IRBs Could Use Pre-Clinical Data Better
In a Perspective article, James Lavery of the University of Toronto (uninvolved in the proposal) provides feedback on this proposal from the point of view of Institutional Review Boards (IRBs) and how they might better consider pre-clinical data in their deliberations. He says that the Kimmelman and London proposal is valuable "because it encourages IRB members, and other reviewers, to engage with less familiar challenges and guard against complacency in reviewing risk and benefit data from pre-clinical studies. But its true potential value likely lies in the extent to which it can forge agreement throughout the research enterprise on the need for more creative approaches to presenting and contextualizing pre-clinical evidence, and on broadening the base of responsibility for these difficult judgements."
Funding: The authors were supported by Canadian Institutes of Health Research (EOG 102823) and a fellowship from the Andrew W. Mellon Foundation. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing Interests: The authors have declared that no competing interests exist.
"Predicting Harms and Benefits in Translational Trials: Ethics, Evidence, and Uncertainty."
Kimmelman J, London AJ (2011)
PLos Med 8(3): e1001010.doi:10.1371/journal.pmed.1001010
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