• unnecessary duplication of experiments

• nonstandard housing and husbandry requirements

• impact of the proposed procedures on the animals’ well-being

• appropriate sedation, analgesia, and anesthesia (indices of pain or invasiveness might aid in the preparation and review of protocols; see Appendix A, Anesthesia, Pain, and Surgery)

• conduct of surgical procedures, including multiple operative procedures

• postprocedural care and observation (e.g., inclusion of post-treatment or postsurgical animal assessment forms)

• description and rationale for anticipated or selected endpoints

• criteria and process for timely intervention, removal of animals from a study, or euthanasia if painful or stressful outcomes are anticipated

• method of euthanasia or disposition of animals, including planning for care of long-lived species after study completion

• adequacy of training and experience of personnel in the procedures used, and roles and responsibilities of the personnel involved

• use of hazardous materials and provision of a safe working environment.

While the responsibility for scientific merit review normally lies outside the IACUC, the committee members should evaluate scientific elements of the protocol as they relate to the welfare and use of the animals. For example, hypothesis testing, sample size, group numbers, and adequacy of controls can relate directly to the prevention of unnecessary animal use or duplication of experiments. For some IACUC questions, input from outside experts may be advisable or necessary. In the absence of evidence of a formal scientific merit review, the IACUC may consider conducting or requesting such a review (Mann and Prentice 2004). IACUC members named in protocols or who have other conflicts must recuse themselves from decisions concerning these protocols.

At times, protocols include procedures that have not been previously encountered or that have the potential to cause pain or distress that cannot be reliably predicted or controlled. Relevant objective information about the procedures and the purpose of the study should be sought from the literature, veterinarians, investigators, and others knowledgeable about the effects on animals. If little is known about a specific procedure, limited pilot studies, designed to assess both the procedure’s effects on the animals and the skills of the research team and conducted under IACUC oversight, are appropriate. General guidelines for protocol or method evaluation for some of these situations are provided below, but they may not apply in all instances.