title: Ambiguous articles in new EU Regulation may lead to exploitation of vulnerable research subjects.
abstract: 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'. In this paper, I argue that this addition can be interpreted in different ways. According to one of the possible interpretations, it means that research risks and burdens can be regarded as minimal for a certain group of subjects if they are comparable to those that the subjects have to undergo when being treated for their conditions. As the standard treatments of many conditions are quite risky and burdensome, this interpretation allows for research with risks and burdens far exceeding the level usually regarded as minimal, without explicitly saying so. This is worrisome, because such a lack of clarity may compromise thorough review and valid informed consent procedures and consequently may lead to exploitation of these vulnerable groups. If Europe wants to allow for exceptions to the minimal risk and burden requirement, it should explicitly acknowledge this step as such and accurately formulate in which cases such exceptions are justified.
authors.forename: Anna Eva
authors.initials: AE
authors.lastname: Westra
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D032984:Ethics, Research; D005062:European Union; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence; D016743:Mental Competency / Q000331:legislation & jurisprudence; D033242:Minors / Q000331:legislation & jurisprudence; D035842:Research Subjects / Q000331:legislation & jurisprudence; D018570:Risk Assessment; D035862:Vulnerable Populations / Q000331:legislation & jurisprudence
keywords: Children; Clinical trials; Competence/incompetence; Research Ethics; Research on Special Populations