Variation in Ethics Review of Multi-Site Research Initiatives

Amsterdam Law Forum, Vol. 3, No. 1, 2011

16 Pages Posted: 18 Feb 2011

See all articles by Timothy Caulfield

Timothy Caulfield

University of Alberta - Health Law Institute

Nola M Ries

University of Technology Sydney (UTS)

Graham Barr

University of Cape Town - Faculty of Commerce - School of Economics; University of Cape Town (UCT) - Department of Statistical Sciences

Date Written: February 2, 2011

Abstract

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

Suggested Citation

Caulfield, Timothy and Ries, Nola M and Barr, Graham, Variation in Ethics Review of Multi-Site Research Initiatives (February 2, 2011). Amsterdam Law Forum, Vol. 3, No. 1, 2011. Available at SSRN: https://ssrn.com/abstract=1763193

Timothy Caulfield (Contact Author)

University of Alberta - Health Law Institute ( email )

Law Centre
Edmonton, Alberta T6G 2H5
Canada

Nola M Ries

University of Technology Sydney (UTS) ( email )

15 Broadway, Ultimo
PO Box 123
Sydney, NSW 2007
Australia

Graham Barr

University of Cape Town - Faculty of Commerce - School of Economics

Rondebosch
Cape Town, 7700
South Africa

University of Cape Town (UCT) - Department of Statistical Sciences

South Africa

Register to save articles to
your library

Register

Paper statistics

Downloads
50
Abstract Views
597
PlumX Metrics