San Francisco State University

IACUC Protocol Modification Form

Please complete and submit this form and any appropriate accompanying documents to Human and Animal Protections, via our Grad Stop box at ADM 250, via fax at 415-338-2493, or via email to . Please be advised that you may not institute any modifications until HAP has approved the changes. Approval time depends on the nature of the modification.

According to federal regulations, modifications are classified as “minor” or “major” (significant/substantive changes). If the requested modifications are minor, the Chair, in consultation with the Attending Veterinarian, may approve the change. If the changes are deemed significant, the Chair will notify the investigator that IRB approval is required. If the Chair or any IRB member deems it necessary, a complete new protocol must be filed.

Major modifications include: Change in purpose or specific aim;

change in principal investigator; change/addition of species: increase in

animal numbers; change in research or husbandry procedures

Minor modifications include: Addition/substitution of a qualified student, technician or faculty member; change in sex of animal to be used; small increase in animal numbers; need to repeat an experiment with small increase in animal numbers; addition of additional sampling times (provided increase in volume collected is small)

Principal Investigator Name:

Study Title:

Protocol #

1. Please describe the changes you want to make and why.

(If this Modification is being requested due to an adverse or unanticipated event, e.g.,

unanticipated increase in symptoms or deaths, please also submit the details of this event to the IACUC for their review.)

2. Please describe why, in your opinion, these changes will or will not introduce any new risks to the animals.

3. Please explain if these changes affect animals currently involved in the study.

4. What type of modification would you like to make?

□  Change Principal Investigator:

·  submit a new Protocol Approval Form (PAF) with the appropriate signatures;

·  submit an updated Qualifications section;

·  submit animal subjects course completion certificate for the new PI.

□  Add Research Assistant (RA)/Student:

·  submit a brief statement that includes the new RA’s qualifications and any pertinent training he or she has received to aid in your research;

·  submit animal subjects course completion certificate for each new RA.

□  Change Research Procedures (including aims, species, procedures, numbers, husbandry):

·  submit changes on this form and, if required, submit a revised protocol.

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03/09