title: Monitoring and oversight in critical care research.
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.
authors.affiliation: Centre for Global Health Research and Inner City Health Research Unit, St. Michael's Hospital, Department of Public Health Sciences and Joint Centre for Bioethics, University of Toronto, Toronto, Canada. laveryj@smh.toronto.on.ca
authors.forename: James V
authors.initials: JV
authors.lastname: Lavery
authors.forename: Marleen L P
authors.initials: ML
authors.lastname: Van Laethem
authors.forename: Arthur S
authors.initials: AS
authors.lastname: Slutsky
mesh_terms: D035843:Biomedical Research / Q000592:standards*; D002170:Canada; D002985:Clinical Protocols; D003422:Critical Care; D028744:Ethics Committees, Research / Q000458:organization & administration*; D006801:Humans; D018579:Patient Selection; D017712:Peer Review, Research