2.  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.  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. 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. 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. 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.  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.  Dresser: ◦ quality of research design, ◦ justification of animal numbers, ◦ methods of pain alleviation

9.  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. 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. 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 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 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 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 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?