chapter  5
18 Pages


Consent has been described as ‘a precondition for autonomous decision-making’

(Pattinson, 2006: 97). As such, both ethics and law demand that persons have a

right to self-determination and choice about matters relating to their personal and

physical integrity, including their participation in research. There is, however, no

specific statute-based law of consent in the United Kingdom, and the concept has

developed through common law judgments. Similarly, there is no UK case law

pertaining explicitly to consent in research. However, many influential judicial

statements have concerned the relationship between autonomy and consent in the

context of medical treatment, and have been informed by ethical principles to the

effect that informed consent ‘ensures that due respect is given to the autonomy

and dignity of each patient’ (Chester v Afshar (2004), para 18). In addition, a number of the more recently enacted statutes in the field of

healthcare locate consent at their core. For example, the Human Tissue Act 2004,

which will be discussed in Chapter 8, the Human Fertilisation and Embryology

Act 2008, the EU Clinical Trials Directive (2001/20/EC) and the Medicines for

Human Use (Clinical Trials) Regulations 2004, SI 2004/1031 (‘Clinical Trials

Regulations’), all revolve around the issue of consent. Despite this there is little

statutory guidance in relation to what consent means and how to obtain a valid

consent. Practical guidance on this is largely the domain of professional guidance

such as that issued by the General Medical Council (GMC, 2008) and the Medical

Research Council (MRC, 1967, 2000, 2004), together with guidance published by

the National Research Ethics Service (NRES) pertaining specifically to clinical

research (NRES, May 2007 and May 2008). This chapter will begin with an out-

line of the law and ethics surrounding informed consent, followed by an analysis

of its practical operation in relation to research, touching on notions such as

voluntarism and information provision. These will be addressed in the context of

the detailed requirements set out in the Clinical Trials Directive and the Clinical

Trials Regulations, and their relationship to the common law more generally.