T hese recommendations are primarily intended to standardize health monitoring programmes and reporting. In this way they may also help to standardize the microbiological quality of animals. However, it is not a requirement of these recommendations that animals tested are free from all of the microorganisms listed.Health monitoring is a complex issue. T herefore, it is recommended that a person with suf®cient understanding of the principles of health monitoring (FELASA Category D, Nevalainen e t a l. 1999 ) be identi®ed as the individual responsible for devising and maintai ning a health monitoring policy for the facility.It should be noted that health monitoring is not con®ned to laboratory reporting. T here should also be engendered a culture of communicat ion between anim al technicians, facility managers, veterinarians and researchers so that observed abnormalities in breeding anim als and experimental data can rapidly be evaluated and appropriate action taken.Animals that are standardized as much as possible are important prerequisites for reproducible anim al experiments.

International regulations and guidelines strongly suggest that the use of animal models in scientific research should be initiated only after the authority responsible for the review of animal studies has concluded a well-thought-out harm–benefit analysis (HBA) and deemed the project to be appropriate. Although the process for conducting HBAs may not be new, the relevant factors and algorithms used in conducting them during the review process are deemed to be poorly defined or lacking by committees in many institutions. This paper presents the current concept of HBAs based on a literature review. References on cost or risk benefit from clinical trials and other industries are also included. Several approaches to HBA have been discovered including algorithms, graphic presentations and generic processes. The aim of this study is to better aid and harmonize understanding of the concepts of ‘harm’, ‘benefit’ and ‘harm–benefit analysis’.

International regulations and guidelines strongly suggest that the use of animal models in scientific research should be initiated only after the authority responsible for the review of animal studies has concluded a well-thought-out harm–benefit analysis (HBA) and deemed the project to be appropriate. The AALAS–FELASA working group on HBA has performed a literature review and based on this review, proposed a method for HBA. Examples of the working group’s approach are included in this report.

The European Federation of Pharmaceutical Industries and Associations’ Research and Animal Welfare group members reflected on the concept of a Culture of Care in relation to animal care and use and on differences in its understanding and application across European pharmaceutical companies. The term ‘Culture of Care’ is used across different regions and organizations but rarely with any defined indicators to support working practice. The European Federation of Pharmaceutical Industries and Associations’ Research and Animal Welfare group has developed a framework to help organizations identify gaps or potential areas for improvement in support of a positive Culture of Care. The framework is a tool that identifies five areas of focus for a Culture of Care: company values; strategic approach at establishment level; implementation structures; staff support; and animal care and procedures. The framework is intended as an aid for continuous improvement, highlighting where indicators of good practice are present. We expect it to provide points of reflection and ideas for those looking to implement a Culture of Care in a structured way, while facilitating a professional and strategic approach. To prevent it supporting a ‘tick-box’ exercise, the framework must not be used as an auditing tool, but as a starting point for consideration and discussion about how care manifests within the context and constraints of individual establishments.

To address concerns that a flavivirus vaccine/wild-type recombinant virus might have a high mosquito infectivity phenotype, the yellow fever virus (YFV) 17D backbone of the ChimeriVax-dengue 4 virus was replaced with the corresponding gene sequences of the virulent YFV Asibi strain. Field-collected and laboratory-colonized Aedes aegypti mosquitoes were fed on blood containing each of the viruses under investigation and held for 14 days after infection. Infection and dissemination rates were based on antigen detection in titrated body or head triturates. Our data indicate that, even in the highly unlikely event of recombination or substantial backbone reversion, virulent sequences do not enhance the transmissibility of ChimeriVax viruses. In light of the low-level viremias that have been observed after vaccination in human volunteers coupled with low mosquito infectivity, it is predicted that the risk of mosquito infection and transmission of ChimeriVax vaccine recombinant/revertant viruses in nature is minimal.