Ethical review of patient safety and public health in eu clinical trials legislation: Impact of covid-19 pandemic

Abstract

Purpose: The study considers the ethical review of the European Union (EU) clinical trials (CTs) legislation, namely the Clinical Trials Regulation (CTR) (EU) 2014/536, the Directive 2001/20/EC and the “Guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic” (GMCT) (version 3) issued on 28 April 2020 by the European authorities in the field. Background: The Directive 2001/20/EC focuses the legal provisions for the conduct of CTs by acknowledging the screening role of the Ethics Committees (ECs) and of the national competent authorities (NCA) in the Member States (MS) to protect the CT subject and the personal data. Content: The present article displays the ethical requirements for conducting, monitoring and reporting of the CTs by raising awareness on the: (i) new conceptual framework of the “clinical trial”, “low-intervention clinical trial”, “non-interventional study” and “ethics committee”; (ii) ethical considerations addressed in Part I and Part II of the assessment report; (iii) evaluation of the coronavirus disease 2019 (COVID-19) pandemic on the current regulatory framework. Conclusions: The CTR stimulates the EU clinical research and enables an independent control with regard to the respect of the interests of the CT subject.