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

ABSTRACT: 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.

SUBMITTER: Bernasconi L

PROVIDER: S-EPMC6975025 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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

Bernasconi Lara L Şen Selçuk S Angerame Luca L Balyegisawa Apolo P AP Hong Yew Hui Damien D Hotter Maximilian M Hsu Chung Y CY Ito Tatsuya T Jörger Francisca F Krassnitzer Wolfgang W Phillips Adam T AT Li Rui R Stockley Louise L Tay Fabian F von Heijne Widlund Charlotte C Wan Ming M Wong Creany C Yau Henry H Hiemstra Thomas F TF Uresin Yagiz Y Senti Gabriela G

BMC medical ethics 20200121 1

<h4>Background</h4>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.<h4>Main text</h4>Here, the Int ...[more]

PMID: 31964390

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Project description:IntroductionData linkage for health research purposes enables the answering of countless new research questions, is said to be cost effective and less intrusive than other means of data collection. Nevertheless, health researchers are currently dealing with a complicated, fragmented, and inconsistent regulatory landscape with regard to the processing of data, and progress in health research is hindered.AimWe designed a qualitative study to assess what different stakeholders perceive as ethical and legal obstacles to data linkage for health research purposes, and how these obstacles could be overcome.MethodsTwo focus groups and eighteen semi-structured in-depth interviews were held to collect opinions and insights of various stakeholders. An inductive thematic analysis approach was used to identify overarching themes.ResultsThis study showed that the ambiguity regarding the 'correct' interpretation of the law, the fragmentation of policies governing the processing of personal health data, and the demandingness of legal requirements are experienced as causes for the impediment of data linkage for research purposes by the participating stakeholders. To remove or reduce these obstacles authoritative interpretations of the laws and regulations governing data linkage should be issued. The participants furthermore encouraged the harmonisation of data linkage policies, as well as promoting trust and transparency and the enhancement of technical and organisational measures. Lastly, there is a demand for legislative and regulatory modifications amongst the participants.ConclusionsTo overcome the obstacles in data linkage for scientific research purposes, perhaps we should shift the focus from adapting the current laws and regulations governing data linkage, or even designing completely new laws, towards creating a more thorough understanding of the law and making better use of the flexibilities within the existing legislation. Important steps in achieving this shift could be clarification of the legal provisions governing data linkage by issuing authoritative interpretations, as well as the strengthening of ethical-legal oversight bodies.

Project description:BackgroundThe loss of human lives from cyberattacks in health care is no longer a probabilistic quantification but a reality that has begun. In addition, the threat scope is also expanding to involve a threat of national security, among others, resulting in surging data breaches within the health care sector. For that matter, there have been provisions of various legislation, regulations, and information security governance tools such as policies, standards, and directives toward enhancing health care information security-conscious care behavior among users. Meanwhile, in a research scenario, there are no comprehensive required security practices to serve as a yardstick in assessing security practices in health care. Moreover, an analysis of the holistic view of the requirements that need more concentration of management, end users, or both has not been comprehensively developed. Thus, there is a possibility that security practice research will leave out vital requirements.ObjectiveThe objective of this study was to systematically identify, assess, and analyze the state-of-the-art information security requirements in health care. These requirements can be used to develop a framework to serve as a yardstick for measuring the future real security practices of health care staff.MethodsA scoping review was, as a result, adopted to identify, assess, and analyze the information security requirement sources within health care in Norway, Indonesia, and Ghana.ResultsOf 188 security and privacy requirement sources that were initially identified, 130 (69.1%) were fully read by the authors. Subsequently, of these 188 requirement documents, 82 (43.6%) fully met the inclusion criteria and were accessed and analyzed. In total, 253 security and privacy requirements were identified in this work. The findings were then used to develop a framework to serve as a benchmark for modeling and analyzing health care security practices.ConclusionsOn the basis of these findings, a framework for modeling, analyzing, and developing effective security countermeasures, including incentivization measures, was developed. Following this framework, research results of health care security practices would be more reliable and effective than relying on incomprehensive security requirements.

Dataset Information

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

Publications

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

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