Over-regulation of clinical research: a threat to public health

Abstract

Clinical research is subject to increasing regulation by research ethics committees and research and development offices which are responding to social and political pressures, as well as to new legislation, both European and national, some of which is still being worked out. The resulting bureaucracy, expense and confusion are putting insuperable hurdles in the way of clinical research and clinical care is compromised. What research is still possible will only be done in large organisations and may even be seriously biased. The solutions are to inform and seek the help of the public and to forge alliances with patient groups. Patients have far more to lose than clinical researchers who, if clinically qualified, can more easily pursue a fulfilling career as clinicians rather than researchers.