Abstract
Introduction
Regulation EU 536/2014 EU introduces a separation between two parts (technical-scientific aspects and locally relevant ethical aspects) in the assessment of applications for approval of trials and provides for each ‘Member State concerned’ to arrive at ‘one single decision’ regarding the application for authorisation to conduct a trial.
Proposals
The Regulation should be implemented in such a way as to avoid a separation between scientific assessment and ethical assessment; guarantee the absence of conflicts of interest in the institutions responsible for decision-making; promote efficiency on the part of ethics committees. In particular, (i) it is not appropriate to assess Parts I and II of the application for approval to conduct a trial separately (scientific soundness is the principal requisite for ethical soundness); (ii) conflicts of interest should be avoided, especially as regards links with the national authority responsible for drugs regulation; (iii) decision-making in each state should be the responsibility of a single coordinating ethics committee divided into sections specialising in different therapeutic fields; (iv) local committees affiliated to institutions where trial participants are recruited should be able to interact with the coordinating committee, provide consultation services—including on issues of clinical ethics—and promote training in the field of biomedical ethics.
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References
European Parliament, Council of the European Union (2014) Regulation (EU) 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Off J Eur Union L158:1–76
World Medical Association (1964-2013) Declaration of Helsinki. Ethical principles for medical research involving human subjects. www.wma.net/en/30publications/10policies/b3/. Accessed 11 November 2015
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World Health Organization (2015) WHO statement on public disclosure of clinical trial results. http://www.who.int/entity/ictrp/results/WHO_Statement_results_reporting_clinical_trials.pdf?ua=1. Accessed 11 November 2015
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Petrini, C., Garattini, S. Trials, Regulation and tribulations. Eur J Clin Pharmacol 72, 503–505 (2016). https://doi.org/10.1007/s00228-016-2009-1
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DOI: https://doi.org/10.1007/s00228-016-2009-1