Harm-benefit analysis – University of Copenhagen

Harm-benefit analysis

Harm–benefit analysis – what is the added value? A review of alternative strategies for weighing harms and benefits as part of the assessment of animal research

By H. Grimm, I.A.S. Olsson & P. Sandøe (2018)
Laboratory Animals. SAGE journals.

Abstract

Animal experiments are widely required to comply with the 3Rs, to minimise harm to the animals and to serve certain purposes in order to be ethically acceptable. Recently, however, there has been a drift towards adding a so-called harm–benefit analysis as an additional requirement in assessing experiments. According to this, an experiment should only be allowed if there is a positive balance when the expected harm is weighed against the expected benefits. This paper aims to assess the added value of this requirement. Two models, the discourse model and the metric model, are presented. According to the former, the weighing of harms and benefits must be conducted by a committee in which different stakeholders engage in a dialogue. Research into how this works in practice, however, shows that in the absence of an explicit and clearly defined methodology, there are issues about transparency, consistency and fairness. According to the metric model, on the other hand, several dimensions of harms and benefits are defined beforehand and integrated in an explicit weighing scheme. This model, however, has the problem that it makes no real room for ethical deliberation of the sort committees undertake, and it has therefore been criticised for being too technocratic. Also, it is unclear who is to be held accountable for built-in ethical assumptions. Ultimately, we argue that the two models are not mutually exclusive and may be combined to make the most of their advantages while reducing the disadvantages of how harm–benefit analysis is typically undertaken.

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Harms to animals – Can we agree on how best to limit them?

By P. Sandøe, N. H. Franco, T. B. Lund, D. M. Weary, & I. A. S. Olsson (2015)
ALTEX 
4 (1). Springer. 

Abstract

The harm benefit framework seems to have wide public support as a basis for making decisions about the use of animals in biomedical research. The present paper, which is the first of two papers that deal with the conceptual underpinning of the harm-benefit analysis, focuses on the assessment of harms to animals. The goals of the 3Rs have gained wide acceptance over the 50 years since they were first proposed. However, there are controversial ethical issues hidden within the 3Rs principle. Five such hidden value conflicts are highlighted and it is argued that these conflicts challenge the idea that adherence to the 3Rs is bound to generate a wide public consensus. It is argued that underlying value differences will lead to conflicting interpretations of how to apply the 3Rs and thereby decide when and how to limit the harm imposed on animals. 

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A matter of importance: Considering benefit in animal ethics review

I. A. S. Olsson, O. Varga, & P. Sandøe (2015)
ALTEX 
4 (1). Springer.

Abstract

Animal-based research presents an ethical dilemma between harms (to animals) and benefits (mainly to humans). According to Directive 2010/63/EU, project evaluation should include “a harm-benefit analysis of the project, to assess whether the harm to the animals in terms of suffering, pain and distress is justified by the expected outcome”. By defining benefit and its assessment very generally, legislation opens for a variety of interpretations. In this paper, we review different approaches, consider potential disagreements and highlight the need for a wider discussion of the role of the harm-benefit analysis in ethics review. 

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A case for integrity: gains from including more than animal welfare in animal ethics committee deliberations

Röcklinsberg, H., Gamborg, C., & Gjerris, M. (2014)
Laboratory Animals, 48(1). SAGE.

Abstract

From January 2013, a new EU Directive 63/2010/EU requires that research using animals must undergo a harm–benefit analysis, which takes ethical considerations into account (Art. 38 (2) d) – a so-called ‘project authorization’ (Art. 36). A competent authority in each member state has to ensure that no project is carried out without such a project validation process, but often delegates the actual assessment to an animal ethics committee (AEC) or its equivalent. The core task of the AEC is to formulate a justifiable balance between the animals' suffering caused by research and the potential human benefit. AECs traditionally focus on animal welfare issues, but according to the new directive other public concerns must also be taken into account. Taking the new EU Directive as a point of departure, the central aim of this paper is to discuss the evaluation process in relation to animal welfare and animal ethics through the concept of animal integrity. A further aim is to elaborate on possible improvements to project evaluation by considering animal integrity. We argue that concepts like animal integrity are often left out of project authorization processes within AECs, because animal ethics is often interpreted narrowly to include only certain aspects of animal welfare. Firstly, we describe the task of an AEC and discuss what has typically been regarded as ethically relevant in the assessment process. Secondly, we categorize four notions of integrity found in the literature to show the complexity of the concept and furthermore to indicate its strengths. Thirdly, we discuss how certain interpretations of integrity can be included in AEC assessments to encapsulate wider ethical concerns and, perhaps even increase the democratic legitimacy of AECs.

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