Are Requirements to Deposit Data in Research Repositories Compatible With the European Union's General Data Protection Regulation?

Mascalzoni, Deborah; Bentzen, Heidi Beate; Budin‐Ljøsne, Isabelle; Bygrave, Lee A.; Bell, Jéssica; Dove, Edward S.; Fuchsberger, Christian; Hveem, Kristian; Mayrhofer, Michaela Th.; Meraviglia, Viviana; O’Brien, David R.; Pattaro, Cristian; Pramstaller, Peter P.; Rakić, Vojin; Rossini, Alessandra; Shabani, Mahsa; Svantesson, Dan Jerker B.; Tomasi, Marta; Ursin, Lars Øystein; Wjst, Matthias; Kaye, Jane

doi:10.7326/m18-2854

Cited by 31 publications

(21 citation statements)

References 4 publications

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“…Next, guidance on the principles of responsible data and sample exchange should be agreed and published, allowing governments and regulators to benchmark and harmonize national regulations and laws. Finding the balance between a subject's right to privacy and the public interest in advancing medical research in a manner that would be widely acceptable will be challenging, as already anticipated by the existing conflicts between current requirements to deposit data in research repositories and the GDPR [51]. The work of other groups such as the Global Initiative for the Ethical Use of Human Specimens (GIFT), who elaborated a set of recommendations for standardizing informed consent, should also be taken into consideration during this phase [52].…”

Section: Discussionmentioning

confidence: 99%

Legal and ethical framework for global health information and biospecimen exchange - an international perspective

et al. 2020

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Background: The progress of electronic health technologies and biobanks holds enormous promise for efficient research. Evidence shows that studies based on sharing and secondary use of data/samples have the potential to significantly advance medical knowledge. However, sharing of such resources for international collaboration is hampered by the lack of clarity about ethical and legal requirements for transfer of data and samples across international borders. Main text: Here, the International Clinical Trial Center Network (ICN) reports the legal and ethical requirements governing data and sample exchange (DSE) across four continents. The most recurring requirement is ethical approval, whereas only in specific conditions approval of national health authorities is required. Informed consent is not required in all sharing situations. However, waiver of informed consent is only allowed in certain countries/ regions and under certain circumstances. The current legal and ethical landscape appears to be very complex and under constant evolution. Regulations differ between countries/regions and are often incomplete, leading to uncertainty. Conclusion: With this work, ICN illuminates the unmet need for a single international collaborative framework to facilitate DSE. Harmonising requirements for global DSE will reduce inefficiency and waste in research. There are many challenges to realising this ambitious vision, including inconsistent terminology and definitions, and heterogeneous and dynamic legal constraints. Here, we identify areas of agreement and significant difference as a necessary first step towards facilitating international collaboration. We propose the establishment of a working group to continue the comparison across jurisdictions, create a standardised glossary and define a set of basic principles and fundamental requirements for DSE.

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Section: Discussionmentioning

confidence: 99%

Legal and ethical framework for global health information and biospecimen exchange - an international perspective

et al. 2020

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“…Among the 19 shortlisted papers, seven focused on various forms of data sharing and/or data use, five addressed privacy concerns, and one paper addressed both topic areas. Articles in the data sharing area explored a broad range of issues including passive data collection [6]; [patient] participatory methods in data-intensive biomedical research [7] and disease surveillance [8]; data management, use/re-use, and sharing internationally [9] and under the GDPR [10]; posthumous data donation [11]; and human protection with regard to data sharing [12]. Papers focused on privacy looked at the use and understanding of anonymization and de-identification practices in the literature [13]; health information disclosure [14]; balancing privacy and data use under the GDPR [15]; activities that work against citizen and patient trust with regard to personal information [16]; and terms of use violations by researchers accessing online patient information [17].…”

Section: Discussionmentioning

confidence: 99%

Special Section on Ethics in Health Informatics

Petersen

Subbian

2020

Yearb Med Inform

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Summary Objective: To summarize significant research contributions on ethics in medical informatics published in 2019. Methods: An extensive search using PubMed/Medline was conducted to identify the scientific contributions published in 2019 that address ethics issues in medical informatics. The selection process comprised three steps: 1) 15 candidate best papers were first selected by the two section editors; 2) external reviewers from internationally renowned research teams reviewed each candidate best paper; and 3) the final selection of three best papers was conducted by the editorial committee of the Yearbook. Results: The three selected best papers explore timely issues of concern to the community and demonstrate how ethics considerations influence applied informatics. Conclusion: With regard to ethics in informatics, data sharing and privacy remain primary areas of concern. Ethics issues related to the development and implementation of artificial intelligence is an emerging topic of interest.

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“…Efforts to balance patients’ right to data protection/confidentiality against the need to promote medical science advances through clinical research has been a topic of significant debate in recent years. 31 To ensure ethical and regulatory compliance and the sustainability and success of data sharing initiatives in cancer research, appropriate legislation and guidelines need to be implemented. Joint multi-stakeholder agreements and efforts need to be pursued to foster cultural (ie, conceptual) and technological (ie, practical) adaptation or discovery-led changes that will enable patients’ preferences regarding sharing of their own health data to be respected.…”

Section: Conceptual Challenges To Data Sharing In Iomentioning

confidence: 99%

Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume I—conceptual challenges

Rutella

Cannarile

Gnjatic

et al. 2020

J Immunother Cancer

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The sharing of clinical trial data and biomarker data sets among the scientific community, whether the data originates from pharmaceutical companies or academic institutions, is of critical importance to enable the development of new and improved cancer immunotherapy modalities. Through data sharing, a better understanding of current therapies in terms of their efficacy, safety and biomarker data profiles can be achieved. However, the sharing of these data sets involves a number of stakeholder groups including patients, researchers, private industry, scientific journals and professional societies. Each of these stakeholder groups has differing interests in the use and sharing of clinical trial and biomarker data, and the conflicts caused by these differing interests represent significant obstacles to effective, widespread sharing of data. Thus, the Society for Immunotherapy of Cancer (SITC) Biomarkers Committee convened to identify the current barriers to biomarker data sharing in immuno-oncology (IO) and to help in establishing professional standards for the responsible sharing of clinical trial data. The conclusions of the committee are described in two position papers: Volume I—conceptual challenges and Volume II—practical challenges, the first of which is presented in this manuscript. Additionally, the committee suggests actions by key stakeholders in the field (including organizations and professional societies) as the best path forward, encouraging the cultural shift needed to ensure responsible data sharing in the IO research setting.

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Are Requirements to Deposit Data in Research Repositories Compatible With the European Union's General Data Protection Regulation?

Cited by 31 publications

References 4 publications

Legal and ethical framework for global health information and biospecimen exchange - an international perspective

Legal and ethical framework for global health information and biospecimen exchange - an international perspective

Special Section on Ethics in Health Informatics

Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume I—conceptual challenges

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