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.
journal_name
Crit Carejournal_title
Critical care (London, England)authors
Lavery JV,Van Laethem ML,Slutsky ASdoi
10.1186/cc2964keywords:
subject
Has Abstractpub_date
2004-12-01 00:00:00pages
403-5issue
6eissn
1364-8535issn
1466-609Xpii
cc2964journal_volume
8pub_type
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