Collection of Biospecimen Resources for Cancer Research

Abstract

The collection of tissue samples has become a valuable basis for medical research. Relying on a deeply rooted tradition in cancer research, a common biobank project has been established in Heidelberg within the “National Center for Tumor Diseases” (NCT). As there is a lack of specific legal regulation in Germany, organisational requirements are uncertain. The use of a one-time general informed consent procedure containing both oral and written elements, attended by a physician, should guarantee the utmost legal security and respect for ethical considerations. The project is also mentioned in the hospital treatment contract. As the idea of ‘informed consent’ has become indispensable to medical ethics it is questionable whether, under well-defined circumstances, it might nevertheless be replaceable by regulatory means. Given the experience of the ‘NCT Tissue Bank’ that not a single patient refused to donate leftover tissue for subsequent use, a procedure based on contradiction might be regarded as more appropriate. In addition to ethical and legal considerations, the perspectives of those directly involved should be appreciated. We asked our patients, therefore, for their opinions as to whether the established informed consent procedure is satisfactory or in any way deficient.