Abstract
With the ethical, legal, and societal issues (ELSI) Knowledge Base, we introduce a key element of the Biobanking and Biomolecular Resources Research Infrastructure—European Research Infrastructure Consortium (BBMRI-ERIC) Common Service ELSI, which provides ethical, legal, and societal support for researchers and biobankers involved in transnational research. In contrast to the customized support provided by the ELSI Helpdesk, the ELSI Knowledge Base will be available to the user on a self-serve basis. The information that is made available through a knowledge base comes from multiple sources, usually from several expert contributors who are well versed in the subject matter. The knowledge base provides users with a first orientation on the subject matter, as well as allowing them to explore more detailed information if desired in a self-service manner. It is crucial that the information and knowledge provided are shared in a manner that is user friendly. Long lists of links, legalistic language, and multiple links have to be avoided wherever possible. The long-term sustainability and accuracy of a knowledge base need to be ensured by placing its expert curation and technical maintenance under the responsibility of an organization rather than a research consortium. In its core, it builds on a scenario-based approach using a nonlegalistic language. In addition, the knowledge base connects to frequently asked questions, promotes contract and informed consent templates, how-to-guides, best-practice models, and scripts. The ELSI Knowledge Base is a key element of the BBMRI-ERIC Common Service ELSI, which currently serves biobanks but will be enlarged to serve the biological and medical sciences community. In contrast to the ELSI Helpdesk, which provides customized support, the ELSI Knowledge Base is available to the user on a self-serve basis. The conceptualization of the ELSI Knowledge Base builds on assessments of several ethical, legal, and societal guidance tools that favor a single sustainable knowledge base for closing the knowledge gap by providing practical hands-on guidance for researchers. Ultimately, the ELSI Knowledge Base aims at promoting practical know-how and skills for conducting responsible research.
Highlights
This article concentrates on ethical and legal guidance for researchers in practice and presents a novel resource for guiding researchers and promoting knowledge in ethical, legal, and societal matters in the form of a knowledge base.why is a novel approach necessary and what should it achieve? Identifying and navigating through the applicable ethical and legal requirements for conducting biomedical research can be quite a practical challenge for investigators, especially when a research project encompasses participants from more than two countries and jurisdictions
Based on the experiences and assessments of ELSI guidance tools, which are excellent in their own right but limited in their usage, we proposed a reconceptualization that defines a clear user group and established the ELSI Knowledge Base
The ELSI Knowledge Base will be fully operational in Q4 2018
Summary
This article concentrates on ethical and legal guidance for researchers in practice and presents a novel resource for guiding researchers and promoting knowledge in ethical, legal, and societal matters in the form of a knowledge base. Circulated through the CORBEL BMS RIs, the survey consisted of 24 questions that aimed to assess if the tools and platforms researchers use in relation to ethical, legal, and societal issues were deemed informative for their daily work and which questions are yet to be answered. We propose that several real-life cases can be taken and transformed into an informative, archetypical situation (scenario) Such scenarios might be helpful to the researcher in various ways such as identifying and taking into account in an appropriate manner the actual ethical and legal challenges, ideally before data and samples are collected. An overview over the existing templates and whether and by whom they are approved, as well as experiences with similar scenarios, would provide major support for researchers as well as for ethics review committees
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