Institutional animal care and use committees and the challenges of evaluating animal research proposals.

BACKGROUND

In the U.S. and many other countries, animal use in research, testing, and education is under the purview of Institutional Animal Care and Use Committees or similar bodies. Their responsibility for reviewing proposed experiments, particularly with regard to adherence to legal and ethical mandates, can be a challenging task.

OBJECTIVE

To understand factors that may limit the effectiveness of Institutional Animal Care and Use Committees and identify possible solutions.

METHODS

This editorial review summarizes scientific literature describing the challenges faced by U.S. Institutional Animal Care and Use Committees and those who rely on them and describes actions that may improve their functioning.

RESULTS

Apart from what may be a sizable workload and the need to satisfy applicable regulations, committees have fundamental structural challenges and limitations. Under U.S. law, there is no requirement that committee members have expertise in the research areas under review or in methods that could replace animal use, nor could expertise in such vast technical areas be expected, in contrast with the review process of many scientific journals in which experts in the conditions being studied critique the choice of subjects and methods used. Although investigators are expected to consider alternatives to procedures that may cause more than momentary or slight pain or distress, they are not required to use them. While investigators must assure committee members that studies do not duplicate other research, committee members are not required to verify this. Consideration of alternatives to painful procedures is not required at all for experiments on animals not covered by the Animal Welfare Act. The majority of U.S. research institutions now allow research proposals to be approved by a single committee member, using a system called Designated Member Review, without full committee consideration. In other countries, requirements differ considerably. In the European Union, for example, investigators must complete a harm-benefit analysis and must use alternatives, not simply consider them.

CONCLUSIONS

The review process may be improved by requiring searches for nonanimal methods regardless of species, favoring alternatives based on human biology, improving the education of committee members and investigators, using reviewers with subject matter expertise, and minimizing conflicts of interest. Because of the limitations of the review process, funding institutions and scientific journals should not use Institutional Animal Care and Use Committee approval of submissions as evidence of adherence to ethical guidelines beyond those legally required.