A European consistency for functioning of RECs? We just lost our chance
- Correspondence to Dr Marcin Waligora, Department of Philosophy and Bioethics, Jagiellonian University, Medical College, Michalowskiego 12, Krakow 31-126, Poland;
- Received 9 November 2012
- Accepted 13 November 2012
- Published Online First 8 December 2012
On 17 July 2012, the European Commission formally adopted a proposal for a new European Union (EU) Directive regarding clinical trials, which will repeal and replace the existing Directive 2001/20/EC. The main reasons for the revision were: (1) the decreasing number of clinical trials in the region and (2) harsh criticism of the present version of the Directive. The proposed regulation could simplify the rules for conducting clinical trials and also rebuild the entire system of clinical trial assessment. However, it seems that we probably have already lost our chance regarding the consistency and quality of functioning of research ethics committees in the EU.
- Clinical trials
- Drugs and Drug Industry
- Ethics Committees/Consultation
- Research Ethics
On 17 July 2012, the European Commission formally adopted a proposal for a new European Union (EU) Directive regarding clinical trials, which will repeal and replace the existing Directive 2001/20/EC. The proposal was adopted after 3 years of debate. The main reasons for the revision were: (1) the decreasing number of clinical trials in the region and (2) harsh criticism of the present version of the Directive. Researchers and sponsors frequently complain that the present Directive is overly bureaucratic and creates many unnecessary difficulties in conducting clinical trials in the EU. This may partially explain why there were only 3800 applications to conduct trials in the region last year, compared with 5028 applications in 2007 (a 25% decrease). Moreover, the cost of conducting clinical trials has significantly increased. For instance, insurance fees have increased by 800% for industry sponsors due to Directive 2001/20/EC. The average delay to initiate clinical trials increased by 90%.1
One of the most criticised elements of the current system is the two-tier assessment procedure. Two review bodies, a research ethics committee (REC) and a national competent body, must each evaluate the same clinical trial protocol. This requirement will change. The Commission proposes to create a portal to submit an application for a clinical trial. The portal will be managed by the Commission and is free of charge for sponsors. Many other rules will be standardised and unified throughout the EU. The authorisation procedure for conducting clinical trials will be faster. The reporting procedure will be simplified, and information about the results of the trial more transparent. The Commission will have the opportunity to conduct controls in member statesto ensure that the new rules are appropriately introduced and supervised.
Other notable features of the new proposal include:
The rules on informed consent will not be changed. However, to address the specificity of the clinical trials in emergency situations, some additional requirements have been added. Emergency research was regulated in different ways2 throughout the EU or not regulated at all.3
‘Clinical trials are increasingly initiated by loose networks of scientists or scientific institutions within one Member State or across several Member States’.1 Thus a new regulation introduces the concept of ‘co-sponsorship’ clinical trials with a requirement of clear information about the body responsible for a trial.
A proposed regulation distinguishes between clinical trials which ‘do not pose an additional risk to subjects compared to treatment in normal clinical practice’1 and those which do pose an additional risk. There is no requirement to provide additional insurance in case of the former, but there is in the case of the latter. Generally, the new regulation clearly distinguishes types of risk (risk to subject safety and the risk of data reliability), as well as the proportionality of risk.
Each member state will define their national assessment process. Although the assessors must be independent, it is not clearly stated that it has to be RECs: ‘The proposed Regulation does not, unlike Directive 2001/20/EC, establish which body or bodies within a Member State approves (or not) a clinical trial’.1
The latter is criticised by The European Network of Research Ethics Committees (EUREC). EUREC alerts that such wide discretion in constituting national assessments processes runs a real risk of strengthening different standards of authorisation of trials across the EU. Giving sponsors additional opportunity to choose which member state to nominate as the reporting member state creates an additional risk of choosing the member state with a weak assessment regime.4 Certainly, there are some doubts whether already existing member states’ assessments bodies work appropriately.5 Eugenijus Gefenas et al stressed that some RECs could function only as a ‘rubber stamp’ to legitimise research.6 Richard Ashcroft warns that ethics committees in countries in transition could become only a ‘moral figleaf’ covering the structural violence.7
Thus, many commentators suggested a new proposed regulation that gives the opportunity to create a law which establishes consistency of functioning of RECs across the EU. ‘The current two-tier assessment system’—wrote Marcel Kenter and Adam Cohen—‘should be replaced by one integrated assessment and the establishment of a transparency quality and accreditation system for RECs in the EU’.8
Indeed, the organisation of RECs in the EU varies widely. There are differences in the number of RECs in various countries, from one REC in Portugal, Romania, Hungary and Slovenia, to 52 in Poland, to 136 in Spain. There are also stark differences in the required number of lay members; RECs in The Netherlands only need one lay member, as compared with boards in nearby Denmark, where half the members must come from the community. Kenter and Cohen underlined that the ‘assessment of drug trials is probably equally diverse’.8
Unfortunately, the new European Commission proposal is not going to change this alarming situation. ‘The proposed Regulation does hence not regulate or harmonise the precise functioning of Ethics Committees, impose a systematic cooperation at an operational level between Ethics Committees in the EU, or limit the Ethics Committee's scope of the assessment to genuinely-ethical issues (science and ethics cannot be separated). Rather, the proposal leaves it up to Member States to organise, internally, the attribution of tasks to different bodies’. The proposed regulations contain only general hints regarding the RECs: ‘application of a clinical trial will have to be assessed jointly by a reasonable number of persons who are independent, who have collectively the necessary qualifications and experience in all relevant fields, including the view of a lay person’.1
The proposed regulation could simplify the rules for conducting clinical trials and also rebuild the entire system of clinical trial assessment. However, it seems that we probably have already lost our chance regarding the consistency and quality of functioning of RECs in the EU.
The author would like to thank Sean Philpott and Phyllis Zych Budka for comments and suggestions on earlier drafts.
Funding National Science Centre, Poland, DEC-2011/03/D/HS1/01695.
Competing interests None.
Provenance and peer review Not commissioned; externally peer reviewed.