The extent of the
In the previous three chapters we have been considering how ethically to regulate research involving human subjects. Accordingly, we have focused on the responsibility of the researcher towards subjects. We have considered, for example, whether, and to what extent, property rights and inducements in medical research should be regulated (chapter 2), whether paternalism with regard to the subject is ethically necessary (chapter 3), and we have discussed the particular ethical issues which arise when undertaking medical research on vulnerable groups (chapters 3 and 4).
In this last chapter, we will now take much more into account the responsibility of the researcher towards his or her sponsor and towards the scientific community. After examining the case and commentaries of the open label extension study, we will consider the relationship between 'bad science' and 'bad ethics'.
by Paul Wainwright
The following case study illustrates a situation in which the possibility of a proper consent becomes a central issue. In particular it raises questions about the extent to which the