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Office of
Research and Sponsored Programs


California State University Los Angeles

Institutional Animal Care and Use Committee

policies and procedures

information for researchers

Approved April 1, 2003

Guidelines Regarding Significant Changes

to Animal Study Proposals

The Animal Welfare Regulations and the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy), which implements the Health Research Extension Act of 1985, require that Animal Care and Use Committees review and approve significant changes regarding the use of animals in on- going activities described in an IACUC approved protocol. The NIH interprets significant changes to mean those that have the potential to impact substantially and directly on the health and well-being of the experimental animals, and thus need review and approval by the IACUC.

When these significant changes are planned, researchers must use Form A to request protocol approval.

To aid the researchers in fulfilling their responsibilities regarding changes in approved protocols, the IACUC at Cal State LA offers the following examples of changes that should be considered significant:

 1.    A change in the overall aims or objectives of the study;

 2.    A change which may involve an increase in the levels of pain, distress, and/or discomfort;

 3.    A change from non-surgery to surgery, from minor to major surgery, from non-survival to survival surgery, or from single to multiple survival surgery;

 4.    A change in the genus or species of animals used (provide a rationale for use of the new species);

 5.    A change in the personnel who will be performing procedures involving animals;

 6.    The addition of the use of hazardous agents in animal procedures; or

 7.    A change in the final disposition of the animals being used in the study.

This list of examples is not meant to be comprehensive. Whether or not other modifications are significant is determined by several factors. It should be understood that changes covering details beyond what is required in the original protocol are not to be considered significant, and do not need IACUC review and approval.