An Ethical Framework for Thinking about Canine Research and Animal - - PowerPoint PPT Presentation
An Ethical Framework for Thinking about Canine Research and Animal Research More Generally DAVID DEGRAZIA, PH.D. SENIOR RESEARCH FELLOW, DEPARTMENT OF BIOETHICS, NIH ELTON PROFESSOR OF PHILOSOPHY, GWU Disclaimer & Disclosure I speak
DAVID DEGRAZIA, PH.D. SENIOR RESEARCH FELLOW, DEPARTMENT OF BIOETHICS, NIH ELTON PROFESSOR OF PHILOSOPHY, GWU
I speak today for myself, not for NIH or any other part of the U.S. federal government I have no conflicts of interest
Background for the ethical framework Principles of Social Benefit Principles of Animal Welfare A word about the 3 Rs A decision tree for evaluating canine studies Final thoughts
PART 1
Beauchamp & DeGrazia, Principles of Animal Research Ethics (Oxford UP, in production) About my coauthor: coauthor of Principles of Biomedical Ethics Commentaries by
Growing public concerns about animals Advances in scientific study of animal cognition & consciousness Growth of animal ethics as a discipline Increasing concerns among scientists about translation Advances in science of alternatives
Present a framework of general principles for (laboratory) animal research Should be
Differences about animals’ moral status & value of animal research
Claims that open-minded members of both communities can accept:
status must appeal to substantial social benefits
considerations of animal welfare
Sentience = capacity to have (un)pleasant experiences Which animals? Working assumption: vertebrates & cephalopods Includes dogs Works well with current US and EU policy
Any justification of animal research must appeal to:
Core values: social benefit & animal welfare Already accepted Yet support principles of a new framework
Social Benefit
No Alternative Method Expected Net Benefit Sufficient Value to Justify Harm
Animal Welfare
No Unnecessary Harm Basic Needs Upper Limits to Harm
PART 2
The knowledge sought must not be realistically obtainable from alternatives Idea: Beings w/moral status shouldn’t be harmed if benefits are obtainable w/out harming them If principle is met, animal study offers prospect of unique benefit
Where alternatives are adequate, animal studies don’t offer unique benefits The scientific issues are highly complex But alternatives are making progress
the best animal tests of chemicals—and much faster & cheaper (“Ending the use of animals in toxicity testing and risk evaluation,” CQHE 24 [2015]: 448-58) Some scientists are impressed by potential of microdosing
(R. D. Combes et al., “Early microdose drug studies in human volunteers can minimise animal testing,” European Journal
Growing interest in naturally occurring diseases in animals, including dogs, as a model (J. Rowell, “Dog models of naturally occurring cancer,” Trends in
Molecular Medicine [17] [2011]: 380-88; G. Ranieri et al., “A Model of Study for Human Cancer: Spontaneous occurring tumors in dogs,” Critical Reviews in Oncology/Hematology 88 [2013]: 187-197)
FDA Commissioner S. Gottlieb about the possibility of eliminating use of dogs in animal drug development: “In our study, no dogs would be euthanized. …[R]esearchers will draw a small amount of blood … at specified intervals…. [W]e expect to be able to use these data to develop informatics tools that can model the absorption of drugs in the future, rather than requiring the drugs to be tested on live dogs” (FDA Statement, November 16, 2018; available at
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626060.htm)
Isn’t No Alternative Method equivalent to “Replacement”? Different force
in vitro biological systems should be considered” (U.S. Government Principles)
Some animal studies offer unique benefits All animal research has costs This principle focuses on costs & benefits to humans Requires that prospect of benefit exceed anticipated costs
Expected benefit = (1) amount of benefit (if achieved) x (2) likelihood of achieving it So hoped-for benefit must be multiplied by x < 1 While logically obvious, the probability factor is often
Attrition rate from successful animal studies may be 80 or 90% (I.
Kola & J. Landis, “Can the pharmaceutical industry reduce attrition rates?” Nature Reviews 3 [2004]: 711-715; H. B. van der Worp et al., “Can animal models of disease reliably inform human studies?” PLOS Medicine 7 [3] [2010]; S. Perrin, “Make mouse studies work,” Nature 507 [2014]: 423-425); J. Garner, “The significance of meaning: Why do over 90% of behavioral neuroscience results fail to translate to humans, and what can we do to fix it?” ILAR Journal 55 [2014]: 438-456)
A systematic review: Among highly cited animal studies, about 1/3 translated (D. G. Hackman and D. A. Redelmeier, “Translation of research evidence from animals to humans,”
JAMA 296 [2006]: 1731-1732)
Don’t have data for canine studies in particular
Relevant costs in Expected Net Benefit are costs to humans Include financial costs, opportunity costs & risks associated w/imperfect models The less adequate an animal model (for testing), the greater the risk of
Expected Net Benefit is required for justification even from a human-centered standpoint As a necessary condition, seems self-evident Yet it sets a rigorous standard
Suppose 1st two principles are met: an animal study (1)
projected costs (to humans) Doesn’t follow that it’s ethical Q: Is the prospect of benefit important enough to justify anticipated harms to canine (or other animal) subjects? Note: We cannot expect full agreement on the answer
Together, principles of social benefit require prospect of unique, net benefit sufficient to justify anticipated harms to animals Both champions of animal research & animal protectionists can accept this demand Will sometimes disagree on which studies satisfy it
PART 3
Grounded in nonmaleficence States that animal subjects must never be harmed (1) through negligence or (2) intentionally unless such harm is unavoidable given scientific objectives that satisfy principles
Relevant harms not limited to procedures Include conditions of housing, handling, transport, accidental spread of disease, etc.
Requires meeting animals’ basic needs unless incompatible with scientific objectives Basic needs = what’s ordinarily required for a decent life
Why do research animals deserve such benefits? Principle justified via special relationship between human personnel & animal subjects Idea: In relationships where some are made totally dependent on others’ continued care, failure to meet basic needs = harm
Nutritious food & clean water Appropriate shelter Adequate stimulation, exercise, opportunities for canine- typical functioning Sufficient rest for health Veterinary care
Access to compatible dogs or social group members Freedom from significant experiential harm Freedom from disease, injury, disability Freedom of movement w/adequate space
Avoidance of premature death? Left open …
Principles so far permit harm when necessary for justified scientific objectives Set no limit on permissible harm None exists in U.S. policy Permitted
regional stress kinase activation by cardiac resynchronization,” Circulation 117 [2008]: 1369-77)
(J. Zwischenberger et al., “The paracorporeal artificial lung improves 5-Day outcomes from lethal smoke/burn- induced acute respiratory distress syndrome in sheep,” Annals of Thoracic Surgery 74 [2002]: 1011-18)
European Directive 2010/63/EU: “… the performance of procedures that result in severe pain, suffering or distress [that] is likely to be long-lasting and cannot be ameliorated should be prohibited” (art. 23) Shouldn’t apply only to procedures Ex.: Should prohibit desolate housing conditions that would cause severe long-term suffering
Standard: Lab animals should not be made to endure severe suffering for any significant length of time We find standard plausible given axiom that sentient animals have moral status We also leave open possibility of extremely rare exceptions
PART 4
The 3 R’s framework presented in Russell & Burch’s Principles of Humane Experimental Technique (1959) enjoys nearly unquestioned status in mainstream biomedicine The framework calls for
Was a great advance in promoting animal welfare but not adequate today Unlike our approach, the 3 R’s do not:
important type of harm
means to pursuing them are justified—in light of social importance, costs or risks to humans & anticipated harms to animals
PART 5
Does the proposed use of dogs offer a unique social benefit? NO Don’t use YES Does the proposed use of dogs offer the prospect of net benefit to humanity? NO Don’t use YES Is the prospect of unique net benefit important enough to justify harming the dogs in the ways anticipated? NO Don’t use. YES Does the proposed research avoid unnecessary harm? NO Don’t use. YES Will the dogs’ basic needs be met except where incompatible with scientific objectives? NO Don’t use. YES Will the dogs avoid severe, persisting suffering?
YES
PART 6
Recent decades have seen growing concern about animal protection The American public today expresses ambivalence about animal research (Ike Swetlitz, “Americans’ opposition to animal testing at record high,” STAT (May 12,
2017; https://www.statnews.com/2017/05/12/americans-oppose-animal-testing/); NAVS, “Gallup poll: More Americans support animal testing” (June 6, 2018; https://www.navs.org/gallup-poll-americans-support-medical-testing-animals/;
tank/2018/08/16])
Yet protections of animal subjects—at least in the U.S.— have not evolved much since the 1980s Leaves an opening An adequate framework must reflect honesty about animal research science & competence in animal ethics
Our framework may be acceptable to
idea that animals have moral status
studies, or categories of animal research, on their merits
We hope it shows how socially beneficial involvement of animals in research is compatible with their having decent lives