Animals used for research, quality control and safety evaluation, are of obvious social importance. However, their use is controversial. Since 1989, all animal research in Sweden is therefore evaluated by an ethical committee which weighs the benefit of the research against the harm to the animals.
Animals used for research is controversial and contains difficult ethical dilemmas and arouses strong emotions. Therefore, it is extremely important that society has a well-functioning system to ensure that animals are treated well when developing new scientific knowledge.
In order to ensure public confidence in both researchers and animal welfare, all animals used for research in the EU must be preceded by an ethical review (Directive 2010/63 / EU). Animals must not be subjected to unnecessary suffering, and only trials where the benefit outweighs the animals' suffering may be carried out, which an ethics committee must guarantee through a so-called harm / benefit analysis. But the ethical test is complicated: on one hand, it is impossible to know in advance what results the experiment will give, and on the other hand, it is difficult to know how much suffering the animals will experience. Both of these factors are based on an estimate of a potential benefit resp. damage.
International as well as national research on the work of the ethics committees has criticized the model of ethical review for being inappropriate: it excludes in advance important ethical factors (eg that the animals are killed) and, according to the critics, the animals' suffering is never fully taken into account. The boards also find it difficult to assess whether there are alternative methods to the experiments that are planned, despite the fact that only such research where animal-free methods are lacking may be approved. A challenge in the decision-making process itself is that members have different views on their assignment, what is to be reviewed and according to which criteria, which is why some believe that an actual ethical review never takes place. Another problem is the imbalance in how the board members can influence the decision-making process: in general, researchers and judges are more satisfied with both the decision-making process and decision-makers than the lay people. All in all, this has led to regular questions about whether the boards really carry out a thorough ethical evaluation in accordance with the stated criteria, and whether the process is even legally certain. That there is a distrust of the animal experiment ethics committees is worrying. The ethical review is an exercise of authority and unprofessional case management risks jeopardizing society's trust.
In a recent pilotstudy, led by the applicant, applications and decisions on ethical review were analyzed. The results show several shortcomings in the review process: gaps between European and Swedish legislation and between the law and the application form that researchers use; indications that an ethical weighing of benefit and harm is often lacking and that the three R:s (Replace (alternative methods); Reduce (that the lowest possible number of animals is used) and Refine (that the use that takes place are refined) have not been applied as the law. The results indicate that researchers have difficulty filling out the applications and that the boards tends to focus on technical details in the often difficult-to-read applications instead of seeing the big picture and discussing ethics. which cannot be elucidated and responded to solely through analysis of the written documentation, namely decision-making structures and an unfamiliar practice of ethical reasoning.
To facilitate and improve the decision making process in the AEC s, we therefore plan to:
- Analyze how the task of the ethical committees is defined by Swedish and European governmental bills and legislation.
- Send out questionnaires to researchers, committee members and other core actors, as well as attend committee meetings to assess the procedure.
- Develop a model for ethical decision-making that ensures a proper HBA is performed,
the 3Rs duly considered and the legal certainty of the AEC s safeguarded.
The results will have great practical significance for the work of the committees and researchers, the welfare of the experimental animals, the reliability of the research and the public's trust.