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The principal objective of this volume is to provide the first-ever integrated, multidisciplinary and cross-cutting analysis of health research regulation, drawing on experiences and expertise from across the globe. The book confronts the gaps between documented law and regulation in action; it demonstrates the relevance and value of ethical and social theories to good governance in research, and it seeks to capture and capitalise on lessons learned from research practice. This chapter provides an account of the changing landscape of health research regulation since the millennium, exposing themes and issues that become the focus of the subsequent sections and chapters of the book. Together, the contributions lay the foundation for the development of a Learning Health Research Regulation System, and the potential elements of such a system are explored in the Afterword.
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