Special Populations

Abstract

Certain patients cannot participate as readily in the informed consent process because of a language or hearing defect or because their medical condition temporarily does not permit them to do so (e.g., unconscious patients). Other patients such as children, prisoners, or the mentally infirm may be less able to give their informed consent because they are especially vulnerable to coercion or misinformation. This chapter is concerned with some issues relevant to subjects who fall in these categories and with possible solutions. Table 19 lists the types of problems to be considered in the text that follows. The conditions under which such subjects should be allowed to take part in a study are clear-cut. They include the following: (1) The person must be able to assimilate the study information and consent to participation. (2) The person must be able to give consent legally. Various levels of interference with one or the other of these key conditions are presented in Table 19.