Abstract
Tissue engineering using human cells and tissue has one of the greatest scientific and economical potential in the coming years. There are public concerns during the ongoing discussion about future trends in life sciences and if ethic boundaries might be respected sufficiently in the course of striving for industrial profit and scientific knowledge. Until now, the legal situation of using human tissue material for research is not clear. Accordingly, transparency of action and patients' information are a central component when handling patient material inside and outside of the patient-specific treatment. Whereas in the field of therapeutic use of tissue (e.g. transplantation) there is an emergency situation by the shortage of organs with the risk of the premature death of the potential recipient, this cannot be claimed for tissue donation for research. The basis of every surgical operation is the treatment contract, which places the doctor under obligation to the careful exercise of medical treatment containing the patient's informed consent. This contract only covers the treatment that is intended to cure the patient and the medical measures that are necessary therefor. The further scientific use of body-substances, which are discarded after an operation, are not included. Therefore a personal and independent written enlightenment of the patient and a declaration of informed consent is necessary. Examples of guidelines for tissue supply, Patients information and consent were worked out by theologists, lawyers, scientists and physicians reflecting their practical experience in transplant surgery and liver cell research. As a consequence to cover the ethical and legal aspect of tissue donation in Germany a charitable state-controlled foundation Human Tissue and Cell Research (HTCR) was introduced and established.
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References
Anderson R, Balls M, Burke MD, Cummins M et al. (2001) The establishment of human research tissue banking in the UK and several Western European Countries: The report and recommendations of ECVAM workshop 44. Altern Lab Anim 29: 125–134
Anderson R, O'Hare M, Balls M, Brady M et al. (1998) The availability of human tissue for biomedical research: The report and recommendations of the ECVAM workshop 32. Altern Lab Anim 26: 763–777
Ashcroft R and Toth B (1997) Informed consent. Research suffers if patients suspect that their rights may be breached. BMJ 315: 252–253
Banks RE, Dunn MJ, Hochstrasser DF, Sanchez JC et al. (2000) Proteomics: New perspectives, new biomedical opportunities. Lancet 356: 1749–1756
Beauchamp TL and Combes R (1989) Principles of Biomedical Ethics. University Press, New York, Oxford
Caplan AL (1985) Blood, sweat, tears, and profits: The ethics of the sale and use of patient derived materials in biomedicine. Clin Res 33: 448–451
Denker H (1999) Embryonic stem cells: An exciting field for basic research and tissue engineering, but also an ethical dilemma? Cells Tissues Organs 165: 246–249
European Convention of Human Rights and Biomedicine online (cited 08 April 2003). http://conventions.coe.int/Treaty/EN/CadreListeTraites.htm ETS No 164
Fletcher JC and Boverman M (1983) Evolution of the role of an applied bioethicist in a research hospital. Prog Clin Biol Res 128: 131–158
Forkel H (1974) Verfügungen über Teile des menschlichen Körpers. Juristische Zeitschrift 29: 593–599
Goldberg AM and Frazier JM (1989) Alternatives to animals in toxicity testing. Sci Am 261: 24–30
Gray N, Womack C and Jack SJ (1999) Supplying commercial biomedical companies from a human tissue bank in an NHS hospital — a view from personal experience. J Clin Pathol 52: 254–256
Hengerer B (1993) A rapid procedure for mRNA extraction from a large number of samples. Biotechniques 14: 522–524
Irrgang B (1995) Outlines of Medical Ethics. München, Basel
Irrgang B (1997) Research Ethics, Genetic Engineering and New Biotechnology Basis under Special Consideration of Genetic Engineering Projects on Plants, Animals and Micro organisms. Hirzel Publisher, Stuttgart
Janke J, Engeli S, Gorzelniak K and Sharma AM (2001) Extraction of total RNA from adipocytes. Horm Metab Res 33: 213–215
Jo M, Kim TH, Seol DW, Esplen JE et al. (2000) Apoptosis induced in normal human hepatocytes by tumor necrosis factor-related apoptosis-inducing ligand. Nat Med 6: 564–567
King N (1988) The Physician as the Captain of the Ship. A critical Reappraisal. D. Reichel Publisher, Dordrecht, NL
Levine RJ (1986) Research that could yield marketable products from human materials: The problem of informed consent. IRB 8: 6–7
Li AP, Maurel P, Gomez-Lechon MJ, Cheng LC et al. (1997) Preclinical evaluation of drug-drug interaction potential: Present status of the application of primary human hepatocytes in the evaluation of cytochrome P450 induction. Chem Biol Interact 107: 5–16
Malcolm JG (1988) Treatment Choices and Informed Consent. University Press, Springfield
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Thasler, W.E., Weiss, T.S., Schillhorn, K. et al. Charitable State-Controlled Foundation Human Tissue and Cell Research: Ethic and Legal Aspects in the Supply of Surgically Removed Human Tissue For Research in the Academic and Commercial Sector in Germany. Cell Tissue Banking 4, 49–56 (2003). https://doi.org/10.1023/A:1026392429112
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DOI: https://doi.org/10.1023/A:1026392429112