The role of research ethics committees after the approval of clinical trial protocols in the EU and the USA: a descriptive content analysis of international and regional normative documents

Abstract

Aim

To conduct a descriptive content analysis of normative documents on the role of research ethics committees (RECs) after the approval of clinical trial protocols. The question to be addressed is whether and to what extent normative documents support a monitoring role for RECs in the United States and the European Union.

Design

A qualitative content analysis of 19 normative documents on clinical research as outlined by the International Compilation of Human Research Standards 2020 edition and other related documents for the EU and USA.

Results

After the approval of research protocols, RECs’ general role is to receive reports from researchers on the trials’ progress. Additionally, RECs receive notifications of protocol amendments, deviations and, to a lesser extent, violations, which is the remit of the regulatory/competent authorities. RECs are expected to issue opinions on clinical trials’ progress and give supplemental opinions/approval or withdraw/suspend/terminate previous favorable opinions on adverse events or safety concerns that may arise. RECs are to receive an end of the trial report.

Conclusion

The role of RECs post approval of protocols is to protect human participants through activities such as continuing review of: (a) progress reports, (b) notifications of significant protocol amendments, (c) adverse events, (d) protocol deviations, and (e) protocol violations. Although some international guidelines such as the Declaration of Helsinki emphasize the right to monitor, RECs’ predominant activity is document review. In the USA, RECs are authorized to issue approvals and terminate/suspend previously issued approvals. However, in the EU, the approach is to relegate to member states to decide the extent of legislative power they wish to give to the RECs. The REC’s opinion on the end of trial report is identified as an area for further exploration.

Keywords:

• Ethics committees
• Institutional review board
• role
• clinical trials
• post approval
• post-trial

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

S.C., J.H.S. and R.D.L.C.B. have disclosed that they are employees of the University of Oslo, Norway. CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

All the authors were involved in the entire process of developing this manuscript. S.C. is the main author and did most of the core research. There were regular meetings with supervisors R.D.L.C.B. and J.H.S. throughout the research process. All authors were involved in conceptualization, design, analysis and interpretation. The manuscript was drafted by S.C., while the other authors were involved in the revision and final version to be published.

Acknowledgements

No assistance in the preparation of this article is to be declared.