Content area
Full Text
Abstract
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.
Monitoring of clinical research enables research ethics boards to ensure that the standards that they approve in theory are being applied in practice.1,2 It has been suggested that such review be performed regularly, (e.g., annually) and that it include monitoring of a variety of aspects of research, such as the consent process, adherence to the approved protocol and data integrity.1,3 Although various bodies have recommended that research be monitored as it progresses, a study over the period 1990 to 1993 indicated that few research ethics boards affiliated with Canadian faculties of medicine monitored projects after they had been approved .4
In 1998 the 3 Canadian government research funding bodies issued the TriCouncil Policy Statement: Ethical Conduct for Research Involving Humans,5 which requires each institution conducting funded research to establish a monitoring program. The policy statement suggests that, in addition to the minimum requirement of submission of an annual status report to the research ethics board, review of research projects exceeding the threshold of minimal risk might include the following aspects: formal review of the informed consent process, establishment of a committee to monitor safety, periodic review by a third party of the documents generated by the study, review of reports of adverse...