ABSTRACT
During the course of any given research project it is incumbent upon all parties involved (the investigative team, the veterinary team, and the IACUC) to continually review the project’s progress as data are collected and analyzed. At any point during the experimental process there may be a need to amend or revise a protocol to reect changes in the intended research plan. Any significant change from the work outlined in the approved protocol should not only be communicated to the IACUC, in the form of an amendment, but must also be reviewed by the IACUC prior to implementation. In addition, any relevant, secondary parties (e.g., veterinarians, diagnostic services/quality assurance, occupational health and safety) should review such changes prior to implementation. According to the Guide (p. 33), “Continuing IACUC oversight of animal activities is required by federal laws, regulations, and policies”… and … “a variety of mechanisms can be used to facilitate ongoing protocol assessment.” The AWAR (§2.31,c,7; §2.31,d,1) require that investigators receive IACUC approval for all significant changes to approved animal research protocols. The AWAR (§2.31,d,1,i-xi) further delineate the criteria that should be used to evaluate all proposed changes. In accordance with AWAR (§2.31, d, 8), only the IACUC can approve protocols and protocol changes, although proposed activities and proposed changes that have already been approved by the IACUC may be subject to appropriate review by of- cials of the institution.
