Data protection-compliant broad consent for secondary use of health care data and human biosamples for (bio)medical research: Towards a new German national standard

Zenker, Sven; Strech, Daniel; Ihrig, Kristina; Jahns, Roland; Müller, Gabriele; Schickhardt, Christoph; Schmidt, Georg; Speer, Ronald; Winkler, Eva C.; Kielmansegg, Sebastian Graf von; Drepper, Johannes

doi:10.1016/j.jbi.2022.104096

Cited by 38 publications

(19 citation statements)

References 38 publications

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“…2. In the case of the broad consent scenario, 1-time consent is provided for future medical studies with clinical data; moderate control and research utility are presumed (option 2 in Figure 1). This vignette refers to the implementation of a broad consent process for the German Medical Informatics Initiative; the development of a unified template for broad consent was accompanied by the German Working Group of Research Ethics Committees [18]. In practice, this model involves safeguards such as the review of each individual research project by a research ethics committee and data access committees, organizational measures to protect patient data, and comprehensive information for patients [18].…”

Section: Operationalization Of Consent Scenariosmentioning

confidence: 99%

“…This vignette refers to the implementation of a broad consent process for the German Medical Informatics Initiative; the development of a unified template for broad consent was accompanied by the German Working Group of Research Ethics Committees [18]. In practice, this model involves safeguards such as the review of each individual research project by a research ethics committee and data access committees, organizational measures to protect patient data, and comprehensive information for patients [18]. To ensure comprehensibility, the details of these safeguards are not provided to the participants of this study.…”

Section: Operationalization Of Consent Scenariosmentioning

confidence: 99%

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Patients’ Willingness to Provide Their Clinical Data for Research Purposes and Acceptance of Different Consent Models: Findings From a Representative Survey of Patients With Cancer

Köngeter¹,

Schickhardt²,

Jungkunz³

et al. 2022

J Med Internet Res

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Background Secondary use of clinical data for biomedical research purposes holds great potential for various types of noninterventional, data-driven studies. Patients’ willingness to support research with their clinical data is a crucial prerequisite for research progress. Objective The aim of the study was to learn about patients’ attitudes and expectations regarding secondary use of their clinical data. In a next step, our results can inform the development of an appropriate governance framework for secondary use of clinical data for research purposes. Methods A questionnaire was developed to assess the willingness of patients with cancer to provide their clinical data for biomedical research purposes, considering different conditions of data sharing and consent models. The Cancer Registry of the German federal state of Baden-Württemberg recruited a proportionally stratified random sample of patients with cancer and survivors of cancer based on a full census. Results In total, 838 participants completed the survey. Approximately all participants (810/838, 96.7%) showed general willingness to make clinical data available for biomedical research purposes; however, they expected certain requirements to be met, such as comparable data protection standards for data use abroad and the possibility to renew consent at regular time intervals. Most participants (620/838, 73.9%) supported data use also by researchers in commercial companies. More than half of the participants (503/838, 60%) were willing to give up control over clinical data in favor of research benefits. Most participants expressed acceptance of the broad consent model (494/838, 58.9%), followed by data use by default (with the option to opt out at any time; 419/838, 50%); specific consent for every study showed the lowest acceptance rate (327/838, 39%). Patients expected physicians to share their data (763/838, 91.1%) and their fellow patients to support secondary use with their clinical data (679/838, 81%). Conclusions Although patients’ general willingness to make their clinical data available for biomedical research purposes is very high, the willingness of a substantial proportion of patients depends on additional requirements. Taking these perspectives into account is essential for designing trustworthy governance of clinical data reuse and sharing. The willingness to accept the loss of control over clinical data to enhance the benefits of research should be given special consideration.

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Section: Operationalization Of Consent Scenariosmentioning

confidence: 99%

Section: Operationalization Of Consent Scenariosmentioning

confidence: 99%

Patients’ Willingness to Provide Their Clinical Data for Research Purposes and Acceptance of Different Consent Models: Findings From a Representative Survey of Patients With Cancer

Köngeter¹,

Schickhardt²,

Jungkunz³

et al. 2022

J Med Internet Res

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“…Diese zentrale Dateninfrastruktur 6 wird zukünftig um eine Datenmanagementstelle 7 erweitert. Dies ermöglicht mittelfristig die Durchführung von Verbundforschungsprojekten 8 , indem Daten zu allen Kerndatensatzmodulen von NUM-RDP und MII von den DIZ entgegengenommen und für Broad-Consent-basierte Forschungsprojekte zur Verfügung gestellt werden [ 3 ]. Darüber hinaus unterstützt das NUM-Dashboard das Pandemiemanagement mit echtzeitnahem zentralem Tracking der Versorgungsaufwände und Patient*inneneigenschaften.…”

Section: Die Fünf Komponenten Der Num-forschungsdateninfrastrukturunclassified

Das Netzwerk Universitätsmedizin: Technisch-organisatorische Ansätze für Forschungsdatenplattformen

Heyder

2023

Bundesgesundheitsbl

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ZusammenfassungDas Netzwerk Universitätsmedizin (NUM) besteht aus den 36 Standorten der Universitätsmedizin in Deutschland. Der Auftrag ist die Koordinierung der universitätsmedizinischen COVID-19-Forschung auf nationaler Ebene. Dazu werden u. a. gemeinsame Infrastrukturen für die Sammlung, Haltung und Nutzung medizinischer Forschungsdaten benötigt. Diese standen beim Start des NUM-Projekts im April 2020 nicht im erforderlichen Rahmen zur Verfügung. Medizinische Forschungsdaten sind extrem heterogen und gehen weit über „Real World Data“ (Daten aus dem Versorgungsalltag) hinaus. Eine universelle Lösung dafür gab es nicht, deshalb hat das NUM fünf Forschungsinfrastrukturen für unterschiedliche Datenarten, unterschiedliche Wege der Datengewinnung und unterschiedliche Datenentstehungssettings aufgebaut. Um die Bildung neuer Datensilos zu verhindern, arbeiten alle fünf Infrastrukturen auf Basis der FAIR-Prinzipien, nach denen Daten auffindbar (findable), zugänglich (accessible), interoperabel (interoperable) und wiederverwendbar (reusable) sein sollen. Zudem implementiert das NUM einen übergreifenden Steuerungsrahmen (Governance Framework), um die Weiterentwicklung dieser fünf Infrastrukturen zentral zu steuern. Der Artikel beschreibt den aktuellen Stand der Infrastrukturentwicklung im NUM und mögliche Perspektiven. Ein starker Fokus wird dabei auf die technisch-organisatorischen Grundlagen gerichtet.

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“…In close cooperation between WG Consent and the Technology, Methods, and Infrastructure for Networked Medical Research e. V. (TMF), the already approved MII Broad Consent (MII BC) [14] was extended for NUM by a NUM-specific consent module (version 1.6f ) [15]. This supplementary module (called Z-module) grants patients the opportunity to decide on their own responsibility (1) whether their data may be transmitted to the central platform CODEX for the purpose of COVID-19 and pandemic research, in order to then be used for research in conformity with the GDPR, and (2) may even be transferred to countries in which the European Commission did not explicitly confirm a suitable level of data protection, yet ("unsecure third countries" [16]).…”

Section: A Broad Consent Promotes Broad Researchmentioning

confidence: 99%

A FHIR has been lit on gICS: facilitating the standardised exchange of informed consent in a large network of university medicine

Bialke

Geidel

Hampf

et al. 2022

BMC Med Inform Decis Mak

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Background The Federal Ministry of Education and Research of Germany (BMBF) funds a network of university medicines (NUM) to support COVID-19 and pandemic research at national level. The “COVID-19 Data Exchange Platform” (CODEX) as part of NUM establishes a harmonised infrastructure that supports research use of COVID-19 datasets. The broad consent (BC) of the Medical Informatics Initiative (MII) is agreed by all German federal states and forms the legal base for data processing. All 34 participating university hospitals (NUM sites) work upon a harmonised infrastructural as well as legal basis for their data protection-compliant collection and transfer of their research dataset to the central CODEX platform. Each NUM site ensures that the exchanged consent information conforms to the already-balloted HL7 FHIR consent profiles and the interoperability concept of the MII Task Force “Consent Implementation” (TFCI). The Independent Trusted Third-Party (TTP) of the University Medicine Greifswald supports data protection-compliant data processing and provides the consent management solutions gICS. Methods Based on a stakeholder dialogue a required set of FHIR-functionalities was identified and technically specified supported by official FHIR experts. Next, a “TTP-FHIR Gateway” for the HL7 FHIR-compliant exchange of consent information using gICS was implemented. A last step included external integration tests and the development of a pre-configured consent template for the BC for the NUM sites. Results A FHIR-compliant gICS-release and a corresponding consent template for the BC were provided to all NUM sites in June 2021. All FHIR functionalities comply with the already-balloted FHIR consent profiles of the HL7 Working Group Consent Management. The consent template simplifies the technical BC rollout and the corresponding implementation of the TFCI interoperability concept at the NUM sites. Conclusions This article shows that a HL7 FHIR-compliant and interoperable nationwide exchange of consent information could be built using of the consent management software gICS and the provided TTP-FHIR Gateway. The initial functional scope of the solution covers the requirements identified in the NUM-CODEX setting. The semantic correctness of these functionalities was validated by project-partners from the Ludwig-Maximilian University in Munich. The production rollout of the solution package to all NUM sites has started successfully.

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Data protection-compliant broad consent for secondary use of health care data and human biosamples for (bio)medical research: Towards a new German national standard

Cited by 38 publications

References 38 publications

Patients’ Willingness to Provide Their Clinical Data for Research Purposes and Acceptance of Different Consent Models: Findings From a Representative Survey of Patients With Cancer

Patients’ Willingness to Provide Their Clinical Data for Research Purposes and Acceptance of Different Consent Models: Findings From a Representative Survey of Patients With Cancer

Das Netzwerk Universitätsmedizin: Technisch-organisatorische Ansätze für Forschungsdatenplattformen

A FHIR has been lit on gICS: facilitating the standardised exchange of informed consent in a large network of university medicine

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