Abstract Background Since 1996, genetically modified (GM) crops have been grown on an ever increasing area worldwide. Maize producing a Cry protein from the bacterium Bacillus thuringiensis (Bt) was among the first GM crops released for commercial production and it is the only GM crop currently cultivated in Europe. A major part of the regulatory process that precedes the commercial release of GM crops is the environmental risk assessment. Because Bt maize is modified to produce insecticidal proteins, potential interactions with non-target organisms are a major area of concern to be addressed in the risk assessment. In particular, beneficial arthropods that provide important agro-ecological services, such as pollination, decomposition, and biological control are the focus. This systematic review will evaluate if the growing of Bt maize changes abundance or ecological function of non-target animals compared to the growing of conventional, non-GM maize. The review will be limited to plot or field level data including field margins. Potential cropping system effects and off-field effects will not be addressed. Bt maize will be compared to conventional maize either untreated or treated with chemical insecticides. Methods Stakeholders from academia, competent authorities, industry, and civil society organizations were given the opportunity to comment on the review question and an earlier draft of this review protocol. Keyword searches will be conducted in a range of abstracting and full text literature databases. Retrieved records will be screened against a set of inclusion criteria, first on title and abstract level, then on full text level. Selected studies will be evaluated for risks of bias (quality assessment). Data on field/plot characteristics, maize cultivars, insecticide treatments, non-target animal taxa, sampling methods, and response variables of populations and ecological functions will be extracted. Meta-analysis will be conducted using the effect size estimator Hedge’s d on a range of comparisons and including sensitivity analysis. The review process will be fully documented in CADIMA, an open access online data portal for evidence synthesis.
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