Monitoring clinical research

Research ethics boards are social oversight mechanisms set up to ensure that all human research subjects are protected. Little evidence has been reported on the processes, costs and outcomes of the activities of these bodies.

In this issue of CMAJ, Jane McCusker and colleagues report on 3 years of monitoring experience by the research ethics board of a 313-bed university-affiliated hospital in Montreal. The authors monitored 33 protocols through 188 consent-form audits and interviews with 17 research subjects. The authors report most investigators supported monitoring (67%), but few (19%) thought that research grants should cover the associated costs. The study�s authors conclude that the types of monitoring conducted as part of the study were feasible and important given that they revealed several problems in obtaining informed consent (language barriers, perceived pressure to participate in studies etc.).

In a related commentary, bioethicist Dr. Charles Weijer says the study raises some interesting issues, particularly who should pay the costs associated with ethical monitoring activities.

Monitoring clinical research: report of one hospital�s experience
� J. McCusker et al

Continuing review of research approved by Canadian research ethics boards
� C. Weijer
(Dr. Charles Weijer, Department of Bioethics at Dalhousie University in Halifax can be reached at 902-494-3801