IACUC Protocol Submission & Review

1. Submit Required Documentation

A. Complete the required training.

All personnel (faculty, staff, and students) listed on an IACUC protocol must complete the required training courses or submit equivalent documentation to the IACUC Administrative Office. Visit the Training Page for detailed instructions.

• AALAS Training: If you are conducting studies involving laboratory animals, you must complete appropriate training. AALAS training can be accessed via the AALAS Learning Library.
• Laboratory Safety Training Requirements
• Occupational Health Program (OHP): All personnel with research-related animal contact or exposure must enroll in the OHP through the University of Texas Health Houston Services (UTHS): Rice University ACO OHP Enrollment Form

*Research Personnel Training Record
Research personnel participating in animal subject research must receive hands-on training specific to the procedures they will perform. Each team member should have an individual training record documenting the training received for their assigned animal-related role and responsibilities. Documentation of this training ensures that anyone handling live animals is adequately trained to do so. This training form does not need to be submitted to the IACUC; however, it must be maintained and readily available within the lab for IACUC inspections or regulatory review.

B. Submitting a Protocol

To conduct research or teaching involving live vertebrate animals, investigators must submit an animal protocol for review and approval by the Institutional Animal Care and Use Committee (IACUC). No animals may be ordered or used until written IACUC approval is received. All protocol submissions must be submitted through the Cayuse Animal Oversight module. Investigators are encouraged to consult with the Attending Veterinarian for guidance on protocol design and the IACUC Administration for assistance with submission procedures.

Protocol Submission Types

• Live Animals
  Submit your new or triennial (de novo) review protocol(s) through the Cayuse Animal Oversight.
• Non-Living, Unfixed Animal Tissues
  Use the IACUC Tissue Protocol Application for studies involving only non-living, unfixed animal tissues.
• Collaborative Animal Research with External Institutions
  Submit your study application through Cayuse Animal Oversight along with the IACUC Memorandum of Understanding (MOU) form. The MOU establishes the responsibilities for off-site animal care and use, animal ownership, and IACUC oversight, in accordance with the Guide for the Care and Use of Laboratory Animals (8th edition, p. 15)

2. Protocol Submission Review

The IACUC Office and Attending Veterinarian conduct a pre-review of submitted protocols. This preliminary review may include requests for revisions to clarify information or address important concerns before the protocol proceeds to full committee review. Required IACUC training completion is also verified during this stage.

Refer to the Meeting & Submission Deadlines calendar for IACUC submission deadlines. Animal protocols are subject to a full review at least every three years.

3. Committee Review

The IACUC reviews by one of two methods:

• Full Committee Review (FCR) for protocols involving: Death as an Endpoint, Food and Fluid Regulation or Restriction, Prolonged Restraint, Multiple Survival Surgery, Exemptions from Standards of Care, and Animal Welfare Act Regulations (AWAR) Covered species
• Designated-Member Review (DMR) for protocols not requiring FCR and reviewed by one or more designated IACUC members, as authorized by the committee.

For more information, please see RU Guidelines on IACUC Protocol Review and RU Guidelines on Changes and Modifications to approved IACUC Protocols.

4. Committee's Communication of Outcomes

After a thorough review at a convened meeting, the Investigator will receive a determination letter via the electronic protocol system, informing the investigator whether the protocol has been approved, modifications are required, or receive withhold approval.

• Approval

Animal research activities can commence. Only the research activities and animal manipulations described in the approved protocol should be conducted; if any proposed changes are planned, an amendment/modification must be submitted for IACUC review and approval. The investigator needs to add a reminder of the triennial review submission dates on his/her calendar to avoid delay in approval.

• Modifications Required to Secure Approval

Further modifications/clarifications are required before final approval is granted. The revisions will require review by assigned IACUC reviewers. A final approval letter will be sent once the modifications have been reviewed and clarified.

• Withhold Approval

Significant information is missing or considerations as detailed in the Guide, PHS Policy requirements, and U.S. Government Principles have not been met. The PI will receive reasons for withheld approval, and revisions will go back to a fully convened meeting for review and approval.