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A decision tool to guide the ethics review of a challenging breed of emerging genomic projects


Joly, Y and So, D and Osien, G and Crimi, L and Bobrow, M and Chalmers, D and Wallace, SE and Zeps, N and Knoppers, B, A decision tool to guide the ethics review of a challenging breed of emerging genomic projects, European Journal of Human Genetics, 24 pp. 1099-1103. ISSN 1476-5438 (2016) [Refereed Article]

Copyright Statement

Copyright 2016 Macmillan Publishers Limited

DOI: doi:10.1038/ejhg.2015.279


Recent projects conducted by the International Cancer Genome Consortium (ICGC) have raised the important issue of distinguishing quality assurance (QA) activities from research in the context of genomics. Research was historically defined as a systematic effort to expand a shared body of knowledge, whereas QA was defined as an effort to ascertain whether a specific project met desired standards. However, the two categories increasingly overlap due to advances in bioinformatics and the shift toward open science. As few ethics review policies take these changes into account, it is often difficult to determine the appropriate level of review. Mislabeling can result in unnecessary burdens for the investigators or, conversely, in underestimation of the risks to participants. Therefore, it is important to develop a consistent method of selecting the review process for genomics and bioinformatics projects. This paper begins by discussing two case studies from the ICGC, followed by a literature review on the distinction between QA and research and a comparative analysis of ethics review policies from Canada, the United States, the United Kingdom, and Australia. These results are synthesized into a novel two-step decision tool for researchers and policymakers, which uses traditional criteria to sort clearly defined activities while requiring the use of actual risk levels to decide more complex cases.

Item Details

Item Type:Refereed Article
Research Division:Law and Legal Studies
Research Group:International and comparative law
Research Field:International humanitarian and human rights law
Objective Division:Expanding Knowledge
Objective Group:Expanding knowledge
Objective Field:Expanding knowledge in law and legal studies
UTAS Author:Chalmers, D (Professor Don Chalmers)
ID Code:106061
Year Published:2016
Deposited By:Law
Deposited On:2016-01-27
Last Modified:2017-11-09

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