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Cover Medical Law

10. Clinical Research  

This chapter first summarizes the rules governing experiments on animals. It then examines international codes of research ethics and the UK’s regulatory system; the role of ethics committees in authorizing and monitoring research; whether the benefits and burdens of research participation are evenly distributed; conflicts of interests and publication ethics; and compensation for injuries sustained as a result of participation in research.

Chapter

Cover Mason and McCall Smith's Law and Medical Ethics

6. Health Research and Innovation  

A. M. Farrell and E. S. Dove

This chapter covers the regulatory environment of health research and biotechnological innovation in the UK, with some specific focus on genomics (including gene editing), artificial intelligence, and brain organoids. The Covid-19 pandemic demonstrated the limitations and strengths of a regulatory regime that enables (or thwarts) research into life-saving treatments and vaccines, as well as the importance of sharing data within and across organisations and institutions to address health emergencies. The chapter covers the governance of health research (focusing on biomedical research), the regimes that seek to promote innovation in science and medicine while accounting for the risks of biomedical research, as well as the development of research ethics codes. Following Brexit, the UK’s regulatory landscape for health research is somewhat in flux, with a flurry of policy papers and consultations regarding proposed legislative reform. As such, it remains to be seen what the contours of the landscape will be, and whether it promotes or hinders innovation—and creates fewer or greater risks for patients and research participants.