RESUMEN
AIM: To assess the range of issues that arise for researchers, research participants and ethics committee members in the setting of a hospital-based research environment and to develop a tool that could be used to assist in the process of monitoring. METHODS: A qualitative phase comprising focus group sessions and interviews involving research participants, researchers and ethics committee members of a public teaching hospital and a quantitative phase involving distribution of a questionnaire to research participants and researchers. The data from the qualitative phase were used to assist with the development of the quantitative instrument. Descriptive statistics were derived to describe the various attitudes and practices with respect to the conduct of research. RESULTS: The qualitative study identified issues concerning monitoring procedures and the quality of communication between researchers and study participants. The quantitative analysis showed that parts of the Explanatory Statement (also known as the Participant Information Statement) were incomprehensible to 21% of research participants; the Explanatory Statement was considered too long by 34% of researchers; 6% of researchers believed that explicit consent was not always necessary; of the participants who were out of pocket for attending a study, 53% were offered compensation; and 44% of research participants were unaware of the existence of the ethics committee. In addition, 12% of researchers felt that the quality of monitoring should be improved. CONCLUSIONS: Improvements are necessary in the communication between ethics committees and researchers and research participants, and there is a need for more effective monitoring by ethics committees of research practices. The questionnaire designed for this study could be applied in a prospective manner as a useful tool for monitoring the conduct of research.