Research with Animals Phil 133 – Ethics in Science San José State University
In discussing animal-based research, need to distinguish: Scientific issues. Ethical issues. Legal/regulatory issues.
Ethical issues: Do we have ethical obligations to non-human animals?  (Always? In special circumstances?) Do non-human animals have  rights ?  (Where do rights come from? What follows from having rights?) What kind of use or treatment of non-human animals is ethically permissible? Ethically required?
Animal rights: If animals cannot consent to X, humans cannot do X without violating animals’ rights. Rule of thumb: if you couldn’t ethically do X to a human infant, you cannot ethically do X to a human animal.
Animal welfare: Pain, distress, suffering, boredom or non-human animals ought to be minimized. While we have duties to animals’ welfare, animals fall short of having rights.
Recognizing the range of positions available, or represented.
The challenge: societal views about animals vary widely. Some people committed to animal rights. Some people committed to animal welfare. Some people committed to neither animal rights nor animal welfare.
Scientific research with animals: Aimed at learning more about non-human animals themselves (plus broader issues like comparative anatomy and physiology, evolution, development, genetics, etc.). Use of animal models to answer questions about human (and animal) health.
Scientific questions: What can experiments with organism X tell us about the functioning or response of organism Y in analogous conditions? (How much similarity vs. difference?) What counts as an appropriate model organism for a particular research question?
Alternatives to research with animals: Tissue culture studies (but culture media are animal-derived) Computer simulations (but accurate simulation depends on accurate information about the system you’re simulating)
Federal regulations: Laboratory Animal Welfare Act (1966) U.S. Dept. of Agriculture rules AWA Amendments of 1970 and 1985. Nine U.S. Government Principles for the Utilization and Care of Vertebrate Animals in Testing, Research, and Training.
Also regulations from funding agencies: National Institutes of Health Policy of 1971 Health Research Extension Act Public Health Service Policy
At colleges and universities: Oversight through Institutional Animal Care and Use Committee (IACUC). IACUC reviews and monitors animal use protocols. Assures compliance of institutions animal care program and facilities. Investigates animal welfare concerns.
IACUC membership: Veterinarian with training/experience in laboratory animal science and medicine Practicing scientist experienced in research involving animals Someone unaffiliated with the institution Non-scientist (representing interests of the public)
What must be described in protocols? Project justification: Scientific aims of study. Relevance and value of the research. (Why does it matter to answer this question?) How this work is novel (and doesn’t unnecessarily duplicate previous research).
What must be described in protocols? Rationale for using animals: Proper identification of species to be used (and number of animals). Appropriate species (in terms of anatomy, physiology, etc.) for the research question? Are all the proposed study methods necessary to obtain valuable results?
Reduction, replacement, refinement (the 3 R’s): Smallest number of animals to get reliable and statistically significant results? Does proposed protocol address whether nonliving tissue or inanimate models can be used to achieve the scientific goal? Procedures designed to impose least amount of potential pain, discomfort, stress, morbidity, or mortality on the animal?
Must explicitly consider  availability of alternatives. “For procedures involving more than momentary or slight pain and distress, the principal investigator must provide a written narrative describing the methods and sources used to determine that alternatives to painful or distressful procedures were not available.” USDA Policy 12
Assessing pain and distress: “Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals.” U.S. Government Principles – Part IV
Pain and Distress Categories C-1: None anticipated C-2: Momentary or no pain and discomfort C-3: Management of mild to moderate pain (protocol should details plans to relieve suffering, supplement care)
Pain and Distress Categories C-4: Alleviation of substantial pain or discomfort with analgesics and supportive care. (Research requires physical documentation of actual steps taken to alleviate.) C-5: Research where management or alleviation of pain or discomfort is contraindicated. (Requires clear scientific justification.)
Animal research as a privilege,  not a right. Principal investigator must get approval from IACUC to conduct research. IACUC does not automatically approve new submissions or annual reviews of previously approved protocols. Dialogue between PI and IACUC members to ensure good science while minimizing the ethical cost.
Current climate for researchers in larger society: Recent history of violent attacks (especially in California). Public isn’t always clear on what scientific questions are being pursued, what kind of research is required to answer them. Public opinion not uniform (animal lovers, patients in need of cures, those who are both) Basic vs. applied research.

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"Research with Animals" lecture

  • 1. Research with Animals Phil 133 – Ethics in Science San José State University
  • 2. In discussing animal-based research, need to distinguish: Scientific issues. Ethical issues. Legal/regulatory issues.
  • 3. Ethical issues: Do we have ethical obligations to non-human animals? (Always? In special circumstances?) Do non-human animals have rights ? (Where do rights come from? What follows from having rights?) What kind of use or treatment of non-human animals is ethically permissible? Ethically required?
  • 4. Animal rights: If animals cannot consent to X, humans cannot do X without violating animals’ rights. Rule of thumb: if you couldn’t ethically do X to a human infant, you cannot ethically do X to a human animal.
  • 5. Animal welfare: Pain, distress, suffering, boredom or non-human animals ought to be minimized. While we have duties to animals’ welfare, animals fall short of having rights.
  • 6. Recognizing the range of positions available, or represented.
  • 7. The challenge: societal views about animals vary widely. Some people committed to animal rights. Some people committed to animal welfare. Some people committed to neither animal rights nor animal welfare.
  • 8. Scientific research with animals: Aimed at learning more about non-human animals themselves (plus broader issues like comparative anatomy and physiology, evolution, development, genetics, etc.). Use of animal models to answer questions about human (and animal) health.
  • 9. Scientific questions: What can experiments with organism X tell us about the functioning or response of organism Y in analogous conditions? (How much similarity vs. difference?) What counts as an appropriate model organism for a particular research question?
  • 10. Alternatives to research with animals: Tissue culture studies (but culture media are animal-derived) Computer simulations (but accurate simulation depends on accurate information about the system you’re simulating)
  • 11. Federal regulations: Laboratory Animal Welfare Act (1966) U.S. Dept. of Agriculture rules AWA Amendments of 1970 and 1985. Nine U.S. Government Principles for the Utilization and Care of Vertebrate Animals in Testing, Research, and Training.
  • 12. Also regulations from funding agencies: National Institutes of Health Policy of 1971 Health Research Extension Act Public Health Service Policy
  • 13. At colleges and universities: Oversight through Institutional Animal Care and Use Committee (IACUC). IACUC reviews and monitors animal use protocols. Assures compliance of institutions animal care program and facilities. Investigates animal welfare concerns.
  • 14. IACUC membership: Veterinarian with training/experience in laboratory animal science and medicine Practicing scientist experienced in research involving animals Someone unaffiliated with the institution Non-scientist (representing interests of the public)
  • 15. What must be described in protocols? Project justification: Scientific aims of study. Relevance and value of the research. (Why does it matter to answer this question?) How this work is novel (and doesn’t unnecessarily duplicate previous research).
  • 16. What must be described in protocols? Rationale for using animals: Proper identification of species to be used (and number of animals). Appropriate species (in terms of anatomy, physiology, etc.) for the research question? Are all the proposed study methods necessary to obtain valuable results?
  • 17. Reduction, replacement, refinement (the 3 R’s): Smallest number of animals to get reliable and statistically significant results? Does proposed protocol address whether nonliving tissue or inanimate models can be used to achieve the scientific goal? Procedures designed to impose least amount of potential pain, discomfort, stress, morbidity, or mortality on the animal?
  • 18. Must explicitly consider availability of alternatives. “For procedures involving more than momentary or slight pain and distress, the principal investigator must provide a written narrative describing the methods and sources used to determine that alternatives to painful or distressful procedures were not available.” USDA Policy 12
  • 19. Assessing pain and distress: “Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals.” U.S. Government Principles – Part IV
  • 20. Pain and Distress Categories C-1: None anticipated C-2: Momentary or no pain and discomfort C-3: Management of mild to moderate pain (protocol should details plans to relieve suffering, supplement care)
  • 21. Pain and Distress Categories C-4: Alleviation of substantial pain or discomfort with analgesics and supportive care. (Research requires physical documentation of actual steps taken to alleviate.) C-5: Research where management or alleviation of pain or discomfort is contraindicated. (Requires clear scientific justification.)
  • 22. Animal research as a privilege, not a right. Principal investigator must get approval from IACUC to conduct research. IACUC does not automatically approve new submissions or annual reviews of previously approved protocols. Dialogue between PI and IACUC members to ensure good science while minimizing the ethical cost.
  • 23. Current climate for researchers in larger society: Recent history of violent attacks (especially in California). Public isn’t always clear on what scientific questions are being pursued, what kind of research is required to answer them. Public opinion not uniform (animal lovers, patients in need of cures, those who are both) Basic vs. applied research.

Editor's Notes

  • #7: Graph on the DrugMonkey blog in April, making a point about the three options offered by an LA Times poll on animal research that appeared with their coverage of the April UCLA Pro-Test rally. (http://scienceblogs.com/drugmonkey/2009/04/polling_attitudes_on_animals_i.php)