Research Ethics Committees: can they contribute to the improvement of clinical research in Europe?

Abstract

There is an increasing crisis of credibility in the world of clinical and epidemiological research because of lack of transparency in the identification of research priorities, increasing dominance of commercial interests over patients' problems, limited funds for independent research, and lack of awareness that clinical research is integral to the duties of clinicians as patients' agents. Research Ethics Committees (RECs) are an important component of the research world and since their institution there are expectations at their ability to protect patients and improve clinico-epidemiological research. To many people, however, the task of RECs is still essentially that of safeguarding the ethical/informed consent issues related to research protocols without a role in the core content (scientific and clinical) of the research projects themselves. Others argue that the duties of RECs should be broader because scientifically invalid research is in itself unethical. The remits of RECs, therefore, should embrace a full range of issues, from assessment of the core content of research (objectives, nonredundancy, clinical relevance, and likelihood of reaching the stated goals) to the protection of publication and dissemination rights of researchers from the intrusiveness of commercial sponsors. This debate is further complicated by current arrangements in countries where RECs' decentralization has made their operation less homogeneous and reproducible, with a diffuse discontent about the end results of their activities. In the first part of the article I discuss the evolution of the concept of the ethics of clinical research and the main differences in the arrangements of RECs across Europe. In the second part, after a brief discussion of the new European Directive on Clinical Trials and its potential problematic impact on publicly-funded trials, I propose a series of actions that should be taken to improve the functioning of RECs and outline the cultural changes needed for research of better methodological quality and of greater relevance to patients.