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Reviewing the Review: A Pilot Study of the Ethical Review Process of Animal Research in Sweden.

ABSTRACT: The use of animals in research entails a range of societal and ethical issues, and there is widespread consensus that animals are to be kept safe from unnecessary suffering. Therefore, harm done to animals in the name of research has to be carefully regulated and undergo ethical review for approval. Since 2013, this has been enforced within the European Union through Directive 2010/63/EU on the protection of animals used for scientific purposes. However, critics argue that the directive and its implementation by member states do not properly consider all aspects of animal welfare, which risks causing unnecessary animal suffering and decreased public trust in the system. In this pilot study, the ethical review process in Sweden was investigated to determine whether or not the system is in fact flawed, and if so, what may be the underlying cause of this. Through in-depth analysis of 18 applications and decisions of ethical reviews, we found that there are recurring problems within the ethical review process in Sweden. Discrepancies between demands set by legislation and the structure of the application form lead to submitted information being incomplete by design. In turn, this prevents the Animal Ethics Committees from being able to fulfill their task of performing a harm-benefit analysis and ensuring Replacement, Reduction, and Refinement (the 3Rs). Results further showed that a significant number of applications failed to meet legal requirements regarding content. Similarly, no Animal Ethics Committee decision contained any account of evaluation of the 3Rs and a majority failed to include harm-benefit analysis as required by law. Hence, the welfare may be at risk, as well as the fulfilling of the legal requirement of only approving "necessary suffering". We argue that the results show an unacceptably low level of compliance in the investigated applications with the legal requirement of performing both a harm-benefit analysis and applying the 3Rs within the decision-making process, and that by implication, public insight through transparency is not achieved in these cases. In order to improve the ethical review, the process needs to be restructured, and the legal demands put on both the applicants and the Animal Ethics Committees as such need to be made clear. We further propose a number of improvements, including a revision of the application form. We also encourage future research to further investigate and address issues unearthed by this pilot study.

SUBMITTER: Jorgensen S

PROVIDER: S-EPMC8002130 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe burgeoning field of biomedical research involving the mixture of human and animal materials has attracted significant ethical controversy. Due to the many dimensions of potential ethical conflict involved in this type of research, and the wide variety of research projects under discussion, it is difficult to obtain an overview of the ethical debate. This paper attempts to remedy this by providing a systematic review of ethical reasons in academic publications on human-animal chimera research.MethodsWe conducted a systematic review of the ethical literature concerning human-animal chimeras based on the research question: "What ethical reasons have been given for or against conducting human-animal chimera research, and how have these reasons been treated in the ongoing debate?" Our search extends until the end of the year 2017, including MEDLINE, Embase, PhilPapers and EthxWeb databases, restricted to peer-reviewed journal publications in English. Papers containing ethical reasons were analyzed, and the reasons were coded according to whether they were endorsed, mentioned or rejected.ResultsFour hundred thirty-one articles were retrieved by our search, and 88 were ultimately included and analyzed. Within these articles, we found 464 passages containing reasons for and against conducting human-animal chimera research. We classified these reasons into five categories and, within these, identified 12 broad and 31 narrow reason types. 15% of the retrieved passages contained reasons in favor of conducting chimera research (Category P), while 85% of the passages contained reasons against it. The reasons against conducting chimera research fell into four further categories: reasons concerning the creation of a chimera (Category A), its treatment (Category B), reasons referring to metaphysical or social issues resulting from its existence (Category C) and to potential downstream effects of chimera research (Category D). A significant proportion of identified passages (46%) fell under Category C.ConclusionsWe hope that our results, in revealing the conceptual and argumentative structure of the debate and highlighting some its most notable tendencies and prominent positions, will facilitate continued discussion and provide a basis for the development of relevant policy and legislation.

Project description:BACKGROUND:Marginalized communities often attract more than their share of research. Too often, this research benefits researchers disproportionately and leaves such communities feeling exploited, misrepresented, and exhausted. The Downtown Eastside (DTES) neighborhood of Vancouver, Canada, has been the site of multiple public health epidemics related to injection drug use as well as the site of much community-led resistance and struggle that has led to the development of cutting-edge harm reduction interventions (e.g., North America's first supervised injection facility, Insite) and a strong sense of community organization. This background has made the DTES one of the most heavily researched communities in the world. Amidst ongoing experiences of unethical or disrespectful research engagement in the neighborhood, a collaboration between local academic researchers and community representatives developed to explore how we could work together to encourage more respectful, community-responsive research and discourage exploitative or disrespectful research. METHODS:We developed a series of six weekly workshops called "Research 101." These workshops brought together approximately 13 representatives from peer-based organizations in the DTES with a variety of experiences with research. Research 101 created space for community members themselves to discuss the pitfalls and potential of research in their neighborhood and to express community expectations for more ethical and respectful research. RESULTS:We summarized workshop discussions in a co-authored "Manifesto for Ethical Research in the Downtown Eastside." This document serves as a resource to empower community organizations to develop more equitable partnerships with researchers and help researchers ground their work in the principles of locally developed "community ethics." Manifesto guidelines include increased researcher transparency, community-based ethical review of projects, empowering peer researchers in meaningful roles within a research project, and taking seriously the need for reciprocity in the research exchange. CONCLUSIONS:Research 101 was a process for eliciting and presenting a local vision of "community ethics" in a heavily researched neighborhood to guide researchers and empower community organizations. Our ongoing work involves building consensus for these guidelines within the community and communicating these expectations to researchers and ethics offices at local universities. We also describe how our Research 101 process could be replicated in other heavily researched communities.

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Reviewing the Review: A Pilot Study of the Ethical Review Process of Animal Research in Sweden.

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