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

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 emphasizes 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.PMID:33734933 | DOI:10.1080/03007995.2021.1905621
Source: Current Medical Research and Opinion - Category: Research Authors: Source Type: research