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

BackgroundFor approximately six decades, Research Ethics Committees (RECs), also known as Institutional Review Boards (IRBs), have played an integral part in the identification of ethical issues before the commencement of clinical research globally. The importance and relevance of the REC/IRB prospective review are widely acknowledged, admired, and critiqued. In many jurisdictions, legislative and policy frameworks are in place to prevent clinical research from taking place without prior review and approval by a REC/IRB. It is, therefore, reasonable to assume that research with a favorable opinion of a REC/IRB is ethically sound and scientifically appropriate. There is evidence, however, that researchers may deviate from the approved protocols. Many of these deviations are ethically relevant yet remain unaddressed. These unaddressed deviations form the basis for this interrogative thesis into the post-approval role of RECs/IRBs. It employs the sociological frame of role theory to illuminate concepts such as role expectations, identity, and behavior concerning REC/IRBs in the post-approval oversight of clinical trials. MethodsQualitative research methods were employed to explore the main objectives. The research approach includes hermeneutic content analysis combined with thematic analysis to guide data extraction, reading, interpretation, and reporting. The primary data sources were regional and international normative documents related to clinical research and REC/IRBs in Europe and the USA and US Academic health center IRBs' web page content. Stakeholder engagement included REC representatives in Europe using the European Network for Research Ethics Committee (EUREC) member list. ResultsThe general post-approval role expectations of REC/IRBs are 1) to review significant protocol amendments and issue opinions or approval on these amendments, 2) to receive notification of safety and adverse events reports, and 3) to receive notification of the end of a trial and a final report. There is disagreement between regions on whether RECs ought to conduct continuing reviews. Within the EU and allied countries, continuing review is considered a form of active monitoring delegated to the regulatory authorities. Contrariwise, the law mandates continuing review within the USA, which is also distinguished from active monitoring. There are challenges with the use of and interpretation of clinical trial nomenclature. The authority of US IRBs to suspend and terminate trials is not commonplace in the EU. Conclusion/RecommendationsThe overarching role expectation of REC/IRBs after the approval of clinical trial protocols is to protect research participants. This may be achieved through post-approval activities such as continuing review, active monitoring, ethics support and education to researchers, and the issuance of an opinion on the final reports at the end of clinical trials. There may be hesitancy in European countries to conduct active follow-up of approved trials due to a lack of supporting legislation/policy, types of org...