The role of oversight in the protection of research subjects

During a five-year period, the Regional Ethical Review Boards (cf. IRB) in Sweden handled applications regarding more than 13 000 studies. This may seem to offer significant protection, but the question is to what extent this review procedure really protects research subjects, if the way in which research is actually conducted is not monitored as well. For instance, do researchers really apply for ethical approval whenever this is required by the law, and do those who get an ethical approval proceed as described in their experimental treatment on
dying patients – implanting an artificial trachea – was conducted without any approval from the Regional Ethical Review Board. It is reasonable to assume that there is a need for an effective and efficient system of oversight. Indeed, The
Ethical Review Act and the preparatory work on which it is based explicitly acknowledges the need for oversight. Moreover, there are authorities responsible for conducting it. In this presentation, however, we will provide empirical data that reveals an almost total lack of actual oversight in Sweden. We shall also discuss the significance of oversight in more general terms.