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.
Highlights
The quest for important medical knowledge – the kind that clarifies understanding of or that leads to successful interventions for important clinical problems – has always required departure from accepted norms of medical practice
As recently as the early 1960s, peer review in research was viewed by many investigators and research administrators with the same suspicion that Percival undoubtedly encountered in the 1800s
How should the risks associated with medical research be dealt with, and, NIH = National Institutes of Health; research ethics boards (REBs) = research ethics board
Summary
The quest for important medical knowledge – the kind that clarifies understanding of or that leads to successful interventions for important clinical problems – has always required departure from accepted norms of medical practice. The current state of oversight and monitoring of clinical research make them the Achilles’ Heel of research ethics, the flaw that fatally weakens the rest of the operation These practices have long been recognized as essential 404 features of sound research ethics, they are seldom exercised in ways that fulfill their motivating goals, which are ‘to ensure that research is conducted as planned, that research subjects comprehend the information presented to them in the consent process, and that the potential benefits and risks of study participation remain acceptable’ [7]. Our researchers have responded very favourably to acknowledgement and support for the high standards of their conduct, and to recommendations for improvement, when these are warranted
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