How do the u.s. government principles address animal pain and distress in research?

CONSIDERATION OF “THE 3 R’s”

Background:

Principle 3 of the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training states that “animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered”. In addition, federal regulations stipulate that elimination or reduction of unnecessary pain/distress must be considered when preparing research applications. These ideas, commonly referred to as the “3 R’s” [i.e., replacement, refinement, and reduction], were originally articulated by Russell and Burch [1959], and are important considerations for all animal research studies.

ARC Application:

For those protocols that involve animals in Pain Category D [Pain/distress relieved by the use of appropriate anesthetics, analgesics, tranquilizers or by euthanasia] and/or E [Pain/distress can not be relieved by use of anesthetics, analgesics, or tranquilizers, as the use of these agents would interfere with the experimental design], the Committee requires completion of the Pain Category and Pain Literature Search sections.

In the Pain Category section, Questions #3A-C address the concepts of replacement [#3A], refinement [#3B], and reduction [#3C]. When addressing these questions, the Committee asks that you focus your response on why each of these concepts is not an acceptable alternative for the proposed research. For example:

  • When answering Question #3A, your response should focus on why the proposed species cannot be replaced with a phylogenetically lower species or a non-animal model.
  • Similarly, when addressing Question #3B, the response should discuss why the proposed painful and/or distressful experiments cannot be refined to further minimize the potential for pain and/or distress.
  • Finally, in your response to Question #3C, please discuss why the number of animals requested for the three-year period of the protocol cannot be further reduced.

Pain Literature Search:

According to PHS Policy IV.C.1.a, the Guide for the Care and Use of Laboratory Animals [the Guide p. 10], and USDA Animal Welfare Act Regulations §2.31[d][1][i] “procedures involving animals will avoid or minimize discomfort, distress, and pain to the animals.” Further, in order to meet the above-mentioned regulatory requirement and in accordance with UCLA’s Animal Welfare Assurance on file with the National Institutes of Health Office of Laboratory Animal Welfare [OLAW], the Committee must ensure that the “principal investigator has considered alternatives to procedures that may cause more than momentary or slight pain or distress to the animals, and has provided a written narrative description of the methods and sources used to determine alternatives were not available.”

In the Pain Literature Search section, the Committee requests that you document your most recent search for alternatives. Noting that the intent of the search is to identify potential procedural refinements, the Committee highly recommends that your search strategy include a combination of the animal model being used, keywords specific to the proposed painful and/or distressful procedures, and refinement terminology.

For example, a search strategy for a mouse protocol that utilizes sleep deprivation to study changes in activity in the hippocampus may include the following combinations:

  • Mouse and sleep deprivation and welfare
  • Mouse and sleep deprivation and [stress or distress]
  • Mouse and sleep and hippocampus
  • Sleep and hippocampus and vitro
  • Sleep deprivation and alternative

When you complete the Pain Literature Search section, please specify under Question #2 the different combinations of keywords used to determine that acceptable alternatives are not available.

Please see the UCLA ARC website and the USDA Animal Care Policy #12 for more information.

If you have any questions regarding the information included in this email, please contact the OPRS/ARC staff at x66308 or .

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Open Access

Peer-reviewed

Research Article

  • Robert Streiffer ,
  • Jennifer Dykema,
  • Nadia Assad,
  • Jackson Moberg

Influence of animal pain and distress on judgments of animal research justifiability among university undergraduate students and faculty

  • Eric P. Sandgren, 
  • Robert Streiffer, 
  • Jennifer Dykema, 
  • Nadia Assad, 
  • Jackson Moberg

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  • Published: August 8, 2022
  • //doi.org/10.1371/journal.pone.0272306

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Abstract

Acceptance of animal research by the public depends on several characteristics of the specific experimental study. In particular, acceptance decreases as potential animal pain or distress increases. Our objective in this study was to quantify the magnitude of pain/distress that university undergraduate students and faculty would find to be justifiable in animal research, and to see how that justifiability varied according to the purpose of the research, or the species to which the animal belonged. We also evaluate how demographic characteristics of respondents may be associated with their opinions about justifiability. To accomplish this goal, we developed and administered a survey to students and faculty at the University of Wisconsin-Madison. Our survey employed Likert-style questions that asked them to designate the level of animal pain or distress that they felt was justifiable for each of the following six purposes—animal disease, human disease, basic research, human medicine, chemical testing, or cosmetic testing. These questions were asked about five different species of animals including monkeys, dogs/cats, pig/sheep, rats/mice, or small fish. We used the data to establish a purpose-specific pain/distress scale, a species-specific pain/distress scale, and a composite pain/distress scale that, for each respondent, averaged the extent of justifiable pain/distress across all purposes and species. For purpose, students were more likely to choose higher levels of pain for animal disease research, followed by human disease, basic research, human medicine, chemical testing, and cosmetic testing. Faculty were more likely to choose the same level of pain for the first four purposes, followed by lower levels of pain for chemical and cosmetic testing. For species, students were more likely to choose higher levels of pain for small fish and rats/mice [tied], pigs/sheep and monkeys [tied], than for dogs/cats. For faculty, order from least to most justifiable pain/distress was small fish, rats/mice, pigs/sheep, then dogs/cats and monkeys [the latter two tied]. Interestingly, exploratory factor analysis of the pain/distress scales indicated that when it comes to justifying higher levels of pain and distress, respondents identified two distinct categories of purposes, chemical and cosmetic testing, for which respondents were less likely to justify higher levels of pain or distress as compared to other purposes; and two distinct categories of species, small fish and rats/mice, for which respondents were more likely to justify higher levels of pain/distress than other species. We found that the spread of acceptance of animal research was much smaller when survey questions included pain/distress compared to when only purpose or species were part of the question. Demographically, women, vegetarians/vegans, and respondents with no experience in animal research justified less animal pain/distress than their counterparts. Not surprisingly, a lower level of support for animal research in general was correlated with lower justifiability of pain/distress. Based on these findings, we discuss the role of animal pain/distress in regulatory considerations underlying decisions about whether to approve specific animal uses, and suggest ways to strengthen the ethical review and public acceptance of animal research.

Citation: Sandgren EP, Streiffer R, Dykema J, Assad N, Moberg J [2022] Influence of animal pain and distress on judgments of animal research justifiability among university undergraduate students and faculty. PLoS ONE 17[8]: e0272306. //doi.org/10.1371/journal.pone.0272306

Editor: Simon Clegg, University of Lincoln - Brayford Campus: University of Lincoln, UNITED KINGDOM

Received: December 7, 2021; Accepted: July 18, 2022; Published: August 8, 2022

Copyright: © 2022 Sandgren et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: All relevant data are available from openICPSR at //doi.org/10.3886/E112044V1.

Funding: This study was funded by the UW-Madison Office of the Vice Chancellor for Research and Graduate Education, the School of Veterinary Medicine, and the Common Ground on Animal Research Initiative at the School of Veterinary Medicine to EPS. UW-Madison and the School of Veterinary Medicine had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.

Introduction

Public support for animal research has been reported to vary according to three principle elements: the purpose of the research [1–7], the kind of animal employed [1, 2, 4–10], and the extent of potential pain and/or distress experienced by the animals [1, 6, 8, 11–13]. Identifying how these elements of a specific study influence people’s views can guide efforts to incorporate the public’s moral values into the criteria used in the research review process. The animal research community has a strategic interest in such efforts because animal research that strays too far from what the public finds ethically acceptable provides attractive targets for animal activist campaigns [14, 15]. Thus, incorporating the public’s moral values can help insulate the research community from criticism and maintain public support [16]. There also are direct ethical reasons for such efforts when public funding is used to support animal research [17] and when the justification for the animal research appeals to benefits to the public [18]. Identifying public views toward animal research are among the key research questions proposed in “Developing a Collaborative Agenda for Humanities and Social Scientific Research on Laboratory Animal Science and Welfare,” published in 2016 [19].

Surveys are used commonly to explore ethical views about animal research. We have taken this approach to identify university undergraduate and faculty views on animal research [20, 21]. In the current report, we examine the role of animal pain or distress on views about animal research. As noted above, the extent of animal pain or distress is an important determinant of research approval. For example, Plous [1] and Henry and Pulcino [8] reported that psychology student support for animal research using several species was far less if the research procedures caused pain, injury, or death. Ormandy and colleagues reported decreased animal research support when invasive procedures were involved [13]. A review by Hagelin and colleagues [12] reported that, in general, survey questions containing the words death, pain, or suffering elicited less respondent support for animal research. Richmond [22] found that, among the 44.9% of their respondents who reported being totally against or having serious reservations about animal research, the leading objection to animal research was that it “causes pain and suffering and/or is cruel.” Ipsos MORI has been carrying out research on public attitudes towards animal research since 1999. They found lower approval ratings for painful research [23]. Also in 1999, their focus group work for the Medical Research Council concluded that “the groups were extremely concerned about basic animal welfare issues, and about preventing pain from being experienced by animals” [24]. A consistent finding among their more recent research is that the avoidance of unnecessary suffering is an important proviso among supporters of animal research and that a significant minority say they cannot support animal research because of animal welfare concerns [25]. Most recently, they have found that “public regard for animal welfare appears to be increasing” [26]. These findings are not surprising, given the connections that people often develop with animals of various species, and people’s general aversion to causing animals pain or harm [27, 28].

In addition to the importance of understanding the pubilc’s views on animal research, specific institutions that engage in animal research should have an understanding of the views of their local community. Students and faculty have an especially strong interest in the kinds of animal research that takes place at their own academic institution. We administered our survey to undergraduate students and faculty at the University of Wisconsin-Madison [UW-Madison]. Few surveys have included both faculty and students, and most surveys of undergraduate students included only a selected subset of respondents [for example, undergraduate psychology majors]. UW-Madison is a large public research university that supports an expansive animal research program. It also has been the target of protests by animal activists. Our overarching objectives in this study were to determine the importance of the issue of animal research to our academic community and to evaluate their knowledge about and trust in specific sources of information on this subject [20], to understand the dependence of judgements about research justifiability on experimental purpose and species [21], and to identify whether and how animal pain or distress influenced views of research justifiability. Below, we present findings and conclusions related to this latter objective by addressing the following specific questions: [i] how does experimental pain or distress influence respondents’ judgements about the justifiability of different research purposes; [ii] how does it influence perceived justifiability of use of different research species; and [iii] how does support of research involving animal pain or distress depend on respondent gender, academic discipline, student year or faculty rank, dietary preferences, and experience with animal research? The answers to these questions can help us formulate policy and direct university decisions about animal research.

Materials and methods

We have described our survey, survey methodology, and respondent populations previously [20, 21]. Briefly, in fall of 2016, we administered the survey to 8,000 randomly selected undergraduate students [out of a total enrolled population of 29,536], and in spring of 2017 to all 2,153 faculty. Students were contacted by email and received up to three email reminders. Faculty were contacted by letter containing a $2-bill cash incentive and received up to three email and one written reminders. Responses were received from 782 undergraduate students, for a response rate of 9.8%, and from 942 members of the faculty, for a response rate of 44%. Although the student response rate is low, Fosnacht and colleagues [29] reported good data reliability in student surveys with 5–10% response rate as long as the sample size reached 500 respondents. The UW-Madison Educational and Social/Behavioral Sciences Institutional Review Board reviewed and approved this study.

Survey questions asked respondents for self-reports about the importance of animal research, how much they know about animal research and its regulation, what sources they trust to provide unbiased information on the subject, and about the justifiability of animal research for certain research purposes, for different kinds of animals, and with varying amounts of animal pain or distress. Finally, we asked questions to identify respondent’s general attitudes toward animal use by humans, whether they had been vegetarian or vegan, whether they had participated in animal research, and demographic characteristics including gender, academic discipline, year in school for students, and rank for faculty.

Statistical analyses employed STATA [Stata Corporation] using non-parametric tests, as the latter do not assume that dependent variables are normally distributed. These included Wilcoxon/Mann-Whitney and Kruskal-Wallis tests. We used an ordinal logistic regression model or logistical regression for dichotomous dependent variables. Significance is expressed as: *p

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