ABSTRACT
This chapter will begin by outlining the statutory framework within which NHS
research ethics committees (RECs) now operate to try to locate the responsi-
bilities of RECs within their legal context. It will include some discussion of the
background to the Medicines for Human Use (Clinical Trials) Regulations 2004,
SI 2004/1031 (‘Clinical Trials Regulations’) and their relationship to the EU
Clinical Trials Directive (2001/20/EC), the full title of which is the ‘Directive
of the European Parliament and of the Council on the approximation of laws,
regulations and administrative provisions of the Member States relating to imple-
mentation of good clinical practice in the conduct of clinical trials on medicinal
products for human use’. This will be followed by a detailed overview of the law
of negligence in relation to the Clinical Trials Regulations. In order to provide
some contextual analysis, the law will be examined by referring to a hypothetical
case study whose aim is to demonstrate the ways in which the law might apply to
any REC or REC member who neglected their basic duty to conduct a competent
ethical review. The situation relating to breaches of statutory obligations under the
Mental Capacity Act 2005 and the Human Tissue Act 2004 will be discussed in
Chapters 7 and 8, and more general discussion of the common law that applies to
consent and confidentiality will be discussed in Chapters 5 and 6 respectively.
