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Monitoring Clinical Research: An Obligation Unfulfilled
Canadian Medical Association Journal (1995)
  • Charles Weijer, McGill University
  • Stanley Shapiro, McGill University
  • Abraham Fuks, McGill University
  • Kathleen Cranley Glass, McGill University
  • Myriam Skrutkowska, McGill University

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.

  • Clinical Protocols,
  • Informed Consent,
  • Peer Review,
  • Research,
  • Research Support
Publication Date
June 15, 1995
Publisher Statement
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.
Citation Information
Charles Weijer, Stanley Shapiro, Abraham Fuks, Kathleen Cranley Glass, et al.. "Monitoring Clinical Research: An Obligation Unfulfilled" Canadian Medical Association Journal Vol. 152 Iss. 12 (1995)
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