Medical Law and Research

The second edition of the HARD COPY BOOK of 'Medical Law and Research' incorporates comprehensive updates in the ever changing medico-legal environment in which research on humans is performed. Nevertheless, the basic concept of 'Medical Law and Research' remains a focus on those core areas of medical law that specifically relate to medical and clinical research. In addition, there is now discussion on attempts at the national implementation of European Community (EC) Clinical Trials Directive 2001/20/EC across Europe that has resulted in a confusingly wide divergence of interpretations and practices – despite the original intention of harmonisation.

'Medical Law and Research' remains a comprehensive and indispensable medico-legal reference text reference work for healthcare, managerial, administrative and research professionals involved in bioresearch, whether they work within hospitals, general practice, the pharmaceutical industry, contract research, public research, academia or members of ethics committees , that explains the implications of medical and scientific interventions on volunteers and patients recruited for clinical or medical research.

Each of nine chapters is supported by explanatory footnotes that summarise historical developments, cites illustrative case law and discusses seminal legal landmarks. The chapters cover the key areas of :

•liability and indemnity,
•negligence,
•approval systems and regulatory affairs,
•confidentiality,
•consent in adults with or without capacity and in children,
•publication,
•misconduct and fraud in clinical trials.

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