Here you will find information and assistance for submitting studies to one or more ethics committees involving the use and collection of biological samples and related data in biobanks
Today, biobanks form an important building block of medical research. Their characteristic feature is the collection and storage of biosamples (or biospecimens) and associated data for research purposes. In terms of size, purpose and structure, there are very different manifestations, from small project-related sample collections to large research biobanks that are thematically open and accessible to external researchers. The same applies to the sponsorship. Research biobanks are operated both by (mostly state-run) academic institutions and by private-sector companies.
All of these types are basically subject to the same ethical and legal requirements. However, these are not codified in Germany or the EU. The legal framework is primarily derived from the general norms of civil, criminal and professional law, as well as – significantly – from data protection law. In the case of sample collections in the context of drug studies, the German Medicines Act and EU Regulation 536/2014 must also be noted. At the international level, important principles are summarized in biobank-specific guidelines, which, however, are not legally binding.
According to the german professional laws for physicians (§15 MBO), research with body materials that can be attributed to a specific human being is subject to the obligation to consult the responsible ethics committee. Applications for the use of biospecimens for research purposes are therefore generally subject to the general application and review procedure for other studies. However, the collection of biospecimens is also widely used in the context of clinical medical products trials. Here, it is particularly important whether the biosamples are to be used within or outside the respective clinical trial.
Of decisive importance for the ethical and legal admissibility of the operation of biobanks is the consent of the sample donors (informed consent). The Association has therefore developed a series of texts and templates for the information and consent of sample donors for different addressees or constellations: for adult donors capable of giving consent; for minors of different age groups (12-17 and 7-11) and their parents/guardians; and for the collection of biomaterials on the occasion of a clinical trial for use outside the trial protocol.
The templates and textes available in english are at the end of that page.