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

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

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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.

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What we dont 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 dont 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?

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What we dont 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?

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What we dont 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?