Ambiguous articles in new EU Regulation may lead to exploitation of vulnerable research subjects.

Research involving minors or other incompetent subjects is ethically complex, particularly if the research does not directly benefit the subjects. Thus, many guidelines and regulations state that incompetent research subjects must not be included in such research unless it entails minimal risk and minimal burden. The new EU Clinical Trials Regulation adds the following to this well-known requirement: 'in comparison with the standard treatment of the subjects' condition'.

Improving the Helsinki Declaration's guidance on research in incompetent subjects.

Research involving children or other incompetent subjects who are deemed unable to provide informed consent is complex, particularly in the case of research that does not directly benefit the research subjects themselves. The Helsinki Declaration, the World Medical Association's landmark document for research ethics, therefore states that incompetent research subjects must not be included in such research unless it entails only minimal risk and minimal burden. In this paper, we argue that now that research in these groups is expected to expand, this undifferentiated minimal risk and burden requirement does not suffice any more.