Training and feasibility protocols make good sense for just the reasons this Committee has cited. It would be silly to create a new protocol or amendment every time someone was going to be trained on subcutaneous injections. Moreover, such a protocol allows investigators a degree of scientific spontaneity; this is valuable, but it must also comply with regulations. The training and feasibility protocol at Great Eastern is basically sound. The safeguards are relatively well thought out and include: veterinarian in attendance, anesthesia and analgesia required, terminal procedures required (unless recovery was essential for evaluation), IACUC Chair involvement with option for full Committee review, pilot studies generating publishable data not allowed, and a monthly report from the AV to the Committee.
There are, however, areas of vulnerability in this protocol that could lead to problems with regulatory compliance. The AWARs and PHS Policy require protocols to include the following: (1) identification of the species and the approximate number of animals to be used; (2) a rationale for involving animals, and for the appropriateness of the species and numbers of animals to be used; (3) a complete description of the proposed use of the animals; (4) 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, including provision for the use of analgesic, anesthetic, and tranquilizing drugs where indicated and appropriate to minimize discomfort and pain to animals; (5) a description of any euthanasia method to be used.
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