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Review
. 2016 Aug;24(8):1099-103.
doi: 10.1038/ejhg.2015.279. Epub 2016 Jan 20.

A Decision Tool to Guide the Ethics Review of a Challenging Breed of Emerging Genomic Projects

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Review

A Decision Tool to Guide the Ethics Review of a Challenging Breed of Emerging Genomic Projects

Yann Joly et al. Eur J Hum Genet. .
Free PMC article

Abstract

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.

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Figure 1
Figure 1
A decision tool for assessing proposed QA projects in a research context. A decision tree to facilitate the classification of activities undertaken in genomics projects. The colored bar represents the spectrum between QA and research, with activities of uncertain type falling in the middle. The six criteria determining where a project falls are listed above the bar. Below each extreme of the spectrum, the flowchart indicates the appropriate level of ethics review, whereas the middle section proceeds to a second level of review. This step uses the criterion of risk level to divide projects between the use of exemption, expedited review, or administrative approval and the use of an independent ethics review.

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