ABSTRACT

The main moral rationale of clinical equipoise, beneficence and the special duty of healthcare workers towards patients are not easily applicable to research in preventive medicine. It is clear parallels with the ongoing ethical debate about medical research in developing countries and critique of the Helsinki Declaration which takes a very restrictive stance towards placebo-controlled trials. It focuses however on the moral rationale of equipoise, and only briefly reflects on requirements for placebo-controlled trials as such. Vaccine trials raise numerous moral issues about safety, trust, exploitation, informed consent, and pre-randomization. In order to keep the focus on the topic of equipoise, it simply assumes that ethical requirements other than those related to equipoise are satisfied. Although this analysis of research on reduced vaccination schemes is relevant for research on vaccination in general, and especially for developing world contexts, it will be helpful to start with a specific case in the Netherlands in which the problem of equipoise emerged.