Learning from Clinical Data: Ethical, Social and Legal Aspects
Final Report Abstract
We based our work on a socio empirical expert interview study on the potentials and risks of SeConts. We also provided an overview of the potential benefits as well as the challenges and risks of secondary use of clinical data in non-interventional, datagathering research or learning activities (SeConts). With respect to possible informational risks for patients whose data are used in SeConts, we developed a riskassessment framework to estimate both probability of re-identification risk and magnitude of possible resulting harm that can be used by research ethics committees and data use and access committees, as well as scientists, bioethicists, and funders. Furthermore, in the ethical subproject, we argue, that there are good reasons for a physicians’ professional duty to support SeConts by providing their patients’ clinical data if certain measures are taken to prevent conflict with physicians’ duties. In the socio-empirical subproject, we found that physicians show a high in-principle willingness to support secondary use and a large part of them see this support as a medical duty – however, this is linked to conditions such as ensuring privacy of patients and providing means for documentation and consent. In addition, group-specific conditions were identified that need to be addressed. Regarding the role of patients, in the ethical subproject we argue that there are good reasons for a patients’ duty to provide their clinical data for SeConts due to the general duty to help and the duty to act in the common interest. The socio-empirical results among cancer patients show that this patient group is highly willing to make their data available. They consider other patients and physicians to be obliged to support secondary use. Regarding different consent models, the Broad Consent Model received the highest acceptance, followed by the Opt-Out Model and the Specific Consent Model. In the legal subproject we came to the result, that current data protection law contains the possibility of de facto anonymity by contractually shielding medical information from identifying information, if different legal entities are concerned. The processing of de facto anonymous data does not fall under the restrictions of data protection law. Within the processing of personal data, the concept of consent as basis for SeConts and the specification of the research purpose are subject to further debates. We concluded in the legal investigation that broad consent can be restrictively used if the research purpose is yet unknown prior to processing. This might be the case regarding data repositories. Apart from consent, research privileges as legal basis are restrictive and should be expanded in the future. In this context we scrutinized inter alia section 27 par. 1 BDSG and concluded that the necessity of substantial outweighing of research interest over data subject´s interest collides with fundamental rights, especially the freedom of research. We argued for a more balanced and generally applicable research privilege in section 27 par. 1 BDSG. The necessary regulatory consolidation in terms of research privileges might be solved soon, for the new government has announced to enact a research data protection law. Currently we are finalizing a position paper that will contain and summarize the most important results of all subprojects as well as concrete and application-oriented recommendations for the establishment of a culture and framework of SeConts. This position paper will be disseminated to inform policy makers, professional societies like the Bundesärztekammer, and data sharing initiatives like the Medical Informatics Initiative (MII) or The German Human Genome-Phenome Archive (GHGA). Furthermore, our results from all subprojects and work packages will inform future research (e.g., the DaDuHealth project currently conducted in Freiburg and Karlsruhe) and was an important building block of the application for the extension of the Heisenberg Professorship for Translational Medical Ethics.
Publications
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Personenbezogene Daten im Kontext biomedizinischer Sekundärforschungsnutzung. Datenreiche Medizin und das Problem der Einwilligung, 101-120. Springer Berlin Heidelberg.
Spitz, Markus & Cornelius, Kai
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Rechtlicher Rahmen für eine privilegierte Nutzung klinischer Daten zu Forschungszwecken. Medizinrecht, 39(6), 499-504.
Spitz, Markus; Cornelius, Kai; Jungkunz, Martin & Schickhardt, Christoph
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Secondary Use of Clinical Data in Data-Gathering, Non-Interventional Research or Learning Activities: Definition, Types, and a Framework for Risk Assessment. Journal of Medical Internet Research, 23(6), e26631.
Jungkunz, Martin; Köngeter, Anja; Mehlis, Katja; Winkler, Eva C. & Schickhardt, Christoph
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Sekundärnutzung klinischer Daten aus der Patientenversorgung für Forschungszwecke – Eine qualitative Interviewstudie zu Nutzen- und Risikopotenzialen aus Sicht von Expertinnen und Experten für den deutschen Forschungskontext. Datenreiche Medizin und das Problem der Einwilligung, 185-210. Springer Berlin Heidelberg.
Köngeter, Anja; Jungkunz, Martin; Winkler, Eva C.; Schickhardt, Christoph & Mehlis, Katja
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Sekundärnutzung klinischer Daten in datensammelnden, nicht-interventionellen Forschungs- oder Lernaktivitäten – Begriff, Studientypen und ethische Herausforderungen. Datenreiche Medizin und das Problem der Einwilligung, 71-98. Springer Berlin Heidelberg.
Jungkunz, Martin; Köngeter, Anja; Winkler, Eva C.; Mehlis, Katja & Schickhardt, Christoph
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Einwilligung und gesetzliche Forschungsklausel als Rechtsgrundlagen für die Sekundärnutzung klinischer Daten zu Forschungszwecken. Medizinrecht, 40(3), 191-198.
Spitz, Markus & Cornelius, Kai
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Haben Patient*innen die moralische Pflicht, ihre klinischen Daten für Forschung bereitzustellen? Eine kritische Prüfung möglicher Gründe. Ethik in der Medizin, 34(2), 195-220.
Jungkunz, Martin; Köngeter, Anja; Mehlis, Katja; Spitz, Markus; Winkler, Eva C. & Schickhardt, Christoph
