Monitoring Clinical Research: An Obligation Unfulfilled
Document Type
Article
Publication Date
6-15-1995
Source
Canadian Medical Association Journal
Volume
152
Issue
12
First Page
1973
Last Page
1980
Abstract
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 such monitoring depends on the nature of the protocol. Although appropriate research monitoring requires substantial investment of personnel and financial resources, it is required under guidelines regulating research involving human subjects in Canada. Research monitoring is a step forward in re-establishing public confidence in medical research.
Notes
Reprinted in: Emanuel EJ, Crouch RA, Arras JD, Moreno JD, Grady C. (Eds.). Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. 2003. 425-429.
Dr. Charles Weijer is currently a faculty member of The University of Western Ontario.