25. Project Evaluator

This module provides guidance and information to enable individuals involved in project evaluation to understand the context, the principles and the criteria of project evaluation and to develop a consistent approach of project evaluation and to formulate well-informed, impartial and justified opinions.

This module should be completed by anyone carrying out project evaluation, irrespective of their individual background and knowledge (e.g. science, techniques, veterinary medicine, ethics, the Three Rs, animal welfare, laypersons). It focuses on common training needs for all those involved in project evaluation. Those include in particular training in how the objectives of the project, the application of the Three Rs and the assessment of severity classification should be evaluated, and how the harm-benefit analysis should be undertaken. Considerations on the requirements for retrospective assessment of projects and how amendments are dealt with are also included.

Learning Outcomes

Trainees should be able to:

Understand EU and National legislation and in particular the obligations of PE and the principles for PE, as well as their roles and responsibilities, rights and duties, particularly as concerns conflict of interest

1. Describe the legal requirements underlying the PE process and discuss the distinction between project evaluation and authorisation
2. Describe the range of expertise required and issues of impartiality, confidentiality and conflict(s) of interest
3. Appreciate the importance of a transparent project evaluation process
4. List the different purposes of procedures (as listed in Article 5) and illustrate by some examples

Ethical and welfare issues

5. Analyse the ethical and welfare issues related to the use of animals in scientific procedures, and soundly appreciate the importance of the implementation of the Three Rs in all scientific research

Harm-benefit analysis

6. Discuss how to contribute to the harm-benefit analysis of a project, including understanding of the process and significance of the outcome of a harm-benefit analysis
7. Define the Three Rs and give a realistic and relevant example of each of the Three Rs covering scientific areas of animal use including regulatory testing
8. List the criteria to consider when identifying the potential harm to the animals
9. Identify potential sources of pain, suffering, distress and lasting harm
10. Describe methods to prevent or ameliorate suffering68
11. Explain the severity classification and be able to classify procedures with consistency (using case-studies), taking into account specific considerations for animals that are physiologically compromised, such as genetically modified animals, where relevant
12. Describe the concepts of direct and contingent suffering
13. Describe factors to be considered in assessing cumulative suffering
14. Interpret the proposed/expected benefits of the project. Explain and discuss the essential information needed in the project application to enable consideration of the relevance of the proposed work in relation to current knowledge and/or the subject (or legal requirements) to be addressed
15. Assessment of the likelihood of success. List the criteria to consider when assessing the likelihood of success of a project

Sources of Information

16. Describe sources of information related to availability and relevance of other (non-animal) methods, e.g. replacement methods, data obtained from clinical studies
17. Describe the benefits of a “project evaluation check list”

Methods of harm-benefit assessment

18. Recognise the various systems available to assist the process of project evaluation and how these can be applied in practice
19. Compare and discuss different approaches and tools to weigh and comparatively analyse harms and benefits of a project

Outcomes of project evaluation

20. Describe the legal basis of why project evaluation needs to formulate a well-informed, valid and timely decision on a project and the need to justify any additional recommendations
21. Describe the principles and approaches used to ensure consistency in judgment and outcome of evaluation, to guarantee confidentiality, competence and ensure impartiality for each project evaluated
22. List the arguments for reaching a decision and which should be documented in the decision

Retrospective assessment

23. Describe legal requirements for retrospective assessment (RA) of projects (requirements and principles for identifying projects subject to RA) and other factors impacting on the selection of projects for RA
24. Describe the process of RA
25. Discuss possible outcomes of RA and how they may impact on future practices