If at any point you have questions regarding the IACUC review process, please feel free to contact the Office of Research Services Research Protections staff at firstname.lastname@example.org .
Animal use protocols must receive final approval from the IACUC before a researcher may acquire, house, or use animals for research, research training, teaching, experimentation, biological testing, exhibition, and related activities.
Complete The Necessary Training
All scientists, animal technicians, and other personnel involved in animal care, treatment, and use for research, research training, teaching, experimentation, biological testing, exhibition, and related activities (including observational studies) must complete appropriate training and/or instruction in the use and care of animals. To learn more about the training requirements, click here.
Please Note: If your project involves housing animals in the Research Support Facility (RSF), you must completed RSF orientation as well.
Submission & Review Process
1. Prior to Completing and Submitting the IACUC Protocol Application Form
- Determine if there is space in the Research Support Facility (RSF) for your work, if applicable. Space assignments are determined by the RSF Director.
- If your activity involves long-term use and housing of animals, you must discuss your plans with the institutional veterinarian, so that all factors related to shipping and receipt, quarantine and acclimation, and long-term care and use of the animals are considered prior to the receipt of the animals.
- Determine when you plan to begin your work. All new protocols receive Full Committee Review, so you must plan to submit your materials allowing for sufficient time to complete the review process. See Meetings page for more information regarding the IACUC meeting schedule.
2. Completing the IACUC Protocol Application
- Complete the “Protocol Form” (Form 100). This application form gathers the necessary information for the IACUC to understand your activity plans. The form can found on the Forms and Templates page.
- Please be sure to be detailed and specific in the protocol application. Lack of sufficient information for the IACUC to understand your activity plans will result in the IACUC requesting clarification, additional information, or that changes or modifications be made.
3. Standard Operating Procedures (SOPs)
The development and submission of SOPs are required for the following:
- Species Specific SOPs: If your project involves housing and maintaining animals on campus then Species Specific SOPs that address daily care and feeding procedures must be submitted.
- Surgery SOPs: If your project involves surgery then a Surgery SOP outlining the procedures and after surgery care and monitoring for pain and distress is required.
4. Submit Your IACUC Materials
|Protocol application completed
|Signed protocol application by either scanned PDF, electronic signature, or hard copy
|Grant Proposal: If the research is federally funded, submit a copy of the full grant proposal submitted to the funding agency. For research funded from other sources, copies of the proposals may be submitted to provide additional details not provided in the IACUC submission form.
|Training : All training except CITI and those already on file with the Office of Research Services must be submitted. Note - Documentation of species specific training for individual research personnel may be submitted after the IACUC approval is received. However, the training must be provided to the IACUC, before an individual conducts any unsupervised activities with the animals.
|Standard Operating Procedures (SOPs): Species Specific, Surgery
|Occupational Health and Safety Training: Must be completed by all personnel listed on the application. Documentation of training must be provided to the Office of Research Services staff by Office of Risk Management and Environmental Health and Safety.
Submit materials to email@example.com. No need to interoffice mail your protocol submission unless you are mailing a signed hard copy of the protocol application. If you are mailing a signed protocol application, please mail the signed document to Diana Alfaro, Office of Research Services. If you have specific questions on your protocol application, please contact Research Protections Staff, see IACUC Contact page.
New protocols are reviewed by the full committee review. Please see Meetings page for more information.
5. IACUC Review
The protocol will be reviewed at a convened IACUC meeting. After the committee meets to review your application, you will receive a written notification regarding the review decision within 5 business days from that meeting.
The IACUC will either grant:
- Approval: You may begin your work. The IACUC looks forward to hearing from you during annual review. If you need to make changes see the tab section titled, After Approval.
- Request Modifications: If the IACUC asks for revisions or additional information, prepare revised/additional materials and submit them to the IACUC, along with a cover memo itemizing the changes/additions. Once you have appropriately addressed all the IACUCs concerns and the IACUC reviews the revised materials, the IACUC will issue an approval memo in writing. You may not begin your activity until you receive this written notice of approval.
- Defer/Tabled: The IACUC may defer/table a protocol without review if substantial materials or information is missing such that a review cannot occur. If tabled, the IACUC will explain in detail why the IACUC tabled your protocol and indicate what needs to be addressed in order to receive further IACUC review.
- Disapproval: Disapproval means that the IACUC cannot approve the protocol as currently outlined. If disapproved, the IACUC will explain in writing why the IACUC disapproved your project and what changes would need to be made in order for you to obtain approval from the IACUC.
*Conducting animal activities without IACUC approval is considered a noncompliance.
Once the IACUC has approved a project, the project must be conducted as approved. The investigator and the IACUC have additional responsibilities after approval of the protocol.
Changes in location, staff, or any other substantive change to the protocol must be approved by the IACUC before implementing the change. In order to submit a protocol change for review and approval you should complete and submit the Revision Form 200. Substantial changes to the protocol plan must be incorporated into the original research protocol, so that there is one document reflecting the current and complete protocol. If the change is limited to changes in personnel, you should complete and submit the Change in Personnel Form. Either form can be found on the Forms and Templates page. Forms and supporting materials should be submitted via email to the IACUC at firstname.lastname@example.org.
The IACUC may ask for revisions to the amendment materials. You may not initiate the protocol changes until you receive written notification of approval for the revisions from the IACUC.
Approved protocols MUST be reviewed annually, and if the protocol will continue past the three-year anniversary it must be resubmitted in full as a new protocol. In order to renew the protocol, you must complete and submit the renewal form to the IACUC electronically via email, email@example.com. You must be sure to submit the application with sufficient time for review to ensure that the protocol is reviewed before the end of the annual review period. The IACUC cannot extend the protocol approval past the expiration date indicated in the approval letter.
Once the project is completed you must notify the IACUC and officially close the protocol. The renewal form should be used to provide this report and the investigator should be sure to include:
- The number of animals used during the last annual approval period (i.e., since the last annual renewal form was submitted) and the TOTAL number of animals used for the study
- A summary of the results to date
- A listing of any publications resulting from the work
- The disposition of animals used for the protocol. Animals cannot be housed under an expired or approved protocol; therefore, animals must be transferred to another approved protocol or humanely euthanized before you close a protocol.
The IACUC meets with individual investigators to discuss their concerns and questions about the Guide, but also to talk to investigators to better understand their research protocols and any animal care issues for a particular protocol. These meetings are intended to be educational for the IACUC members, as well as for the investigators. In addition, the IACUC conducts post-approval monitoring activities including the review of protocols at the time of renewal, during routine veterinarian care and treatment visits to the facility.