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Appropriate use of animals in research: What we know about IACUC decision making?

Appropriate use of animals in research: What we know about IACUC decision making?. Charles W. Lidz Ph.D. Jerald Silverman D.V.M. What is an IACUC. IACUCs are animal research analogs of IRBs.

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Appropriate use of animals in research: What we know about IACUC decision making?

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  1. Appropriate use of animals in research:What we know about IACUC decision making? Charles W. Lidz Ph.D. Jerald Silverman D.V.M.

  2. What is an IACUC • IACUCs are animal research analogs of IRBs. • They are designed to assure that regulations about the appropriate use of animals in research are upheld. • IACUCs are mandated for institutions receiving PHS research dollars or those using species covered by the Animal Welfare Act.

  3. Why is the regulation of animal research important? • This is big business • An estimated 70-100 million animals are used every year in research. • The overwhelming majority of these are euthanized after their use. •  there are at least 250 animal rights groups in the U.S. All oppose the use of animals in biomedical research • the majority of animals used in research experiments experience more than mild pain or distress

  4. Why should we care about IACUCs? • IACUCs are on front line of the regulation of animal use in the US • IACUCs are responsible for ensuring that animals are used properly. • Between 1/3 and ½ of the NIH budget is spent on research that uses laboratory animals • Animal rights groups almost uniformly think that IACUCs are part of the problem.

  5. What are the Regulations? • Two agencies regulate animal use • NIH Office of Laboratory Animal Welfare (OLAW) • Department of Agriculture • OLAW specifies 3 principles that should guide IACUC decisions: • Minimize the number of animals used. • Consider the alternatives to using live animals • Minimize the pain and suffering of the animals used.

  6. Controversy about IACUCs • Shapiro has argued that IACUC regulation is very weak and ineffective • Ehinger: IACUCs “have been turned into what they were not intended to be, an organization predominantly occupied with technical and bureaucratic details.” • Steneck: “IACUCs should be limited to advisory, rather than decision making, roles …control… should be returned to animal care professionals.”

  7. What do we know about how IACUCs actually make decisions • Plous and Herzog in Science gave 50 academic IACUCs the same protocol: “IACUC protocol reviews did not exceed chance levels of inter-committee agreement.” • Two responses to this paper were strongly critical of the methods and one argued that failure to agree was a strength as it showed local judgment.

  8. On what do IACUCs focus • Dresser: • quality of research design, • justification of animal numbers, • methods of pain alleviation

  9. What is important to IACUC members? • Graham interviewed members: • The need for better scientific merit review • Better pain relief for higher mammals • Silverman (and also Hawkins) found that members appear to take much more seriously the needs, pain and lives of higher mammals than of fish and rodents.

  10. Canadian Data • Houde et al. in probably the best study, described the ethical concerns and aspects of decision making in 3 IACUCs at one university. • the majority of IACUC comments at committee meetings were technical: • euthanasia procedures • personnel qualifications • animal manipulations • There were also many scientific comments • end points • experimental design

  11. Canadian Data II • Institutional political comments were also fairly frequent • pressure on the committee • how the IACUC would be perceived by the researcher • Ethical comments were found to permeate both technical and scientific comments of IACUC members.

  12. What we don’t know – Roles • What is the role and influence of the Chair? • If an informal pre-review is used, does it influence the subsequent decision-making of the formal reviewers? • Do the different categories of committee members (i.e., veterinarian, non-scientist, scientist, and the unaffiliated member) differ in their approach to the implementation of research norms?

  13. What we don’t know – Cognitive Processes • What cognitive schemas do reviewers use to organize and simplify reviewing? • What information resources are used by IACUC members to identify protocol problems? • are the issues & concerns of researchers considered in the review process? • How do investigators and IACUC members use regulatory concepts?

  14. What we don’t know - Social Processes • What are the key issues that are focused on (e.g., pain, regulatory compliance, animal numbers, need for animals, species used, scientific quality)? • Does the focus of a review change when Full Committee or Designated Member review procedures are used? • How much variability is there by site?

  15. What we don’t know - Compliance • What do IACUCs do to assure that researchers implement the results of the reviews and regulations in general? • How often are the regulations and informal norms of animal use violated by researchers?

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