council of Europe? How can diverging standards in the handling of new and existing tissue collections be avoided? How are individual interests to be weighed against the public good? Finally, should a joint regulatory approach be established in the European Union?

Since the selection and availability of human tissue specimens for academic purposes represents an activity which has generally taken place in an ill-defined ethical and legal framework, this chapter discusses the German, British, and European regulations regarding secondary use of human tissue. Whilst the Royal College of Pathologists made specific suggestions for the handling of archived human tissue, in Germany several laws and regulations touch on this subject, but no specific regulations exist concerning the handling of already archived tissue. This fact leads to uncertainty and doubt about the feasibility of the academic use of surplus tissue and signals the great need for a definitive framework for the use and protection of archived tissue samples. Since informed consent is needed, based on the comparison of German, European, and British regulations solutions, a formalized informed consent for the additional use of human tissue samples is recommended.

This chapter presents an empirical case study on informed consent procedures for medical research on leftovers from surgery in Austria. It suggests a way to understand informed consent as a ‘boundary object’ between medical professionals and patient-donors. As such, informed consent might be better understood as an appropriate tool to satisfy divergent interests in the medical encounter than as a tool for patients' empowerment. It is argued that different motives for both obtaining and giving consent account for the contemporary unchallenged practice of informed consent. This can be seen as a contribution to the ongoing interdisciplinary analysis regarding the question of how to deal with informed consent in the area of tissue research and banking in the European Union and its associated countries.

This chapter focuses on the present and future Swiss legal and regulatory framework for human tissue research. As to date there is no uniform legislation or regulation of research with human biological material and personal data at federal level in Switzerland. Since 2006, the Swiss legislator has been working on the implementation of a federal act regarding research with humans (Humanforschungsgesetz); the draft bill of the act on research with humans has recently been published. The chapter describes and critically evaluates these regulatory activities and also gives a brief overview of existing biobanks and networks in Switzerland. It concludes that the proposed Swiss regulatory framework is a first step towards finding an appropriate balance between the interests of scientific knowledge, the law, and public welfare on one hand and protection of personality of participating persons on the other.

The use of human biological samples in medical research has the potential to transform our understanding of health and disease in the age of the genome, but the collection and banking of samples for currently unknowable future research purposes presents both ethical and legal challenges. Given the primacy of biospecimens in genomic research, it is critical to develop regulatory policies that appropriately balance public preferences about privacy and consent with the scientific imperatives of investigator access and broad data sharing. The Advanced Notice of Proposed Rulemaking (ANPRM) proposes a requirement for written informed consent for research uses of previously collected human biological samples. This chapter explores the impact of that regulatory proposal with respect to the ethics and operations of research involving biospecimens. It describes specific shortcomings of the current federal regulations protecting human biospecimens and associated data used in research, explains how proposed changes to consent procedures in the ANPRM could address these limitations while at the same time pose new challenges for health care institutions, and finally, sets forth the thesis that enhanced education and collaboration with participant communities would greatly improve implementation of the ANPRM’s written consent requirement for secondary uses of biospecimens in research.