Medical Research Involving Incapacitated Adults: Implications of the Eu Clinical Trials Directive 2001/20/Ec

Recent legislative developments in Europe, especially in relation to tissue, data and clinical trials,2 have deeply worried clinical investigators and their academic sponsors.3 They argue that the array of new laws (described by one as ‘an ever-growing threnody’)4 hinders the quality and efficiency of clinical research,5 yet the contorted regulation researchers must now follow has not made research any more ethical. Similar concerns have been expressed in the US.6 The great irony is that this regulation occurs at the same time that governments are pouring additional investment into research (over £3.3 billion has been promised for 2007–08 in the UK alone).7 On the other hand, it would be naive to overlook the heavy involvement of a profit-motivated industry.8 This has led other commentators to question the extent to which research brings about real benefits for patients and the criteria on which research agendas are set.9 Furthermore, they point to continued instances of trials gone awry that are reminders of the difficulties and risks surrounding scientific progress.10 The shameful history of research during the mid-part of the twentieth century also warns against a cavalier approach.11