Implementation of the EU clinical trial regulation transforms the ethics committee systems and endangers ethical standards

Abstract

The upcoming Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use (Regulation), which will replace the current Clinical Trial Directive at the end of 2021, has triggered a significant reform of research ethics committee systems in Europe. Changes related to ethics review of clinical trials in the EU were considered to be essential to create a more favourable environment to conduct clinical trials in the EU. The concern is, however, that the role of the research ethics committees will weaken in at least some of the Member States because the new Regulation allows narrowing down the scope of ethics review as compared with the currently valid Clinical Trial Directive. Although the new Regulation may lead to faster approval procedures for clinical trials, which is especially relevant in the context of pandemics, high-quality ethics reviews integrating methodological aspects of a clinical trial should nevertheless be ensured. To maintain high research ethics standards as well as to foster measures to mitigate potential negative consequences of the reform, it is therefore of vital importance to start debating and sharing the reflections about the potential consequences of these transformations and trends as soon as possible.

Characterizing pharmacogenetic programs using the consolidated framework for implementation research: A structured scoping review

“…Several organizations implemented pharmacogenetics within the context of a research trial, requiring formal written consent approved under research ethics. The structure and governance of these trials varied and, in part, was prescribed by the prevailing regulatory landscape for conducting clinical research ( 27 , 28 ). Some of these studies were focused on specific populations or disease states as part of the research design.…”

The Multidimensional Nature of Research Ethics: Letters Issued by a French Research Ethics Committee Included Similar Proportions of Ethical and Scientific Queries

“…Therefore, the dichotomy between science and ethics during research review needs to be questioned further (Angell et al, 2008; Dawson & Yentis, 2007). The current implementation of European Union regulation 536/2014 leads to a clear separation of those two fields and so influences RECs (Lukaseviciene et al, 2020; Tusino & Furfaro, 2021). The scope of ethics review may be narrower in some countries because their RECs only analyze ethical documents, whereas scientific documents (protocols, investigator brochures) are analyzed separately and centrally.…”

“…Analysis of REC letters to researchers enables the definition of what RECs identify as attributions in their role as gatekeepers. In most cases, authors classify REC queries according to predetermined categories on the basis of ethical guidelines, whereas other authors base their analyses on identifying problematic documents within research folders (Dal-Ré et al, 2004; Happo et al, 2017; Hemminki et al, 2015; Lukaseviciene et al, 2020; Martín-Arribas et al, 2012; Silaigwana & Wassenaar, 2019; Tersmette & Engberts, 2017). Informed consent is the most frequent topic of queries from RECs (and therefore, informed consent documents are the most common problematic documents) (Boyce, 2002; Decullier et al, 2005; Tsoka-Gwegweni & Wassenaar, 2014).…”

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

“…36 The idea that basic aspects of clinical trials-like its methodology, clinical relevance, objectives, the admissibility of placebo and the risk/benefit ratio-do not require an ethics review is clearly incoherent with the role of RECs as described above and is in contrast with the main international documents relevant to the ethics of research with human subjects. 38 CIOMS Guideline 23 is very clear in this regard: "research ethics committees must always have the opportunity to combine scientific and ethical review in order to ensure the social value of the research […] The ethical review must consider, among other aspects: the study design; provisions for minimizing risk; an appropriate balance of risks in relation to potential individual benefits for participants and the social value of the research; safety of the study site, medical interventions, and monitoring safety during the study; and the feasibility of the research". 9(p88) That in some European countries this could soon not be the case anymore is indeed very worrisome.…”

“…18) and some member states have already opted for narrowing the scope of the ethics review performed by RECs to Part II. 38 For this reason commentators wrote that the new Regulation "defeats the role of ethics committees" 39(p504) that are gravely marginalized. 36 The idea that basic aspects of clinical trials-like its methodology, clinical relevance, objectives, the admissibility of placebo and the risk/benefit ratio-do not require an ethics review is clearly incoherent with the role of RECs as described above and is in contrast with the main international documents relevant to the ethics of research with human subjects.…”