Framework for setting up and operating biobanks

Research output: Journal contributionsJournal articlesResearchpeer-review

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.

Original languageEnglish
JournalJournal International de Bioethique
Volume20
Issue number3
Pages (from-to)17-46
Number of pages30
ISSN1287-7352
Publication statusPublished - 2009

    Research areas

  • Law - biological warfare, ethics, germany, legislation and jurisprudence, practice guideline, safety, synthetic biologiy

Recently viewed

Publications

  1. Perfect anti-windup in output tracking scheme with preaction
  2. Introducing a multivariate model for predicting driving performance
  3. Semantic Parsing for Knowledge Graph Question Answering with Large Language Models
  4. Reading and Calculating in Word Problem Solving
  5. Selection and Recognition of Statistically Defined Signals in Learning Systems
  6. Inversion of fuzzy neural networks for the reduction of noise in the control loop
  7. Age-related differences in processing visual device and task characteristics when using technical devices
  8. Evaluating the construct validity of Objective Personality Tests using a multitrait-multimethod-Multioccasion-(MTMM-MO)-approach
  9. A denoising procedure using wavelet packets for instantaneous detection of pantograph oscillations
  10. Managing Business Process in Distributed Systems: Requirements, Models, and Implementation
  11. Evaluating OWL 2 reasoners in the context of checking entity-relationship diagrams during software development
  12. The elicitation process in developing of case library for Case-Based Reasoner system whilst consideration for validating electronic communication technologies
  13. A multi input sliding mode control for Peltier Cells using a cold-hot sliding surface
  14. Design and Control of an Inductive Power Transmission System with AC-AC Converter for a Constant Output Current
  15. On robustness properties in permanent magnet machine control by using decoupling controller
  16. Construct Objectification and De-Objectification in Organization Theory
  17. Vision-Based Deep Learning Algorithm for Detecting Potholes
  18. Methodologies for Noise and Gross Error Detection using Univariate Signal-Based Approaches in Industrial Application
  19. A model predictive control in Robotino and its implementation using ROS system
  20. Analysis and comparison of two finite element algorithms for dislocation density based crystal plasticity
  21. A New Framework for Production Planning and Control to Support the Positioning in Fields of Tension Created by Opposing Logistic Objectives
  22. Finding Similar Movements in Positional Data Streams
  23. Empowering materials processing and performance from data and AI
  24. Integrating errors into the training process
  25. Modeling Effective and Ineffective Knowledge Communication and Learning Discourses in CSCL with Hidden Markov Models
  26. Stepwise-based optimizing approaches for arrangements of loudspeaker in multi-zone sound field reproduction
  27. Using Decision Trees and Reinforcement Learning for the Dynamic Adjustment of Composite Sequencing Rules in a Flexible Manufacturing System
  28. Changes of Perception
  29. Real-time RDF extraction from unstructured data streams
  30. A Quadrant Approach of Camera Calibration Method for Depth Estimation Using a Stereo Vision System
  31. DialogueMaps: Supporting interactive transdisciplinary dialogues with a web-based tool for multi-layer knowledge maps
  32. A sufficient asymptotic stability condition in generalised model predictive control to avoid input saturation
  33. Gaussian processes for dispatching rule selection in production scheduling
  34. Comments on "Tracking Control of Robotic Manipulators With Uncertain Kinematics and Dynamics"
  35. Authenticity and authentication in language learning