Vad innebär egentligen lagkravet på etikprövning av forskning som utförs enligt en metod som syftar till att påverka eller innebär uppenbar risk att skada? En rättslig analys av 4 § 2 p. lagen (2003:460) om etikprövning av forskning som avser människor

Abstract

The article provides a legal analysis of the legal requirement for ethical review of research conducted according to a method that aims to influence or involves an obvious risk of harming the research subject. The provision has a potentially very extensive area of application for social medicine research and has been criticized in a previous article in this journal for being unclear and open to interpretation. Our analysis shows that the meaning of the provision is indeed unclear, but for other reasons and in partly other respects than previously claimed. In addition, our discussion of the relationship between statements in the preparatory works and the Board of Appeal's application of the provision indicates that there is reason to consider, within the framework of the ongoing investigation into the scope of the Ethical Review Act, a delimiting specification of this requirement.