Research ethics committees in Europe: implementing the directive, respecting diversity

A Hedgecoe, F Carvalho, P Lobmayer… - Journal of medical ethics, 2006 - jme.bmj.com
With the recent Clinical Trials Directive, a degree of harmonisation into research ethics
committees (RECs) across Europe, including the time taken to assess a trial proposal and …

Harmonisation of ethics committees' practice in 10 European countries

R Hernandez, M Cooney, C Dualé, M Gálvez… - Journal of Medical …, 2009 - jme.bmj.com
Background: The Directive 2001/20/EC was an important first step towards consistency in
the requirements and processes for clinical trials across Europe. However, by applying the …

Research ethics committees in the regulation of clinical research: comparison of Finland to England, Canada, and the United States

E Hemminki - Health research policy and systems, 2016 - Springer
Background The aim of this paper is to compare common features and variation in the work
of research ethics committees (RECs) in Finland to three other countries–England, Canada …

Standards for research ethics committees: purpose, problems and the possibilities of other approaches

H Davies, F Wells, M Czarkowski - Journal of Medical Ethics, 2009 - jme.bmj.com
Criticism of ethical review of research continues and research ethics committees (RECs)
need to demonstrate that they are “fit for purpose” by meeting acknowledged standards of …

Research ethics committees: agents of research policy?

E Hemminki - Health Research Policy and Systems, 2005 - Springer
The purpose of this commentary is to describe the unintended effects ethics committees may
have on research and to analyse the regulatory and administrative problems of clinical trials …

New governance arrangements for research ethics committees: is facilitating research achieved at the cost of participants' interest

E Cave, S Holm - Journal of Medical Ethics, 2002 - jme.bmj.com
This paper examines the UK's response to a recent European Clinical Trials Directive,
namely the Department of Health, Central Office for Research Ethics Committee guidance …

Impact of recent legislative bills regarding clinical research on Italian ethics committee activity

L Porcu, D Poli, V Torri, E Rulli, MC Di Tullio… - Journal of medical …, 2008 - jme.bmj.com
Aims and background: The present work assessed the impact of two decrees on ethics
committees in Italy, aimed at bringing the national laws on the conduct of clinical trials into …

Evaluation of research ethics committees: Criteria for the ethical quality of the review process

G Scherzinger, M Bobbert - Accountability in research, 2017 - Taylor & Francis
Repeatedly, adequacy, performance and quality of Ethics Committees that oversee medical
research trials are being discussed. Although they play a crucial role in reviewing medical …

Rethinking the role of Research Ethics Committees in the light of Regulation (EU) No 536/2014 on clinical trials and the COVID‐19 pandemic

S Tusino, M Furfaro - British Journal of Clinical Pharmacology, 2022 - Wiley Online Library
Research Ethics Committees (RECs)—or Institutional Review Boards (IRBs), as they are
known in the US—were created about 50 years ago to independently assess the ethical …

Research ethics committees and post-approval activities: a qualitative study on the perspectives of European research ethics committee representatives

S Cox, JH Solbakk, RDLC Bernabe - Current Medical Research …, 2022 - Taylor & Francis
Objective To explore the views of Research Ethics Committee (REC) representatives in the
European Union (EU) on what the status quo is in terms of RECs' activities after the approval …