Research ethics committees and post-approval activities: a qualitative study on the perspectives of European research ethics committee representatives

Abstract

Objective

To explore the views of Research Ethics Committee (REC) representatives in the European Union (EU) on what the status quo is in terms of RECs’ activities after the approval of trial protocols for clinical studies.

Method

This is a qualitative study. The participants in this study are members or representatives of a research ethics committee from the member countries of the European Network of Research Ethics Committees (EUREC) and the United Kingdom. Thematic analysis was the method to assess interview transcripts.

Results

Interviews of REC representatives from 19 countries across Europe reveals that REC post-approval activities are predominantly limited to review and approval of protocol amendments. The majority of the RECs do not have mandatory continuing reviews or receipt of notifications of adverse events or protocol violations. In fact, most post-approval activities are the remit of the regulatory authorities. The interviewed members were also of the opinion that RECs in the EU do not have the legislative support, the organizational structure, the expert staff nor time to do active post approval follow-up.

Conclusions

Post-approval follow-up activities for clinical studies by RECs is a valuable resource and means for early detection and resolution of protocol deviations and violations. However, a majority of RECs within Europe do not have active post-approval follow-up of approved protocols. The interviews revealed that resource challenges such as time, personnel, and organizational structure contribute to the lack of follow-up by RECs. Some RECs in the represented countries do not identify post-approval follow-up as part of their mandate but instead place emphasis on the culture of trust between the RECs and researchers. Current EU Regulations do not directly address the role of the REC after the approval of clinical trials.

Keywords:

• Clinical trials
• compliance
• institutional review boards
• post-approval monitoring
• research ethics committees
• responsibility
• research integrity

Transparency

Declaration of funding

This manuscript was developed as part of a project at the Centre for Medical Ethics, University of Oslo. There was no external funding.

Declaration of financial/other relationships

The authors are employees of the University of Oslo, Norway. There are no conflicts of interest to declare. A reviewer on this manuscript has disclosed that they are a chair of three research ethics committees and also conduct research in this area. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Author contributions

All the authors were involved in the entire process of developing this manuscript. Shereen Cox, Doctoral Research Fellow, is the main author and did most of the core research. There were regular meetings with supervisors, Professors Rosemarie de la Cruz Bernabe and Jan Helge Solbakk throughout the research process. All authors were involved in conceptualization, design, interviews, analysis, and interpretation. The manuscript was drafted by Shereen Cox, while the other authors were involved in the revision and final version to be published.

Acknowledgements

The authors would like to acknowledge the editorial contribution of researcher Dr. Vivian Mbanya.

Notes

i Structure and Organization of RECs in Europe-The EU Directives 2001/20/EC and 2005/28/EC and subsequently the EU Regulation 536/2014 govern the EU countries regarding good clinical practice in clinical trials, with Norway and the UK having harmonized regulations. The EU Regulation 536/2014 also provides a basis for harmonization in terms of the composition and procedure of EU RECs. The organization of RECs within the various EU countries is: (1) national, (2) regional, and (3) institutional (university or hospital). These countries have legislation for regulating clinical trials. The legislation governs the activities of the regulatory authority (RA) (also known as the medicines/drug board) and RECs. Based on a requirement in law, clinical trial protocols must have the favorable opinion/approval of both the regulatory authorities and the ethics committees prior to commencement of actual research. The favorable opinion of the REC is usually required prior to RA approval.

ii Alexander Kon describes Lay of the land as ¨studies that seek to define current practices, opinions, beliefs, of other aspects that may be considered the status quo. Such studies may be descriptive or explanatory in nature….asking questions such as what do ….think about x? This work sets the stage for further research"¹⁵.