Abstract
Traditionally, informed consent documents are a set of paper sheets signed by a patient or healthy volunteer. This approach is not appropriate for today’s requirements and it does not provide for instant access or for the automated processing of its contents, especially when using data and biomaterials for specific research purposes. Storing a scan of the paper document does not facilitate automated processing in complex, large-scale study environments. Once paper is archived and all other informed consent processing is done in electronic form, then ethics really meets IT. This chapter will explain selected technical and ethical aspects on the subject of processing data items that belong to persons who have agreed to take part in medical research projects using their medical or identifying data such as name, date of birth, etc. Approaches and mechanisms to manage informed consent are explained, discussing the GANI_MED solution as an example project. Requirements with regards to an automated processing by an IT platform are summarized. Quality criteria for informed consent documents are named and discussed as the quality of informed consent documents have a significant impact to the precision an IT platform can ensure when determining scope and contents of an informed consent. Ways to determine the scope of an informed consent and its automatic application during a data use and access process are presented. A data model to manage the scope challenge for the example of a hospital-wide broad consent is introduced. To conclude, implementation aspects of such IT-based platform managing consent are discussed.
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Bahls, T., Liedtke, W., Geidel, L., Langanke, M. (2015). Ethics Meets IT: Aspects and Elements of Computer-based Informed Consent Processing. In: Fischer, T., Langanke, M., Marschall, P., Michl, S. (eds) Individualized Medicine. Advances in Predictive, Preventive and Personalised Medicine, vol 7. Springer, Cham. https://doi.org/10.1007/978-3-319-11719-5_11
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DOI: https://doi.org/10.1007/978-3-319-11719-5_11
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