Deborah Mascalzoni

The COVID-19 pandemic demonstrated the benefits of international data sharing. Data sharing enabled the health care policy makers to make decisions based on real-time data, it enabled the tracking of the virus, and importantly it enabled the development of vaccines that were crucial to mitigating the impact of the virus. This data sharing is not the norm as data sharing needs to navigate complex ethical and legal rules, and in particular, the fragmented application of the General Data Protection Regulation (GDPR). The introduction of the draft regulation for a European Health Data Space (EHDS) in May 2022 seeks to address some of these legal issues. If passed, it will create an obligation to share electronic health data for certain secondary purposes. While there is a clear need to address the legal complexities involved with data sharing, it is critical that any proposed reforms are in line with ethical principles and the expectations of the data subjects. In this paper we offer a critique of the EHDS and offer some recommendations for this evolving regulatory space.

Biobank research and genomic information are changing the way we look at health and medicine. Genomics challenges our values and has always been controversial and difficult to regulate. In the future lies the promise of tailored medical treatments and pharmacogenomics but the borders between medical research and clinical practice are becoming blurred. We see sequencing platforms for research that can have diagnostic value for patients. Clinical applications and research have been kept separate, but the blurring lines challenges existing regulations and ethical frameworks.Then how do we regulate it? This book contains an overview of the existing regulatory landscape for biobank research in the Western world and some critical chapters to show how regulations and ethical frameworks are developed and work. How should international sharing work? How design an ethical informed consent? An underlying critique: the regulatory systems are becoming increasingly complex and opaque. The international community is building systems that should respond to that. According to the authors in fact, it is time to turn the ship around. Biobank researchers have a moral responsibility to look at and assess their work in relation to the bigger picture: the shared norms and values of current society. Research ethics shouldn't only be a matter of bioethicists writing guidelines that professionals have to follow. Ethics should be practiced through discourse and regulatory frameworks need to be part of that public discourse. Ethics review should be then not merely application of bureaucracy and a burden for researchers but an arena where researchers discuss their projects, receive advice and practice their ethics skills.

BackgroundHealth data-driven activities have become central in diverse fields (research, AI development, wearables, etc.), and new ethical challenges have arisen with regards to privacy, integrity, and appropriateness of use. To ensure the protection of individuals’ fundamental rights and freedoms in a changing environment, including their right to the protection of personal data, we aim to identify the ethical approaches adopted by scientists during intensive data exploitation when collecting, using, or sharing peoples’ health data.MethodsTwelve scientists who were collecting, using, or sharing health data in different contexts in Sweden, were interviewed. We used systematic expert interviews to access these scientists’ specialist knowledge, and analysed the interviews with thematic analysis. Phrases, sentences, or paragraphs through which ethical values and norms were expressed, were identified and coded. Codes that reflected similar concepts were grouped, subcategories were formulated, and categories were connected to traditional ethical approaches.ResultsThrough several examples, the respondents expressed four different ethical approaches, which formed the main conceptual categories: consideration of consequences, respect for rights, procedural compliance, and being professional.ConclusionsTo a large extent, the scientists’ ethical approaches were consistent with ethical and legal principles. Data sharing was considered important and worth pursuing, even though it is difficult. An awareness of the complex issues involved in data sharing was reflected from different perspectives, and the respondents commonly perceived a general lack of practical procedures that would by default ensure ethical and legally compliant data collection and sharing. We suggest that it is an opportune time to move on from policy discussions to practical technological ethics-by-design solutions that integrate these principles into practice.

New advances in genomics changed the research landscape significantly in the last few years. The power and significance of already existing tissue collections is enhanced by their growing size, and all over the world national projects aim to connect with each other at the international level, calling for integrated and common regulations in the transnational research field. The post genomics era faces problems that are partially different from those within the classical bioethical framework. The challenge is to find new ways to deal with regulations in order to facilitate research without frustrating personal rights. Informed Consent has been the center of this wide debate. We propose a model for rethinking consent in an open-time/open-goal framework suitable to genomics research. Consensus becomes more than a single legal step and goes more in the direction of a participated governance mechanism, a circular open process of communication which the IC sheet signature is just one instance of. This approach provides a governance framework based on different levels of consensus and participation that already contains mechanisms to resolve conflicts between different instances and to protect both the interest of research and the rights of participants

BackgroundInnovations in technology have contributed to rapid changes in the way that modern biomedical research is carried out. Researchers are increasingly required to endorse adaptive and flexible approaches to accommodate these innovations and comply with ethical, legal and regulatory requirements. This paper explores how Dynamic Consent may provide solutions to address challenges encountered when researchers invite individuals to participate in research and follow them up over time in a continuously changing environment.MethodsAn interdisciplinary workshop jointly organised by the University of Oxford and the COST Action CHIP ME gathered clinicians, researchers, ethicists, lawyers, research participants and patient representatives to discuss experiences of using Dynamic Consent, and how such use may facilitate the conduct of specific research tasks. The data collected during the workshop were analysed using a content analysis approach.ResultsDynamic Consent can provide practical, sustainable and future-proof solutions to challenges related to participant recruitment, the attainment of informed consent, participant retention and consent management, and may bring economic efficiencies.ConclusionsDynamic Consent offers opportunities for ongoing communication between researchers and research participants that can positively impact research. Dynamic Consent supports inter-sector, cross-border approaches and large scale data-sharing. Whilst it is relatively easy to set up and maintain, its implementation will require that researchers re-consider their relationship with research participants and adopt new procedures.