Framework for setting up and operating biobanks

Publikation: Beiträge in ZeitschriftenZeitschriftenaufsätzeForschungbegutachtet

Authors

  • Jürgen Simon
  • Jürgen Robienski

1. Body materials taken from a living person remains usually to be the property of that person according to this opinion. Only if a clear, preferably written declaration of the donor/patient is available showing that he transfers the ownership of the materials to the collecting party (doctor, clinic, Biobank etc.), a lawful transferral of ownership has in fact taken place. Even though literature shows a stron opinion that the ownership of the materials transfers on the basis of a conclusive declaration of intent, one may not exclude the possibility that a court of law will not follow this opinion. In order to exclude the risk of punishment or of code of law claims for damages, it is recommendable to include a passage both in the patient information as well as the declarations of intent to the effect that the ownership of the body materials transfers to the collecting party. As an alternative, the explicit - though limited - usufruct of the body materials may be agreed upon. This may actually be preferable under certain circumstances. This may be the case in particular if the donor/patient is to be granted the right to request the return or destruction of the body materials at any time. In case of an old sample which was collected during a contract for treatment for the purpose of making a diagnosis or was collected as a «by-or waste product» during treatment, the obligation for the disposal of the body materials is given unless as an exception it is necessary to store the sample for medical-therapeutic reasons. Doing research with these body materials is usually not permitted without prior consent of the donor. Therefore, old samples should not be used for research purposes. One aspect has not been cleared to satisfaction whether a complete anonymization is to be set equal to a destruction, thus allowing research thereafter. 2. Even after the ownership of the body materials has been transferred to the Biobank, the personality rights of the donor/patient superimpose the ownership rights. Therefore, the Biobank may not do with the body materials in an unlimited manner. In particular, the general personality rights and the data protections law limit the rights derived from the ownership of the body materials. A mostly free disposal of the body materials is usually only possible if the sample has been absolute or at factually anonymized. 3. Provided the biobank is the owner of the body materials, it may pass it on to third parties under observation of the rights of the donor and of the data protection stipulations. Therefore, an unlimited passing on to third parties is only possible, if the body materials do not show any further person relationship, i.e. have been anonymized. In this case, a protective conveyance is possible. Passing on pseudomized or body material not at all reduced in it personrelationship is permissible only with the consent of the patient/donor. If the donor objected to the passing on of his body materials, even an anonymized transferral may be prohibited. It is certainly recommendable to include a regulation in the declaration of intent allowing the Biobank to pass on body materials - at least once it is anonymized. 4. As a precaution, the declaration of intent should include a passage allowing the Biobank to anonymize body materials at any time. At the same time, the patient information must note that if that were the case, the patient/donor may not make a claim for return or destruction of the materials since it would be impossible after anonymization. 5. The donor/patient, on principle, may not waive his general personality rights. At best, he may consent to interventions in his general personality rights after having been completely and fully informed. Therefore, the information and declaration of consent of the patient play a central role. 6. The donor usually does not have the right to make claims of any kind as to research results, if he has transferred the ownership of his body materials to the Biobank and has consented properly to research being done thereon. This applies particularly for commercial utilizations. The patient must be informed in this respect by means of the patient information brochure. The declaration of intent should include correspondingly a passage to the effect that the donor agrees to the Biobank using the research results commercially at their own risk and for their own benefit.

OriginalspracheEnglisch
ZeitschriftJournal International de Bioethique
Jahrgang20
Ausgabenummer3
Seiten (von - bis)17-46
Anzahl der Seiten30
ISSN1287-7352
PublikationsstatusErschienen - 2009

Zuletzt angesehen

Presse / Medien

  1. Durch Kunst fair im Verkehr

Publikationen

  1. Design of controllers applied to autonomous unmanned aerial vehicles using software in the loop
  2. Mechanical performance prediction for friction riveting joints of dissimilar materials via machine learning
  3. Kontext
  4. TACKLING THE GLOBAL WASTE PROBLEM AS A MULTI-LEVEL PROCESS
  5. A Systematic Literature Review Of Machine Learning Approaches For The Prediction Of Delivery Dates
  6. Modelling of a servo piezo mechanical hydraulic actuator and its feed-forward control
  7. Implicit processes in moral decision making: Why milliseconds matter
  8. The principle of unjust enrichment
  9. Institutional Proxy Representatives of Future Generations
  10. Phantasmal Spaces
  11. Essential ecosystem service variables for monitoring progress towards sustainability
  12. Union membership and age: the inverted u-shape hypothesis under test
  13. No-Code Platforms in Startups: Explaining Decisions for Adoption and Abandonment
  14. Quality based prevention of overweight in the school setting: the HEPS quality checklist
  15. Lernprotokollunterstütztes Lernen - ein Vergleich zwischen unstrukturiertem und systemkontrolliertem diskursivem Lernen im Netz
  16. Global networks & local partnerships
  17. Widening the evaluative space for ecosystem services
  18. Constellations of Transdisciplinary Practices: A Map and Research Agenda for the Responsible Management Learning Field
  19. On the measuring accuracy of the “Vehrs-Hebel”, a scaling apparatus for nonverbal real-time assessment of perceived quantity
  20. „Das ewig Dauernde in uns“. Immanenz und Transzendenz in Stifters Nachsommer
  21. Rudi Carrell
  22. Borders, Citizenship, War, Class
  23. Consumer preferences and willingness to pay for apples from agrivoltaics
  24. A journey worth taking
  25. “They Are Stumbling Around Quite Helplessly”: How Supporters of Refugee Families Frame Vulnerability and Agency Relating to Childcare
  26. Microstructural evolution and mechanical properties of Mg-11Gd-4.5Y-1Nd-1.5Zn-0.5Zr alloy prepared via pre-ageing and hot extrusion
  27. Von Joseph Ratzinger zu Papst Benedikt XVI
  28. Best practice for bio-waste collection as a prerequisite for high-quality compost
  29. Self-Control Following Prior Exertion
  30. Making education for sustainable development happen in elementary schools
  31. Ästhetische Bildung der Differenz