Design of Experiments and Sample Surveys Commons^™

Non-Human Primates In Neuroscience Research: The Case Against Its Scientific Necessity, Jarrod Bailey, Katy Taylor

Experimentation Collection

Public opposition to non-human primate (NHP) experiments is significant, yet those who defend them cite minimal harm to NHPs and substantial human benefit. Here we review these claims of benefit, specifically in neuroscience, and show that: a) there is a default assumption of their human relevance and benefit, rather than robust evidence; b) their human relevance and essential contribution and necessity are wholly overstated; c) the contribution and capacity of non-animal investigative methods are greatly understated; and d) confounding issues, such as species differences and the effects of stress and anaesthesia, are usually overlooked. This is the case in NHP …

Expectations For Methodology And Translation Of Animal Research: A Survey Of Health Care Workers, Ari Joffe, Meredith Bara, Natalie Anton, Nathan Nobis

Experimentation Collection

Background: Health care workers (HCW) often perform, promote, and advocate use of public funds for animal research (AR); therefore, an awareness of the empirical costs and benefits of animal research is an important issue for HCW. We aim to determine what health-care-workers consider should be acceptable standards of AR methodology and translation rate to humans.

Methods: After development and validation, an e-mail survey was sent to all pediatricians and pediatric intensive care unit nurses and respiratory-therapists (RTs) affiliated with a Canadian University. We presented questions about demographics, methodology of AR, and expectations from AR. Responses of pediatricians and nurses/RTs were …

The Usefulness Of Systematic Reviews Of Animal Experiments For The Design Of Preclinical And Clinical Studies, Rob B.M. De Vries, Kimberley E. Weaver, Marc T. Avey, Martin Stephens, Emily S. Sena, Marlies Leenaars

Experimentation Collection

The question of how animal studies should be designed, conducted, and analyzed remains underexposed in societal debates on animal experimentation. This is not only a scientific but also amoral question. After all, if animal experiments are not appropriately designed, conducted, and analyzed, the results produced are unlikely to be reliable and the animals have in effect been wasted. In this article, we focus on one particular method to address this moral question, namely systematic reviews of previously performed animal experiments. We discuss how the design, conduct, and analysis of future (animal and human) experiments may be optimized through such systematic …

Food For Thought … Mechanistic Validation, Thomas Hartung, Sebastian Hoffman, Martin Stephens

Experimentation Collection

Validation of new approaches in regulatory toxicology is commonly defined as the independent assessment of the reproducibility and relevance (the scientific basis and predictive capacity) of a test for a particular purpose. In large ring trials, the emphasis to date has been mainly on reproducibility and predictive capacity (comparison to the traditional test) with less attention given to the scientific or mechanistic basis. Assessing predictive capacity is difficult for novel approaches (which are based on mechanism), such as pathways of toxicity or the complex networks within the organism (systems toxicology). This is highly relevant for implementing Toxicology for the 21st …

Assessing The Necessity Of Chimpanzee Experimentation, Andrew Knight

Experimentation Collection

No abstract provided.

The Scher Report On Non-Human Primate Research — Biased And Deeply Flawed, Jarrod Bailey, Katy Taylor

Experimentation Collection

The European Commission’s Scientific Committee on Health and Environmental Risks (SCHER) recently issued an Opinion on the need for non-human primate (NHP) use in biomedical research, and the possibilities of replacing NHP use with alternatives, as part of the Directive 86/609/EEC revision process. Here, we summarise our recent complaint to the European Ombudsman about SCHER’s Opinion and the entire consultation process. It is our opinion that the Working Group almost entirely failed to address its remit, and that the Group was unbalanced and contained insufficient expertise. The Opinion presumed the validity of NHP research with inadequate supporting evidence, and ignored …

Addressing Distress And Pain In Animal Research: The Veterinary, Research, Societal, Regulatory And Ethical Contexts For Moving Forward, Kathleen Conlee, Martin Stephens, Andrew N. Rowan

Experimentation Collection

While most people recognize that biomedical scientists are searching for knowledge that will improve the health of humans and animals, the image of someone deliberately causing harm to an animal in order to produce data that may lead to some future benefit has always prompted an uncomfortable reaction outside the laboratory. However, proponents of animal research have usually justified the practice by reference to greater benefits (new knowledge and medical treatments) over lesser costs (in animal suffering and death). Given that one of the costs of animal research is the suffering experienced by the animals, the goal of eliminating distress …

The Validity Of Animal Experiments In Medical Research, Gill Langley

Experimentation Collection

Other animals, such as mice, rats, rabbits, dogs and monkeys, are widely used as surrogates for humans in fundamental medical research. This involves creating disorders in animals by chemical, surgical or genetic means, with the aim of mimicking selected aspects of human illnesses.

It is a truism that any model or surrogate is not identical to the target being modelled. So, in medical research, experiments using animals or cell cultures or even healthy volunteers instead of patients (being the target population with the target illness) will inevitably have limitations, although these will be greater or lesser depending on the model.

The Beginning Of The End For Chimpanzee Experiments?, Andrew Knight

Experimentation Collection

The advanced sensory, psychological and social abilities of chimpanzees confer upon them a profound ability to suffer when born into unnatural captive environments, or captured from the wild – as many older research chimpanzees once were – and when subsequently subjected to confinement, social disruption, and involuntary participation in potentially harmful biomedical research. Justifications for such research depend primarily on the important contributions advocates claim it has made toward medical advancements. However, a recent large-scale systematic review indicates that invasive chimpanzee experiments rarely provide benefits in excess of their profound animal welfare, bioethical and financial costs. The approval of large …

Systematic Reviews Of Animal Experiments Demonstrate Poor Contributions To Human Healthcare, Andrew Knight

Experimentation Collection

Widespread reliance on animal models during preclinical research and toxicity testing assumes their reasonable predictivity for human outcomes. However, of 20 published systematic reviews examining human clinical utility located during a comprehensive literature search, animal models demonstrated significant potential to contribute toward clinical interventions in only two cases, one of which was contentious. Included were experiments expected by ethics committees to lead to medical advances, highly-cited experiments published in major journals, and chimpanzee experiments—the species most generally predictive of human outcomes. Seven additional reviews failed to demonstrate utility in reliably predicting human toxicological outcomes such as carcinogenicity and teratogenicity. Results …

Systematic Reviews Of Animal Experiments Demonstrate Poor Human Clinical And Toxicological Utility, Andrew Knight

Experimentation Collection

The assumption that animal models are reasonably predictive of human outcomes provides the basis for their widespread use in toxicity testing and in biomedical research aimed at developing cures for human diseases. To investigate the validity of this assumption, the comprehensive Scopus biomedical bibliographic databases were searched for published systematic reviews of the human clinical or toxicological utility of animal experiments. In 20 reviews in which clinical utility was examined, the authors concluded that animal models were either significantly useful in contributing to the development of clinical interventions, or were substantially consistent with clinical outcomes, in only two cases, one …

Overcoming Ideology: Why It Is Necessary To Create A Culture In Which The Ethical Review Of Protocols Can Flourish, Bernard E. Rollin

Experimentation Collection

My objective in this commentary is to describe and discuss a major threat to the continued thriving of science in our society, which is all the more insidious because it is largely unrecognized by those in the scientific community who are in a position to rectify the problem. Astute people in that community are well aware of many threats to science that include but are not limited to the following: appalling public scientific illiteracy; the unfortunate resurgence of “magic thinking”—reflected in turn in the reappearance of Creationism, which is hostile to evolution—and the billions of dollars spent on evidentially baseless …

The Poor Contribution Of Chimpanzee Experiments To Biomedical Progress, Andrew Knight

Experimentation Collection

Biomedical research on captive chimpanzees incurs substantial nonhuman animal welfare, ethical, and financial costs that advocates claim result in substantial advancements in biomedical knowledge. However, demonstrating minimal contribution toward the advancement of biomedical knowledge generally, subsequent papers did not cite 49.5% (47/95), of 95 experiments randomly selected from a population of 749 published worldwide between 1995 and 2004. Only 14.7% (14/95) were cited by 27 papers that abstracts indicated described well-developed methods for combating human diseases. However, detailed examination of these medical papers revealed that in vitro studies, human clinical and epidemiological studies, molecular assays and methods, and genomic studies …

Animal Model Research: The Apples And Oranges Quandary, Kenneth J. Shapiro

Experimentation Collection

In this paper, I explore the premises underlying the problem of the evaluation of animal models. I argue that the presence of similarities and differences between the model and the modelled, although historically and currently a dominant antinomy framing evaluation, is not a bottom-line consideration. What is critical is 1) whether we learn and 2) whether we improve treatment through the animal model research. Similarity between model and modelled and the closely related concept of validity are not coterminus with these critical evaluative measures. In fact, differences between the model and modelled also can provide impetus to new understanding and …

Behavioral Evaluation Of The Psychological Welfare And Environmental Requirements Of Agricultural Research Animals: Theory, Measurement, Ethics, And Practical Implications, Lesley A. King

Experimentation Collection

The welfare of agricultural research animals relies not only on measures of good health but also on the presence of positive emotional states and the absence of aversive or unpleasant subjective states such as fear, frustration, or association with pain. Although subjective states are not inherently observable, their interaction with motivational states can be measured through assessment of motivated behavior, which indicates the priority animals place on obtaining or avoiding specific environmental stimuli and thus allows conclusions regarding the impact of housing, husbandry, and experimental procedures on animal welfare. Preference tests and consumer demand models demonstrate that animal choices are …

Evaluation Of Animal Model Research, Kenneth J. Shapiro

Experimentation Collection

It is argued that a concept of evaluation of animal models that is broader and more useful than validation is available. Productive generativity refers to the degree to which a model furthers understanding and leads to more-effective treatment interventions. Results of the application of this novel evaluative frame to several animal models of eating disorders show that this animal-based research has not been productive. The question of the relation between clinic and animal laboratory is discussed.

Unrelieved Pain And Distress In Animals: An Analysis Of Usda Data On Experimental Procedures, Martin Stephens, Philip Mendoza, Adrianna Weaver, Tamara Hamilton

Experimentation Collection

Pain and distress are core issues in the field of animal experimentation and in the controversy that surrounds it. We sought to add to the empirical base of the literature on pain and distress by examining government data on experimental procedures that caused unrelieved pain and distress (UPAD) in animals. Of the species regulated by the U.S. Department of Agriculture (USDA), most of the approximately 100,000 animals subjected to UP AD during the year analyzed (1992) were guinea pigs and hamsters. Most of these animals were used in industry laboratories for various testing procedures, primarily vaccine potency testing. We discuss …

The Significance Of Alternative Techniques In Biomedical Research: An Analysis Of Nobel Prize Awards, Martin Stephens

Experimentation Collection

No abstract provided.

The Cruel Deception, Robert Sharpe

Experimentation Collection

With new legislation to replace the Cruelty to Animals Act 1876 near at hand, the powerful vested interest groups whose profits and livelihood depend on laboratory animals are stepping up their campaigns to ensure the survival of vivisection. Have the benefits really been so great, and can vivisection achieve major advances in our present state of health?

History shows (McKeown 1979) that the real reasons for the dramatic increase in life expectancy since the middle of the last century are improvements in nutrition, living and working conditions, hygiene and sanitation, with medical measures only having a relatively marginal effect. The …

The Potential Role Of Local Ethical Committees In The Moderation Of Experiments On Animals In Britain, D. P. Britt

Experimentation Collection

Scientists working with laboratory animals in Britain are made aware forcibly that a serious ethical dilemma surrounds the use of animals in experiments. Certain vociferous sections of the community press the issue on the attention of the general public and media sources tend to propagate views expressed by the most extreme parties, while neglecting coverage of mature, rational opinion. It is, perhaps no bad thing for the scientific community to be frequently reminded to take a responsible attitude to the use of animals but recent overt, even illegal, activity on the part of extremist animal protectionist groups has encouraged a …

Protection Of Animals And Animal Experimentation: A Survey Of Scientific Experts, Norbert Lagoni, Joachim Fiebelkorn, Hans-Joachim Wormuth

Experimentation Collection

This article summarizes information from a survey of biomedical scientists, specifically pharmacologists and toxicologists, on the use of laboratory animals and the potential for replacing their use with alternative methods for the development and evaluation of pharmaceutical substances. The majority of those surveyed felt that the alternatives could supplement or complement animal tests, but not replace the tests altogether. However, most favored the use of nonsentient material in safety tests.

Scientific Issues And Regulation Of Primate Use, Andrew N. Rowan

Experimentation Collection

Some of the patterns of use of nonhuman primates in the USA and Europe are outlined and a few specific examples of inappropriate and/or unnecessary use are described. The primate research resources program in the USA is examined and some suggestions as to how the program could be made more responsive to humane and conservation concerns are presented.

Regulation Of Biomedical Research, Andrew N. Rowan

Experimentation Collection

The idea of abolishing or simplifying government regulations has a large following in Washington at the moment. As Reagan and his minions start to prune the growth of the past twenty years, we must hope that they are able to distinguish between the healthy growth which provides needed support and the unnecessary growth which strangles necessary initiatives. However, there is one area where we need more regulation rather than less, namely, biomedical research. In calling for more regulation in biomedical research, I do not mean the imposition of outside controls by allegedly ignorant and insensitive bureaucrats (although I think some …