Variation in Ethics Review of Multi-Site Research Initiatives
Amsterdam Law Forum, Vol. 3, No. 1, 2011
16 Pages Posted: 18 Feb 2011
Date Written: February 2, 2011
In this commentary, we focus on the issue of REB [research ethics board] variability. Indeed, variation in ethics review across multiple REBs appears to be the rule rather than the exception.6 Studies from around the world have found substantial variation across REBs, and even among members on the same REB, when reviewing the same protocol. The studies summarised in Table 1 indicate that this variation can occur across several dimensions, including how REBs assess consent processes and documents and how they apply the concept of minimal risk. In addition to variation in the results of the review, the length of time required for review of studies varies substantially. The growth in the number of privacy laws may also contribute to variability in ethics review. The majority of REB members do not have legal training. As such, attempts to understand and comply with legislative requirements may contribute to variability as each committee may interpret the laws in a slightly different manner. Each of these topics is discussed in more detail below. The overall goal of the paper is to draw together existing literature – including relevant empirical studies – to examine the issue of REB variation and identify emerging policy reform themes. Some specific examples are drawn from the Canadian context to offer points of comparison for international readers.
Keywords: Caulfield, Barr, Ries, Variation, Ethics, Review, Multi-Site, research, board
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