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Chapter five describes the ethical framework regulating research using linked data and examines the applicable international ethics guidelines. A hypothetical research project is used to compare how these guidelines address the ethical assessment of research using linked data and in particular to compare how they address a waiver of consent and the extent to which they consider collective interests. The chapter goes on to discuss how the core ethical values of research merit and integrity, justice, beneficence, and respect can be reinterpreted to encompass the ethical concerns raised by research using linked data.
Chapter 7 uses three case studies to describe existing practice and processes for using and sharing data for linkage research in three jurisdictions: Western Australia, Scotland and Manitoba. Each case study looks at the decision makers; the relevant law, policy and guidelines regulating the decision-making process; and the ethical review process. The chapter assesses the practice and process in each case study against metrics of good decision making. These metrics are efficiency, transparency, accountability and community participation. The chapter concludes that there are significant similarities between the jurisdictions but that there are many areas in which decision making can be improved in all jurisdictions.
Chapter 4 considers the human rights relevant to research using linked data without consent; how these rights come into tension with each other and other relevant interests; and how these tensions should be considered and resolved. It notes the emphasis placed in the West on civil and political rights, such as the right to privacy, and the lack of attention to economic, social, and cultural rights, such as the right to health, and how this has resulted in an unbalanced approach to the regulation of research.
Chapter 6 considers the legal basis on which linked data is used and disclosed for research in the three jurisdictions under consideration. The bodies of law relevant to research using individual-level data without consent are examined. The chapter describes how these bodies of law regulate the use of data and balance the relevant private and public interests in play. The chapter critiques these bodies of law in terms of clarity and consistency, including consistency with the human rights norms and ethical principles discussed in previous chapters.
The concept of social licence is increasingly being used to draw attention to the need for community support and acceptance of research, particularly of data-based research. Chapter three examines the nature of social licence and its application to research using linked data. Social licence is framed as an analytical tool to design and evaluate decision making for sharing and using linked data for research. The chapter examines the qualitative evidence of public perceptions and the conditions for community support and identifies the substantive and procedural conditions that lead to trust and legitmacy. The chapter concludes that these conditions should be embedded in the governance of research using linked data to develop and sustain community acceptance.
Chapter two considers the interwoven interests of individual participants, collectives interests and the wider public interests in research using linked data. The chapter discusses the research participants interests including dignity, autonomy and privacy and the traditional approaches to protecting them — consent and anonymisation — and concludes that these do not operate to effectively to protect individual interests in this context. Research using linked data can also have impacts, both beneficial and harmful on others, including socio-demographic groups, disease groups and the wider community and these should be explicitly recognised and evaluated by decision makers. The current legal and ethical regulation of data linkage research are critiqued for being too individualistic and alternative approaches are discussed.
The future of health research around the world relies on access to data. Much of the most valuable, reliable, and comprehensive data collections are held by governments. These collections contain data on whole populations and are, therefore, a powerful tool in the hands of researchers, especially when the data collections are linked and analysed. Research using linked data has the capacity to address “wicked’ health problems and emerging global threats to health, such as COVID-19. These data collections are made up of sensitive information about the members of the community. They must only be used in a way that respects the values, interests, and rights of individuals and the community. This book provides a template for allowing access to government data collections for research in a regulatory environment that respects and protects these values, interests, and rights to build the social licence needed to support the research enterprise.
Chapter 8 concludes the book by proposing ways to improve decision-making in relation to sharing linked data for research. It considers improvements in a number of areas: the decision-making framework of interests, values, and rights; the decision-making criteria and conditions; the decision makers who are best placed to make each decision; and the decision-making process. The chapter sets out the interests, values and rights that should frame decisions in this sphere, not all of which are currently represented in decision-making frameworks. It provides a list of decision-making criteria and considerations that should be taken into consideration by the relevant decision makers. The chapter distinguishes between ethical decisions, which should be made by ethics committees and governance decisions, which should be made data custodians. Finally, the chapter makes recommendations for a decision-making process that will be efficient, transparent, accountable and collaborative. This process is designed to lead to better decisions and to ensure that both the decision-making process and the decisions themselves develop and sustain the social licence needed to support the important enterprise of research using linked data.