European ethics committees in transition: challenges of new requirements

Abstract

Guided by the example of ethics committees in medicine, the ethical review system of research projects in Europe is increasingly expanding to other disciplines such as psychology, the social sciences, and engineering, especially when human subjects are directly involved or personal data are collected. However, ethical reviews are not uniformly regulated in most European countries.With the new EU Regulation No. 536/2014, which is expected to come into force in 2020, it is intended to standardize the work of medical research ethics committees for clinical trials. Clear deadlines and the use of acentral electronic EU portal are also given in order to accelerate the approval process for economic reasons. Member states are left free in terms of the scope of the ethical review, but this would run counter to unification and could lead some to choose atest model that excludes the evaluation of the methodology and risks of astudy and thus contributes less to the protection of the participants.The European Research Ethics Committees have been working together since 2005 within the European Network of Research Ethics Committees (EUREC). For adiscussion on the impact and implementation of the new EU Regulation and on the development of the EU portal, EUREC has provided aforum for aqualified debate.In this period of change, it is not clear yet which direction the ethics committees will develop. Professional management can have apositive impact on the quality of the ethics review. However, the marginalization inherent in the EU Regulation is counteracting the increasing evaluation of nonmedical research projects and adequate protection of subjects.