Monitoring clinical research: report of one hospital's experience

MONITORING OF RESEARCH BY RESEARCH ETHICS BOARDS HAS BEEN RECOMMENDED by various organizations that fund clinical studies and by other groups. However, little evidence has been reported on the processes, costs and outcomes of these activities, information that would be helpful to guide the boards in their current work and future policies. We report here 3 years of monitoring experience by the research ethics board of a 313-bed university-affiliated community hospital. Activities newly implemented at the beginning of the study period included the use of recruitment logs, audits of completed consent forms and interviews with research subjects. Over the study period, we monitored 33 protocols, through 188 consent form audits and interviews with 17 research subjects. In addition, 26 of 34 research investigators and collaborators responded to a survey about the monitoring. In general, the investigators were supportive of monitoring activities, but most were not willing to contribute financially. The types of monitoring we conducted are feasible and may be suitable (or could be adapted) for use in other institutions.