ISBN : 9780199587551
The use of human tissue for medical research and scientific progress raises many ethical and legal challenges. The procurement, storage and transfer of human tissue for research purposes have posed significant questions over recent years, and a number of high profile scandals in the UK prompted the publication of the Madden Report on Post Mortem Practice and Procedures in Irish hospitals in 2006. Additionally, tissue-related research tends to be most promising if samples and information are shared across national borders, but the heterogeneity of current rules and guidelines within the member states of the European Union calls all the more for clarification. This multi-authored interdisciplinary text, edited by four experienced researchers, explores many of the issues concerning biobank-related research and aims to provide answers to the most urgent questions by means of ethical, philosophical, and legal investigation. It provides a fascinating insight into a wide range of interlinking research perspectives and serves as a comprehensive reference to the state of play ethically and legally in Europe. It will be of value to medics and social scientists, human tissue researchers, and policy makers who have an interest in ethical and legal issues of human tissue research.
Preface: Introduction by the editors
1 - KEY CONCEPTS OF THE ETHICAL DEBATE
1. The biomedical uses of the body: lessons from the history of human rights and dignity
2. Exploring an alternative for informed consent in biobank research
3. Respect as a precondition for use of human tissue for research purposes
4. Risky business - re-evaluating participant risk in biobanking
5. Reciprocity, trust, and public interest in research biobanking: in search for a balance
6. Taking solidarity seriously: do biobank institutions have a moral obligation to inform their patients on incidental health findings?
7. Beyond the dichotomy of individualism and solidarity: participation in biobank research in Sweden and Norway
2 - THE LEGAL REGULATION OF HUMAN TISSUE RESEARCH
8. Law, ethics, and human tissue research - integration or competition?
9. Legal paradigms of human tissues
10. Research with human biological material and personal data in biobanks - legal and regulatory framework in Switzerland
11. Legal issues surrounding French research-focused biobanks
12. Biobanks: ethical and legal aspects of the collection and storage of human biological material in Italy
13. How to achieve 'free movement of tissue' in the EU research area
3 - PRACTICES - DISCIPLINARY PERSPECTIVES
14. Ethical recommendations for the use of human biological material stored in pathology archives for research purposes
15. Informed consent when donating cells for the production of human tissue engineered products
16. The regulation of autologous stem cells in heart repair: comparing the UK and Germany
17. Discovering informed consent: a case study on the practice of informed consent to tissue donation in Austria
Epilogue: Conclusions and future prospects from the articles of the present volume by the editors