Empirical findings from a Swedish longitudinal screening study show that many of the research subjects had a limited understanding of the study. Nevertheless they were satisfied with the understanding they had and found it sufficient for informed continued participation. Were they wrong? In this paper, it is argued that the kind of understanding that is morally required depends partly on the kind of understanding on which the research subjects want to base their decisions, and partly on what kind of knowledge (...) they lack. Researchers must ensure that the information process is not flawed and that participants receive the information they want. To achieve this, new information efforts may be needed. Researchers must also ensure that research subjects have knowledge about aspects of importance to them. Lack of understanding may, however, be the result of conscious choices by research subjects to disregard some of the information because it is not important to them. Such choices should normally be respected. (shrink)

Informed consent is increasingly heralded as an ethical panacea, a tool to counter autocratic and paternalistic medical practices. Debate about the implementation of informed consent is constricted and polarised, centring on the right of individuals to be fully informed and to freely choose versus an autocratic, paternalistic practice that negates individual choice. A bioethical framework, based on a principle-led form of reductive/deductive reasoning, dominates the current model of informed consent. Such a model tends to abstract the process of consent from (...) its clinical and social setting. By fleshing out the social process involved when patients and healthy volunteer subjects consent to take part in clinical drug trials, this paper attempts to address the problem arising from the current ‘empty ethics’ model. My arguments are substantiated by qualitative interview data drawn from a study I conducted on the process of consent as experienced by participants in clinical drug trials. (shrink)