PT  - JOURNAL ARTICLE
AU  - C. Weijer
AU  - S. Shapiro
AU  - A. Fuks
AU  - K. C. Glass
AU  - M. Skrutkowska
TI  - Monitoring clinical research: an obligation unfulfilled
DP  - 1995 Jun 15
TA  - Canadian Medical Association Journal
PG  - 1973--1980
VI  - 152
IP  - 12
4099  - http://www.cmaj.ca/content/152/12/1973.short
4100  - http://www.cmaj.ca/content/152/12/1973.full
SO  - CMAJ1995 Jun 15; 152
AB  - The revelation that data obtained for the US-based National Surgical Adjuvant Breast and Bowel Project (NSABP) from subjects enrolled at Hopital 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.