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
10. Clinical Research
Chapter
6. Medical Confidentiality
G. T. Laurie, S. H. E. Harmon, and E. S. Dove
This chapter discusses ethical and legal aspects of medical confidentiality. It covers the relationship between confidentiality and data protection law; the possible exceptions to the confidentiality rule; confidentiality and the legal process; confidentiality for the purposes of medical research; patient access to medical records; remedies for breach of confidentiality; and confidentiality and death.
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20. Biomedical Human Research and Experimentation
G. T. Laurie, S. H. E. Harmon, and E. S. Dove
This chapter discusses ethical and legal aspects of biomedical research. After highlighting the evolution and acceleration of rule-making in this setting, it differentiates between research and experimentation, and articulates a core regulatory concept, namely risk. It then covers ethical codes and legal instruments in human biomedical research, research ethics committees, randomised controlled trials, and experimental treatment, paying particular attention to informed consent and research involving people lacking capacity. It also addresses the unethical researcher, compensation for personal injury in research, research involving human tissue and personal data, and new approaches to research governance.
Chapter
10. Ethico-Legal Issues Affecting Children
G. T. Laurie, S. H. E. Harmon, and E. S. Dove
This chapter examines a range of ethico-legal issues as the impact on children. The focus is one consent of mature minors, and the limits therefore, and also on the range of rights and responsibilities relating to children concerning protection of the ir personal data. The chapter then discusses ethical and legal aspects of non-therapeutic research on children; therapeutic research on children; foetal research and experimentation; and embryos and embryonic stem cell research.