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Ethical review of patient safety and public health in EU clinical trials legislation: impact of COVID-19 pandemic.
Olimid, Anca Parmena; Olimid, Daniel Alin.
  • Olimid AP; Faculty of Social Sciences, University of Craiova, Romania; parmena2002@yahoo.com.
Rom J Morphol Embryol ; 61(1): 277-281, 2020.
Article in English | MEDLINE | ID: covidwho-694465
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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Clinical Trials as Topic / Coronavirus Infections / Ethical Review / Ethics, Research / Health Policy Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Rom J Morphol Embryol Journal subject: Anatomy / Embryology Year: 2020 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Clinical Trials as Topic / Coronavirus Infections / Ethical Review / Ethics, Research / Health Policy Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Rom J Morphol Embryol Journal subject: Anatomy / Embryology Year: 2020 Document Type: Article