title: Reforming the EU Clinical Trials Directive: streamlining processes or a radical "new" agenda?.
abstract: From its conception the EU Clinical Trials Directive met with controversy. Some saw it as an unnecessary inhibitor to scientific research, introducing bureaucracy which was unduly expensive, slowing down the clinical trial approval system. The Directive however also enshrined respect for fundamental rights in relation to clinical trials decision-making and impacted upon the domestic law of member states facilitating the alignment of trial review processes. Nearly a decade after its implementation the EU is moving towards implementation of further reform in this area, from a Directive to a Regulation, from a system placing the research ethics system at the heart of the clinical trials approval committee to one which does not and which represents a see change in international and domestic approaches to research ethics. This article critically examines the proposed reform of the regulation of clinical trials on medicinal product through the introduction of a new EU Regulation and asks whether this can be seen as a natural streamlining of processes or a radical new agenda in EU health law and regulation.
authors: Birmingham Law School, University of Birmingham, UK.
authors: Jean V
authors: JV
authors: McHale
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence*; D028744:Ethics Committees, Research; D005062:European Union; D006805:Human Experimentation / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D016743:Mental Competency / Q000331:legislation & jurisprudence