Medicine and Health Sciences Commons^™

Monitoring Clinical Research: An Obligation Unfulfilled, Charles Weijer, Stanley Shapiro, Abraham Fuks, Kathleen Glass, Myriam Skrutkowska

Charles Weijer

The revelation that data obtained for the US-based National Surgical Adjuvant Breast and Bowel Project (NSABP) from subjects enrolled at Hôpital Saint-Luc in Montreal was falsified has eroded public trust in research. Institutions can educate researchers and help prevent unethical research practices by establishing procedures to monitor research involving human subjects. Research monitoring encompasses four categories of activity: annual reviews of continuing research, monitoring of informed consent, monitoring of adherence to approved protocols and monitoring 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 …