Guidance on the assessment of learning outcomes for those designing procedures and projects - Report of an ETPLAS Working Group.

This document provides assessment criteria for evaluation of each of the Learning Outcomes of the Modules specified (in addition to the Core Modules) for those designing procedures and projects in the Education and Training Framework guidance document by the European Commission and endorsed by the Member States Competent Authorities. This Working Group was tasked to produce these criteria by the Education & Training Platform for Laboratory Animal Science, which was funded by the European Commission to this aim. The assessment criteria address knowledge and skills (including critical thinking) expected to be acquired during education and training of persons preparing to design research procedures and projects using animals under the scope of Directive 2010/63/EU.

Case-based teaching of experimental design - contributions for meaningful learning.

This article argues the need for education and training of researchers carrying out animal studies on the fundamentals of experimental design (ED), as a key means of improving the reliability and reproducibility of preclinical results. The current landscape in ED education in Europe is presented, and we make the case for dedicated tutor-guided teaching of ED. With less than a day dedicated to it in many courses effective techniques for communicating key issues are needed.

What is the optimum design for my animal experiment?

Within preclinical research, attention has focused on experimental design and how current practices can lead to poor reproducibility. There are numerous decision points when designing experiments. Ethically, when working with animals we need to conduct a harm-benefit analysis to ensure the animal use is justified for the scientific gain.

The Experimental Design Assistant.

Addressing the common problems that researchers encounter when designing and analysing animal experiments will improve the reliability of in vivo research. In this article, the Experimental Design Assistant (EDA) is introduced. The EDA is a web-based tool that guides the in vivo researcher through the experimental design and analysis process, providing automated feedback on the proposed design and generating a graphical summary that aids communication with colleagues, funders, regulatory authorities, and the wider scientific community.

Teaching experimental design.

Awareness of poor design and published concerns over study quality stimulated the development of courses on experimental design intended to improve matters. This article describes some of the thinking behind these courses and how the topics can be presented in a variety of formats. The premises are that education in experimental design should be undertaken with an awareness of educational principles, of how adults learn, and of the particular topics in the subject that need emphasis.

Survey of the quality of experimental design, statistical analysis and reporting of research using animals.

For scientific, ethical and economic reasons, experiments involving animals should be appropriately designed, correctly analysed and transparently reported. This increases the scientific validity of the results, and maximises the knowledge gained from each experiment. A minimum amount of relevant information must be included in scientific publications to ensure that the methods and results of a study can be reviewed, analysed and repeated.

Planning for reduction.

Reduction is one of the Three Rs which can be readily achieved in practice. This can be done by careful consideration of the experimental strategy and the implementation of good experimental design. Moreover, strategic planning leads to 'best' scientific practice and can have a positive impact on both refinement and replacement.

Reduction by well-defined objectives.

Examination of programmes of experimental work involving live animals indicates scope for worthwhile reduction in animal usage by identifying more clearly the objectives of the different stages of a programme. Having a defined first objective for new or transferred methodology as "to optimise the methods", rather than an exploratory "try it with a few animals and modify" approach, is more likely to obtain the conditions for largest divergence between the effect to be measured and the background variability. Where several experiments will use the same methodology, even small improvements in this "signal to noise" ratio may be worthwhile, as the reduction is cumulative.