Approved June 28, 2000.

This policy is to assist principal investigators who want to amend an already approved IACUC protocol.

For the purposes of this policy, Amendments include, but are not limited to:

• Change of personnel
• Change of funding source
• Change in strain or source of animals

Amendments to protocols may be submitted via memo from the principal investigator and may be approved administratively by the IACP staff.

• If the personnel to be changed includes the principal investigator, the memo must include
• the 3 paragraphs that appear on page 7 of the protocol form (the signature page), as well as
• a statement that the PI has read the referenced protocol including any and all modifications, amendments, and progress reports, and that the PI agrees to conduct the project as described therein.
• All personnel must complete the training requirements before approval of such changes can be granted.
• For changes in funding source, animal strain, or source of animals, a simple explanation of the reasons for the change should suffice.

For the purposes of this policy, modifications are proposed significant changes which include, but are not limited to:

• Change in procedure/manipulations
• Addition of procedures/ manipulations
• Change in drugs/compounds administered
• Addition of drugs/compounds administered (except for those protocols in which the PI is required to submit this information as it is received from the sponsoring agency; i.e. drug trials)
• Change in method of euthanasia
• Change in duration, frequency, or number of procedures performed on an animal
• Change of species
• Increase in number of animals to be used

For modifications, the PI should submit the applicable page(s) of the IACUC protocol available at with signed cover memo outlining the proposed change(s). modifications to protocols will receive expedited review as described in the IACUCs protocol review policy, with the following exception: a 50% increase in the number of animals to be used will automatically send the protocol to review by the full committee. To request an increase in the number of animals, complete the applicable form available from either LAR (567-6166) or the IACP Office (567-3718).

At the discretion of the IACUC reviewers, principal investigators may be required to submit a complete, revised protocol form rather than an amendment memo or modified form before approval can be considered.

In compliance with federal regulations, neither amendments nor modifications can be applied to work in progress until the IACUC has reviewed and approved the changes. For further information, please contact the Institutional Animal Care Program staff at 567-3718.

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