ABSTRACT
The nature of vulnerability has been much debated (Liamputtong, 2007) and is not
the primary focus of this chapter, although more will be included in Chapter 9.
Instead, this chapter will concentrate on specific groups for whom particular
legal rules apply, namely children, and adults who lack decision-making capac-
ity. Vulnerability in these groups stems chiefly from their limited ability to
exercise individual autonomy, either through immaturity or because of impaired
mental capacity. As a consequence, people in these groups have traditionally
been thought of as requiring special protection, especially in the context of
research. Despite this, research involving members of groups who are viewed
as vulnerable because of their inability to give a legally valid consent has been
regarded as important, and ethical guidelines have been developed to support its
facilitation. In 1964, for example, the World Medical Association’s Declaration
of Helsinki endorsed research in these populations if ‘the research is necessary to
promote the health of the population represented and this research cannot instead
be performed on legally competent persons’. The EU Clinical Trials Directive
(2001/20/EC), preamble, para 3 states that:
Persons who are incapable of giving legal consent to clinical trials should be
given special protection. It is incumbent on the Member states to lay down
rules to this effect. Such persons may not be included in clinical trials if the
same results can be obtained using persons capable of giving consent.
