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The ethical and legal framework for international tissue transfer
Other Talks in the Series: Tissue in Research
The ethics and regulation of cell and tissue therapies in the UK
- Prof. Mark Lowdell
- University College London, UK
Legal and ethical issues in uses of stored tissue in human subjects research
- Ms. Gail Javitt
- Johns Hopkins University, USA
The legal and ethical framework for international tissue transfer
- Prof. Dr. Christian Lenk
- Ulm University, Germany
My name is Christian Lenk from the Institute for the History, Theory & Ethics of Medicine at Ulm University in Germany. And I'm also the Chair of the Research Ethics Committee at my university. And today I will talk to you about the theme, The Ethical and Legal Framework for International Tissue Transfer.
On table of contents, you see that I will first give you a short introduction into the theme, and then I will go into some more theoretical issues for the introduction, namely the no-property rule, then the bundle theory of property, and the problem of commodification of body material. And then I will go more to practical issues of transfer of human tissue for research, and then the last points come to some conclusions for the practice of research that are surely also interesting for you.
I will then come to my introduction and first, it is important to describe the area of relevance for my talk and the handling of tissue for research has to be distinguished from other fields. For example, tissue and body material from transplantation purposes because there you will find other ethical and legal regulations. Many of the notions which are used in ethics and law do also have a meaning in common language, like for example, the notion of donation, or also of commercialization. In the case of donation, when you make a donation, in practice, normally you will see that this is implicitly or explicitly bound to a specific use and this is also the case in the area of tissue research. Tissue or body material is given by the donor for a noncommercial use normally in medical research and on the other side, it is expected that it is used for specified and described aims, for example, non-commercial research at the university hospital. So you see, on the one hand, the term of donation is also used in common language, we can say, and on the other hand, it is in a specified way used in medical practice and in research. And then you have to see, okay, what issues are there important for me if I talk of tissue donation? And so we can say obviously also in medical research, we have then the donation as a gift with a specified use and the researcher has then the right to use the tissue in a specified way. You can also say about the time that we have different ethical and legal qualities of human tissue. For example, first, it is donated from the patient, the tissue, but then it might change its character or its quality. For example, if it is used as a medicinal product, like, for example, a blood donation. We can also say that sometimes there are different ethical and legal qualities of human tissue. For example, directly at the donation then tissue or body material comes from the patient and then it is used in the medical system for other purposes. Think of a blood donation, for example, if you do something with this body material and later on, you can use it, for example, as a medicinal product. Then it is very important to see that in different countries, there are also different ethical and legal regulations. For example, in the European area or in the US area, and I only want to give you one example for such a regulation and this is the last point, the recommendation REC from 2006 number 4 of the Council of Europe, from the Committee of Ministers on research on biological materials of human origin and for medical research, such recommendations and guidelines are very important to see for a larger area, like here for the European countries, okay. What are common rules for the treatment and for dealing with human tissue and body material, and this makes it quite easier, for example, in the international context, to have contact with colleagues in other countries and to use also body material from other countries. And if you take this recommendation, for example, then you have an overview about the most important points there, namely the information of patients, how you should use body material for research and also what limitations there are, for example, in respect to possible commercialization of body material. The last point is very important.