Monitoring and oversight in critical care research

doi:10.1186/cc2964

Critical Care
Volume 8
Issue 6

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Slutsky AS

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This article is part of a series on Ethics, edited by Dr Laura Hawryluck.

Commentary

Monitoring and oversight in critical care research

James V Lavery¹ , Marleen LP Van Laethem² and Arthur S Slutsky³

¹Research Scientist, Centre for Global Health Research and Inner City Health Research Unit, St. Michael's Hospital, and Assistant Professor, Department of Public Health Sciences and Joint Centre for Bioethics, University of Toronto, Toronto, Canada

²Research Ethics Monitor, St. Michael's Hospital, Toronto, Canada

³Vice President, Research, St. Michael's Hospital, and Division Director, Interdepartmental Division of Critical Care Medicine, Professor of Medicine, Surgery and Biomedical Engineering, University of Toronto, Toronto, Canada

author email corresponding author email

Critical Care 2004, 8:403-405doi:10.1186/cc2964


Published:	28 September 2004

Abstract

Institutionally based research ethics review is a form of peer review that has – for better or worse – become the norm throughout the world. The vast majority of research ethics review takes the form of protocol review alone, conducted in advance of the research. Although oversight and monitoring in clinical research have long been recognized as essential features of sound research ethics, they are seldom exercised in ways that fulfill their motivating goals: to ensure that research is conducted as planned; that research participants comprehend the information presented to them in the consent process; and that the potential benefits and risks of study participation remain acceptable. Annual review of continuing research, monitoring informed consent, monitoring adherence to approved protocols and monitoring integrity of research data comprise the main types of monitoring and oversight activity. We believe that our institutionally based systems of research ethics review and responsibility require greater engagement and participation from researchers and research administrators. The appropriate role of critical care researchers and research administrators is to provide leadership to move toward a greater recognition of the importance of monitoring and oversight for ethical and high quality clinical research.