MONITORING CLINICAL RESEARCH - AN OBLIGATION UNFULFILLED

The revelation that data obtained for the US-based National Surgical A djuvant Breast and Bowel Project (NSABP) from subjects enrolled at Hos pital Saint-Luc in Montreal was falsified has eroded public trust in r esearch. Institutions can educate researchers and help prevent unethic al research practices by establishing procedures to monitor research i nvolving human subjects. Research monitoring encompasses four categori es of activity: annual reviews of continuing research, monitoring of i nformed consent, monitoring of adherence to approved protocols and mon itoring of the integrity of data. The authors describe characteristics of research projects that may call for monitoring procedures in each category. The form taken by such monitoring depends on the nature of t he protocol. Although appropriate research monitoring requires substan tial investment of personnel and financial resources, it is required u nder guidelines regulating research involving human subjects in Canada . Research monitoring is a step forward in re-establishing public conf idence in medical research.