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Human biological materials and related data stored in biobanks are valuable resources for biomedical research. Transparent, effective, and efficient governance structures and procedures for access, compensation, and priority setting are needed, but recent debates indicate challenges in the practical application of such governance processes. This study aimed to assess the practical experiences and attitudes of biobank experts regarding the governance of biosample access, prioritization, and compensation. Qualitative, semi-structured telephone interviews were conducted with 20 biobank directors from eight countries. Respondents highlighted the need for sound governance structures in order to ensure acceptance by all stakeholders (patients/donors, researchers, research funders, public, and others). They stressed practical difficulties in trying to make best use of biomaterials. As biobanks often form part of larger academic and clinical settings, the different and sometimes conflicting interests of researchers, clinicians, patients, funders, and biobank staff currently affect the governance of access decisions. Investments such as intellectual input, financial, and human resources need to be compensated adequately. Biobanks thereby have a dual role stewarding the hosted biosamples and acting as a service provider for local researchers from universities or hospitals. In order to facilitate efficient use of human biological materials, greater harmonization of at least minimum standards for access and compensation are required at both a national and an international level.

Background: The aim of the German Medical Informatics Initiative is to establish a national infrastructure for integrating and sharing health data. To this, Data Integration Centers are set up at university medical centers, which address data harmonization, information security and data protection. To capture patient consent, a common informed consent template has been developed. It consists of different modules addressing permissions for using data and biosamples. On the technical level, a common digital representation of information from signed consent templates is needed. As the partners in the initiative are free to adopt different solutions for managing consent information (e.g. IHE BPPC or HL7 FHIR Consent Resources), we had to develop an interoperability layer. Methods: First, we compiled an overview of data items required to reflect the information from the MII consent template as well as patient preferences and derived permissions. Next, we created entity-relationship diagrams to formally describe the conceptual data model underlying relevant items. We then compared this data model to conceptual models describing representations of consent information using different interoperability standards. We used the result of this comparison to derive an interoperable representation that can be mapped to common standards. Results: The digital representation needs to capture the following information: (1) version of the consent, (2) consent status for each module, and (3) period of validity of the status. We found that there is no generally accepted solution to represent status information in a manner interoperable with all relevant standards. Hence, we developed a pragmatic solution, comprising codes which describe combinations of modules with a basic set of status labels. We propose to maintain these codes in a public registry called ART-DECOR. We present concrete technical implementations of our approach using HL7 FHIR and IHE BPPC which are also compatible with the open-source consent management software gICS.

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.

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