Abstract
Abstract Background Human biobanks are generally recognized as essential resources for effective biomedical research. All over the world biosamples and data from human subjects are collected in large biobanks. The biological material is stored long term for current and future (undetermined) research issues, which often require cross-border exchange of biosamples and related data. Content Commonly, the informed consent for research on human biospecimen is intended to cover only defined, specific research objectives. In June 2016, the biobank Task-Force of the Working Party of the German Medical Ethics Committees (WP-GMEC) updated its template for the broad use of human biological samples and related data. It complies with the current Organisation for Economic Co-operation and Development (OECD) and World Medical Association (WMA) recommendations and furnishes a framework that permits long-term storage and multi-purpose research use of human biological material and related data, including cross-border research. However, both (i) human biobanks storing and (ii) research projects requesting “broad consent” biological samples generally require an ethical approval; in addition, “broad consent” conditions should be reciprocated by making biobank processes transparent and by fostering both donor and public involvement. Outlook The broad consent template of the WP-GMEC clearly states that biological samples and data donated for medical research serve to address current and future research questions. It appears perfectly suited as a template for a Europe-wide harmonized broad consent facilitating biobank-based cross-border research.
Highlights
Today, human biobanks have been recognized as important resources for medical research, in particular for the progress in targeted drug therapy [1, 2]
Task-Force of the Working Party of the German Medical Ethics Committees (WP-GMEC) updated its template for the broad use of human biological samples and related data. It complies with the current Organisation for Economic Co-operation and Development (OECD) and World Medical Association (WMA) recommendations and furnishes a framework that permits long-term storage and multi-purpose research use of human biological material and related data, including cross-border research
There is international [3, 4, 6, 9] and European Union (EU)-wide consensus [5, 7, 8] that broad consent is ethically legitimate based on two key arguments: (i) opening new vistas for medical research and (ii) optimizing public health care [6, 8, 21, 24, 28]
Summary
Human biobanks have been recognized as important resources for medical research, in particular for the progress in targeted drug therapy [1, 2]. As a pre-condition for legal validity of a broad consent, the unpredictability of the future use of donated biological samples and related data must be compensated by appropriate measures and procedures [3, 4, 8, 9, 21, 25, 26] In this regard, in Germany, independent competent ethics committees are of paramount relevance for both (i) the assessment of the human biobank itself (during set-up and during operation) and (ii) the assessment of individual research projects requesting “broad consent” biological samples as a general pre-condition for the release and delivery of such samples [8, 28, 29]. The same holds true for all the other different internal (clinicians, clinician scientists, researcher, faculty, hospital department(s)) and external stakeholders (external user, government, founders, press) of a biobank, requiring regular stakeholder analysis together with an implementation of strategies and tools to assess and to adequately respond to the respective stakeholder needs [34, 35, 43]
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