TY - JOUR

T1 - Framework for setting up and operating biobanks

AU - Simon, Jürgen

AU - Robienski, Jürgen

PY - 2009

Y1 - 2009

N2 - 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.

AB - 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.

KW - Law

KW - biological warfare

KW - ethics

KW - germany

KW - legislation and jurisprudence

KW - practice guideline

KW - safety

KW - synthetic biologiy

UR - http://www.scopus.com/inward/record.url?scp=77953105130&partnerID=8YFLogxK

M3 - Journal articles

C2 - 20425938

AN - SCOPUS:77953105130

VL - 20

SP - 17

EP - 46

JO - Journal International de Bioethique

JF - Journal International de Bioethique

SN - 1287-7352

IS - 3

ER -