Facilities and equipment

Abstract

The facilities in which clinical research is conducted obviously vary enormously with circumstances. High quality research which has far reaching consequences can be performed in some of the poorest countries in the world using the most basic facilities. Conversely, research of inferior quality is sometimes performed in teaching hospitals and purpose-built contract research organisations in the West. Nevertheless, it is common sense that failure to be adequately equipped to meet the requirements of conducting a specific study in humans will have a negative impact on the quality of data obtained and is likely to compromise the safety of the subjects. The Association of the British Pharmaceutical Industry (ABPI) has therefore issued guidelines on minimum standards for facilities for the conduct of studies in non-patient volunteers and, in our view, these standards are applicable to most clinical research that is conducted on inpatients as well. While these guidelines are not legally binding there are certainly medico-legal implications for clinicians conducting research in conditions which do not meet the requirements and everyone involved in such activities should be familiar with them.