The Road to Hell Is Paved with Good Intentions: Why Harm–Benefit Analysis and Its Emphasis on Practical Benefit Jeopardizes the Credibility of Research (original) (raw)
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2018
Simple Summary: According to Directive 2010/63/EU, project proposals involving experiments on animals have to be approved in a harm-benefit-analysis (HBA) that weighs the potential benefits of the experiment against the harm inflicted on animals. Only if the benefit outweighs the harm, will the project be approved. However, it is unclear what counts as a valid benefit. In this paper, we analyze the underlying premises of the HBA and its consequences for the project evaluation process. We come to the conclusion that knowledge, as such, is considered a low benefit and that only knowledge applied to benefit society, e.g., new cancer treatment or potent vaccine, etc., is considered to be a high benefit. However, we demonstrate that benefit of this kind cannot be assessed prospectively for research proposals due to the inherent uncertainties of research and the difficulty of determining extra-scientific factors that are crucial for the generation of societal benefit. As a consequence, we advocate a reevaluation of current project evaluation and propose to develop an alternative model for project evaluation. Abstract: Directive 2010/63/EU (henceforth "Directive") on the protection of animals used for scientific purposes mandates that every project proposal in EU member states involving procedures on living non-human vertebrates and cephalopods has to be approved in an review process, including a harm-benefit-analysis (HBA), to assess "whether the harm to the animals in terms of suffering, pain and distress is justified by the expected outcome taking into account ethical consideration and may ultimately benefit human beings, animals or the environment". Despite the justifying relevance of "outcome" and "benefit", it remains unclear how to understand these concepts. However, national authorities and applicants require a clear understanding of this to carry out a HBA. To analyze the underlying premises of the HBA and its consequences for the evaluation process, we introduce a heuristic to analyze the relation between "outcome", "benefit" and "prospective benefit assessment". We then apply the heuristic to all seven legitimate purposes for animal research stated in the Directive, namely basic research, translational or applied research, product safety, education and training, protection of the environment, preservation of species and forensic inquiries. As we show, regardless of which purpose is aimed for, applicants are hard-pressed to demonstrate tangible benefits in a prospective assessment. In the HBA, this becomes a problem since-as we argue-the only reasonable, expected and tangible outcome of research can ever be knowledge. The potential long-term benefits on the basis of gained knowledge are unforeseeable and impossible to predict. Research is bound to fall short of these proclaimed societal benefits and its credibility will suffer as long as research has to validate itself through short-term societal benefit. We propose to revise the ethical evaluation based on the HBA and we think it necessary to develop an alternative model for project evaluation that focuses on the value of knowledge as a scientific outcome as a necessary but not sufficient condition for societal benefit.
2018
Directive 2010/63/EU regulates the use of animals for scientific purposes in EU member states and mandates that every project proposal involving procedures on living non-human vertebrates and cephalopods has to be approved in a review process that includes a Harm-Benefit-Analysis, to assess "whether the harm to the animals in terms of suffering, pain and distress is justified by the expected outcome taking into account ethical consideration and may ultimately benefit human beings, animals or the environment (EU Directive 2010/63, Art 38d). The aim of this paper is 1) to summarize recent criticism on the epistemic and practical limitations of the prospective benefit assessment in the HBA in its current form and on the focus on tangible societal benefits in project evaluation and 2) as a proof of principle, demonstrate the argumentation of these papers on 2 concrete examples, namely the insulin inhalator Exubera and the cancer drug Ipilimumab. First, we show that the HBA suffers from a logical and methodological flaw. The outcome of an experiment is per definition uncertain. If it wasn't, the experiment would not generate new knowledge and would therefore be illegal. Moreover, as long as animals are used as models for humans there will always be uncertainty regarding the translatability of knowledge from model to target species. Second, we show that practical flaws further complicate prospective benefit assessment. There are non-scientific factors, such as market potential, lobbying, patient compliance, etc., that are impossible to predict and yet, are important parameters in prospective benefit assessment. Together, these uncertainties make a prospective benefit assessment implausible. Also, the requirement to demonstrate societal benefits might incentivize researchers to overstate the tangible benefits of their research in project proposals, thereby making prospective benefit assessment in project evaluation more difficult for committees. Overstating potential societal benefits that are eventually not realized might also be detrimental to the credibility of science. In light of these flaws we think it necessary to develop an alternative model for project evaluation that focuses on potential knowledge gains as outcome of a project rather than prospective assessment of potential societal benefits.
2019
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 in typically undertaken.
Journal of Applied Animal Ethics Research, 2020
The topic of this contribution is the moral justification of the use of non-human animals in scientific research. First, we will discuss the position of leading antispeciesist approaches of animal ethics, arguing that a radical position is not tenable and justification of some animal use in research can be given based on the importance of science for human civilization. Such use must be justified case by case. Therefore, the harm-benefit analysis will be introduced, as an example of a case-by-case scenario. We will describe the challenge encountered by the evaluators of project proposals, and possible ways of considering harms and benefits in basic, translational and regulatory research, minimizing harms and possible future scenarios. Our approach can be regarded as a virtue consequentialist view of the ethics of human/animal relationships in scientific use, where the development of a morally appreciable character is a key topic for the education of scientists.
The Role of Controversial Research in the IRB's Risk/Benefit Analysis
The American Journal of Bioethics, 2011
When an institutional review board (IRB) is asked to approve potentially controversial research, such as research into genetic enhancement or harm reduction in illegal activities, is it prohibited from considering the long-range sociopolitical effects of the research in its ...
Laboratory Animals, 2016
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’.
Laboratory Animals
Using animals for research raises ethical concerns that are addressed in project evaluation by weighing expected harm to animals against expected benefit to society. A harm–benefit analysis (HBA) relies on two preconditions: (a) the study protocol is scientifically suitable and (b) the use of (sentient) animals and harm imposed on them are necessary for achieving the study’s aims. The 3Rs (Replace, Reduce and Refine) provide a guiding principle for evaluating whether the use of animals, their number and the harm imposed on them are necessary. A similar guiding principle for evaluating whether a study protocol is scientifically suitable has recently been proposed: the 3Vs principle referring to the three main aspects of scientific validity in animal research (construct, internal and external validity). Here, we analyse the internal consistency and compatibility of these two principles, address conflicts within and between the 3Rs and 3Vs principles and discuss their implications for ...
The benefits and ethics of animal research
Scientific American, 1997
F or the past 20 years, we have witnessed an intense but largely unproductive debate over the propriety and value of using animals in medical and scientific research, testing and education. Emotionally evocative images and simple assertions of opinion and fact are the usual fare. But we do not have to accept such low standards of exchange. Sound bites and pithy rhetoric may have their place in the fight for the public's ear, but there is always room for dispassionate analysis and solid scholarship. When it comes to animal research, there is plenty of reason for legitimate dispute. First, one has to determine what values are being brought to the table. If one believes animals should not be used simply as means to ends, that assumption greatly restricts what animal research one is willing to accept. Most people, though, believe some form of cost-benefit analysis should be performed to determine whether the use of animals is acceptable. The costs consist mainly of animal pain, distress and death, whereas the benefits include the acquisition of new knowledge and the development of new medical therapies for humans. There is considerable disagreement among scientists in judging how much pain and suffering occur in the housing and use of research animals. More attention is at last being given to assessing these questions and to finding ways of minimizing such discomfort. Developing techniques that explicitly address and eliminate animal suffering in laboratories will reduce both public and scientific uneasiness about the ways animals are used in science. At present, indications are that public attention to the animal research issue has declined somewhat; however, the level of concern among scientists, research institutions, animal-rights groups and those who regulate animal use remains high. There is also much room to challenge the benefits of animal research and much room to defend such research. In the next few pages, you will find a debate between opponents and supporters of animal research. It is followed by an article that sets out the historical, philosophical and social context of the animalresearch controversy. We leave it to you to judge the case.