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3. Controversies between regulations of research ethics and protection of personal data:informed consent at a cross‑road

Author

Gefenas, Eugenijus, Lekstutiene, Jurata, Lukaseviciene, Vilma, Hartlev, Mette, Mourby, Miranda, Ó Cathaoir, Katharina, Gefenas, Eugenijus, Lekstutiene, Jurata, Lukaseviciene, Vilma, Hartlev, Mette, Mourby, Miranda, and Ó Cathaoir, Katharina

Abstract

This paper explores some key discrepancies between two sets of normative requirements applicable to the research use of personal data and human biological materials: (a) the data protection regime which follows the application of the European Union General Data Protection Regulation (GDPR), and (b) the Declaration of Helsinki, CIOMS guidelines and other research ethics regulations. One source of this controversy is that the GDPR requires consent to process personal data to be clear, concise, specific and granular, freely given and revocable and therefore has challenged the concept of ‘broad consent’, which has been widely applied in the context of biobanking. Another source of controversy is the interplay between regulations of research ethics and protection of personal data related to the secondary use of personal data and biological materials. In this case, the GDPR ‘research condition’ provides an alternative to re-consent for the use of previously collected personal data and biological materials. Although the mentioned controversies have been raised in the legal literature, they have not been explicitly addressed from the research ethics perspective. Should consent be regarded as a priority legal basis for personal data processing in health data research? Can broad consent still be a suitable legal ground for biobanking? What should be the role of research ethics provisions that differ from the GDPR standards, and what should be the role and function of research ethics committees in the changing environment of health data research? These are the ongoing controversies to be explored in the paper.

Published
2021

6. Implementation of the EU clinical trial regulation transforms the ethics committee systems and endangers ethical standards

Author

Lukaseviciene, Vilma, Hasford, Joerg, Lanzerath, Dirk, and Gefenas, Eugenijus

Abstract

The upcoming Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (Regulation), which will replace the current Clinical Trial Directive at the end of 2021, has triggered a significant reform of research ethics committee systems in Europe. Changes related to ethics review of clinical trials in the EU were considered to be essential to create a more favourable environment to conduct clinical trials in the EU. The concern is, however, that the role of the research ethics committees will weaken in at least some of the Member States because the new Regulation allows narrowing down the scope of ethics review as compared with the currently valid Clinical Trial Directive. Although the new Regulation may lead to faster approval procedures for clinical trials, which is especially relevant in the context of pandemics, high-quality ethics reviews integrating methodological aspects of a clinical trial should nevertheless be ensured. To maintain high research ethics standards as well as to foster measures to mitigate potential negative consequences of the reform, it is therefore of vital importance to start debating and sharing the reflections about the potential consequences of these transformations and trends as soon as possible.

Published
2021
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7. Legal and ethical review of in silico modelling

Author

�� Cathaoir, Katharina, Gefenas, Eugenijus, Mourby, Miranda, and Lukaseviciene, Vilma

Subjects
consent in data integration, personalised medicine, fair and transparent, patients' rights, silico models, 3. Good health, lawful and ethical data integration
Abstract

The development of in silico models for personalised medicine in the EU requires lawful and ethical data integration. The ultimate use of these models will also require the use of information in these automated systems in a fair and transparent way, which respects patients��� rights. This report therefore surveys the legal landscape for health data integration, and the challenges which arise when information is re-used to develop analytical or predictive models, which are then re-applied to a patient population. Particular attention is paid to the nature and role of consent in data integration and use within in silico models. Consent has a role within the Clinical Trials Regulation, the General Data Protection Regulation, and more broadly as authorising the use of private or confidential information. It also has key limitations, particularly when it cannot easily be revoked, or where it is not sufficient to allow significant decisions to be made in the context of automated processing.

8. Legal and ethical review of in silico modelling

Author

Ó Cathaoir, Katharina, Gefenas, Eugenijus, Mourby, Miranda, and Lukaseviciene, Vilma

Subjects
consent in data integration, personalised medicine, fair and transparent, patients' rights, silico models, 3. Good health, lawful and ethical data integration
Abstract

The development of in silico models for personalised medicine in the EU requires lawful and ethical data integration. The ultimate use of these models will also require the use of information in these automated systems in a fair and transparent way, which respects patients’ rights. This report therefore surveys the legal landscape for health data integration, and the challenges which arise when information is re-used to develop analytical or predictive models, which are then re-applied to a patient population. Particular attention is paid to the nature and role of consent in data integration and use within in silico models. Consent has a role within the Clinical Trials Regulation, the General Data Protection Regulation, and more broadly as authorising the use of private or confidential information. It also has key limitations, particularly when it cannot easily be revoked, or where it is not sufficient to allow significant decisions to be made in the context of automated processing.

9. Harmonization and integration of big data of relevance for personalized medicine into in silico modelling? ��� Recommendations for technically feasible, and ethico-legal sustainable avenues

Author

�� Cathaoir, Katharina, Gefenas, Eugenijus, Hartlev, Mette, Mourby, Miranda, and Lukaseviciene, Vilma

Subjects
GDPR, legally and ethically sustainable avenues for harmonization/integration of big data, education, personalized medicine, in silico modelling, 3. Good health
Abstract

This report is the second deliverable of WP3 in the EU-STANDS4PM project. WP3 is responsible for providing guidance on the legal, ethical and policy considerations arising from data integration for in silico modelling for personalized medicine. In our first deliverable, we provided a legal and ethical analysis based on the data sources relevant for development of in silico models. The report included: 1. a survey of the international and European data protection and clinical trials regulation as well as legal and ethical regulation relevant for protection of equal access to health, and right to information and self-determination relevant for harmonization and integration of data in in silico modelling, and 2. an assessment of the challenges and opportunities this regulation provides for harmonization and integration of data for in silico modelling. The aim of this report is to explore solutions to the challenges identified in the first report and outline technically feasible as well as legally and ethically sustainable avenues for harmonization/integration of big data of relevance for personalized medicine into in silico modelling.

10. Harmonization and integration of big data of relevance for personalized medicine into in silico modelling? – Recommendations for technically feasible, and ethico-legal sustainable avenues

Author

Ó Cathaoir, Katharina, Gefenas, Eugenijus, Hartlev, Mette, Mourby, Miranda, and Lukaseviciene, Vilma

Subjects
GDPR, legally and ethically sustainable avenues for harmonization/integration of big data, education, personalized medicine, in silico modelling, 3. Good health
Abstract

This report is the second deliverable of WP3 in the EU-STANDS4PM project. WP3 is responsible for providing guidance on the legal, ethical and policy considerations arising from data integration for in silico modelling for personalized medicine. In our first deliverable, we provided a legal and ethical analysis based on the data sources relevant for development of in silico models. The report included: 1. a survey of the international and European data protection and clinical trials regulation as well as legal and ethical regulation relevant for protection of equal access to health, and right to information and self-determination relevant for harmonization and integration of data in in silico modelling, and 2. an assessment of the challenges and opportunities this regulation provides for harmonization and integration of data for in silico modelling. The aim of this report is to explore solutions to the challenges identified in the first report and outline technically feasible as well as legally and ethically sustainable avenues for harmonization/integration of big data of relevance for personalized medicine into in silico modelling.

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