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Assessing Scientific Merit

While the primary focus of the IACUC is animal welfare and not scientific merit, ethical consideration and federal regulations dictate that the IACUC assess the overall scientific rationale and design of an Animal Care and Use Protocol to the extent necessary to justify the use of live vertebrate animals in the project. The IACUC is composed, in part, of research scientists who must apply their training in experimental design and critical thinking to the material supplied in the animal protocol by the lead researcher. The general scientific relevance should be evident and the experimental design should be sound and clearly presented. The presumption is that a study that does not meet these basic tenets would be inherently invalid or wasteful and, therefore, not justifiable for use of live animals.

Specific regulatory mandates to the IACUC are outlined below:

  1. The IACUC must evaluate "the relevance of a [live animal] procedure to human or animal health, the advancement of knowledge, or the good of society." The animals must be used in the "conduct of scientifically valuable research." (U.S. Government Principles for the Utilization and Care of Vertebrate Animals in Testing, Research and Training--PHS Policy)
  2. The IACUC must evaluate the "rationale for involving animals, and for the appropriateness of the species and numbers of animals to be used." (Animal Welfare Act & PHS Policy)
  3. The IACUC must evaluate whether the intended use of live animals is "consistent with sound research design." (PHS Policy)
  4. The IACUC must evaluate the justification for multiple survival surgery based on the "scientific reasons [given] by the principal investigator, in writing." (Animal Welfare Act)
  5. The IACUC must evaluate "a description of procedures designed to assure that discomfort and pain to animals will be limited to that which is unavoidable for the conduct of scientifically valuable research." (Animal Welfare Act)

If the IACUC does not feel it has sufficient scientific expertise to evaluate the rationale or design of the proposed study, the committee has the option of asking the lead researcher for more information and/or reference material or seek the advice of an ad hoc consultant with expertise in the field of study. [Note: Consultants cannot approve or withhold approval of an activity, and cannot vote unless they are also members of the IACUC.]