The Ethics and Governance of Health Research Infrastructure

Large-scale data processing and analysis offers the promise of personalizing health and biomedicine. In order to realize this promise, growing numbers of patients and citizens are contributing data to health research. The infrastructures facilitating these processes raise multiple ethical challenges. These cannot be articulated and addressed properly through direct application of the principles and frameworks of clinical research ethics. Clinical research ethics assumes and reinforces a model of research with clear boundaries between individual research projects, and between research on the one hand and other societal domains such as the provision of health care on the other. Focusing on (clinical) biobanking, this thesis aims to identify and evaluate the emerging ethical challenges raised by health research infrastructures. Three themes will be addressed in particular: the ethics of research data stewardship (chapters 2 and 6), the integration of research and care (chapters 3 to 5), and changing forms of research participation (chapters 6 and 7). Many keys to the ethics of ‘Big Data’ research reside in the responsible organization of health research infrastructures. Lacking prespecifiable research objectives of traditional hypothesis-driven research, norms for responsible research data stewardship can be specified. Sharp distinctions between research and care should make way for guidance about the responsible integration of both, with safeguards and controlled learning exercises to ensure that both current and future patients benefit from such arrangements. And new rights and roles for participants that are tailored to long-term, distributed and data-mediated forms of participation in health research infrastructures should be developed further, with an eye towards effective protections, a meaningful role for participants in governance, and public accountability. Each of these areas calls for further ethical attention. Ethics parallel research can help to anticipate, identify and evaluate the ethical issues at stake, by making explicit the normative considerations in technoscientific developments and associated legal, regulatory and policy frameworks, and help guide the choices made in the process. The diversity of approaches taken in this thesis reflects the variety of ways in which ethics parallel research can help bring normative considerations to the fore. Now that patients and participants are increasingly contributing to an infrastructural ecosystem of health data for research purposes, it becomes more and more important to organize this ecosystem in a transparent and accountable manner, responsive to patients’, citizens’ and participants’ needs. Research ethics has an important role to play in achieving this, in collaboration with health research, data stewardship, legal scholarship, social science and citizens, patients and participants