In the previous chapter, fundamental questions on the regulation of research on human beings were considered with respect to their ethical relevance. In particular, the issues of ownership of research samples and of inducement or financial compensation were addressed.
However, in all of these questions pertaining to regulation, the issue of informed consent on the part of the subject or patient is crucial. Yet it is not always possible to attain informed consent. In the following two chapters, we will consider subjects, or groups of subjects, with whom, for a variety of reasons, particular problems of informed consent arise. The following case is an example of such a situation, as the application of the principle of informed consent is ethically problematic. The question arises how the trial design is to be altered.
Also we need to ask if restricting informed consent might lead to paternalism on the part of the physician-researcher, and to what extent such paternalism might be justifiable.
We then consider ethical issues related to the use of women as subjects in clinical research.
This chapter concludes with a discussion on the regulations of emergency research and the problem of informed consent in this context.