Monitoring Clinical Research: An Obligation Unfulfilled


Authors
Charles Weijer
University of Western Ontario
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
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Citations of this work BETA

Data and Safety Monitoring Boards: Some Enduring Questions.Charles J. Kowalski & Jan L. Hewett - 2009 - Journal of Law, Medicine and Ethics 37 (3):496-506.
Data and Safety Monitoring Boards: Some Enduring Questions.Charles J. Kowalski & Jan L. Hewett - 2009 - Journal of Law, Medicine and Ethics 37 (3):496-506.
Views and Experiences of IRBs Concerning Research Integrity.Robert Klitzman - 2011 - Journal of Law, Medicine and Ethics 39 (3):513-528.

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