Ethical review within regulations

A thorough and critical ethical review should be an integral part of project authorisation in any system regulating animal research and testing. This is written into legislation in many countries. It is also recommended as good practice by the World Organisation for Animal Health (OIE) and the International Council on Laboratory Animal Science (ICLAS).

Small white mouse being held

The way regulations, and ethical review, are implemented varies between different countries.  Regulations may be administered by a central government department (such as the UK Home Office) or overseen by specialist committees at a national, regional or institutional level.

The name given to such committees varies in different countries; Regional Ethics Committees in Sweden;  Animal Ethics Committees in Australia and New Zealand;  Institutional Animal Care (or Animal Care and Use) Committees in Canada and USA. Whatever the name, form or function of the committee, good communications are essential - both within the establishment and with committees at other institutions.

In the UK individual establishments have an Animal Welfare and Ethical Review Body (AWERB) which acts as an adjunct to the Home Office, reviewing projects from a local perspective and developing and applying local policies before project applications go before the regulator.

The functions and membership of all these committees have much in common. They deal with formal ethical review, including a harm-benefit analysis of project applications; review of practical issues such as animal housing, husbandry and care; application of the 3Rs; and staff training; and may also deal with retrospective review. Most publish documents setting out their terms of reference with guidance or standard protocols on operational issues.

Within the European Union all establishments breeding, supplying or using animals for research must have an Animal Welfare Body (AWB). These must 'follow the development and outcome' of projects and deal with practical 3Rs and welfare issues, but they are not responsible for formal evaluation and authorisation of projects - this is the responsibility of the competent authority in each member state. However, some establishments are incorporating the AWB into existing ethics committees, which is a positive approach to be recommended.