title: Division and discord in the Clinical Trials Regulation.
abstract: The Clinical Trials Regulation is intended to harmonise and streamline the review and conduct of clinical trials in the European Union. In this paper, we identify and analyse several serious issues concerning the division imposed by the Regulation between scientific review and ethical review. We conclude that these problems may compromise the objectives of the Regulation.
authors.affiliation: Department of Health, Ethics and Society, CAPHRI Research School, Maastricht University, Maastricht, the Netherlands.|Institute for Biomedical Ethics, University of Basel, Basel, Switzerland.
authors.forename: David
authors.initials: D
authors.lastname: Shaw
authors.affiliation: Department of Health, Ethics and Society, CAPHRI Research School, Maastricht University, Maastricht, the Netherlands.
authors.forename: David
authors.initials: D
authors.lastname: Townend
keywords: Clinical trials; Ethics Committees/Consultation; Policy Guidelines/Inst. Review Boards/Review Cttes.